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2012 MDEA Winners Announced!

MD+DI is proud to present the WINNERS of the 2012 MDEA competition!

Sponsored by MD+DI and organized by UBM Canon, the Medical Design Excellence Awards (MDEA) competition is the premier awards program for the medical technology community, recognizing the achievements of medical product manufacturers and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare
 

Scroll down to view a slideshow of each category, including finalists and winners.

For more information on the competition, visit the MDEA Web site.

 

Critical-Care and Emergency Medicine Products

Dental Instruments, Equipment, and Supplies

Finished Packaging

General Hospital Devices and Therapeutic Products

Implant and Tissue-Replacement Products

In Vitro Diagnostics

Over-the-counter and Self-care products

Radiological and Electro-mechanical Devices

Rehabilitation and Assistive-Technology Products

Surgical Equipment, Instruments, and Supplies

Winning products were announced at the MDEA Presentation Ceremony held on Wednesday, May 23, 2012 at 4:30 pm during a cocktail reception inside the Philadelphia Marriott Downtown hotel. The ceremony was held in conjunction with the MD&M East Event at the adjacent Pennsylvania Convention Center, May 22-24.

Also, at the MDEA Presentation Ceremony, held on May 23, 2012 during MD&M East:

  • The NCIIA announced the winners of the 2012 BMEidea biomedical engineering competition for university students.
  • Famed inventor Dr. Thomas Fogarty was presented with the prestigious 2012 MDEA Lifetime Achievement Award for his contributions over a long career that have had a demonstrable impact on technological, business, and cultural advancements in medical devices.
For more information about the Medical Design Excellence Awards—including additional details about the manufacturers and suppliers that created the 2012 MDEA-finalist products—visit the MDEA website at www.MDEAwards.com or e-mail: [email protected].
 
 

This Week in Devices: Robots are Invading! Bionic Limbs, Medical Devices go DIY, Don Draper's Advice to the Medical Industry, and the Medical Industry Embraces… Pinterest?

 This Week in Devices [ 3/23/2012]

Robots are Invading our Hospitals

Real Bionic Limbs are far out of Reach

Medical Devices go DIY

Don Draper has some Advice for the Medical Industry

The Medical Industry Embraces… Pinterest?

ToucHb: The Latest Medical Device Innovation Revealed at TED 2012

  
  • Hospitals are taking a cue from the auto industry and are beginning to replace many tasks normally handled by blue-collar works with automated robots. But is this trend a good thing for the healthcare industry or just another sign that our robotic overlords are taking over? Mark Graban discusses on the MD+DI blog
  • People in the medical device industry might want to invest in a set of LEGOs. DIY medical devices? It’s not a game. A team of MIT researchers have created the MEDIKit, component-based medical device kits made of repurposed toys and other gadgets to help provide medical service and education to developing countries. 
  • If you’re doing anything this Sunday, it’ll likely be watching the premiere of the new season of Mad Men. And if the womanizing, heavy drinking and smoking, and snappy suits weren’t enough to convince you of Don’s cool. Brian Johnson over at MassDevice suggests the med tech industry could actually learn a lot from him. 
  • Have you tried Pinterest? (Unless you’re female, probably not). The rapidly growing site is becoming the hottest thing on the Internet. MedCity News thinks it could be more than just another social sharing Web site and actually have benefits for the medical industry. 
 

How Electrolyte Thinness Can Affect Li-Ion Battery Performance

Using transmission electron microscopy, NIST researchers observed nanosized batteries with electrolytes of different thicknesses charge and discharge. The team found that there is likely a lower limit to how thin an electrolyte layer can be made before it causes the battery to malfunction. (Image by Talin/NIST)

Researchers from the National Institute of Standards and Technology (NIST: Gaithersburg, MD), the University of Maryland (College Park), and Sandia National Laboratories (Albuquerque, NM) have built nanowire batteries to demonstrate that lithium-ion (Li-ion) battery performance is impaired when the battery's electrolyte layer becomes too thin. This discovery highlights that there is effectively a lower limit to the size of tiny power sources.

These findings are important for a range of electro devices because battery size and performance are key to the development of autonomous microelectromechanical systems (MEMS). MEMS devices, which can be tens of micrometers in size, are potentially suitable for many medical device applications because they generally rely on batteries that can last for long periods of time and be recharged quickly. However, because of current battery technology, MEMS devices much smaller than a millimeter in size cannot be fabricated.

To determine how small they could make solid-state Li-ion batteries using existing materials, NIST researcher Alec Talin and his colleagues created a forest of tiny batteries measuring approximately 7 µm tall x 800 nm wide. Starting with silicon nanowires, they created a contact out of layers of metal, cathode material, electrolyte, and anode materials with various thicknesses to form the miniature batteries. Then, they employed transmission electron microscopy to observe the flow of current through the batteries and study the materials as they charged and discharged.

The team found that when the thickness of the electrolyte film falls below approximately 200 nm, the electrons can jump the electrolyte border instead of flow through the wire to the device and on to the cathode. This short circuiting causes the electrolyte to break down and the battery to quickly discharge. "What isn't clear is exactly why the electrolyte breaks down," Talin remarks. "But what is clear is that we need to develop a new electrolyte if we are going to construct smaller batteries. The predominant material, LiPON, just won't work at the thicknesses necessary to make practical high-energy-density rechargeable batteries for autonomous MEMS."

Getting Your CAPA House in Order

Getting Your CAPA House in Order

Nancy Singer Mark Lagunovich
       Nancy Singer         Mark Lagunovich

Successfully implementing and documenting corrective and preventive actions (CAPAs) is one of the critical processes in a device company’s day-to-day quality operations. CAPAs carry significant implications for both product quality andcompliance with FDA regulatory directives, and remain vital to any company’s ability to address incidents that inevitably arise in the manufacturing processes and take necessary steps to prevent them from reoccurring.CAPA remains one of the top FDA 483 citations year after year, due typically to either inadequate processes or inconsistent adherence to processes. This includes failing to define which issues should or should not be elevated to CAPA status, insufficiently documenting the data required by FDA to adequately assess the CAPA’s effectiveness, or relying on outmoded systems to collect and analyze the data and demonstrate that the firm is operating in a state of control.

This article looks at some of the common causes for inconsistency in CAPA processes, and offers several recommendations for how companies can improve their internal systems.

What Makes a CAPA a CAPA? 

ISO 9001 standards identify three distinct components that are critical to understanding how to set up a CAPA system:

  • Correction—Action to eliminate a detected nonconformity (this can be a rework or regrade).
  • Corrective Action—Action to eliminate the cause of a detected non-conformity or other undesirable situation (italics added).
  • Preventive Action—Action to eliminate the cause of a potential non-conformity or other undesirable situation (italics added).

Many companies fail to distinguish among the definitions. Traditionally, companies have thought it appropriate to have correction, corrective action, and preventive action on the same issue. But, as you can see with the above ISO definitions, not all situations require that preventive action be taken, and there are times when firms want to independently take preventive action to solve a potential problem before it actually occurs. Nevertheless, both corrective actions and preventive actions share an effectivity check, or the future verification that the issue was truly resolved and nothing else was negatively impacted.

The first thing companies typically fail to address in their CAPA programs is determining when a deviation or nonconformance in the manufacturing process should be escalated to corrective action status, and delegating the appropriate responsibility and authority to the firm’s employees to resolve the issue. The reasons for this failure vary from company to company, and the lack of precise standard operating procedures for CAPA processes and documentation makes it even more difficult for companies to determine just which issues should be escalated.

This confusion is partly due to the fact that FDA does not clearly define the correct approach to CAPA escalation processes and instead relies on companies and their management to ensure that processes will incorporate the necessary procedures and actions to effectively resolve issues. This lack of guidance often results in companies escalating too many routine deviations to CAPA status—or too few severe ones—and maintaining insufficient documentation for regulators to properly discern whether issues have been resolved correctly and within the right time frame.

A good rule of thumb to keep in mind is that CAPAs should be prioritized on risk, and take into account the frequency with which a nonconformity might occur and the severity of the risk if it does—meaning events deemed severe enough to result in a negative impact on patient safety should be escalated to CAPA status. Although FDA does not clearly define exactly what needs to be included in a firm’s CAPA procedures or processes, the agency has made it clear that management is ultimately responsible for resolving the issue. Companies have a good indicator of how they should proceed: Whatever is severe enough to report to management is worthy of consideration for CAPA status.

What Does FDA Need to See?

Now that we’ve covered some CAPA basics, we’ll look at what just what the FDA expects to see when documenting your CAPA processes. The responsibility for CAPAs ultimately falls to management, and failure to adequately and sufficiently document your CAPA processes can result in 483 observations or a warning letter from the FDA that will be posted on the FDA’s Web site, where it will also be available for the firm’s competitors and the public to view.

It is important to remember when documenting a CAPA that such documentation is intended to provide the following elements to FDA:

  • A structure for directing current and future activities.
  • A tool for forward and backward traceability.
  • The history explaining how the company complied with the requirements to correct a nonconformity and employed reasonable measures to limit the risk to its consumers of being exposed to unsafe or ineffective products.

When documenting CAPAs, it is critical to articulate the timeline for when the incidents occurred, and when each of the appropriate steps was taken to resolve them. Volume and error reports are some of the most elementary components of a quality system. These should always be evaluated as part of the CAPA process. Companies should include as much detail about the steps taken through the process so that FDA is left with little question about when the incident occurred, when and how it was corrected, and how quickly the loop was closed.

Including the names of individuals involved in the CAPA process is another step that helps FDA assess the reasonableness of the firm’s actions. Firms may be reluctant to provide such detail, and may provide only the title of the person who resolved the CAPA. However, it is important that the actual names be provided due to the frequency of personnel changes and the firm’s real need to have backward traceability during potential future regulatory or legal reviews. FDA’s investigators understand this, and may want to know the names of all personnel assigned to deal with the CAPA in question.

Another thing to remember: Don’t use passive voice, as in “the report has been distributed,” or “the complaints were closed.” Assign an actor to the CAPA, so the person reading the document understands exactly what was done, and by whom, as well as how long it took.

Correctly documenting CAPA processes is crucial to ensuring compliance and avoiding warning letters from the FDA. Don’t overlook the importance of understanding exactly how much data needs to be captured.

How to Collect the Data

Companies typically collect and manage CAPA data in one of three ways: via paper-based processes, in rudimentary electronic applications such as Excel spreadsheets or Access databases, or using purpose-built quality management software (QMS).

Paper-based processes, by far the longest-used process (for obvious reasons), have little upside in their ability to accurately capture and report CAPA data. Paper documents can be cumbersome to manage. They also often end up collecting dust on individuals’ desks for long periods of time, resulting in failures to meet project deadlines or, worse yet, inability to track and trend issues across the enterprise. Beyond this, paper-based processes are also generally poor at capturing essential data such as incident and resolution timelines.

Related Links:

Electronic applications like Excel spreadsheets and Access databases are somewhat better than paper. With these tools, users can manually input required CAPA data directly into the databases, while administrators can set basic access privileges by administering passwords to ensure only authorized users have the ability to manipulate the data.

Yet these applications also come with several significant problems. First, like paper processes, they offer limited visibility into the full scope of how CAPAs are initiated and resolved or the full timeline of who performed what actions and when. Second, because of the manual nature of these tools, Excel spreadsheets are enormously prone to error, with little ability to identify and correct the inconsistencies that arise in the data entry. And finally, because of their disconnected nature, Excel databases can result in major process inefficiencies and frequent miscommunication for global device organizations that typically have multiple sites and hundreds of users all requiring access to the same system.

The third common way organizations manage their CAPA processes is through QMS. There are many advantages to such a system, as most are designed specifically to manage CAPA documentation processes along with a host of other quality and compliance functions. With these QMS systems, companies can prioritize incidents that occur during the manufacturing process based on risk, and determine which of those incidents needs to be elevated to CAPA status, assigning the right personnel to initiate the CAPA. Once a CAPA is initiated, companies can then centrally manage and automate the processes of resolving it across any number of sites, setting user access privileges as necessary and setting up e-mail alerts to ensure the right personnel take the required action efficiently and effectively. Finally, and perhaps most importantly, as many such systems feature templates configured in an FDA-ready format, QMS systems prove especially adept when it comes time to extract data from the system to track and trend across departments and demonstrate compliance to third parties.

Conclusion

Regardless of which tools companies choose to manage their CAPA processes, it’s important to keep in mind that even the most effective QMS system on the market will have little use if the company is not entering the right data into that system. CAPA processes are critical to the day-to-day operation of any device organization. By following the right approach to documenting their CAPAs, companies can not only consistently meet the strict and evolving requirements of regulatory authorities, but also ensure that the products they deliver to market are consistently safe for public use.

Nancy Singer is president of Compliance-Alliance, LLC, an organization designed to help professionals employed in the medical device industry establish a culture of compliance.

Mark Lagunowich works at Sparta Systems and specializes in advising companies on solutions to improve manage quality systems, sales effectiveness, and supply chain processes.
 

Your Next Blood Test Might Not Require Bleeding

    image copyright BioSense
But the problem wasn’t in the availability of treatment, it was in the diagnosis. In India, public healthcare is handled primarily by ASHA (Accredited Social Health Activist) workers, not doctors. Typically, testing for anemia involves drawing blood and testing with expensive medical machinery that requires a trained technician. One can see very quickly how this can become time-consuming and cost prohibitive in some areas of the world.
 
Ingawale, an engineer, also saw the need for a solution: It would have to be simple enough for an ASHA worker to use, small and portable, and also be needleless (to avoid the complications associated with handling medical waste). He co-founded BioSense Technologies with the goal of creating this solution and, after 32 unsuccessful attempts, they succeeded.
 
The ToucHb is a non-invasive, mobile phone-sized device that uses wavelengths of light to instantly measure hemoglobin, oxygen saturation, and heart rate, enabling workers to diagnose anemia at the point of care. The device is based on a principle called photoplethysmography (say that 10 times fast). By passing light through tissue (the fingertip in the ToucHb’s case) and measuring how much light is transmitted, absorbed, or scattered, scientists can get a sense of a patient’s hemoglobin.
 
While the device is still being developed, BioSense hopes that the ToucHb will become ubiquitous, not just in developing or remote nations, but throughout the world. Hopefully creating one less problem for health workers.
 
 
 Ingawale discusses the ToucHb at TED 2012:

Americans Support Strong Medical Device Safety Oversight, Poll Finds

WASHINGTON, March 20, 2012 /PRNewswire-USNewswire/ -- A new Consumer Reports poll shows overwhelming public support for strong medical device safety oversight. The poll was released just as House and Senate Committees have issued draft legislation to reauthorize the statute governing medical devices and at a time when the FDA's process for reviewing new implants has come under intense criticism. Read More

New Tongue Drive Uses a Tongue Piercing and iPhone for Wheelchair Control

Georgia Tech researchers have found a better and more comfortable way for disabled patients to steer their wheelchairs. Maysam Ghovanloo, an associate professor in the School of Electrical and Computer Engineering at the Georgia Institute of Technology, and a team of researchers, have announced the newest prototype of the Tongue Drive System. The Tongue Drive System features a dental retainer-like device that allows patients to wirelessly control an electric wheelchair using only tongue movements.

The retainer fits comfortably in the mouth and contains a series of sensors that track tongue movements using a small, tongue-mounted magnet. As the patient moves his tongue, the sensors in the retainer pick up the movements of the magnet. These signals are then wirelessly transmitted to an iPod or iPhone and can be translated into movement previously handled by the wheelchair’s joystick. The device can also be modified for use with a computer to move a mouse cursor around a screen.

Previous iterations of the Tongue Drive System were mounted on a headset, but researchers found that by using a dental retainer they could make the device more inconspicuous and eliminate calibration errors that would occur when the headset shifted during use.
 
The researchers hope to move the Tongue Drive System into clinical trails soon.
 
 
 
Dr. Maysam Ghovanloo explains and demonstrates the older Tongue Drive System.

Why Old-Timey Radio Programs Could Create Better Alarms: Adventures in Medical Device Usability

I admit it. I used to be a philosopher. 

When I left academia and got a real job more years ago than I want to think about, I didn’t expect to have many opportunities to use my philosophy background (I was educated in and teaching psychology, but my “professional work”, as we called it, was to examine the “metatheories” that formed the foundation for cognitive psychology, i.e., roughly that branch of philosophy called epistemology).

Well, I was wrong. Working in medical device development, hardly a day goes by that I don’t use something that I’ve learned from philosophers like Ludwig Wittgenstein or John Dewey. I don’t want to go off on too much of a tangent about philosophy, but let me just say that the stereotype of the philosopher—spending his or her days in windy, idle speculation about what is never provable—may or may not be a fair characterization of some types of philosophy (it may actually be fair, judging from the Philosophy section of the typical book store), but that stereotype is dead wrong as a blanket summary of philosophy. There are some problems that can’t usefully be approached with any other than philosophical tools—namely, those problems that don’t lend themselves to being solved by evidence. How can there be such a thing? 

Well, if we live by evidence (and I certainly do, since I’m not running for office), we have to decide: 

  • What counts as evidence.
  • When the evidence is adequate.
  • What conclusions follow from what evidence, and so on.

More Adventures
in Medical Device Usability

The Myth of Brainstorming

These are questions that can’t be answered by the evidence itself because they are logically prior to the evidence—you have to decide, for example, what counts as evidence before you have any evidence to apply.

Thus, there are two types of errors. First, empirical errors, such as false evidence that a drug works when it doesn’t. Second, what we might call philosophical errors, like those of the astrologer, who has all the trappings of science—data, measurement, an agreed-upon methodology, etc.—but underlying assumptions that are just loony (offence intended).

We have scientific tools to identify and eliminate the first type of error, but identifying and eliminating the second type of error requires, yes, philosophical tools. In practice, we get by without philosophical tools by simply taking our underlying assumptions for granted. This usually works, but not always, as my example of astrology indicates. And, as the astrology example also indicates, when one makes a philosophical, as opposed to an empirical error, it can be a doozy. 

This brings me to my actual topic—medical-device alarms, which I think suffer from, among other things, some philosophical baggage that alarm designers inherited from psychology. I want to summarize some ideas I explored in an article on alarms (A human factors perspective on auditory alarm signals).

I don’t know anyone who’s satisfied with medical-device alarms. The two biggest problems are that the number of false alarm signals in the ICU or the OR is of epidemic proportions and that alarm signals from different devices have no relationship to each other—causing utter chaos when a few things go wrong at the same time. What my philosophical comments connect to is a related problem—that the auditory signals themselves are difficult to learn, to differentiate, to understand, etc. 

The alarm problem stems from a bad (and unexamined) underlying theory (i.e., metatheory) of how the human auditory system works. We have a simple way of characterizing sound (via sine waves with defined amplitudes and frequencies, for example) that comes from classical physics, namely acoustics. This approach proved so productive that it was natural, when psychology began to emerge, to define the problem of auditory perception as the study of how the human auditory system processes this physical input. Since a pure tone (what’s simplest from the point of view of acoustics) was “obviously” the simplest type of auditory signal, pure tones became the building blocks that were used to create auditory signals when studying auditory perception, and later, the building blocks for artificially-created signals, including alarms. 

Indeed, the international standard for medical-device alarms (IEC 60601-1-8) mandates that alarms be created out of pure tones, in that it specifies the required pulse parameters of alarm signals in basic terms—combinations of wave forms with guidelines for amplitudes, frequencies, etc. The problem with this is that what’s acoustically simple isn’t what’s simple for the human auditory system and vice versa. The simplest sounds, from the point of view of human perception—meowing cats, screeching brakes, breaking glass, bouncing balls—are almost impossibly complex to define in acoustic terms, i.e., in terms of their waveform structures.  Likewise, the simplest sounds from the point of view of acoustics (e.g., pure tones), are not particularly easy to differentiate, to remember, etc. by humans. 

The invidious comparison is between the natural situation where we can clearly hear and comprehend lots of simultaneous sounds (cars driving by, birds chirping, nearby conversations, phones ringing, etc.) and the alarm situation where even 3 or 4 simultaneous signals can be overwhelming.

It follows that, in order to create better alarm signals, we don’t necessarily need more data. An emerging field called “ecological psychoacoustics” (I recommend reading Ecological Psychoacoustics edited by John Neuhoff) presents a new way to think about the problem. Rather than starting with acoustics and determining how people hear acoustic signals, start from natural (ecologically relevant) sounds and try to find the acoustic parameters that correlate with them. What they’ve been finding is that the key parameters tend to be quite complex—properties of 3rd- and 4th-order derivatives of wave forms, for example, rather than properties of the underlying wave forms themselves. It follows that the basic acoustic parameters that create alarm signals are fundamentally out of sync with the human ear and brain.

How could we develop alarm signals that are in sync with the human auditory system? I suggest three ways:

  1. Using “earcons”—analogous to visual icons—as described by McGookin and Brewster [PDF].
  2. Using methods for “faking” natural sounds, e.g., those used by the “Foley artists” responsible for sound effects in old radio shows ( One book to read is Sound Effects: Radio, TV, and Film, by Robert Mott).
  3. Creating sounds out of the higher-order acoustic parameters found by the experts on ecological acoustics, as discussed in Neuhoff’s book.


I didn’t say it was easy. 

In making alarms easy for ourselves (designers), we’ve made it really hard for the people who have to respond to alarm signals. Maybe it’s time to make it harder for ourselves in order to make it easier for our device users.

+++++++

Stephen B. Wilcox, is a principal and the founder of Design Science (Philadelphia), a 25-person firm that specializes in optimizing the human interface of products—particularly medical devices. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He has served as a vice president and member of the IDSA Board of Directors, and for several years was chair of the IDSA Human Factors Professional Interest Section. He also serves on the human engineering committee of the Association for the Advancement of Medical Instrumentation (AAMI), which has produced the HE 74 and HE 75 Human Factors standards for medical devices.

Spotlight on Pumps & Valves

Fluid dispensers and pumps
Suitable for use in medical diagnostic and analytical instrumentation, an OEM line of fluid dispensers and metering pumps from Fluid Metering Inc. is designed to offer precision, accuracy, and chemical resistance. Available in either fixed- or variable-displacement configurations, all of the low-flow dispensers and pumps have a patented valveless, one-moving-part design. The line comprises standard models with dispense capabilities ranging from a low of 500 nl per dispense to a high of 1.28 ml. Custom dispensers and pumps designed to meet specific application requirements are also available. The components feature coefficients of viscosity of 0.5% or better and exhibit accuracy of ±1%. In addition, stepper control kits available from the manufacturer range from basic levels of control to advanced programmable stepper development kits for achieving precision fluid control.
Fluid Metering Inc.
SYOSSET, NY

Micro diaphragm pump
Capable of handling liquids in a range of medical device and analyzer applications, the customizable Type NF1.25 high-pressure micro diaphragm pump from KNF Neuberger Inc. can be used to dose or transfer liquids or liquid-gas mixtures at flow rates up to 300 ml/min. The small, powerful unit has been engineered to operate either intermittently or continuously against pressures as high as 87 psig over its lifetime. Versions that handle pressures up to 145 psig can also be specially developed. Mountable in any position, the self-priming pump features a patented valve system and sophisticated diaphragm technology. It can also run dry and requires virtually no maintenance. Motor options include iron-core dc, ironless-core dc, and brushless dc units. The brushless version can be supplied either with simple two-wire operation or with four wires to allow advanced tachometer output, speed control input, and a highly linear control curve. The use of polypropylene, PTFE, EPDM, and FFMP materials for components that come into contact with pumped media enables good chemical resistance.
KNF Neuberger Inc.
TRENTON, NJ

In-line check valve
The A220-ADM16 in-line check valve developed by NP Medical is suited for such medical device applications as infusion therapy and enteral feeding. The acrylic valve features a preloaded, normally closed latex-free silicone diaphragm that allows flow in one direction while preventing flow in the opposite direction. Composed of a sonically bonded, DEHP-free thermoplastic body and an elastomeric diaphragm, the valve provides an opening pressure of 0.05 bar with consistent flow characteristics. Fully tested for back pressure and cracking pressure, it withstands a minimum internal air pressure of 3.1 bar with no visible signs of leakage. Manufactured in a Class 100,000 cleanroom in ISO 13485-certified facilities under CGMP guidelines, the valve is made from USP Class VI-approved materials and fits 3.4-mm-OD tubing.
NP Medical
CLINTON, MA

Hemostasis valves
A pair of single-handed hemostasis valves from Qosina Corp. are available in two models: part number 80328, which features an internal diameter that accepts tubing up to 7 Fr, and part number 80329, which accepts tubing up to 9 Fr. Both valves include an easy push-pull mechanism that allows the operator to open and close the valve with one hand. In addition, the valves can be closed traditionally by turning the cap three times to create a seal. Once sealed in this fashion, the valve locks and cannot be reopened via the push-pull method. Made of polycarbonate and silicone, these valves have a rotating male luer lock and a female-luer-lock side port for flushing out the line or checking pressure.
Qosina Corp.
EDGEWOOD, NY

Custom check valves and pumps
A family of check valves and pumps for precise flow control of liquids and gases in advanced low-pressure, low-flow applications is available from Smart Products. The manufacturer offers all of its valves with customized plastic body materials, O-rings, and the desired opening spring pressures, which can range from 0.07 to 20 psi. Designed for easy insertion into any medical device requiring precise flow control, the pumps are configured as single-diaphragm, positive-displacement, or rotary-diaphragm units and offer a range of output pressures and flow rates. The company's ISO 9001:2008-certified manufacturing facility is equipped to meet both medical device industry requirements and specific customer design criteria. It also provides cleanroom molding and assembly, gamma or EtO sterilization, autoclaving, and other capabilities. Custom assembly, special testing, and other value-added services are offered as well.
Smart Products
MORGAN HILL, CA

High-resolution syringe pump
A high-resolution syringe pump for use in automated medical instrumentation is suitable for a variety of applications, including sheath flow and cell counting. Offering up to 192,000 microsteps per full stroke, the C24000 from TriContinent Scientific Inc. addresses the need for low-flow, minimal-pulsation fluid handling. Capable of dispensing microliter to 12.5-ml quantities of fluid per stroke, the company's C-series syringe pumps utilize a proprietary direct-drive design that eliminates the use of belts, which often stretch and wear out, according to the company. The pumps' self-lubricating drive mechanism has been life-tested to several million cycles without the need for maintenance. In addition, the pumps use standard communication protocols and mounting configurations, eliminating the need for redevelopment.
TriContinent Scientific Inc.
GRASS VALLEY, CA

Solenoid valve
At 4.5 mm wide, a flipper-type isolation valve supports miniaturization while matching or surpassing 10-mm valves in terms of fluid-handling performance, according to its manufacturer. The Type 6650 valve from Bürkert Fluid Control Systems enables manufacturers of medical equipment and instruments to pack more valves and functionality into a given space. Its optimized internal design facilitates flushing of materials through the device in the manner of rocker valves, helping to eliminate reagent waste and cross-contamination while enhancing process safety. Patented flipper technology incorporates an elastomeric element that moves between two opposed valve seats under the force of permanent magnets fixed to the flipper element, opening one seat as it closes the other. Because this operation requires only a temporary pulse, it exhibits a short response time. The low-wear valve ensures reproducible fluid-handling performance.
Bürkert Fluid Control Systems
IRVINE, CA

Medtronic Power Struggle Puts Emerging Technologies in the Spotlight

It's been a rough month for Medtronic's implantable cardioverter-defibrillator (ICD) business. The medical device industry giant has been squirming in the hot seat after issuing a safety warning to physicians on March 6 notifying them of a small risk of premature battery depletion in certain models of the company's EnTrust and Escudo lines of ICDs. And as patient panic probably mounts, the industry awaits any word or evaluation of the warning from FDA, and lawyers likely prep for battle, the power-related defect underscores the potential market for emerging energy harvesting technologies for cardiac rhythm-management devices.

Medtronic EnTrust ICD

Medtronic has issued a safety warning for its EnTrust ICD owing to a small risk of premature battery depletion in certain models. Image courtesy of Medtronic.

At the root of the ICD issue is an internal short circuit in the battery that can develop as capacity is consumed, often occurring about 2.5 years after implantation. "Typically, these heart devices have three months of normal operation after the device signals the need for replacement," Medtronic spokesperson Tracy McNulty told MedCity News. "EnTrust devices may require replacement sooner than expected, and result in less than three months of normal operation once the device indicates the need for replacement." As a result, the battery could run out sooner than anticipated, thereby losing the ability to pace or shock the heart as needed.

In response to Medtronic's warning, British regulators at the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a medical device alert last week for the EnTrust ICD. The agency stated that, based on available data, affected EnTrust ICDs demonstrated a rapid voltage decline from elective replacement indicator (ERI) to end of life (EOL) ranging from 96 days to 6 days, with a mean of 41 days. On the bright side, no patient deaths or serious injuries have been reported, according to Medtronic. Furthermore, the company asserts that the battery issue has been identified in less than 0.1% of the models.

To address the issue, MHRA states that all cardiologists and cardiac physiologists should follow up with EnTrust ICD patients within one month if the device has been implanted for longer than 28 months and within three months for other cases. Physicians should test for audible alerts indicating low battery voltage ERI and excessive charge time EOL; advise patients to act immediately if the alert should sound; and track and compare battery voltages during visits for evidence of rapid voltage drop. In addition, the agency recommends that  doctors replace ICDs in which the ERI has been reached in the presence of such a rapid battery voltage drop within two weeks; review patients every three months; and ensure that patients are enrolled in the CareLink program for monitoring and discussion. MHRA doesn't, however, recommend replacement of EnTrust ICDs unless absolutely necessary.

With all of this hubbub surrounding batteries and power issues for cardiac rhythm-management devices, it's hard to prevent one's mind from wandering to the heavily researched area of energy harvesting as a supplemental or autonomous power source. After all, if commercialized, these technologies could eliminate many of the issues presented by battery use and size in such medical implants as ICDs and pacemakers.

And potential power sources are diverse, to say the least. Researchers are exploring options for harvesting energy from irregular vibrations such as walking, from natural body movements such as breathing, from wasted energy, and from differential energy in the chambers of the human heart. Most recently, researchers at the University of Michigan (Ann Arbor) designed a technology to harvest the ambient vibrations from the reverberation of heartbeats through the chest and convert them to electricity to power ICDs and pacemakers.

But that's not to say these energy-harvesting technologies are the panacea for pacemakers and ICDs. They present their own unique challenges, after all. "Energy harvesting can power a pacemaker infinitely long, but at any instant, what is that requirement for the amount of power that I need?" said Guarav Jain, senior research manager, battery research, at Medtronic during a presentation at MD&M West in February. "On the energy-harvesting side, it's [also] important that there are certain engineering wear-out mechanisms; that's where the limitation would come in as to longevity."

So, while there are still a lot of challenges and issues to work out in terms of energy harvesting  for implant powering, it's certainly an exciting research area. The need for such innovative technologies is becoming increasingly evident, after all, as implants continue to shrink--leaving less real estate for bulky batteries--and battery-related defects, as seen in Medtronic's EnTrust ICD, draw unwanted scrutiny while potentially putting patients at risk. --Shana Leonard