MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Researchers Put Their 'Stamp' on Carbon Nanotube Applications

A Rice University graduate student determined a method for transferring carbon nanotube patterns from one substrate to another within minutes.

A Rice University graduate student determined a method for transferring carbon nanotube patterns from one substrate to another within minutes.

The way in which a gecko can stick to a wall has been scrutinized by scientists, who have spent time researching how to replicate van der Waals force in components and adhesives. A Rice University (Houston) graduate student recently applied this principle to a new method of pattern transfer, however, that could lead to advancements in novel carbon nanotube-based applications such as sensors and nanotube circuitry in electronic devices. While experimenting with using water vapor to clean up carbons on nanotubes, graduate student Cary Pint discovered that water could serve as the crux of a pattern-transfer technique.  Employing chemical vapor deposition (CVD), Pint first grew single-walled carbon nanotubes on a substrate. Next, by etching the nanotubes with a blend of hydrogen gas and water vapor, he was able to weaken the bonds between the materials and the metal catalyst. This process readied the patterned single-walled carbon nanotubes for transfer to another substrate. After etching, Pint applied the nanotube-covered substrate to another surface. Likening the transfer method to a rubber stamp, Pint notes that upon 'stamping' the new surface with the nanotube-covered substrate, the nanotubes adhered to the new substrate thanks to van der Waals force. Thus, the technique was able to effectively transfer the nanotube pattern from one substrate to another within minutes. Furthermore, because the catalyst particles remain intact on the original substrate, it can be used as a template on which to grown another batch of carbon nanotubes, according to Pint. In addition to the pattern-transfer technique, Pint also determined a way to easily determine the range of diameters in a given batch of CVD-grown nanotubes. These processes and more are detailed in a paper authored by Pint and his colleagues that was published in the journal, ACS Nano.

Gems Sensors Forms Fluid-Handling Operating Group

Gems Sensors (Plainville, CT) has announced the formation of the Gems Medical Sciences operating group, which promises to deliver "an elite level of engineering, manufacturing, and customer service" to fluid-handling applications in the life sciences. With facilities in Germany, France, Italy, the United Kingdom, China, and Japan, Gems Sensors felt that the time was right to create a division that could address the need for precision application-engineered fluid-handling systems and components in the medical device, diagnostic, life science, and biotechnology sectors, according to Jessica Light, the company's sales and marketing manager. Gems Medical Sciences will combine the parent company's array of intelligent sensors and controls with dedicated engineering expertise, lean manufacturing, and ISO certification. With a broad IP portfolio and decades of application engineering experience, the group is prepared to provide OEM clients with the resources and services they need to develop their next fluid-handling solution, Light remarks.

CDRH Launches Probe into Radiation Overdoses

It was three months ago when Cedars-Sinai Medical Center in Los Angeles announced that over an 18-month period, 260 patients had been exposed to unusually high—eight times higher than normal—radiation doses from CT brain scans. Then a similar situation occurred at Glendale Adventist Medical Center, also in Los Angeles county, although there were only 10 patients affected. Their doses were three or four times normal levels. By December, a third county hospital had reported radiation overdoses, this time Providence St. Joseph Medical Center in Burbank. In addition, a woman who received a CT brain scan at Huntsville Hospital in Alabama received an even higher dosage than the Cedars-Sinai patients. Overall, more than 300 people received elevated doses of radiation.

These incidences were especially mysterious because the equipment could not be traced back to a single manufacturer. In several cases, General Electric manufactured the scanners. A Toshiba machine was involved in the Burbank incident.


“Given the fact that we are dealing with two manufacturers and multiple institutions, we wouldn’t be surprised” to find problems elsewhere, then-acting CDRH director Jeffrey Shuren told the Los Angeles Times late last year.

The center is urging CT technologists to “go back to basics” to ensure that patients receiving CT perfusion scans are not exposed to excess radiation. Shuren told a media briefing in December that FDA is making recommendations for facilities and technologists to follow for all CT perfusion scans while the agency continues its investigation to determine whether problems lie with the equipment, human error, or a combination of the two. He said that over time, facilities may rely on algorithms to calculate the appropriate dosage and that FDA recommends that technologists verify before all scans that the dosage is appropriate for the patient. The agency’s recommendations are as follows:

?    Facilities assess whether patients who have undergone CT perfusion scans received excess radiation.
?    Facilities review radiation dosing protocols for all CT perfusion studies.
?    Facilities implement quality control procedures.
?    Radiologic technologists check the CT scanner display panel before performing a study.
?    If more than one study is performed on a patient during one imaging session, practitioners should adjust the radiation dose so that it is appropriate for each study.

When reporters said that the recommendations seem to be things that should be done routinely, CDRH Division of Mammography Quality and Radiation Programs associate director Charles Finder said that FDA’s intention was to remind facilities and staff of routine good practices.

Shuren said that it is important for patients who have been exposed to excess radiation to be seen by their doctor.

When FDA Takes Its Complaints to Your Customers


SS1
FDA took its message to the streets after it determined that Steris had not complied with the agency’s directive to stop marketing the SS1 shown here. Image courtesy of STERIS CORP.
During the course of 19 months, FDA inspected Steris Corp. twice and issued a warning letter to the company to cease marketing the Steris System 1 (SS1) sterile processing system, which Steris failed to do. In response to that failure, FDA issued a letter to healthcare facility administrators and infection control practitioners saying that they should switch to alternative, legal sterilization and disinfection systems.


According to FDA, this was a step that the company had said that it would take voluntarily 19 months before. Based on an inspection in May 2008, FDA determined that the SS1 had been so significantly modified that it was now adulterated and misbranded, and therefore illegal. But FDA says that Steris delayed by seven months a commitment it made to notify SS1 customers and users about FDA’s concerns and to advise them, in FDA’s words, that they should transition to a legally marketed alternative.


Still far short of that commitment much later, Steris’s Web site was still describing the SS1 in mid-December 2009 as
“the proven, low-temperature sterile processing system for immersible surgical and diagnostic devices. Even delicate, heat-sensitive scopes, cameras, instruments, and accessories can be safely sterile processed in 30 minutes—just in time (JIT) for each procedure.” The site was offering the device for sale “in the U.S. on a ‘one for one’ replacement basis only. Steris,” it said, “will continue to support System 1 for at least two years from the date of the notice with the sale of all accessories, Steris 20 sterilant, service, parts, and replacement units.


“Steris,” it continued, “has submitted a 510(k) premarket notification for an updated System 1, which is currently under review by FDA. Steris will work with our customers on a timetable to transition to the purchase of a replacement.”


Apparently, the company was not getting into the spirit of FDA’s intentions, and a second inspection by the agency found
Steris had not, in FDA’s strained words, “been working effectively to transition its customers to replacements for the SS1.” That’s when FDA decided to go directly to the company’s customers and SS1 users, issue a news release, and open detailed Web pages about the problem on the agency’s Internet site.


The agency’s online notice, signed by CDRH compliance director Timothy A. Ulatowski, spoke of “some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections…” and “reports of injuries, mostly burns from exposure to the sterilant solution.” However, FDA apparently felt it did not have enough to go on to support conventional legal action—i.e., product seizure and a federal court complaint for injunction restraining Steris from its continuing defiance.

Ulatowski
In FDA’s online notice, Ulatowski said that there were malfunctions of the SS1 and reports of injuries—but apparently not enough to justify product seizure.


On the surface, the situation stands in sharp contrast to the civil money penalties action FDA took against the arguably similarly defiant manufacturer of temporomandibular joint implants, TMJ Implants Inc. (TMJI). It might be observed that unlike the Steris case, TMJI’s situation involved alleged adverse-event reports about a Class III implant, rather than a mere 510(k)-level sterilizing system that had been modified without FDA’s consent.


Still, the unusual approach to Steris’s disobedience bared some FDA teeth that are seldom seen in public, teeth that may provide the agency with swifter and more effective results in future enforcement actions than conventional redress to seizure and injunction. By going directly to a balky firm’s customer and user base, FDA is spared the delay inherent in preparing litigation strategies that meet Department of Justice standards—although in FDA parlance, delay is a relative term when you consider that it took the agency nearly a year to implement its response to Steris’s defiance.


Steris’s spokesperson Stephen Norton says that “daily conversations are under way with FDA to reach a resolution to the regulatory matter that is in the best interest of [our] customers.” Norton encourages customers to visit www.steris.com to learn more information about the issue.


How much notice should other companies take of FDA’s unusual action in this case? In a prepared statement, Ulatowski said rather stiffly that “the agency will use the enforcement tools at our disposal to help protect the public health from medical devices violating the law.” He went on to say that

We review industry’s decisions regarding modifications to devices and whether a new 510(k) is needed on a case-by-case basis. FDA informs the industry regarding obligations regarding changes to 510(k)s in guidance, releasable industry records from 510(k)s, observations from inspections and any subsequent actions taken by FDA, answers to numerous calls to FDA on this topic, and presentations to the public, to name a few sources of information from FDA. Other means to foster communication with the industry on this topic are being considered. It’s important that companies keep lines of communication open with FDA and realize that in the case of uncertainty, a call by a manufacturer to the agency could prove helpful.


TMJI Seeks En Banc Review of Court Defeat

Device maker TMJI and its president have petitioned the U.S. 10th Circuit Court of Appeals for an en banc (all 12 judges) review of their appellate loss last October to FDA. The company is arguing a within-circuit decisional conflict, denial of “substantive due process” at FDA, and agency failure to meet its own civil money penalties burden-of-proof requirements. The three-judge unanimous ruling in October 2009 endorsed FDA’s $340,000 civil money penalties imposed for failure to file 17 medical device reports (MDRs) involving the company’s temporomandibular joint implants, effectively affirming that the agency has the last word in interpreting its own regulations.


In their 18-page request for en banc review, TMJI and president Robert W. Christensen contend that the appellate panel’s decision “conflicts with and ignores the prior recent decision in this circuit of the federal district court for the State of Utah…that was involved with the issue of how broad a latitude FDA should be given in the interpretation of its published written policies applicable to companies it regulates.” This 2005 case, U.S. v. Utah Medical Products, has since been written out of FDA enforcement history. It established that in QSR and GMP compliance, FDA may not prescribe how industry is to reach compliance (“many roads lead to Rome”).


FDA argued in the TMJI case that the Utah case was too different to be relevant. However, both in their appeal to the 10th Circuit and in their request for en banc review, TMJI and Christensen persist in their contention “that the court’s decision in Utah Medical be considered as controlling precedent for evaluation of the MDR regulations at issue in this [civil money penalties case].”
On due process, the petitioners contend that the three-judge panel “ignored completely” their “indisputable facts of record” on a “process failure” in the handling of the case at FDA—a failure that had been admitted to two Congress members by former commissioner Andrew von Eschenbach. This involved alleged preparation of the civil money penalties case while the agency mislaid TMJI’s appeal to the commissioner for eight months, a process the petitioners have called an “ambush” and “treachery.” Citing criteria established in a 1976 Supreme Court case, Matthews v. Eldridge, they say they “never received any real substantive due process at the administrative level.”


Regarding FDA civil money penalties burden-of-proof requirements, the petitioners allege that the agency failed to meet—and that the appellate judges ignored—the requirement of CFR part 17.33 that there be a “preponderance of evidence.” In nine of the 17 events, FDA redacted device-identifying information, the petitioners say, contending that nowhere in the underlying statute or in the MDR regulations is there legal justification for the panel’s interpretation—i.e., “that in such situations, MDRs are required even though the device was not the ‘cause in fact’ or even though there is not enough evidence to support a conclusion that the device caused or contributed to a serious injury.”


Endotec Cited for QSR Violations on Implant Production

In December, FDA released a warning letter to Endotec Inc. that resulted from an inspection last May at the company’s Orlando, FL, orthopedic implant manufacturing facility. The inspection revealed multiple violations of FDA’s quality system regulation (QSR). According to the letter from FDA’s Florida district office, observations listed on an FDA-483 included:

?    Failure to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint, and another investigation is not necessary.
?    Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its
specifications.
?    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
?    Failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met.
?    Failure to establish procedures for quality audits and to conduct such audits to ensure that the quality system is in compliance with the established quality system requirements and to determine the quality system’s effectiveness, with quality audits conducted by individuals who do not have direct responsibility for the matters being audited.

The letter said the adequacy of responses Endotec made to these observations could not be determined because they lacked sufficient details on steps the company planned to take to address the issues, and there was no supporting documentation of the steps taken or planned.


Endotec was told to take prompt action to correct the violations (see the sidebar “Endotec: Corrections and Removals”) and to respond with a listing of specific steps taken. The firm’s response must include an explanation of how the company plans to prevent these or similar violations from occurring again. FDA also requested documentation of the corrective actions with a timetable for their completion.


Stryker Recalls Surgical Navigation Device

CDRH reported in December that Stryker had recalled its Operating Room System II Surgical Navigation System. A recall notice says that the device is a computer-aided surgery platform that surgeons use to perform hip, knee, spine, neurology, and ear, nose, and throat surgery. The product was manufactured from March 31 through July 16 and distributed from March 31 through July 28 of last year.


The October 26 Class I recall was initiated because the device may suddenly stop working, CDRH said, the screen may freeze, or the information may update very slowly. The problems may affect all software products used on the workstation. Such failures could result in surgery delays, risk of infection, increased disease symptoms, potential neurological problems, or injury due to the surgeon operating in an unintended area. Depending on the type of surgery, the notice said, the failures could lead to serious adverse health consequences, including death.


Swedish Imports by Abbott Medical Optics Blocked

FDA recently revealed that it was refusing to admit Healon D ophthalmic viscoelastic devices to the U.S. market. The products are made by Abbott Medical Optics’s Swedish subsidiary, AMO Uppsala, and the agency’s actions are due to a serious quality system violation found nine months earlier during an inspection at the firm’s manufacturing facility. A September 18 CDRH warning letter said that its “detention without physical examination” order would not be lifted until the firm’s violations were
corrected.


The letter said the inspection determined that the company failed to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedure. The firm “failed to perform and document equipment cleaning validation for production of Healon D ophthalmic viscoelastic devices,” CDRH wrote. The center said that the firm’s response to the FDA-483 was inadequate because the company did not intend to complete validation of the equipment cleaning process for producing Healon D ophthalmic viscoelastic devices for 10–15 months, pending completion of a root cause investigation from one Healon D lot that had been recalled.


The company was told to respond within 15 days with a list of specific steps taken to correct the violation, including an explanation of how it would prevent this and similar violations from occurring again. The company was also asked to submit documentation of the corrective action taken along with a timetable for completion. FDA said it would tell the company if its response was adequate and whether there was a need to reinspect the facility to verify that appropriate corrections have been made.


FDA Cites Centra Health IRB

An investigator from FDA’s Baltimore district office found “objectionable conditions” during a September 1–14 inspection last year of the Centra Health Institutional Review Board (IRB) in Lynchburg, VA, CDRH said in December. The inspection was conducted under a program intended to ensure that data and information in submissions for investigational device exemptions, premarket approval, and 510(k)s are scientifically valid and accurate. The inspections are also meant to ensure that human subjects are protected from undue hazard or risk during the course of scientific investigations.


A November 20 warning letter said that violations cited in an FDA-483 included the following:

?    Failure to conduct continuing review of research at least annually.
?    Failure to ensure that the IRB reviews proposed research at a convened meeting at which a majority of the members are present.
?    Failure to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings.
?    Failure to have adequate written procedures governing IRB functions and operations.

According to the letter, Centra’s responses were inadequate in that they didn’t give specific action plans for correcting the violations and preventing their recurrence and didn’t document any changes made. The IRB was given 15 days to provide written documentation of actions that have been taken or will be taken to correct the noted violations and prevent recurrence of similar violations.


Medtronic Cardiac Rhythm Unit Gets Warning Letter

An FDA inspection last June at Medtronic’s Cardiac Rhythm Disease Management business unit in Mounds View, MN, found quality system violations in the firm’s manufacturing of implantable pacemakers and pacemaker leads. The agency recently posted a November 9 warning letter from its Minneapolis district office that says the violations included the following:

?    Failure to establish and maintain adequate corrective and preventive action procedures to ensure consistent handling of investigations of the cause of nonconformities relating to product, processes, and the quality system, and identification of actions needed to correct and prevent recurrence of nonconforming product or other quality problems.
?    Failure to follow procedures for validating or verifying design changes before their implementation.
?    Failure to implement procedures addressing documentation of corrective and preventive action activities.
?    Failure to establish and maintain adequate design validation procedures to include risk analysis.
?    Failure to implement procedures for document control.
?    Failure to establish and maintain adequate procedures for purchasing controls ensuring the type and extent of control to be exercised over the product.

The district office told Medtronic to take prompt action to correct violations addressed in the letter. It noted that company responses had promised corrective action but that several of the actions have not been completed. It said that the promised corrective actions appear to be adequate but a follow-up inspection will be needed to ensure that corrections are implemented and effective.


The letter also said that the inspection found deficiencies in MDRs, including failure to submit five reports within mandated time frames. Again, it said, the promised corrective actions appear to adequately address the deficiencies and will be evaluated during a follow-up inspection.

Endotec: Corrections and Removals

?    Failure to include in the report of corrections and removals to FDA information on the device’s model, catalog, or code number and its manufacturing lot or serial number or other identification number.

February 2010 Contributors

He has more than 17 years of industry expertise and has been involved in every aspect of biocompatibility and toxicology testing from study design, to execution, to report writing. Contact him via e-mail at [email protected].

Ryszard Rokicki is author of “Detecting Nitinol Surface Inclusions.” He is owner of Electrobright (Macungie, PA). Currently, hRokickie collaborates with several medical and dental device companies on the implementation of U.S. Patent 7632390 as a finishing step for endovascular nitinol stents, titanium and nitinol bones implants, and endodontic NiTi rotary files. Reach him at [email protected].
 
Rahul Sathe wrote “Neurostimulation in the New Decade.” He is a senior engineer at Cambridge Consultants (Cambridge, MA), an engineering firm that designs medical devices, wireless technology, and consumer technology. His experience includes design, manufacturing, and supplier quality for implantable medical devices, specializing in cardiac rhythm management, neurostimulation, and cardiovascular devices. He has an MS from Georgia Institute of Technology and a BS from the University of Michigan in mechanical engineering. Contact him at [email protected].
 

Ravi Shankar is author of “10 Steps to Managing Master Data for Devices.” He is senior director of product marketing for Siperian (Foster City, CA). With more than 20 years of experience, he directs product and technical marketing activities for the Siperian Multidomain MDM Hub. Shankar is a published author on MDM and data governance. Previously, he directed product marketing, management, and business development efforts at Oracle. Shankar has an MBA from the Haas School of Business at the University of California, Berkeley. Reach him via e-mail at [email protected].

Margretha Zecchini is author of “Following the Road to Regulation.” She holds a BS in business administration from Gwynedd-Mercy College and an MS in bioscience regulatory affairs from Johns Hopkins University. Previously, she was a senior paralegal with Wyeth Pharmaceuticals. Zecchini plans to pursue graduate studies in health services research. Contact her at [email protected].

An Era of Change: New ­Director, New ­Direction for FDA?

color:black;letter-spacing:-.05pt">Jeffrey Shuren, who has been the acting chief of CDRH since the departure of Daniel Schultz, is now officially director of the device unit. On February 1, FDA also announced that it had requested $4.03 billion for several initiatives, including to “invest in medical product safety.” The FY 2011 request represents a 23% increase over the FY 2010 budget. More than $100 million is earmarked for the Protecting Patients Initiative, part of which “will strengthen FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.”

According to FDA, the proposed budget includes support for the FDA’s investment in addressing the challenges of the 21stcentury. Among other initiatives, FDA envisions increased efforts to address medical product safety challenges and a focus on modernizing regulatory science at FDA.

Since his appointment to acting director, Shuren has begun a comprehensive review of many programs and processes and set in motion a strategic planning process. He also prioritized the support of innovation in medical devices, the modernizing of device safety efforts, and the strengthening of important internal procedures.

“On the whole, the choice of Jeff Shuren to head up CDRH is promising,” says Jeffrey K. Shapiro, an attorney with Hyman, Phelps & McNamara. “He is a board-certified neurologist and has a law degree, which is very beneficial at an agency like FDA that regulates medical technology within a law enforcement framework.” Shapiro points to Shuren’s experience in dealing with policy issues at FDA as associate commissioner for policy and planning as solid background for the job.

But, he also notes that the proof will be in the pudding, so to speak. “His stated support for innovation is welcome, but we need to see how the agency moves forward in deeds, not words,” says Shapiro.

For one thing, it will be interesting to see how Shuren and his team at CDRH allocate the funds set aside for improving safety. “From an industry perspective, rather than resulting in tighter regulations, the $100 million FDA budget request for medical product safety will instead translate into more audits and more FDA resources focused on monitoring device companies’ quality operations,” says Tim Mohn, industry principal for Sparta Systems. “More specifically, FDA is investing in technology to allow better tracking and trending of problems without sending investigators on site. This includes the recently announced eMDR legislation that requires companies to submit adverse-event reports electronically to CDRH.” Mohn says that it is in device companies’ best interest to recognize that FDA will evaluate their data in ways that weren’t possible previously. He suggests that companies reevaluate their processes and systems to ensure that they are effectively monitoring their devices.

Industry will certainly need to pay attention to every move CDRH makes. Both AdvaMed and MDMA have issued statements supporting the selection of Shuren as director, but emphasize that FDA’s new direction must also consider the impact on innovation. “Smaller companies are responsible for the majority of innovation in the medical technology arena, and we look forward to working on policies that foster innovation,” says Mark Leahey, MDMA president and CEO. Likewise, ­AdvaMed acknowledged Shuren’s role as one of the key negotiators during the reauthorization of the Medical Device User Fee Act, noting that it demonstrated that he understands the unique needs of the medical technology industry. The industry organization says that Shuren has laid out a well-defined series of goals for the device center and a clear path for achieving his objectives in areas such as regulatory approvals.

FDA has scheduled a public meeting on Feb. 18 to discuss key challenges related to the 510(k) process. A major issue for industry is whether increased regulatory oversight will have adverse effects.

“My concern is that the agency is moving toward increasing the regulatory hurdles in premarket review that will hurt innovation,” says Shapiro. “It is unclear right now whether Dr. Shuren will be able to move CDRH in a different direction. Time will tell.”


Sherrie Conroy for the Editors

Mapping the Regulatory Path of Digital Pathology Systems

whole-slide digital pathology
Whole-slide images, as pictured here can indicate various pathologies. At issue is whether these images can or should replace traditional microscopy. Image courtesy of APERIO

A new system has been overtaking the microscope as a tool for diagnosing pathogens. Whole-slide digital imaging may soon be adopted as the primary method for diagnosic surgical pathology, possibly replacing conventional light microscopy as the standard of care. But questions remain as to how it should pass through the regulatory process.

The FDA Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee met in October 2009 with experts in the field to discuss the technology and whether to require a premarket approval (PMA) process or a 510(k) clearance, and the debate is ongoing. At issue, according to transcripts of the hearing, was whether “digital whole-slide imaging [WSI] can be used safely to capture histomorphologic and cytologic features of hematoxylin and eosin (H&E) glass slides for subsequent digital review by pathologists to render pathologic diagnoses of routine surgical specimens.”

During the presentation, Tremel Faison, a scientific reviewer for FDA, argued that microscopes are Class I and exempt from premarket notification, with the exception of using the them in combination with a different technology, such as an IVD for use in diagnosis, monitoring, or screening on neoplastic disease. If WSI is used for primary diagnosis of surgical pathology specimens, it “carries the risk of serious public health consequences if erroneous results are rendered using these systems.” Faison concluded that digital whole-slide pathology must be subject to premarket submission requirements.

According to Faison, FDA’s concerns are that WSI could be used in place of light microscopy for all surgical pathology specimens, and if it is, FDA wants to know whether the quality of WSI is such that it could replace the traditional method without compromising diagnoses. She says FDA plans to ensure safety and effectiveness by requiring standardization and by requesting postmarket studies, if deemed necessary.

In regards to how FDA should assess WSI, the College of American Pathologists released a statement for the meeting. It recommended that the agency use intrapathologist variability to validate the safety and efficacy of WSI. That is, FDA should “focus on measuring whether the diagnosis arrived at using whole-slide digital imaging systems is the same as the diagnosis arrived at by the same pathologist using conventional microscopy.”

Other speakers at the conference focused on the enormous benefit the technology could have on pathology, and said that FDA should not make the matter a cut-and-dried situation. “It enables glass slides to be dealt with like digital files,” said Michael Becich, chair and professor of biomedical informatics and pathology at the University of Pittsburgh School of Medicine, during the presentation. Becich related the switch to what happened in radiology with the adoption of picture archiving and communications systems. “For a number of years, there was teleradiology. It was off to the side and in a little corner on separate machinery, and then what happened in radiology practices, teleradiology disappeared because it all became digital.”

Becich also refuted the notion that WSI would replace glass slides. “The glass slide is still there,” he said. “In a whole-slide imaging environment, I think we should promote the concept that the pathologist remains in control and can go back to the glass slide and can do all the things they do today.”

According to Becich, both methods use objective tools. “We’re not really talking about changing the way that we acquire images from glass. We’re just changing the way we distribute them.”

AAMI Vows More Interaction in 2010

With the anticipated completion of a device connectivity standard and the rapid growth of home healthcare, AAMI aims to enable medical device OEMs adjust to the requirements of a new standard. IEC 80001, “Application of Risk Management for IT—Networks
Incorporating Medical Devices,” deals with risk management and connectivity challenges that require coordination between clinical engineers in hospitals and OEMs.

“I think a major question for device manufacturers is how to get the standard on the radar screen of hospitals. The second question is how to get hospitals to buy into it, which is probably the biggest challenge, because it’s a new idea to have a standard apply and put responsibilities on hospitals,” says Mary Logan, president of AAMI.

The standard is anticipated to be out during Q4 2010, after which, AAMI plans to provide guidance documents, educational workshops, and training materials to help OEMs implement the standard.

Another area of focus for AAMI in 2010 is home healthcare. “The push on decreasing the cost of healthcare and making healthcare efficient and patient centric—all of those efforts are going to lead to more care being provided outside of the traditional hospital setting,” says Logan. Moving healthcare into the home, an uncontrolled environment, could pose new challenges. AAMI plans to support firms that have a presence in home healthcare, especially because there are no regulatory aspects to this sector in the healthcare reform legislation, according to Logan.

GHTF Outlines Recommendations for a UDI System

The FDA Amendments Act of 2007 requires FDA to create a UDI system for medical devices. The agency has not set a deadline for the establishment of this system, but it did hold a public workshop in February 2009 to collect feedback from stakeholders.
According to the GHTF paper, UDI would improve patient safety by reducing device- related errors, make it easier to identify devices in case of adverse events, and help facilitate traceability. The organization argues that a successful system would be globally applicable, and free of regional adaptations.

GHTF offers guidance for establishing a UDI system (see the sidebar “Essential Principles for a UDI System”). For example, it suggests that the GS1 system and the health industry bar code (HIBC), which are internationally accepted coding systems, be adopted and implemented.

The Health Industry Business Communication Council (HIBCC) supports GHTF’s recommendation of both of these codes. It says, “The fact that a large percentage of manufacturers are already using one of these standards means that widespread compliance will be achievable in the shortest time frame and the lowest cost to the industry.”

However, HIBCC does want clarification from GHTF about the section that says UDI codes should include a combination of static information (device identifier) and dynamic information (product identifier). HIBCC says that more-specific guidelines should be provided “on the class of product that warrants the inclusion of a machine-readable bar code or RFID tag for the dynamic component of the UDI.” HIBCC suggests that the dynamic component be mandated for such devices as implants, but not for more basic products such as drapes and dressings.

Also, HIBCC says that GHTF should allow for country-specific requirements in the UDI database (UDID). The GHTF document calls for a UDID that is publicly available and free of charge.

To facilitate global data exchange, GHTF proposes that regulators in all jurisdictions use the same identification attributes. But HIBCC says that this overlooks the need to accommodate certain country-specific requirements.  For example, a UDID in Australia should include the attribute of rebate codes, which are assigned to implants for insurance purposes.
GS1 Healthcare, another bar code organization, says it welcomes harmonization. “It will make the healthcare supply chain worldwide safer and more efficient if a global UDI system without regional adaptations is implemented,” according to Ulrike Kreysa, director, healthcare for the GS1 global office. The deadline for submitting comments in response to the GHTF document is March 31, 2010.  

To read the GHTF document, visit www.ghtf.org/ahwg/ahwg-proposed.html