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Originally Published April 2000

A draft guidance document issued in February details the agency's new across-the-board enforcement scheme for reprocessed devices.

FDA has traditionally offered a consistent response to complaints from single-use medical device manufacturers about the growing practice of reprocessing and reusing their products. In a nutshell, the agency has told industry, "Show us the dead bodies."

Of course, a reused single-use device (SUD) is a lost sale, and the economic loss to the product maker has been a driving force behind the pressure on FDA to act. An opposing driving force is the need of the cost-beleaguered hospital industry to economize wherever it can by reusing as much as it can.

In the absence of dead bodies, FDA has been caught in the middle. With diminishing fiscal resources and its facility inspection rate at less than 40% of what the law requires, the agency has been reduced to acting only against public health threats. Any rationale it might have had in acting against technicalities under economically motivated pressure may well have been contradicted by the interests of its sister agency, the Health Care Financing Administration (HCFA), in reimbursing hospitals as little as possible for medical procedures.

Despite these disincentives, last October FDA cautiously began moving—without announcement—against selected reprocessing firms that it found to be in violation of good manufacturing practices. But it was in February that FDA's Center for Devices and Radiological Health (CDRH), under a refreshing new director in the person of David W. Feigal, significantly escalated its regulatory pressure when it announced a phased-in, across-the-board enforcement scheme for reprocessed devices.

Appearing before the House Commerce Oversight and Investigations Subcommittee, Feigal said FDA will move first against reprocessed percutaneous transluminal angioplasty catheters, requiring them—among other products—to come under Class III premarket approval (PMA) requirements. Feigal testified that CDRH studies "have determined that cleaning and sterilizing these devices are very difficult. Hospitals and third parties that reprocess these devices would be required to submit to the agency PMAs demonstrating that their reprocessing of these devices is safe and effective, in addition to conforming to the general controls of the FD&C Act."

It may not have been a serendipitous coincidence that, a few weeks earlier, the Association of Disposable Device Manufacturers (ADDM), in formal comments on the emerging CDRH enforcement scheme, had charged Feigal's center with failing to regulate reprocessed percutaneous transluminal coronary angioplasty catheters and electrophysiology catheters, among other high-risk devices.

Feigal's testimony acknowledged that such devices are high risk when reprocessed, and that therefore they would receive first enforcement attention six months after a final guidance is issued under the new regulatory scheme. By contrast, the CDRH director listed oral and nasal catheters—"fairly simple devices"—as examples of low-risk reprocessed devices, to be enforced 18 months after the final guidance. These devices, he said, are currently Class I and exempt from premarket notification. However, 18 months after the new regulations become final, FDA will actively enforce all nonpremarket requirements for hospitals that reprocess such products, "just as we currently do for original equipment manufacturers and third-party reprocessors, including registration, listing, manufacturer adverse-event reports, labeling, corrections and removals, and quality system manufacturing requirements."

Because this new effort could significantly impact FDA resources, Feigal said, "we will be collaborating with third parties, such as JCAHO [the Joint Commission on Accreditation of Healthcare Organizations], HCFA, and state agencies that currently perform oversight of the healthcare sector to assist us in implementing the new policy." In addition, CDRH "will be continuing our outreach efforts to ensure that the healthcare community, manufacturers, reprocessors, patients, and the public are fully aware of the issues involving the reprocessing and reuse of SUDs. Our efforts will include talk papers, public health notifications, and lay articles on an FDA Web page."

Feigal stated that CDRH will also be considering changes to the labeling of single-use devices by original equipment manufacturers, who may be asked to add to their single-use product labeling "any information of which they are aware regarding the potential risks associated with reusing their single-use devices. This information would serve as a caution to users and reprocessors who might attempt to reprocess these single-use devices."

Before Feigal testified, comments submitted by ADDM had told the agency it "should expend its scarce resources on enforcing the law" against reprocessors of single-use devices, not on further research as outlined in FDA's proposed strategy published last November. Prepared by attorney Josephine M. Torrente of Hyman, Phelps & McNamara, ADDM's comments contended that despite FDA's "recognition that Congress intended reprocessors to be subject to the same legal requirements as other manufacturers, the agency has, without justification, refused to enforce certain key safety controls on reprocessors." ADDM cited as support a July letter from CDRH enforcement director Larry Spears stating that while the agency regards third-party reprocessing of single-use devices as unlawful unless all requirements for manufacturers are met, FDA would only exercise "regulatory discretion."

According to ADDM, FDA's policy had caused risk to patients, and the agency had discounted at least 19 scientific studies documenting that 75% of reprocessed devices studied had failed. Moreover, FDA had neglected to make public the results of its own studies on the issue, notwithstanding public statements by its scientific staff that their findings "include safety and effectiveness concerns with reprocessed percutaneous transluminal coronary angioplasty catheters, electrophysiology catheters, and biopsy forceps."

In addition, ADDM's comments charged that FDA had further discounted medical device reporting (MDR) reports suggestive of problems with reprocessed devices, on grounds that the reports were not conclusive—a response that is inconsistent with the agency's traditional use of the MDR database. "FDA has previously used MDR reports as evidence that a problem exists and needs to be addressed," ADDM said. The association characterized FDA's history of dealing with the issue as "marked with inconsistency," but maintained that the "solution to this tortured regulatory construct is simple: full enforcement of the FD&C Act, including all device regulations and premarket submission requirements, on reprocessors of single-use devices."

Following Feigal's testimony, Torrente said she was "pretty encouraged" by the agency's actions, which she said "go a long way toward protecting patients along the lines we suggested." She was particularly impressed by the guidance documents FDA issued during February, but added that some concerns remain unaddressed, such as the status of exempt devices and a previous FDA suggestion that original equipment manufacturers should revise their labeling to include what they know about reprocessing issues.

FDA's enforcement scheme for reprocessed devices is contained in a draft guidance, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. A companion document—Reprocessing and Reuse of Single-Use Devices (SUD): Review Prioritization Scheme—assigns risk ratings to reprocessed devices.

Although Abbott Laboratories has hired high-powered experts in its scientific and regulatory affairs area in the form of former FDA officials Michael Beatrice and Douglas Sporn, their arrival came too late to prevent another embarrassment for the company.

In February, the agency announced that Abbott had recalled its Alcyon 300/300i automated clinical chemistry instrument following an FDA inspection of the firm's Irving, TX, diagnostic device manufacturing facility late last year. In November, Abbott agreed to pay a record fine of $100 million to the U.S. government as part of a consent decree with FDA over continuing compliance problems at another of its diagnostic manufacturing operations, in Lake County, IL.

The inspection in Irving, conducted from October 26 to December 22, grew out of the troubles Abbott was experiencing in FDA's Chicago district after agency officials questioned whether other company facilities might have similar GMP deficiencies, a senior enforcement official told this correspondent. A subsequent eight-page warning letter, dated February 7, revealed that the agency had sent its top national experts into Irving and had indeed found GMP problems with the company's manufacturing of clinical chemistry analyzers.

During the Irving inspection, investigators found that the facility failed to document or investigate "incidents of nonconformance to the depth necessary to correct and prevent problems from recurring." According to the warning letter, numerous investigations into the recently recalled Alcyon diagnostic device were inadequately performed. FDA also said Abbott failed to "establish and maintain procedures to ensure the design requirements relating to the Alcyon software are appropriate and address the intended use, including user needs."

According to FDA, a January 14 Abbott response to the inspection's observations was also inadequate. It allegedly lacked supporting evidence, and, for some findings, the company's response did not address underlying issues that may be part of the deficiencies. FDA added that it was also concerned with the time frame Abbott proposed for correcting some of the problems.

Despite the recall of the Alcyon devices, FDA said it was still concerned that Abbott's deficiencies "may impact other devices made at the Irving, TX, facility." It reminded the company of its commitment not to distribute the Alcyon devices until software problems are corrected and FDA has approved the new software version the company will use. FDA asked the company to respond to the warning letter within 15 working days.

The Health Industry Manufacturers Association (HIMA) has told FDA that its draft document Guidance on Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) That are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease does not appear to be consistent with clinical practice and should be reviewed by practicing clinicians. HIMA said it believes such a review is so important that it is willing to arrange for and participate in the session. The offer is included in the February 11 comments on the draft guidance submitted by HIMA associate vice president for technology and regulatory affairs Carolyn Jones.

The requirements in the guidance are "somewhat excessive in light of the fact that HCV assays, approved by the Center for Biologics Evaluation and Research, have been marketed without significant problems for some time," Jones said. She also suggested addition of a "definitions" section because the agency's use of some terms "may not reflect concurrence within the scientific community" and may be inconsistent with how the terms are used by industry.

The trade group told FDA that, based on recent Microbiology Panel meetings, it is clear that well-characterized, stored samples should be acceptable to demonstrate safety and effectiveness of the assays. HIMA believes that "this concept for sample bank correlation studies should be added to the next draft of the guidance, with the stipulation that each stored sample have sufficient patient clinical information so that the patient information can be used for discrepant resolution when the tests being compared do not give the same answer."

But HIMA's main focus is on the need for a thorough clinician review of the draft. At several points in its cover letter transmitting 13 pages of specific comments, the organization expressed the need for clinician review and its willingness to take the lead in arranging such a session. "Since FDA has gone well beyond the original document's general scope (current HCV technologies) to address intended uses that cannot presently be supported by current clinical practice and technology, we believe that the guidance document should be reviewed by practicing clinicians knowledgeable in this area," Jones said. "We are willing to take the lead in arranging a meeting with such a group."

Three new CDRH guidances describe the means by which specified devices that are currently Class III can comply with the special controls requirement for Class II devices. Being reclassified from Class III to Class II are cardiopulmonary-bypass arterial-line blood filters, extracorporeal-blood-circuit defoamers, and indwelling blood-gas analyzers. In each instance, the guidance identifies relevant material on preclinical studies and labeling to include in a 510(k) premarket notification application.

Designation of the guidance documents as special controls, CDRH says, means that manufacturers attempting to establish that their device is substantially equivalent to a predicate device should demonstrate that the proposed device complies with either the specific recommendations of the relevant guidance or some alternate control that provides an equivalent assessment of safety and effectiveness.

The guidances and their locations on the Web are: Guidance for Extracorporeal Blood Circuit Defoamer, 510(k) Submissions, Guidance for Indwelling Blood Gas Analyzer, and Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter.

HIMA has urged FDA and other agencies assessing the safety of di-(2-ethylhexyl) phthalate (DEHP), a softener used in vinyl medical products, to be guided by the recent decision of the International Agency for Research on Cancer (IARC) to downgrade DEHP from a "probable human carcinogen" to "not classifiable as a human carcinogen."

"IARC's careful and informed review of relevant data represents a major victory for sound science," HIMA executive vice president for technology and regulatory affairs James Benson said in a statement. "For more than 40 years, DEHP has been used safely and effectively in a variety of medical applications. Anesthesia tubing, blood bags, IV sets, and other vinyl products are essential to delivering quality patient care." Benson said that HIMA was concerned that "the continued unfounded allegations against DEHP already settled by both science and experience is diverting valuable resources from more deserving medical research."

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

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