Originally Published January 2000
CDRH set to introduce a new electronic communications link that it claims will facilitate contact with industry.
- What makes FDA inspectors mad
- Standards for reprocessed devices
- HIMA rebuffed by CDRH chief
- Key CDRH staff changes
- ISO problems for FDA foreseen
- No "surrogate" inspections
Frustrated in its efforts to achieve product review efficiencies and greater industry cooperation as its resources continue to dwindle, FDA's Center for Devices and Radiological Health (CDRH) is about to launch an ambitious direct electronic communications link with the companies it regulates.
CDRH director David. W. Feigal has told this reporter that the project will use new communications technology to establish two-way conferencing on the Center's Web site and sophisticated e-mail messaging using a database of companies sortable by product and therapeutic category. The initiative aims to make CDRH independent of trade associations, none of which has even 10% of the total industry base as members, said Feigal. Not that CDRH has anything against such groups—Feigal maintained that the organizations are free to participate in the forums and other means of dialogue the Center will open directly with companies.
The new communications system, Feigal said, will be introduced in the CDRH director's traditional annual letter to all device company CEOs: "It will be very short, written in plain language, and it's essentially going to be an invitation to go to our Web site and start looking at our annual report, and follow the links there." The report would be upgraded to be a current—rather than retrospective—document, with eye-catching banners highlighting topics in a way intended to capture the viewer's curiosity, said Feigal, who is a computer and cyberspace aficionado.
Feigal sees the new electronic communications vehicle as a good way of resolving industry dissatisfaction with FDA's response to FDA Modernization Act (FDAMA) requirements that the agency's statutes and guidances pursue "least burdensome" means to regulatory objectives. To this end, CDRH "needs to roll up our sleeves the way we did with standards, and get very specific, down into the specific product classes," Feigal said. "We're going to need help from the manufacturers to do this. [Office of Device Evaluation director] Susan Alpert, before she left, made the offer to companies to send us drafts of approaches they want us to take, such as evidence needed to show effectiveness and what should be
Although an authoritative list of all the things that could upset your average FDA inspector inside a medical device facility is unlikely to ever be published, attendees at a recent conference got an informal start on such a list from one of the agency's investigators.
"These are the things that make us mad," FDA Division of Emergency and Investigational Operations investigator Karen A. Coleman told a University of Rhode Island device GMP conference in Denver, prefacing a list of the worst process-validation violations she had encountered. Heading the list was "No process validation," followed by "Lack of sufficient data to demonstrate reproducibility," "No performance parameters specified prior to the performance qualification rules, or you are still changing them," and "Sample sizes not based on a reasonable rationale."
Coleman singled out for criticism a remark she said she has often heard while inspecting a facility: "This process is an art." That statement, she said, "tells me you really haven't applied scientific methods and principles to the process."
FDA says it would like to evaluate recognized consensus standards to determine if they could be used in reprocessing single-use devices (SUD), and also wants to identify and develop device-specific standards for reprocessed SUDs. With such standards in place, the agency says, it may be possible to allow SUD reprocessors to declare conformity to a recognized standard to ensure that the device remains safe and effective for its intended use. CDRH posted a 16-page document on its Web site about developing standards as part of its proposed strategy on SUD reuse.
Until examination of the SUD policy is finished and a final policy issued, CDRH said it would not change existing policy with respect to third-party reprocessors or healthcare facilities that reprocess. Current policy is that hospitals that reprocess SUDs assume full liability and responsibility for their reprocessing actions and should ensure that the products are adequately cleaned and sterilized and that device safety, effectiveness, and quality are maintained. Third-party processors currently are subject to registration, listing, quality system regulations, labeling, and medical device reporting requirements.
CDRH's strategy has seven elements in addition to development of consensus standards. It aims to:
- Reconsider the agency's current policy on establishments that reprocess SUDs.
- Explore development of a device-categorization system that would divide SUDs into high-, low-, and moderate-risk reprocessed devices, based on the level of risk presented by reprocessing and reuse, and create an enforcement strategy based on the level of risk.
- Solicit comments on the draft list of 22 frequently reprocessed SUDs.
- Consider asking OEMs to put information on their labels about risks associated with reuse of SUDs.
- Develop definitions for some common terms used in discussing this issue.
- Consider developing a research program on reuse of SUDs and exploring avenues to publish and disseminate research and other information on reuse.
- Convene an open meeting on December 14, 1999, in Rockville, MD, to discuss the proposed strategy.
Meanwhile, federal legislation has been introduced in the House of Representatives by Anna Eshoo (D–CA) and Fred Upton (R–MI) that would require hospitals and companies that reprocess disposable surgical instruments to demonstrate their continued safety and effectiveness to FDA; direct hospitals to inform patients and to obtain their consent before using recycled instruments on them; and require hospitals to monitor and report any injuries or infections that occur as a result of use of a reprocessed medical device. The bill was sent to the House Commerce Committee for consideration.
CDRH director David W. Feigal has dismissed four complaints by the Health Industry Manufacturers Association (HIMA) that FDA has not lived up to product-approval requirements of FDAMA. HIMA's complaints were made by its new president, Pamela G. Bailey, to a hearing of the Senate Committee on Health, Education, Labor, and Pensions. The committee's chairman, Jim Jeffords (R–VT), is the principal author of FDAMA.
HIMA's four complaints about FDA's performance as given to Jeffords are as follows, with Feigal's responses:
FDA has failed to support the implementation of binding determination and agreement meetings.
Feigal: I am unaware of any request for such a meeting that has been turned down. Interestingly, at about half of the meetings the companies ask not to have a binding agreement because they think they have multiple development options and are not willing to be bound to a single course. I don't think we have anticipated this. It isn't that the companies disagree with any of the options, just that they are not willing to be bound on their side.
FDA has failed to implement FDAMA's "least burdensome" requirement, so the agency's demands for proving effectiveness remain unrealistic and inappropriate in too many cases.
Feigal: HIMA's proposal is that companies begin by submitting minimal data and then if it is unsatisfactory that they submit more until they reach the least burdensome amount. There is nothing to keep a company from doing this. Many already do if they have the lead time for multiple submissions. We felt that we should start at a minimum with the well-worked-out precedents and then see if we could accomplish the same with less. I think we are talking about the same thing. It appears to be very symbolic for HIMA to start low and work high, rather than start with what already worked and see what can accomplish the same thing. You might note that we were asked if we had read HIMA's proposal. In fact, it is attached to ours on the guidance Web site so sponsors can read both. Is HIMA also trying to communicate our message to their membership and the 11,000 manufacturers who don't belong to their association? You can't get to their guidance on their Web site because it is password-protected for members only.
FDA has failed to promulgate a scientific-dispute-resolution process regulation or, in the interim, to provide for a satisfactory informal scientific-dispute-resolution alternative.
Feigal: I am not aware of any dispute-resolution request that has not been acted on. We have not had a request for an outside panel as specified in the statute. We have had requests for appeals to the commissioner's office and we have promptly referred them. I would be happy to have any dispute brought to my attention. The mechanism is in place and there is guidance available on the multiple entry places into the system. The flexibility of having multiple ways to get things moving seemed to be criticized by HIMA, which seemed to find it confusing. Part of our dispute-resolution program's function is to help people who think they are stuck get unstuck. The ombudsman position (announced as open this week) will be a single point-of-contact to get things started for those who do not want to work more directly with the branch or division.
FDA has failed to implement a successful third-party review program.
Feigal: Last year, of the 1200 applications that were eligible for third-party review, only approximately 20 did so. They were reviewed without a hitch in about half the FDA time. We thought that development time was money and were a little surprised that there wasn't more interest. I'm not sure how long the third-party reviewers will stay interested if they don't get any business. Although the costs of third-party review are modest, it seems not to be worth it compared to the slower, but still fast, FDA review. If that is the case, then it doesn't seem likely that expanding the program will help. HIMA seems to be taking a position to its membership that the program is not useful to those who already have it available. Since HIMA represents less than 10% of all device manufacturers, however, we may need to find more-direct ways to communicate with the device community than through HIMA.
CDRH has named division of general and rehabilitation devices director Celia Witten, MD, as acting director of the division of cardiovascular and respiratory devices, replacing Thomas Callahan, who died on October 16. Deputy director of the division of general and rehabilitation devices Jim Dillard will become the division's acting director in Witten's absence. In addition, division of ophthalmic and ENT devices deputy director Nancy Brogdon has been named interim deputy director for the division of cardiovascular and respiratory devices.
It's too soon to say, but FDA is apprehensive that it won't be able to adopt the ISO 2000 standards for medical devices now being developed, CDRH quality systems expert Christine Nelson told a University of Rhode Island device GMP conference in Denver in October. FDA's quality system regulation is based firmly on ISO 2000's predecessor, ISO 9000, which is still in effect. Nelson said that the automobile industry is heavily influencing ISO 2000, which is trending toward continual product improvements and customer satisfaction. "As a regulatory agency, we don't know how we could enforce that," Nelson said. "There is a real dilemma as to how this will apply to the medical device industry."
CDRH won't go ahead with a suggestion that it develop "surrogate" inspections by medical device company management in conjunction with external GMP audits as an economy measure, Center Office of Compliance branch chief Tim Wells told Dickinson's FDA Webview in October. Wells was attending a University of Rhode Island medical device GMP conference in Denver, at which he described new developments in the quality system inspection technique (QSIT), which he said were driven by diminished resources for traditional enforcement activities. Instead of pursuing "surrogate" inspections, Wells said the Center will likely look at other options focused on increasing management responsibility for complying with the 1996 quality system regulation (QSR). One such option would be to reduce the frequency and intensity of QSR inspections for firms that had an excellent compliance profile at previous inspections.
Wells told the Denver conference that the necessity for QSIT and higher-management responsibility is dramatized by steadily dwindling agency resources, which are pushing device GMP inspections ever further away from the statutory requirement of every two years. At present, said Wells, it is more likely that such inspection will only be held every seven years at medical device companies. QSIT's target of increasing management responsibility is intended to cope with this lighter schedule by making firms so compliant that inspections can be conducted more quickly and less intrusively. "QSIT inspections start and end with management," Wells said.
The key question FDA is training its investigators to ask themselves throughout every stage of every inspection is, "Did management ensure that an adequate and effective quality system has been established?" Investigators are trained to focus especially on the firm's corrective and preventive actions program under the QSR.
Details of the current FDA training program for investigators doing QSIT inspections are given in an internal guide available on CDRH's Web Site.
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