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Articles from 2001 In February


Current Design Trends in Medical Electronics

 
Electromedical manufacturers and component suppliers are taking steps to improve both performance and cost-effectiveness of increasingly miniaturized, high-precision, portable devices.
Fernando Lynch

One of the staple concepts of futuristic and science-fiction literature and films is the notion that the boundary between humans and machines is dissolving. These scenarios depict us advancing toward an age in which people are partly or mostly robots—or controlled by computers. Though it is unlikely that this will occur during our lifetimes, it is entirely possible that many of us may find ourselves with one or more sensitive electronic devices implanted into our bodies. In fact, products derived from nanotechnology and microelectromechanical systems (MEMS)—with machines fabricated at the millimeter or molecular level—have already become a reality.

For example, the idea of an electronic device stimulating the heart to beat was considered lunacy in 1930, when the first external pacemakers required ac power and penetration of the chest cavity with a probe. By 1958, battery-powered pacemakers were being implanted. Implantable pacers are now considered a mature product (approximately 150,000 annually are installed), with implantable cardioverter defibrillators (ICD) not far behind.

To date, more than one million people on the planet have been implanted with some kind of electronic device. Implantable electronics are now competing with or complementing pharmaceutical and other treatments for such ailments as brachycardia, tachycardia, Lou Gehrig's disease, Huntington's disease, Parkinson's disease, intractable and chronic pain, muscle spasticity, irregular breathing, urge incontinence, diabetes, and deafness. Implantable electronic products include drug pumps, monitors and delivery systems, cochlear implants, and neurostimulators. Experimentation is already under way on electronic retinal implants that could lead to at least a partial cure of blindness.

Although today the average age of a pacemaker recipient is 70, demographic statistics indicate that an enormous number of now-middle-aged baby boomers will be prime candidates for implantable products in the not-too-distant future. The pressure on manufacturers is to produce devices that are smaller and lighter, with lower total system costs. In addition to these ongoing developments in implantable devices, the trend toward portability and delivery of care at the bedside is accelerating the development of a range of next-generation monitoring, display, and testing equipment designed to be more compact, accurate, and versatile. Products that can meet these objectives while providing lower power consumption, superior functionality, or ease of manufacture will fill a profitable niche in this burgeoning industry. This article outlines several areas of electromedical product design in which the limits of conventional semiconductor technology are being extended through the use of existing circuits in new ways or through the combination of several cell or block functions into a single electronic system (see Table I).

Application
COMPONENT DESCRIPTION
Implantable Pacers, Defibrillators, and Neurostimulators
Input protection
TVS (transient voltage suppressor) die, 5–20 V, variety of sizes and metal contacts.
TVS, 3–12 die array, monolithic or "chip-on-strap."
TSPD (thyristor surge-protection device), 3–12 monolithic die array, provides smaller footprint than conventional TVS.
ASICs
ASIC, analog or mixed signal ultra-low power.
Diode/bridge
Schottky die, 20–100 V, variety of sizes and metal contacts.
Schottky die, single and dual, 40–70 V, variety of sizes and metal contacts.
Input protection,
blanking/tip switch
MOSFET die, 0.110 sq in., 1 KV, 13.5 ohm.
MOSFET, 1 KV, 13.5 ohm.
MCM, 6-array MOSFET (MSAFA1N100D).
High-voltage
switching bridge
IGBT die, 0.160 sq in., 1200 V, 55-A surge.
MCM, half-bridge, capacitive-coupled, IC-driven IGBT.
Thyristor-based (SCR and Triac) up to 1200 V.
Schottky die, single and dual, 40–70 V, variety of sizes and metal contacts.
Charging circuit
Rectifier, monolithic-microwave surface-mount (MMSM) package, flip-chipable, up to 70 V, 20 mA.
Rectifier die, up to 1200 V, 55-A surge, standard and ultrafast recovery.
Schottky, 500 V, 1 A, on silicon-carbide substrate.
Rectifier, up to 600 V, ultrafast recovery.
Voltage regulation
Zener die, 1.8–300 V, variety of sizes and metal contacts.
ASICs
ASIC, analog or mixed signal, ultra-low power.
Diagnostic Imaging and MRI
MR surface coils
PIN diode, axial and stud mount for receipt and transmit.
MR transmitters
PIN diode, 1–3 KV, 13 W, stud mount for high-power transmit.
MR receivers
PIN diode, 1 KV, 10 W, axial and stud mount.
Hearing Aids
Class D amplifier
Ultra-low-power, low quiescent current, true 1-V operation, thin die.
Portable Diagnostic Meters (Glucose, Oximetry, Pulse Analyzers)
Analog power management
Analog IC interfaces with the microprocessor for analog functions such as measuring current, temperature, or time. Very low quiescent/standby current (~1–2 µA) and operating current (a few hundred µA).
ESD protection
Polymer-based bidirectional transient-voltage suppressor. Reacts almost instantly to the transient voltage and effectively clamps it below 60 V, resulting in less voltage stress during the clamp period and greater IC protection.
Silicon-based bidirectional transient-voltage suppressor. Low clamping voltages at 1.7 and 3.3-V levels.
Step-up dc-dc converter
High-efficiency (>90%) boost converter IC. Low (typically 16 µA) quiescent/standby current, low (<1 µA) shutdown current, and adjustment via analog reference or direct PWM input.
Power regulation
Low-cost Schottky rectifiers. Applications include battery charge/discharge regulation and general-purpose/low VF rectification.
LED output detection
Visible enhanced photo detector diode. Low-cost die with 1-sq-mm active area or clear SMD package for low dark current and low noise.
CCFL backlight inverter
Direct-drive, high-efficiency IC or complete module with 100:1 wide-range dimming for extended battery life.

Table I. A sampling of electromedical design application areas and selected available components.

SYSTEM SOLUTIONS FOR IMPLANTABLES
 

Devices such as implantable pacers or defibrillators are really miniature computers that employ sensitive, low-voltage, low-power, application-specific integrated circuits (ASICs) to monitor, regulate, and control the delivery of electrical impulses to the heart. Implantable cardioverter defibrillators (ICDs) have been in common use for a number of years. When it detects a potentially life-threatening cardiac fibrillation, the ICD applies a high-voltage pulse between two electrodes connected to the heart. The pulse can be as high as 800 V, with the resulting current (during a few milliseconds) reaching several tens of amperes.

The high voltage is generated and stored on a large capacitor through the use of a charge pump. Normally, the shock is delivered to the heart via a two-phase pulse. Figure 1 shows a principal block diagram of a two-phase defibrillator system that features a typical high-voltage bridge required to generate the biphasic pulse. The application consists of two identical half bridges, each having two switches—one to ground and the other to the high voltage. Insulated-gate bipolar transistors (IGBTs) are very often used as the switch element, since they offer minimum on-resistance relative to silicon area. The high-side IGBT requires a gate voltage that is approximately 10 to 15 volts higher than the voltage to be switched. Normally, a transformer is used for level shifting between the high-voltage controller and the switch. Figure 2 shows a principal block diagram of the components required for one half bridge.

Continuous Monitoring of EtO Concentrations during Sterilization

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2001

STERILIZATION

Patrick G. Smith

Widely used for sterilizing medical equipment, as well as cosmetics, pharmaceuticals, and food products, ethylene oxide (EtO) has proved to be economical, available, and efficacious for eliminating bacterial and viral microbes. Pumped into a closed container, EtO can effectively eliminate microorganisms within an acceptable time frame.

Despite its effectiveness as a sterilant, however, EtO has a number of significant drawbacks. It is highly toxic—even a sniff can be fatal. EtO can also be dangerously explosive in concentrations as low as 3% by volume, or 30,000 ppm—a spark in the presence of just a trace of the gas can pose a serious hazard. And because EtO carries its own oxygen supply, it is also flammable at 100% concentrations. Put simply, it can explode even in anaerobic atmospheres.

 

The effectiveness of EtO sterilization systems is largely dependent on several factors, including gas concentration, diffusion rate, temperature, and humidity. Each of these process elements can either directly or indirectly influence the system's level of microbial lethality. Each factor must also be balanced against any limitations that may become apparent with the use of specific packaging or products that are to be sterilized with the system.

 

Gas Concentration. Generally, as EtO levels increase, the sterilization process becomes more effective and requires less dwell time. Concentrations in the chamber are limited by Ideal Gas Law parameters owing to potential condensation.

Diffusion. Another way to reduce dwell time is to increase the diffusion rate of EtO from the chamber to product in the load. This can be accomplished by creating a vacuum in the chamber before it is charged with EtO. As the EtO is injected into the chamber, pressure difference effectively "pulls" the EtO into the product. Another benefit of reduced pressure is increasing the concentration at which condensation occurs. This allows higher EtO concentrations during the cycle.

Because creating and maintaining a high vacuum can be difficult, time-consuming, and expensive, some chambers have been designed to operate with a partial vacuum or at normal air pressures. Using any vacuum, however, can result in certain product-related problems. Some products, for example, may be sensitive to any negative air pressure in the chamber.

Temperature. Because EtO liquefies at 51°F at STP (standard temperature and pressure), the temperature levels inside the sterilization chamber must be high enough to ensure that the EtO is a gas. Thus, product tolerance for high temperatures is another militating factor because chamber temperatures can range from 100° to 150°F, depending on the product to be sterilized. This will also affect sterilization times and efficiencies.

Humidity. The presence of humidity is believed to increase EtO penetration. Thus, maintaining a wet atmosphere in the sterilization chamber can increase the effectiveness of EtO sterilization. A relative humidity (RH) of 35–90% has been demonstrated to be beneficial for effective EtO sterilization. Water vapor, usually steam, is injected before EtO to shorten the time required to complete the sterilization process. The presence of increased humidity, however, can cause the formation of condensation on the product, the chamber walls, and optical EtO sensors.


Continuous EtO monitoring offers benefits to medical device sterilizers

The vital nature of accurate EtO monitoring is underscored by the many hazards associated with its handling. In a single four-year period, EtO was found to be involved in 10 explosions that occurred at sterilization facilities and EtO repackaging plants. All of the explosions caused building damage. In one instance a worker was killed and 59 injured as a result of the explosion. New sensing technologies are being developed to ensure the safe use of EtO.
Manufactured by Sensor Electronics Corp. (SEC; Minneapolis), the SEC EtO Signature infrared EtO monitor incorporates a sophisticated design for EtO measurement applications. According to SEC, the device seems fain to overcome the problems associated with conventional EtO monitoring systems. In extensive real-time real-world tests, the sensor has yielded excellent results, despite wildly varying applications, EtO levels, product parameters and chamber configurations, the company indicates.
The sensor is designed to be mounted non-intrusively through a .75-in. port in the wall of a chamber and/or circulation pipe to accurately measure the concentration of ethylene oxide during a sterilization cycle. The 18-oz sensor's innovative design has been shown to eliminate the effects of humidity and pressure. The device uses a directly opposed optical system, and requires no mirrors or reflecting surfaces. The optical chamber's surfaces are anodized aluminum, and are heated to counter the formation of condensation.
The SEC EtO Signature has been designed to measure the infrared light absorption of the EtO molecule. The IR light is measured at wavelengths absorbed by EtO, and compared to IR wavelengths not absorbed by EtO. The concentration of EtO is determined by calculating wavelength ratios and using embedded linearization/compensation algorithms to develop an accurate output signal, the company explains.
The sensor monitors actual EtO levels inside the chamber, giving a second-by-second assessment of the sterilization process. Because the EtO sensor is not affected by the presence of condensation, readings better than 95% accuracy can be achieved throughout the entire cycle, including charging, sterilization, and evacuation.
Compared with conventional systems, the sensor's proprietary infrared sensing technology has been found to offer a number of benefits.“Traditional methods of monitoring EtO include scale weight of the EtO gas tanks used in the process and pressure displacement,” says Art Harris, general manager of Chicago Sterilization Services Inc. (CSS; Chicago), which uses the new sensor technology in its sterilization process.
Harris adds, “With this sensor, we have identified visual data that allows us to monitor the rate at which EtO is accepted into the product. A second advantage of having this sensor allows real-time monitoring of the EtO concentration through the entire cycle, allowing us to verify that our cycles provide for a sufficient number of dilute washes after EtO exposure to avoid an EtO rich environment prior to back vent operation.” Harris is a member of the Association for the Advancement of Medical Instrumentation (AAMI), a committee member of AAMI's industrial EtO sterilization working group, and a principal contributor to NIOSH Alerts on EtO safety.
According to Adam Graham, CSS assistant general manager, “From a quality viewpoint, the reliability and consistency of the sensor and its data has made us more confident about validating our customer's products for parametric release (releasing sterilized product solely on the process parameters rather than biological indicators).”
Graham explains that the availability of a sensor capable of continuously monitoring EtO levels offers certain benefits to device sterilizers. “This sensor has allowed us to effectively monitor our EtO input into each sterilization cycle and we can determine the actual percentage of gas concentration used in each run. An advantage to utilizing this sensor is having concrete evidence of gas usage to incorporate in sterilization process improvement activities.”
According to Harris, “I am especially pleased with the consistency of the data and the performance of the sensor. As we ran each test cycle, the output of the sensor data has assured us that it will provide us with accurate repeatability.” He adds that, “It is foreseeable that the savings gained from the sensor as we pursue parametric releasing will pay for itself in no time.”

All these variables—as well as such other factors as product shape and absorption—have made monitoring and controlling the sterilization process imprecise at best. As a result, it has become common for EtO users to add extra time, extra heat, and extra EtO to the process cycle to ensure that satisfactory results are achieved.

 
 
 

Because there has been no precise method of measuring the actual proportion of EtO in the chamber, control of the sterilization process often has been more a function of experience than of instrumentation. Although systems capable of generating fairly accurate EtO measurements have been developed, a number of shortcomings have been associated with the use of these EtO sensors. Currently available EtO-sensing systems include:

 

Near Infrared (IR) Optical Devices. Although EtO absorbs very well in the near IR, so does water, which in vapor form or condensed, typically causes inaccuracies and sometimes erratic signal variations in these systems.

Electrochemical/Solid-State Sensing Cells. Such systems are effective and accurate in an ambient sensing environment; however, they exhibit water response, pressure response, and high drift and short life owing to the in-chamber environment.

Sample-Draw IR Devices. These systems provide accurate results because they measure samples in a controlled external environment. In addition to being costly and complex, they pull toxic and explosive EtO-drenched atmospheres out of the chamber. Leaks into the room are potentially disastrous.

 

The challenge has been to develop a system that can measure an elusive and ever-changing EtO ratio yet is impervious to the deleterious effects of steam, condensation, varying vacuum or pressure levels, and highly corrosive atmospheres. Ideally, the sensor would be capable of quantifying actual EtO levels throughout the entire sterilization cycle. the device should also be able to monitor and verify gas concentrations, show absorption profiles for the specific product being sterilized, and ensure that all toxic gases have been evacuated before the chamber doors are opened.

 

The proportion of EtO at work in a sterilization chamber varies with time and the specific material to be sterilized. Theoretical chamber concentrations are calculated using gas weights, the assumption of an empty chamber, and the application of the Ideal Gas Law. The concentration of EtO that actually reaches the product in the load is generally a function of the load's absorptive properties and the packaging used. If the material does not absorb EtO—as in the case of metallic medical instruments—the initial inrush of EtO causes an immediate peak and the concentration remains high for the duration of the process.

Figure 1. In-chamber EtO concentration as a function of product absorption qualities.

Figure 1 demonstrates the changes that occur in EtO concentration levels as a function of product absorption. If the material is absorbent—as in the case of cloth garments or bandages—the EtOpercentage peaks, then drops back as the gas is absorbed. The level finally equilibrates at a concentration that is usually close to the theoretical concentration. Conversely, as the gas is flushed from the chamber, the rate of EtO desorption from the product material is also a function of load composition.

Figure 2. Actual EtO concentration versus time for same-cycle and different loads.

Reading actual EtO concentrations throughout the entire sterilization cycle can be critical. By continuously and accurately measuring the EtO levels throughout the cycle, a sensor can monitor actual absorption profiles, and thus ensure sterilization effectiveness.

It is important to note that the EtO rate is not usually constant. Variations may occur because of the specific product material, temperature, humidity, nitrogen level in the atmosphere, and product silhouette. Variations may also be associated with the specific product covering. Products covered with plastic, for example, would display different sterilization profiles than products covered in foil or some other material.

Figure 3. Actual EtO concentration versus time for same-cycle and empty chamber. Chamber size: 1014 cu ft; chamber temperature: 120°F; chamber pressure: 9.29 psia; calibration concentration: 520 mg/L. No adjustments, recalibrations, or modifications were made to the SEC EtO monitor during the entire time period.

To address the needs specific to the use of continuous EtO monitoring, a sensor has been developed by Sensor Electronics Corp. (SEC; Minneapolis). The multiwavelength IR light–based sensor is designed to continuously measure the hydrogen-carbon bond IR light absorption of EtO molecules during the sterilization process.

 

Like certain conventional sensors, the new design uses IR absorption technology to precisely define and measure EtO levels throughout the sterilization operating cycle. The sensor, however, has been designed to remain unaffected by saturated RH levels and resulting condensation on the sensor viewing lens. Figures 2 and 3 illustrate in-chamber EtO concentration as measured by the sensor. Figure 2 shows the results of monitoring for loads composed of different materials; Figure 3 indicates the device's sensing accuracy by comparing three empty chamber runs in order to verify the calibration point.

 

The detector uses IR levels to quantify the actual EtO concentration in the sterilizer chamber. The proprietary method uses principles founded in molecular physics. IR radiation at specific wavelengths excites certain molecular resonances. In the process, some IR energy (considered as light) is absorbed, with the amount of absorption being a function of the concentration, as illustrated in the equation:

 

Human Factors Roundtable Part II: Standards Development and Implementation Issues

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2001

A little more than one year ago, Americans were shocked to learn that medical errors in U.S. hospitals were responsible for more deaths annually than were highway accidents, breast cancer, or AIDS. The significant number of ongoing references in the popular press to the Institute of Medicine's now one-year-old report on medical errors is a clear indication of the impact of the study on the consciousness of the general public. The fact that the study's findings attributed a considerable percentage of errors to product-design problems has also caught the attention of the device industry.

More and more, companies are realizing the importance of creating and following a coherent human factors program with the same diligence they might devote to instituting a Web strategy or preparing for ISO certification. Although it can be difficult to identify clear trends in the design world, there is definite movement toward an earlier and more-intensive consideration of human factors issues in the product development process. As reflected in the discussion that follows, the imminent release of the AAMI human factors standard makes it even more urgent for firms to have a viable human factors program currently underway—if a company's not up to speed now, they're already late.

This feature represents the second part of MD&DI's special human factors roundtable. Part I, entitled "The Regulatory Imperative," appeared in the January 2001 issue.

MD&DI: In the area of standards development, could someone give us a short history lesson on the AAMI human factors committee standards development efforts, and tell us when we might expect to see these standards published by AAMI?

Weinger

Weinger: For more than 20 years, there has been a very close relationship between standards-making activities—both national and international—and regulatory activities by FDA. The AAMI human factors guidelines were first approved in 1988, but there was a period of approximately five years of activity prior to that approval. The guidelines were revised over the five-year period after 1988 by a committee that included several members of the present panel. The main changes reflected in the current version—which is designated HE48 1993 and is an AAMI/ANSI standard—are the inclusion of human-computer interaction guidance with regard to designing microprocessor-controlled devices, and the inclusion of a brief description of the human factors engineering process. Beginning in 1996, the committee began deliberating on how to revise the 1993 document, which was still insufficiently specific to medical industry needs and had some gaps because of evolving technology.

However, a larger concern of the post-1996 committee was that the general guidance about how one should design a display, for example, was perhaps less important than a broader approach that would define an optimal human factors design process—especially since this process could vary from device to device. So the committee began work on a separate document that was intended to be a national standard for the human factors design process. That document is currently out for final balloting, and is expected to be approved by July 1, 2001. Over the last year and a half, the committee has concurrently begun a parallel effort to revise and expand the classical "how-to" human factors design guidelines that are in HE48. Our current plan is to do this as a Web site, and in fact we very much need manufacturer support and encouragement to be able to deliver on this opportunity to provide good user interface design guidance.

I should have mentioned earlier that the AAMI human factors committee includes, in almost equal numbers, representatives from industry, clinicians, and others with interest or expertise in human factors and medical device design, including FDA representatives and human factors consultants.

Wiklund: Could you clarify one of the comments you made, which was that the last version of the standard was still considered less than ideal in terms of how well it is suited to medical devices? Perhaps you could retrace the history of why, even after a second revision, it still might not speak to medical devices as effectively as we'd like it to.

Weinger: I think the big problem, frankly, is that especially back in 1993—and even now—we just didn't have a lot of medical device–specific design guidance available. Even though individual device companies have a lot of knowledge and experience (although how much of it was documented is hard to say), this information was not public. The material that was available to the committee prior to the 1993 document consisted primarily of published standards from other domains, especially the military. And so the committee lifted heavily from military design guidance standards, and, together with some material from the NRC and other published design documents, tried to modify them as best they could for the medical industry. However, it was recognized at the time—and certainly since—that some of those modifications were more successful than others. In particular, the human-computer interface sections were not modified sufficiently to address the needs of medical device manufacturers with respect to building actual devices, particularly for critical-care applications.

 

MD&DI: Why did the committee initially focus on design process issues rather than principles of good design? What are the core elements of AAMI's recommended process?

 
Wiklund

Wiklund: What I can perhaps do is personalize the question. As a consultant, I'm asked from time to time to take a look at a medical device and render a judgment regarding its usability and safety by virtue of the quality of its user interface. Now, that's a really hard job to do. Occasionally there might be some low-lying fruit that you can pick—that is, obvious cosmetic shortcomings in the design, the nature of the labeling, the size of characters in a display, things that you can readily identify by inspection and application of known principles of good design. However, it's generally very difficult to make more overarching judgments about the usability of a device just by looking at it. Moreover, as a designer, you may come up with a design that you think would pass any litmus test in terms of good design practices, but, until you validate it in the context of a usability test, you can't be sure that you have developed a good design.

The AAMI work and FDA's guidance do stress good design processes, because we would all probably agree that such an emphasis represents our best hope for producing a high-quality user interface. As a practical objective, it's difficult to create perfection right off the bat by virtue of outstanding design talent being brought to a task. A more workable objective is to create an iterative process of researching users' needs and preferences, turning those into design goals, developing a design concept that reflects those goals as well as good design practices, then going ahead and modeling a design and having people interact with it and seeing how things go—and then repeating the process. You might liken it to the way you wash your hair: you wet, lather, rinse, and repeat. One could say the same thing about cleansing a medical device design of any kind of human factors shortcoming. The objective is to get end-users involved in the process of expressing their needs and preferences up front, and then evaluating the product by having them put their hands and minds on it and seeing how things go when they try to perform tasks. That's probably the most reliable way of producing a design that will perform well.

Hasler: One of the reasons we really focus on design process issues is that—despite the fact that people often want to just pick up some sort of a generic "cookbook" document and look for the exact "recipe" they want—there's simply too much variation in the user interface of medical devices for an encyclopedic guidance to work. In other words, if we're focusing on a ventilator or an infusion device, we could come up with great guidelines, but when it's a matter of the whole industry, an approach emphasizing good processes is initially the best way to proceed.

MD&DI: What is the status of international efforts to promote human factors in medical device design?

Carstensen

Carstensen: The International Electrotechnical Commission (IEC) is in the process of updating its big document, IEC 60601-1, which covers general requirements for the safety of electromedical equipment. As part of that undertaking, about a year ago they initiated efforts to develop a new collateral standard that, once in place, will become part of IEC 60601-1. Its number is IEC 60601-6; there are five other collateral standards, covering areas such as EMC testing. The first committee draft (CD) is scheduled for distribution to national committees for hearing and comment in February 2001, although the target date for publishing the final document is not until the fall of 2004. That sounds like a long time, but the good news is that, historically, companies will get wind of what's going on and procure copies of the first and second CDs and respond to them. They'll react in anticipation of a standard coming down the track, and derive much of the good effects well before the publication date of 2004.

The international standard—basically an international human factors engineering guideline—is based on the AAMI documents. But the IEC document itself probably doesn't occupy more than about 10 pages, plus an informative annex that tells you how to go about doing the job. That informative annex will be the newly revised AAMI human factors design process standard. The intent is to achieve global harmonization at the outset, as opposed to what we usually do, which is to have an international version of a standard and various domestic standards, and then get together years later and sort of argue about the differences and try to settle on something that is reasonably harmonious. This time, we're making sure it's harmonious from the beginning.

In addition, ISO Technical Committee 210 on quality systems has expressed an interest in joining the IEC working group that's developing the international version of the AAMI standard, so as to put out a joint ISO/IEC version of the standard. What that would do is allow us to expand the scope beyond electromedical devices to include all medical equipment.

MD&DI: Rod, as a human factors specialist working at a large company, what is your view of the new regulations? What are the greatest challenges you face in responding to them? What about cost pressures? Finally, are there differences in the way the regulations affect how you develop products for domestic versus foreign markets?

 
 
Hasler

Hasler: Regarding human factors concerns in the medical device industry, companies can be divided into two camps. The camp I come from recognizes the importance of human factors at least as long ago as the early 1990s. At that time, we implemented a customer-focused process to define an IV infusion system, and quickly discovered that the feature most desired by the customer was ease of use. This drove us to see the importance of hu-man factors practices, and how good human factors could benefit us. So my introduction to human factors was really on the marketing side—how to make better-selling products that are easy for customers to use.

And I think that's probably where you're seeing the companies that jumped into the discipline of human factors early on—they were really utilizing it for the ease of use, and to drive a better product to the customer. Those who didn't recognize that are a little bit behind as far as converting.

I think that most of the larger companies followed this same route, and typically have long-standing human factors programs. Many smaller companies are still in something of a catch-up mode; they're trying to understand exactly what is required and how they can implement it. But I believe that this regulation has a very strong upside for the entire medical device industry—it will really improve the industry as a whole, as far as reducing design errors.

 

MD&DI: Do you notice any differences in the emphasis on human factors in products destined for the U.S. market versus the overseas market?

Hasler: What you see much less of in Europe is human factors used as part of a marketing strategy or approach. Regarding domestic and foreign markets, however, one of the problems in the device industry is that we tend to develop products that are oriented toward and designed for a specific customer in a specific country, but are then released to other countries with no changes. Whereas even though the actual clinical application may remain the same, there are often differences on a country-by-country basis in how the users react to the design and employ the device. So the biggest concern I have on a global front concerns releasing a product that was designed for one market into multiple markets.

MD&DI: How do the new rules affect the marketing of devices that were developed before the human factors regulations were adopted? What happens with products that represent slight modifications to older products that may not have incorporated good human factors design principles?

 
 

Wiklund: I'd be happy to answer this question from a consultant's point of view. I think this is going to be a great source of anxiety in the future for those companies that are not getting clear signals as to their vulnerability in terms of selling any product that hasn't benefited from a good human factors design process. Because many companies will be introducing products that represent slight variations of previous versions, one could argue that they should conduct a thorough human factors evaluation of the modified design—which might infer getting customer feedback in the context of usability tests, and so forth. Of course, a company that has marketed a product for a long time—a product that was originally approved by FDA—might ask itself whether it really needs to go through all of that effort after making only minor changes to the product.

Compounding this whole issue is the fact that, once regulations are in place and people become more aware of them, a company that doesn't follow good human factors processes could be accused of not applying due diligence in pursuing state-of-the-art practice. In other words, you raise the possibility of legal liability exposure if a firm fails to follow the new standard. My guess is that companies that carry out minor modifications to existing products will at least want to conduct a usability test to confirm that the new changes are in fact good changes. They'll want to make sure that they haven't inadvertently introduced other kinds of problems, or somehow corrupted the preexisting design in a way that could lead to user error. So at a minimum, I think that companies taking a conservative and careful approach will likely begin doing more usability testing than they would have before these regulations were in place.

Hasler: What I'm seeing in the industry reflects very much what Mike has just described. It can be quite confusing deciding how to handle a product that you've been producing for, say, 20 years once you recognize that a minor feature needs to be changed. According to all previous methods of evaluation, you would have gone ahead and made the change for any additional units sold. Now, however, once you start dealing, for example, with the user interface, you may realize that other aspects of the device may not meet the present standard and may need to be changed. Although a company certainly wants to support its customers, you're now faced with a full-blown project—a whole rework—of something that really isn't the product line you want to move into the future. In short, it is very difficult to understand how the regulations should be applied to older products.

 

Strategies for Evaluating and Validating Supplier Formulation and Process Changes

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2001

BIOMATERIALS

The highly competitive thermoplastic industry is constantly expanding its capacities and developing new products. Additionally, resin manufacturers periodically institute formulation changes due to the availability of raw materials or to enhance manufacturing value and efficiency. Because most disposable medical devices and solution containers are composed of thermoplastic materials, this environment of constant change provides challenges to the medical device manufacturer.

As mandated by regulatory requirements, the medical device manufacturer must evaluate whether a change impacts the product's safety and efficacy.1,2 FDA requires that medical manufacturers institute a process to identify and validate material or design changes.3 These evaluations require varying degrees of time and resources; while some changes occur quickly, others can take years to validate. In addition, an ongoing awareness of process changes enables the medical device manufacturer to have better understanding and control of the materials being used.

If change occurs without the medical device manufacturer's knowledge, the potential arises for mechanical failures, toxicological reactions, or FDA design control violations. In addition, the consequences of a medical device manufacturer failing to be ready to implement a change on time may be loss of production and additional material purchasing costs.

It is important that device manufacturers obtain a commitment from their suppliers regarding immediate notification of any process or material changes.4 Changes that must be approved by the manufacturer include changes in composition or source of raw materials; methods of production, processing, or testing; and manufacturing sites. ISO requirements have forced thermoplastic manufacturers to become more diligent about notifying their customers of changes.5 Nevertheless, each manufacturer should obtain a written supplier commitment to change notification (see Figure 1). Such an agreement solidifies the supplier's intention to work with the device manufacturer.

Figure 1. An example form for a supplier notice of change.

Once notified of an impending change, the challenge to the medical device manufacturer is to validate the change with minimal financial impact. For large, multiple-division medical device manufacturers, communication across divisions is critical to eliminate redundancies and delays in approval. Traditionally, gathering sufficient resources and using them effectively has been an obstacle to resolving process change notifications (PCNs).

To address these challenges, medical device manufacturers should develop a team equipped to handle all aspects and implications of a change. The keys to success are to centralize the approval process, maintain a consistent core team, and apply structured design controls.

 

THE TEAM APPROACH

 

One technique for addressing PCNs from thermoplastic suppliers is for the medical device manufacturer to form a resin process change team (RPCT). This team meets to facilitate communication between the firm's purchasing, engineering, manufacturing, and quality personnel and with suppliers. Additionally, the team tracks project milestones during the approval process and keeps all divisions informed of the project schedule. The engineering function provides centralized testing to be used throughout the company. The flowchart in Figure 2 illustrates the entire procedure.

The RPCT should be organized into three teams: core, divisional (or product group), and plant. A communication network including all three teams is critical to success.

The Core Team. The core team is the central conduit for communicating change notices and validation progress to the company. It is made up of representatives from purchasing and product engineering for each division, and from corporate quality, toxicology, and materials R&D, as well as the RPCT coordinator. Quarterly meetings provide the platform to ensure that each process change is being properly addressed, including the development of action plans and the assigning of responsibilities. Written summaries are then distributed to the divisional and plant team representatives.

The Divisional Team. The divisional team reviews proposed resin changes to determine if performance or safety of the finished product is influenced. Each division establishes its own criteria based on the end-use application. Participants should include the core team members and representatives from product engineering, quality, marketing, regulatory, and purchasing.

The Plant Team. The plant team consists of one representative from each manufacturing location. An individual from inventory control is usually best suited to fulfill this role. The plant team verifies whether or not the plant uses the material in its processes and coordinates the validation activities until the change is resolved.

Once the teams are established, PCNs can be handled more efficiently. Anyone in the company who receives a PCN immediately forwards the information to the RPCT coordinator. If the change could result in a supply interruption, an emergency meeting of the RPCT is called to develop and implement an action plan. For PCNs that would not interrupt supply, the action plan is developed at the next quarterly RPCT meeting. Planned process or material enhancements should be structured to provide sufficient lead time for the RPCT to handle the project on a routine basis. For ongoing PCN projects, the quarterly meeting is used to provide status reports, which are distributed to all three team levels

 

CENTRALIZED ENGINEERING LEADERSHIP

Another, centralized approach to handling PCNs utilizes a focal manager—a corporate engineering manager or technical approver to lead the communication and evaluation process. A key difference between the team and centralized systems is that in the centralized model, the focal manager not only communicates process changes, but this individual is also assigned to review the PCN, coordinate with other divisions, determine required actions, and take ownership as the project leader. The focal manager should be a dedicated resource.

The Support Team. For the centralized approach, the support team is staffed with similar individuals as the core team, but with a less formal approach. Unlike the core team, the support team is not responsible for ensuring the implementation of projects, but provides resources for the technical leader.

Divisional Participation. The divisions function essentially the same under both systems. This system does not have a divisional team assembled, however; instead, participants are selected on a project-by-project basis.

The Plant Team. The role of the plant team is the same for both the team and centralized systems.

In the centralized system, the focal manager determines the significance of the PCN and identifies the divisions affected. The focal manager then works with those divisions to complete the validation.

ACTION PLAN

Once notified of a possible change, manufacturers should immediately develop an action plan. The action plan will determine the following:

 
 

If alternatives to the change are possible and practical.

• Whether to accept the proposed PCN or change to a different material.

The time frame for the resin supplier to implement the change.

• The time needed for the change to be both approved and implemented.

The division and individual who will lead the project.

• All of the components and products affected by the change.

The design control activities that will be required.

 

One alternative method of resolving a PCN is to negotiate with the supplier. Some nonmedical material suppliers are not always fully aware of the impact a change can have on intricate medical devices. A simple explanation of the potential impact may provide the material supplier with ample reason to suspend the PCN or to continue to make the current formulation as a special product. If sufficient time is not available to validate the change, one final production run should be initiated using the original formula.6

The RPCT may decide to change to a different material or supplier rather than approve a process change. The decision to change suppliers is usually made in an effort to move to more "medical-friendly" suppliers or to consolidate material suppliers.

When a PCN requires engineering evaluation, it provides an opportunity to determine if the resin change project could have synergy with another program (e.g., conversion to gamma- grade material, supplier consolidation, or grade consolidation). Combining a PCN resolution with a cost-savings project can actually result in a financial advantage rather than a cost impact.

If the supplier's implementation date will occur before the change can be validated, a medical device manufacturer has options beyond shortening its company's time to approval. Often, the supplier's implementation date can be negotiated. This approach is usually most successful for medical-grade plastics, and least successful for commodity-grade plastics. Another option to increase the timeline for implementation is to stockpile material either with the supplier or within the manufacturer's own company. The medical-friendly supply companies are generally open to work with customers to assist in managing the challenge of a PCN.

The lead division is typically determined after the RPCT coordinator has identified all parts affected by the PCN. The division using the material in the most applications becomes the lead division. Management in that division is responsible for selecting a project leader.

Since most PCN projects require quick turnaround, the project team must emphasize the design control system within the company to ensure quality decisions. The same design controls that apply to new product development must be applied to resin process change projects.

THE ENGINEERING PLAN

 

For both approaches, maintaining centralized engineering for PCN evaluation is more cost-effective than if each product group (or division) completes independent evaluations. This conclusion is not as apparent as it initially seems, however. Each different product group may be using a material in significantly different applications. Therefore, the challenge is to generate enough data to understand the practical impact of the process change without performing excessive testing of each application.

Centralized engineering gives a larger perspective on the project. By examining the corporate-wide applications that are affected by a PCN, a manufacturer may be able to identify opportunities to reduce the quantity of testing. Many lower-stress applications can be validated with data derived from higher-stress applications.

When FDA Doesn't Want Preemption

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2001

A fraud-based case has elicited a new FDA position on preemption.

Also:

  • Bleak Budget Outlook
  • Industry Protests Postmarket Rule

In 1996, when FDA weighed into the Medtronic v. Lohr Supreme Court case, the agency helped establish the right of product liability litigants to sue medical device companies for injuries caused by FDA-approved products. FDA's theory was that such private suits in state courts were complementary to its own budget-beleaguered efforts to keep device companies in compliance with GMP regulations, adding a potent element of psychological intimidation to FDA's armory. Medtronic (Minneapolis) unsuccessfully argued that FDA approval inoculated it from state-level actions, under the federal preemption law.

 

In December of last year, FDA was back in front of the Supreme Court arguing against the main thrust of its 1996 position. In this new preemption case, which was brought by the medical device consulting firm Buckman Company, Inc. (Pleasant Hill, CA) against the Plaintiffs' Legal Committee, the agency faced a different set of facts.

This time, FDA said that an "implied" preemption should protect Buckman—acting for the maker of AcroMed (Cleveland) pedicle screws—from the respondents' claims that the company had fraud- ulently obtained FDA 510(k) clearance by not disclosing the intended use of the device. The actual use of the device allegedly resulted in injury to the plaintiffs.

It was all well and good, FDA argued, for preemption to have been disallowed in the Medtronic case where a product defect and violation of FDA GMP regulations were alleged, but preemption should be allowed in the alleged fraud on FDA by Buckman.

FDA's reason for apparently contradicting itself in the two cases is that the agency thinks private litigation in fraud cases would impede its work because of litigant "discovery" demands. Such a case would likely cause FDA to lose its discretion in dealing with fraud. Private litigation in GMP cases would not bring such harassments.

At the core of the Buckman case is the respondents' claim—which FDA doesn't dispute—that Buckman obtained 510(k) clearance for the pedicle screws by telling FDA that the device was intended for use in long bones. However, the device was meant to be marketed exclusively for use in the spine.

Indeed, FDA's amicus brief to the Supreme Court said that Buckman tried two different times to get 510(k) clearance for the spinal use of the device. Buckman was rebuffed both times on the grounds that the reported use of the device wasn't substantially equivalent to any pre-1976 predicate device. In a third try, Buckman tried to get 510(k) clearance for the use of the screws in long bones and other flat bones and succeeded.

More than 2300 lawsuits claiming injuries from spinal implantation led to the present combined case against Buckman. The claims were first rejected, then agreed to by the lower courts, which resulted in Buckman's appeal to the Supreme Court.

FDA welcomed the added legal weight of private litigation against Medtronic because it brought the company into better compliance with GMP regulations. Regarding the new case's charges that Buckman had committed fraud in its successful 510(k) submission, however, it resisted the application of the same type of dual legal pressure.

FDA agreed that the same exemption from express preemption applied in the Buckman case as had applied in the Medtronic case. That is, it maintained that because the state-level requirements for litigation did not conflict with FDA's federal breach-of-GMPs requirements, the cases should be preempted. Its current position is that an "implied," not an express, preemption did block the new cases, however.

Whereas the complaints against Med-tronic involved device design and manufacture and failure to warn—areas of state concern—the complaints against Buckman involved fraud on FDA—an area of preeminent federal concern, said FDA. In the current case, "respondents simply contend that, but for [Buckman's] alleged misrepresentations to FDA, the agency would not have cleared the device for marketing, the device would not have been marketed, and they would not have been injured," FDA's brief told the Supreme Court.

FDA said that its relationships with regulated companies, including the truthfulness of submissions made by those companies, is traditionally its own business and not the business of state courts. Citing other Supreme Court decisions, FDA said, "when state law implicates an area of preeminent federal concern, the presumption against preemption disappears, and the likelihood of a fatal conflict between state and federal law significantly increases."

FDA argued that it would lose its discretion to decide whether it had been defrauded in a 510(k) submission and what sanctions, if any, to apply. In such situations, juries in 50 states could advise on the appropriate sanctions.

Moreover, FDA went on to say that the respondents' claims against Buckman conflict with its decision to grant market clearance for AcroMed's pedicle screws—a decision to be made by FDA alone and one that is due judicial deference.

If such claims were allowed to proceed in state courts, this "would invite highly intrusive inquiries into FDA's internal deliberations," the agency argued. Such inquiries would include what FDA knew about Buckman's intended uses for the AcroMed devices and when the agency learned of them. This would open FDA decision makers up to private-litigant discovery rights, whereas federal employees have been generally immune from third-party subpoenas issued in private litigation since 1951.

In dealing with the intended use of a device, 21 CFR 801.4 allows FDA to consider, in addition to submitted labeling: (1) advertising matter, (2) manufacturer's statements, (3) knowledge that a product is "offered and used for a purpose for which it is neither labeled nor advertised," and (4) the manufacturer's "knowledge" of facts that would give it "notice" that a product "is to be used" for purposes other than those for which the manufacturer offered it.

Considering this, FDA contended that it has more than adequate power to deal with fraud on itself and doesn't need any help from state courts.


Bleak Budget Outlook

Despite the many improvements at FDA that have led to the approval of innovative new products, the agency admits it has failed to meet its mandates for "rigorous and punctual" review of new product submissions and timely postmarket inspections, according to the FY 2001 FDA Performance Plan. In addition, "a major gap exists between FDA's current clinical research monitoring capability and the level of monitoring that is necessary to ensure that volunteers in these studies are being protected," FDA said, giving unprecedented emphasis to its mounting resources crisis.

 

The plan reports that except for FDA's user fee–supported program for drugs and biologics, it "has been unable to support its review activities with resources commensurate to the rapid development of increasingly complex healthcare products." While CDRH has shortened PMA review times by redirecting resources from other regulatory activities, reinventing its processes and procedures, and assigning a high priority to important applications, it now faces inevitable product- review slowdowns.

"Inadequate funding hampers the development of knowledge bases that will improve the scientific basis of regulatory guidance and advance science and product development," the plan says. "Formal scientific collaborations and stakeholder interactions that are used as a means to educate and increase the availability of scientific knowledge to consumers, healthcare providers, and academia suffer as well."

FDA's performance plan warns that its lack of resources prevents it from inspecting high-risk medical device firms every two years as required by law. Delays in inspecting firms will increase the potential for unsafe medical devices.

For example, last year hospitals alerted FDA to contaminated iodine surgical swabs. The firm that made the swabs had not been inspected for seven years, meaning that as many as 200,000 people could have been infected. "Earlier detection could have prevented and corrected the problem," FDA said.

The agency added that CDRH in FY 2001 will make the most effective use of limited inspection resources by implementing four key strategies. Among the strategies are leveraging through contracts with the states, other third parties, and outreach to small firms; focusing resources on the highest-risk firms and medical devices; ensuring that inspectors have the scientific and technological support necessary to make quick and valid judgments about medical device compliance; and reengineering the process by implementing quality system inspections that will significantly reduce project time and increase effectiveness.

FDA said it will look to help protect clinical trial volunteers by increasing the number of inspections in FY 2001, with an "emphasis on high-risk trials, such as sponsor-investigators who have a proprietary interest in the product under study and studies enrolling vulnerable populations (mentally impaired, pediatric, etc.)."

FDA's performance plan also said it will review and follow up clinical trial complaints within 30 days. "An infusion of new funds is needed for FDA to improve its programs and particularly to enhance its inspections of clinical investigators," FDA said. With over 30,000 clinical sites to inspect, in FY 1999 FDA only inspected 575.


Industry Protests Postmarket Rule

An FDA proposed rule to implement postmarket surveillance (PMS) would impose substantial, unnecessary burdens on all device manufacturers subject to PMS, AdvaMed stated in comments submitted to FDA. In addition, it could force some small manufacturers out of business and create entry barriers for others. "In many instances the proposed rule appears aimed at stimulating the collection of 'interesting data' rather than data useful in protecting patients," AdvaMed continued. "The burdens imposed by the proposed rule are amplified by its lack of clarity in some of the provisions and the inappropriateness of other provisions."

 

In its proposal, FDA said the regulation "is intended to ensure that useful data or other information will be collected to address public-health issues or questions related to the safety or effectiveness of devices for which the agency has issued PMS orders." These public health concerns may include the identification of unanticipated adverse events, and the rate of known adverse events as the indications or conditions for use of the device change, said FDA.

FDA's criteria for imposing PMS on any Class II or Class III device are as follows: If the failure of the device would be reasonably likely to have adverse health consequences; if the device is intended to be implanted for more than one year; or if the device is intended to be life-sustaining or life-supporting and is used outside a device user facility.

AdvaMed proposed a list of modifications to the FDA rule. Among its suggestions are that PMS orders contain FDA's justification for selecting PMS over other alternatives; that a mechanism for alerting manufacturers regarding devices that may be affected by PMS be established; and that FDA be required to meet with manufacturers prior to issuing a PMS order to provide guidance for the submission process.

AdvaMed also suggested that a two-tier approach be applied to PMS where manufacturers would educate appropriate staff members at selected centers to be alert for significant complications associated with the use of a particular device. If this resulted in questions about unexpected serious illness or injury related to the device, a second-tier PMS information collection effort directed at addressing the specific question could be conducted.

Lastly, AdvaMed said that FDA should clarify precisely what it means to include device "claims" in a submission, and should define its criteria for PMS plan evaluation. In turn, manufacturers should be required to obtain FDA approval only for significant changes in PMS plans.

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.



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Copyright ©2001 Medical Device & Diagnostic Industry

Biometrics Technologies are Key Elements of Patient Security

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2001

Potential medical errors, the need for secure information systems integration, and HIPAA compliance are among the factors driving studies of security and identity authentication methods.

Gregg Nighswonger

The memorable phrase from 2001: A Space Odyssey, "Open the pod-bay doors, HAL," evokes images of the lone explorer threatened by an advanced computer system. Although the dawn of our new century has not been marked by developments as dramatic as those involving HAL, there may be more than a little truth to the film's underlying themes of society's sometimes uncertain relationship with its technology. Modern innovations are indeed startling and are occurring at a near-frantic pace—particularly in the various disciplines of medical care. Some of these developments, however, may pose serious hazards that are difficult to assess and mitigate at the rate such advances are taking place.

 

The current state of healthcare is generally being shaped by expanding use of microprocessor- and computer-based systems, as well as increasing reliance on Internet-based tools and applications. Telemedicine would be little more than an intriguing concept without this technical foundation. Similarly, the state of the art in such fields as medical imaging, clinical laboratory functions, and patient monitoring is advancing largely as a result of becoming increasingly "connected." But the increased reliance on computer- and Internet-based systems is also posing risks in terms of patient safety and security. Such risks range from confidentiality concerns to more significant threats to the patient as a result of medical errors. Increased industry concern regarding such hazards, in addition to growth in public regulatory pressure, are promoting research and development of more effective methods of ensuring the security of patients and patient records.

MEDICAL ERRORS AND MALPRACTICE ARE TOP ISSUES

 

Widespread media attention to the 1999 Institute of Medicine report on medical errors quickly brought the issue to the forefront of public attention. A nationwide survey of over 2000 adults conducted last year by the Kaiser Family Foundation (Menlo Park, CA) and the Agency for Healthcare Research and Quality (AHRQ) found that medical errors and malpractice are now among the public's leading measures of healthcare quality. The survey results indicate that people are more concerned about mistakes happening when they are in the hands of the healthcare system than when they are flying on an airplane.

 

Of course, not all medical errors occur inside hospitals. For example, an examination of pharmacists by the Massachusetts State Board of Registration in Pharmacy estimated that as many as 2.4 million prescriptions each year are improperly filled in that state.

Errors in medication, surgery, and diagnosis are considered the easiest to detect. According to the AHRQ, however, "medical errors may result more frequently from the organization of healthcare delivery and the way that resources are provided to the delivery system." The agency adds that any effort to reduce medical errors in an organization requires changes to the system design. Because they address issues on the system level, use of patient tracking and security systems can support efforts to reduce the potential for these types of medical errors.

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

 

A number of factors are driving development of improved systems for ensuring the security of patients and patient records. Among these was passage in 1996 of the Health Insurance Portability and Accountability Act (HIPAA). This federal statute established regulations designed to protect health insurance benefits of and sensitive information about the insured. Intended to provide workers who change employment better access to health insurance coverage, HIPAA limits exclusions for preexisting conditions and restrains health plans from denying health insurance to individuals based on health status. In addition, HIPAA mandated the development and implementation of uniform national standards for the secure electronic transmission of healthcare information.

 

An underlying principle of HIPAA is that the confidentiality of patient records may be threatened by the risk of unauthorized access to the stored information or the interception of such data while it is being transferred from one location or system to another. It has been noted that the potential threat to confidentiality of electronic data is just as serious as the risks associated with the use of paper-based records. In addition, growing reliance on the Internet is generally viewed as posing new challenges and security risks for electronic data.

In addition to requiring establishment of systems to better safeguard patient records, HIPAA mandates that patients must be given easier access to their own health information. The goal was to make it as simple for patients to view that information as it currently is for them to view their own bank statements. To comply with HIPAA requirements, data security systems must incorporate techniques to ensure proof of identity. Adequate authentication is considered to be the only way to differentiate authorized users from potential intruders. Authentication is particularly important in the event that more sophisticated communication methods, such as Internet-based systems, are used.

IDENTIFICATION IS NOT AUTHENTICATION

 

The foundation of most systems intended to safeguard patients and patient records is the ability to accurately verify the identity of all parties involved—including the patient, caregivers, and administrative or support staff. There is an important distinction, however, between identification and authentication (or verification). Within most common frameworks, the process of identification involves determining the identity of an individual user within a given population, based on characteristics associated with that user without the individual necessarily claiming a specific identity. A computer network, for example, may be set up to identify users accessing the systems at a given time based on connectivity addresses. But the actual identity of a given user cannot be guaranteed without the use of additional tools. Authentication, on the other hand, is used to verify a claim of identity. In the example of the network user, an authentication system would verify the individual's identity claim when the individual provides specific information or a specified set of characteristic such as a personal identification number (PIN), password, or physical attribute.

 

Although the use of passwords, PINs, or other information may be sufficient for many applications, the security needs of the healthcare environment often demand measures that can offer considerably more robust capabilities. Advanced authentication systems for medical applications are relying more frequently on biometric information, such as fingerprints, voice patterns, or signature verification to ensure user identity. In most situations, some method is used to clearly identify:

  • Something that is in the individual's possession, such as a smart card.
  • Something that the user knows, such as a password.
  • A physical attribute of the user, such as a fingerprint or other biometric information.

The ability to use these parameters consistently and accurately in authenticating a patient's or caregiver's identity is the basis for the security systems being developed for use in healthcare environments. An effective biometric system would offer accurate performance in two different functions. First, it would be incapable of allowing access by an unauthorized person. Second, it would never deny access to an authorized person. Ideally, it would also function in an unobtrusive manner and be compatible with other equipment to be used, enabling it to be merged relatively seamlessly into existing systems within the facility. Because most available systems have their own strengths and weakness, no single solution has yet emerged as the technology leader.

 

PREVENTING MEDICAL ERRORS

 

Medical errors involving the incorrect administration of medication or transfusions can have catastrophic results. Although such events often gain significant attention in the popular press, mistakes made in collecting specimens for diagnostic testing can pose equally serious hazards for patients. Blood, bodily fluid, and tissue samples can be mislabeled; samples can be taken at the wrong time; or incorrect quantities can be taken. The results can often be a need for new samples, longer hospitalization, and higher costs. In some cases, the results can be more serious, including misdiagnosis or the subsequent incorrect administration of medication or therapy.

 

Results of a survey conducted in 1999 suggest that there is limited awareness of specimen identification errors among hospital department managers. Although more than 90% of CEOs and department heads involved in the survey indicated that they were well informed on medication errors within their facilities, less than 70% were well informed of specimen collection errors. In addition, 58% of hospital CEOs and 38% of nursing administrators could not estimate the number of such errors that had taken place at their facilities in the four weeks prior to the survey.

The use of bar code technology is proving to be useful in ensuring specimen collection accuracy, though costs associated with implementation of such systems has often limited facility-wide use. Becton Dickinson (BD; Franklin Lakes, NJ) is among the companies examining the use of bar code technology. BD acquired the IntelliCode division of Med Plus Inc. (Cincinnati) in January 1998. Intellicode had been working on intelligent bar coding systems that can customize labels to improve workflow and had used bar code technology in its warehousing operations. BD realized there was a strong potential for tying the bar coding technology in with its sample administration and disposable products. A new division, BD.id, determined that a novel method could address two significant issues—the need to "positively associate the right specimen with the right patient and eliminate preventable medication errors."

The company has developed Rx and Dx systems for reducing medication and specimen errors using its bar coding technology. Both the Rx and Dx Solutions use the Symbol SPT 1740 handheld device, coupled with Riverbed Technologies' ScoutSync 3.0 software. The Symbol SPT 1740, based on the Palm OS platform, provides bar code scanning capabilities, along with pick lists and pull-down menus for data capture. Riverbed's ScoutSync software provides the simultaneous, two-way communication between multiple Symbol devices and the BD Rx/Dx Server.

According to the company, "The Rx system allows healthcare providers to access vital information about medication dosage and potential drug interactions before administering a drug. Using the Rx system, nurses scan the bar code labels on unit-dose medications and patient wristbands to ensure that the right drug is given to the right patient at the right time. Built-in management reporting tools track missed doses, misidentification, and other errors."

The Bridge Medication Management System works with bedside computers to reduce medical errors.

The Dx system, which is used during the collection stage of the specimen management process, is intended to ensure positive identification of the patient. The system can also verify vital collection data. It is designed to print the correct bar code specimen label at the point of collection. The company indicates that this capability eliminates the need to manually write the date, time, and caregiver's name on each tube.

 

According to Walter Kalmans, the company's marketing director, "The Rx and Dx systems are designed to significantly reduce errors in medication administration and specimen collection. This has a huge impact on our healthcare system, significantly reducing injuries, improving quality, and lowering costs." He estimates that the systems can pay for themselves in less than two years.

Last year, former-president Clinton announced a comprehensive plan for reducing medical errors. Following the announcement, Bridge Medical Inc. (Solana Beach, CA) and Northern Michigan Hospital (Petoskey, MI) began to assess the use of a technology that includes computer networking and bar code scanning to act as a double check before medication is administered.

The Bridge Medication Management System enables nurses to bar code scan the drug to be administered, the patient ID bracelet, and their own ID badge. According to the firm, "The system then verifies the 'five rights'—right patient, right drug, right dose, right time, and right route of administration." The system also ensures that safe dosing levels are being administered and alerts nurses of potential hazards involving medications that may have a similar appearance or name.

The system is designed to be compatible with bedside computers that interact with a radio-frequency-controlled communication system installed in the ceilings of hospital facilities. The configuration allows changes in medications, dosage levels, or other patient information to be communicated between the hospital information systems and the bedside units in order to keep floor nurses abreast of changes.

The system is intended to reduce the possibility for error and to eliminate many of the manual steps that were previously needed in drug administration. Phase one of the program was initiated in 1998 on the hospital's medical and surgical floor. Phase two is currently under way and involves upgrading the system that automates recordkeeping of medication administration, which nurses currently perform manually and is considered time-consuming.

According to Jim Douglas, RN, Bridge Medical's site coordinator at Northern Michigan, the key to error reduction is to use technology to simplify the medication delivery system and continually improve the process. "Many people don't realize that there are more than 65 steps involved in dispensing and delivering one medication, which clearly leaves room for error." He explains, "Rather than expecting perfect performance in these complex systems, we need to use technology as a backup check for humans, who can make mistakes. We should take the information we collect about 'near misses' and find ways to improve the system, reducing the chance that the same 'near miss' could happen again—that's what this program is all about."

The system is capable of automatically recording the time when a medication dose is given, the staff member who administered the medication, and other pertinent information. Reports can be generated that allow managers to monitor the medications given to patients and help hospital staffs identify opportunities for implementing improvements in their procedures for medication administration.

To date, use of the system has been considered successful. "With the system, we have the capability of tracking medication events and determining whether an error was prevented. Without the system, we are unable to identify all errors, let alone near misses, since the clinician involved is often unaware that an error has occurred," said Trudy Day, RN, a clinical nurse manager at Northern Michigan Hospital.

An Unceremonious Exit: Does Henney Leave a Newly Politicized FDA?

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2001

Editor's Page

Although the device industry and its advocacy groups have been largely silent, there is no lack of rhetoric as FDA awaits the next commissioner.

Last month in this space, I wrote about the future plans of the FDA commissioner under the heading "Agenda for the Century" and the subhead "Henney Pledges Good Science, Openness at FDA." The column was essentially a review of Commissioner Jane Henney's year-end speech before the National Press Club, which she called "FDA: Preparing for the 21st Century." In her talk, Henney maintained that the first of FDA's fundamental principles was to "ground decisions in science," and noted that 75% of recently surveyed consumers, health professionals, and industry representatives believed that FDA does in fact base its decisions on "good science."

 

A few hours ago, someone brought into my office the lead editorial from the day's Wall Street Journal, which ran under the heading "A 21st Century FDA," and the subhead "Unleashing Science." (The subhead was backed by a graphic image of a pretty little caduceus, implying that both wings and serpents were eager for the Journal to unleash them.) Given its title, one might have thought that the editorial was yet another account of the commissioner's speech. In fact, Henney was not mentioned in the piece at all, perhaps because, on January 18, she was dismissed by the Bush administration and given one day to vacate her office.

Rather, the Journal editorial, which concentrates on how a new commissioner should handle drug regulation but ranges somewhat wider, describes an FDA whose "ludicrous overreaching" is symptomatic of an "institutional compulsion to restrict and suppress," whose "staggering economics . . . are an insurmountable hurdle." As an example of the agency's megalomania and the depredations of class-action lawyers and "Nader-ite" groups, the Journal laments the fate of "a drug [used] to treat irritable bowel syndrome, called Lotronex, which sufferers call a miracle drug and which the FDA has just removed from the market because 70 people had bad experiences with it." Calls to several gastroenterologists reveal, in reality, that while no one dies from irritable bowel syndrome, the Journal's "bad experiences" included deaths from ischemic colitis; that Lotronex was far from a "miracle drug"; and that FDA was certainly justified in pulling it from the market. In another example, the Journal upbraids a tyrannic FDA because the agency has recently "forced hospitals to now file paperwork for secondary use of medical devices." Did someone forget to tell the defenders of free enterprise that the device industry had been pleading for such regulation for years?

It happens to be one of nature's elemental laws—and thus no surprise—that the editorial page of The Wall Street Journal congenitally veers away from objectivity. But why is the paper now bringing out the rhetorical big guns to paint a picture of FDA that ignores the significant reforms of recent years as well as the accomplishments of a commissioner who was liked and respected by industry? One suspects that it is all a smokescreen to obscure the fact that Henney was dismissed because of abortion politics: namely, because she concurred with years of scientific study—presumably science unleashed—that determined the abortion pill RU-486 to be safe and effective.

The Journal piece ends with a description of novel autologous cancer vaccines, and counsels "the Bush folks" to install someone at FDA "who understands these realities." Maybe they can find a medical oncologist and talented administrator with experience in academic medicine, clinical research, and government, who was also deputy director of the National Cancer Institute and president of the United States Pharmacopoeial Convention.

And maybe the Journal folks can retitle their editorial "A 19th Century FDA," and subtitle it "Unleashing Politics."

Jon Katz
[email protected]


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Copyright ©2001 Medical Device & Diagnostic Industry

Keeping a Weather Eye on EtO Sterilization

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2001

Patrick G. Smith sees new opportunities for EtO sensing.

It's toxic, explosive, and generally quite nasty—yet ethylene oxide (EtO) remains a remarkably effective method for eliminating microorganisms from medical products. Until an equally effective sterilant is proven, however, the challenges and hazards of working with EtO will remain.

 

This month, potential advantages of an advanced sensing technology are discussed in "Continuous Monitoring of EtO Concentrations During Sterilization," which begins on page 80. According to Patrick G. Smith, vice president of engineering and director of research and development at Sensor Electronics Corp. (Minneapolis), "Sterilization procedures for medical products are tightly controlled, well researched, and closely documented under the watchful eye of the FDA. Every tool available is used and every measurable parameter is monitored to make sure products come out of the chamber absolutely sterile—except one." He explains that because no reliable, affordable EtO monitor has been available, determining in-chamber EtO concentrations has required calculations to be based on other chamber parameters and assumptions.

"The availability of an affordable continuous EtO monitor has many implications," Smith explains. Absorption profiles, which "watch" chamber concentrations, show load absorptive properties and absorption rate. "This could be very useful for load validation by showing when the EtO has reached the product," he states. Verification by actual measurement that all EtO has been evacuated from the chamber adds an additional safeguard to protect the operator when opening the door after a cycle.

Smith adds that parametric release is a way to verify product sterilization by monitoring sterilization cycle parameters. "This allows product shipment after sterilization, eliminating the time and expense required for biological indicator development. Continuous EtO monitoring could be part of the equation for parametric release."

In addition to sterilization processes involved in medical device manufacturing, hospitals are major users of EtO sterilization. Smith says, "Hospitals regularly sterilize reusable medical equipment, such as surgical instruments." He adds that being able to continuously monitor EtO concentrations offers hospitals comparable advantages in verification and for protecting the health of personnel.

Says Smith, "Why should sterilization verification be any less rigorous for the surgeon's scalpel than for the device she/he is about to implant? This is an opportunity for everyone doing EtO sterilization to step up to continuous EtO monitoring without spending a fortune or rebuilding their chambers."

"The new EtO sensor is based on technology that was originally developed for gas monitoring in very difficult and demanding environments such as offshore platforms, coal mines, and chemical plants," Smith notes. The EtO monitor was developed using a similar approach and comparable algorithms. "The sterilizer application turned out to be one of the most difficult we have seen, but the technology is up to it. Our core sensing technology is patent pending."

Development and testing of the new sensing approach required two years' work, and the specific development of the EtO monitor took an additional year.

Smith adds that one of the most difficult problems was combating dew points. He explains sterilizers "create their own 'weather'—rain, fog, dew—which adversely affects an optical sensor." The answer to such problems was use of a two-stage filtering system and heat to ensure accuracy throughout sterilization. The sensor's principal achievement, Smith suggests, has been the ability to continuously measure EtO levels—regardless of the weather.

Gregg Nighswonger is executive editor of MD&DI.


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Copyright ©2001 Medical Device & Diagnostic Industry

Biometrics Technologies are Key Elements of Patient Security

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2001

Gregg Nighswonger

The memorable phrase from 2001: A Space Odyssey, "Open the pod-bay doors, HAL," evokes images of the lone explorer threatened by an advanced computer system. Although the dawn of our new century has not been marked by developments as dramatic as those involving HAL, there may be more than a little truth to the film's underlying themes of society's sometimes uncertain relationship with its technology. Modern innovations are indeed startling and are occurring at a near-frantic pace—particularly in the various disciplines of medical care. Some of these developments, however, may pose serious hazards that are difficult to assess and mitigate at the rate such advances are taking place.

 

The current state of healthcare is generally being shaped by expanding use of microprocessor- and computer-based systems, as well as increasing reliance on Internet-based tools and applications. Telemedicine would be little more than an intriguing concept without this technical foundation. Similarly, the state of the art in such fields as medical imaging, clinical laboratory functions, and patient monitoring is advancing largely as a result of becoming increasingly "connected." But the increased reliance on computer- and Internet-based systems is also posing risks in terms of patient safety and security. Such risks range from confidentiality concerns to more significant threats to the patient as a result of medical errors. Increased industry concern regarding such hazards, in addition to growth in public regulatory pressure, are promoting research and development of more effective methods of ensuring the security of patients and patient records.

MEDICAL ERRORS AND MALPRACTICE ARE TOP ISSUES

 

Widespread media attention to the 1999 Institute of Medicine report on medical errors quickly brought the issue to the forefront of public attention. A nationwide survey of over 2000 adults conducted last year by the Kaiser Family Foundation (Menlo Park, CA) and the Agency for Healthcare Research and Quality (AHRQ) found that medical errors and malpractice are now among the public's leading measures of healthcare quality. The survey results indicate that people are more concerned about mistakes happening when they are in the hands of the healthcare system than when they are flying on an airplane.

 

Of course, not all medical errors occur inside hospitals. For example, an examination of pharmacists by the Massachusetts State Board of Registration in Pharmacy estimated that as many as 2.4 million prescriptions each year are improperly filled in that state.

Errors in medication, surgery, and diagnosis are considered the easiest to detect. According to the AHRQ, however, "medical errors may result more frequently from the organization of healthcare delivery and the way that resources are provided to the delivery system." The agency adds that any effort to reduce medical errors in an organization requires changes to the system design. Because they address issues on the system level, use of patient tracking and security systems can support efforts to reduce the potential for these types of medical errors.

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

 

A number of factors are driving development of improved systems for ensuring the security of patients and patient records. Among these was passage in 1996 of the Health Insurance Portability and Accountability Act (HIPAA). This federal statute established regulations designed to protect health insurance benefits of and sensitive information about the insured. Intended to provide workers who change employment better access to health insurance coverage, HIPAA limits exclusions for preexisting conditions and restrains health plans from denying health insurance to individuals based on health status. In addition, HIPAA mandated the development and implementation of uniform national standards for the secure electronic transmission of healthcare information.

 

An underlying principle of HIPAA is that the confidentiality of patient records may be threatened by the risk of unauthorized access to the stored information or the interception of such data while it is being transferred from one location or system to another. It has been noted that the potential threat to confidentiality of electronic data is just as serious as the risks associated with the use of paper-based records. In addition, growing reliance on the Internet is generally viewed as posing new challenges and security risks for electronic data.

In addition to requiring establishment of systems to better safeguard patient records, HIPAA mandates that patients must be given easier access to their own health information. The goal was to make it as simple for patients to view that information as it currently is for them to view their own bank statements. To comply with HIPAA requirements, data security systems must incorporate techniques to ensure proof of identity. Adequate authentication is considered to be the only way to differentiate authorized users from potential intruders. Authentication is particularly important in the event that more sophisticated communication methods, such as Internet-based systems, are used.

IDENTIFICATION IS NOT AUTHENTICATION

 

The foundation of most systems intended to safeguard patients and patient records is the ability to accurately verify the identity of all parties involved—including the patient, caregivers, and administrative or support staff. There is an important distinction, however, between identification and authentication (or verification). Within most common frameworks, the process of identification involves determining the identity of an individual user within a given population, based on characteristics associated with that user without the individual necessarily claiming a specific identity. A computer network, for example, may be set up to identify users accessing the systems at a given time based on connectivity addresses. But the actual identity of a given user cannot be guaranteed without the use of additional tools. Authentication, on the other hand, is used to verify a claim of identity. In the example of the network user, an authentication system would verify the individual's identity claim when the individual provides specific information or a specified set of characteristic such as a personal identification number (PIN), password, or physical attribute.

 

Although the use of passwords, PINs, or other information may be sufficient for many applications, the security needs of the healthcare environment often demand measures that can offer considerably more robust capabilities. Advanced authentication systems for medical applications are relying more frequently on biometric information, such as fingerprints, voice patterns, or signature verification to ensure user identity. In most situations, some method is used to clearly identify:

  • Something that is in the individual's possession, such as a smart card.
  • Something that the user knows, such as a password.
  • A physical attribute of the user, such as a fingerprint or other biometric information.

The ability to use these parameters consistently and accurately in authenticating a patient's or caregiver's identity is the basis for the security systems being developed for use in healthcare environments. An effective biometric system would offer accurate performance in two different functions. First, it would be incapable of allowing access by an unauthorized person.
Second, it would never deny access to an authorized person. Ideally, it would also function in an unobtrusive manner and be compatible with other equipment to be used, enabling it to
be merged relatively seamlessly into existing systems within the facility. Because most available systems have their own strengths and weakness, no single solution has yet emerged as the technology leader.

 

PREVENTING MEDICAL ERRORS

 

Medical errors involving the incorrect administration of medication or transfusions can have catastrophic results. Although such events often gain significant attention in the popular press, mistakes made in collecting specimens for diagnostic testing can pose equally serious hazards for patients. Blood, bodily fluid, and tissue samples can be mislabeled; samples can be taken at the wrong time; or incorrect quantities can be taken. The results can often be a need for new samples, longer hospitalization, and higher costs. In some cases, the results can be more
serious, including misdiagnosis or the subsequent incorrect administration of medication or therapy.

 

Results of a survey conducted in 1999 suggest that there is limited awareness of specimen identification errors among hospital department managers. Although more than 90% of CEOs and department heads involved in the survey indicated that they were well informed on medication errors within their facilities, less than 70% were well informed of specimen collection errors. In addition, 58% of hospital CEOs and 38% of nursing administrators could not estimate the number of such errors that had taken place at their facilities in the four weeks prior to the survey.

The use of bar code technology is proving to be useful in ensuring specimen collection accuracy, though costs associated with implementation of such systems has often limited facility-wide use. Becton Dickinson (BD; Franklin Lakes, NJ) is among the companies examining the use of bar code technology. BD acquired the IntelliCode division of Med Plus Inc. (Cincinnati) in January 1998. Intellicode had been working on intelligent bar coding systems that can customize labels to improve workflow and had used bar code technology in its warehousing operations. BD realized there was a strong potential for tying the bar coding technology in with its sample administration and disposable products. A new division, BD.id, determined that a novel method could address two significant issues—the need to "positively associate the right specimen with the right patient and eliminate preventable medication errors."

The company has developed Rx and Dx systems for reducing medication and specimen errors using its bar coding technology. Both the Rx and Dx Solutions use the Symbol SPT 1740 handheld device, coupled with Riverbed Technologies' ScoutSync 3.0 software. The Symbol SPT 1740, based on the Palm OS platform, provides bar code scanning capabilities, along with pick lists and pull-down menus for data capture. Riverbed's ScoutSync software provides the simultaneous, two-way communication between multiple Symbol devices and the BD Rx/Dx Server.

According to the company, "The Rx system allows healthcare providers to access vital information about medication dosage and potential drug interactions before administering a drug. Using the Rx system, nurses scan the bar code labels on unit-dose medications and patient wristbands to ensure that the right drug is given to the right patient at the right time. Built-in management reporting tools track missed doses, misidentification, and other errors."

The Bridge Medication Management System works with bedside computers to reduce medical errors.

The Dx system, which is used during the collection stage of the specimen management process, is intended to ensure positive identification of the patient. The system
can also verify vital collection data. It is designed to print the correct bar code specimen label at the point of collection. The company indicates that this capability eliminates the need to manually write the date, time, and caregiver's name on each tube.

 

According to Walter Kalmans, the company's marketing director, "The Rx and Dx systems are designed to significantly reduce errors in medication administration and specimen collection. This has a huge impact on our healthcare system, significantly reducing injuries, improving quality, and lowering costs." He estimates that the systems can pay for themselves in less than two years.

Last year, former-president Clinton announced a comprehensive plan for reducing medical errors. Following the announcement, Bridge Medical Inc. (Solana Beach, CA) and Northern Michigan Hospital (Petoskey, MI) began to assess the use of a technology that includes computer networking and bar code scanning to act as a double check before medication is
administered.

The Bridge Medication Management System enables nurses to bar code scan the drug to be administered, the patient ID bracelet, and their own ID badge. According to the firm, "The system then verifies the 'five rights'—right patient, right drug, right dose, right time, and right route of administration." The system also ensures that safe dosing levels are being administered and alerts nurses of potential hazards involving medications that may have a similar appearance or name.

The system is designed to be compatible with bedside computers that interact with a radio-frequency-controlled communication system installed in the ceilings of hospital facilities. The configuration allows changes in medications, dosage levels, or other patient information to be communicated between the hospital information systems and the bedside units in order to keep floor nurses abreast of changes.

The system is intended to reduce the possibility for error and to eliminate many of the manual steps that were previously needed in drug administration. Phase one of the program was initiated in 1998 on the hospital's medical and surgical floor. Phase two is currently under way and involves upgrading the system that automates recordkeeping of medication administration, which nurses currently perform manually and is considered time-consuming.

According to Jim Douglas, RN, Bridge Medical's site coordinator at Northern Michigan, the key to error reduction is to use technology to simplify the medication delivery system and continually improve the process. "Many people don't realize that there are more than 65 steps involved in dispensing and delivering one medication, which clearly leaves room for error." He explains, "Rather than expecting perfect performance in these complex systems, we need to use technology as a backup check for humans, who can make mistakes. We should take the information we collect about 'near misses' and find ways to improve the system, reducing the chance that the same 'near miss' could happen again—that's what this program is all about."

The system is capable of automatically recording the time when a medication dose is given, the staff member who administered the medication, and other pertinent information. Reports can be generated that allow managers to monitor the medications given to patients and help hospital staffs identify opportunities for implementing improvements in their procedures for medication administration.

To date, use of the system has been considered successful. "With the system, we have the capability of tracking medication events and determining whether an error was prevented. Without the system, we are unable to identify all errors, let alone near misses, since the clinician involved is often unaware that an error has occurred," said Trudy Day, RN, a clinical nurse manager at Northern Michigan Hospital.

SECURITY AT THE FINGERTIPS

 

Among the recently developed biometric technologies are computer-based systems that are able to transfer information in real time using fingerprint scans. Like bar code scanning, fingerprint-based identification methods have been found useful for ensuring patient identity, reducing the risk of medication errors, improving recordkeeping, and preventing other potential problems.

 

Fingerprint scans do have some limitations in their range of applications because they cannot be used by staff members wearing surgical or exam gloves. This type of identification, however, can be used during patient admissions and in some clinical applications, and it is especially useful in situations where patients return frequently. A system such as the HealthID automated fingerprint identification system from NEC Technologies Inc. (Itasca, IL) can be used upon admission to link a patient's fingerprint to medical records contained in existing hospital case-management computer files. The method can even be used in instances when patients are unable to give their medical history to hospital personnel, because the case history can still be obtained and any existing conditions or illnesses identified.

The NEC system is also intended to eliminate other patient record problems. The company indicates that upward of 10% of hospital records are duplicates, or kept in error. Incorrect entry of a name during the admission process can result in the patient being linked to the wrong case history. With HealthID, the patient's finger is placed on a small pad linked to an optical character recognition system. The fingerprint is then displayed on the computer screen, followed by case documents.

In addition to helping improve patient care, the technology can be used to reduce medical care fraud. Many cases of fraud are reported in inner-city hospitals where patients are admitted using a false ID and charges are sent to Medicare. "But now such fraud can be prevented, as the actual patient being treated is accurately identified," says NEC product manager Chris Warner.

Outside of the hospital, fingerprint scans are also proving useful for ensuring security of patients. BioNetrix (Vienna, VA) has licensed its biometrics technology to DrugEmporium.com, the on-line subsidiary of Drug Emporium (Powell, OH), enabling the Web-based firm to authenticate the identities of physicians ordering patient prescriptions over the Internet.

The BioNetrix software prompts doctors placing the on-line prescriptions for biometric IDs to directly authenticate their identity and verify that they are authorized to access the patients' records. The ID can be a fingerprint, retinal or facial scan, or signature, each of which is unique to an individual.

BioNetrix is currently exploring expansion of its Hospital JumpStart, a comprehensive package of authentication software, hardware, and services, into hospitalwide systems. According to John Ticer, BioNetrix CEO, "A growing number of hospitals are exploring ways to provide quick and easy access to information while also increasing privacy and security."

PERVASIVE COMPUTING AND THE WORLD WIDE WEB

 

"Pervasive computing—the concept that computers in the future will be as inextricably woven into our daily lives as electricity is today—is an idea whose time is coming very, very rapidly," says Dick Lampman, director of Hewlett Packard Labs (HPL; Palo Alto, CA). The concept of pervasive computing is also the foundation of one of HPL's development efforts.

 

An Internet-enabled watch is among the first of the next-generation "context-aware" devices that will use biometrics to identify the user. In addition, positioning technology will track the location of the user, and sensors will provide information about the environment.

Another context-aware device in development at HPL is the BadgePAD, a smart badge that physicians or nurses will be able to pick up when they arrive at work. The identity of the physician or nurse will be authenticated through voice recognition. The cell-phone-size badge will then be worn like a conventional security badge, attached to a belt, or hand carried. Until the device is set down, it will continue to track the movements of the physician or nurse and provide continuous authentication for data access.

Within the hospital setting, the patient records system will recognize the caregiver upon entry to the patient's room. Relevant charts will automatically be displayed on the computer screen. If someone else approaches the screen and is not authorized to view that patient's information, it will go blank. If the BadgePAD is set down and picked up by another individual, it will require a new authentication but will have the new set of e-services personalized for that person.

Use of the World Wide Web also figures prominently in several other patient security strategies, including efforts to provide remote data access while maintaining necessary security. For example, HealthCast LLC (Boise, ID) and HospITech Solutions (Montville, NJ) have formed a strategic alliance to offer a range of HIPAA-compliant Internet-based services that will help healthcare providers improve patient care, increase operating efficiencies, and reduce costs.

According to the firms, HealthCast's system is designed to securely integrate clinical and administrative information from disparate legacy systems and from data sources without requiring the creation of a new data repository. A variety of authentication methods are used to enable users to securely access real-time, integrated information via an Internet browser from hospital-based offices or off-site locations, including their homes.

SUPPORT FOR DECISION-MAKING SOFTWARE

 

Concern for maintaining security of patient data is also shaping the design and development of decision-making software for medical applications. Baylor College of Medicine (Houston) and Caducian Inc. (Austin, TX) recently signed a collaborative development agreement intended to enhance Caducian's real-time clinical decision-making support software for use in
critical-care environments.

 

The Caducian system will be designed to allow authorized individuals to view and analyze all of a patient's continuous clinical data flows that have been collected from a variety of monitoring devices from different manufacturers. Sophisticated algorithms will be developed for data mining and analysis of the information flows from the various devices.

"Patients with life-threatening conditions are monitored throughout the clinical process," states J. Robert Beck, MD, vice president for information research and planning at Baylor, adding, "We are pleased to work with Caducian to provide a seamless data flow, which will enhance our research on identifying critical events."

The system "allows for the secure portability of patient data in a way never before possible," the firm indicates. "Previously, patients, doctors, administrators, insurance companies, attorneys, and other interested parties in the healthcare provisioning cycle have had to rely on verbal and hand-rekeyed records of monitoring system read outs, taken at isolated times from isolated proprietary systems." Caducian's technologies will give physicians "a powerful new tool to help them in complex clinical decision making—weaning premature infants from ventilators as early as possible, for example."

SMART CARDS

 

Smart cards are also playing an important role in ensuring the security of patient records. Keyware (Woburn, MA) has been chosen to provide customized fingerprint smart card authentication for eMedicalFiles.com LLC. The system it will supply can store and retrieve comprehensive medical information via an exclusive combination of a smart card and Internet server.
According to Keyware, this product is a "patient-centric" approach to managing medical information. That is, the patient is in control of making his or her up-to-date medical information available when needed. New information can be added to the patient's card in real time at each encounter with a healthcare provider. Keyware's technology is intended to provide secure access to detailed medical records, leading to improved patient care, fewer errors, faster claims resolution and less paperwork. Every type of point-of-care facility—hospitals, doctors, dentists, pharmacies, and rehabilitation facilities—will be able to access patient records in order to obtain accurate, timely information, while biometric technology will provide high-level patient confidentiality and security.

 

Sense Holdings Inc. (Tamarac, FL), through its Sense Technologies subsidiary, has initiated a fingerprint-based smart card to provide enhanced security for storing and accessing portable data, including medical care information. Applications of the firm's BioCard system include securing and managing medication disbursement, patient test results, and treatment schedules.

The company suggests that "biometric technology, coupled with the use of smart cards, has the potential to take security, convenience, and versatility to another level for our customers." Says Dore Perler, CEO and founder of Sense Technologies, "Our ability to store and unlock data with a fingerprint should be of great interest to the medical, financial, and education markets. SmartCard technology offers a reliable yet secure method of storing and accessing portable data."

CONCLUSION

HAL sought to defend his behavior by explaining, "This sort of thing has cropped up before, and it has always been attributable to human error." New technologies to address patient safety and security concerns are, in one sense, part of an effort to avoid the irony of HAL's comment.

 

The more sophisticated technology becomes, the more complex and vital the dual issues of security and access become. On the one hand, systems in development must offer greater certainty that diagnostic or therapeutic care is administered to the correct patient, and that the treatment being provided does not pose undue risk to the patient. To achieve this, up-to-date and accurate data must be readily available to caregivers. On the other hand, research is being directed toward developing methodsto ensure that all data generated in the course of patient care is secure—that access to this sensitive information is granted only to authorized individuals. Use of systems based on biometrics technology—including voice recognition, fingerprints, and
others—will be a key element in creating new systems for maintaining adequate levels of security in both applications.

Gregg Nighswonger is executive editor of MD&DI.


To the MDDI February 2001 table of contents

Copyright ©2001 Medical Device & Diagnostic Industry