Originally Published August 2000
- FDA Expands List of Class II Devices for Third-Party Review
- Airway Devices Receive Down-Classification
- Cal-Test to Destroy Inventory, Cease Distribution
- CDRH Offers Leveraging Page on Web Site
For years, OEMs of single-use devices (SUDs) have been trying to get FDA to prohibit hospitals and third parties from engaging in the lucrative but sales-killing practice of reprocessing such products for second, third, or even more uses. In response, FDA has told these OEMs to provide proof of the damaging effects of device reuse.
The evidence manufacturers produced hasn't been impressive, so FDA hasn't been doing much. In June, the frustrated OEMs were finally able to see the issue aired publicly in a hearing of the Senate Health, Education, Labor, and Pensions Committee. Although committee chairman James Jeffords (R–VT) had cosponsored a bill to put SUD reprocessors on the same regulatory GMP footing as OEMs, his hearing was not the firm remedial directive to FDA that some wished for.
Indeed, the hearing offered a forum for CDRH director David Feigal to reiterate that present law provides adequate authority for the agency to continue protecting the public from safety risks involving the reuse of devices labeled for single use.
Feigal went a little further than that, however. He told the senators that FDA is considering asking SUD OEMs to include, as part of their product's labeling, "any information of which they are aware regarding the potential risks associated with reusing their SUDs. This information would serve as a caution to users and reprocessors."
William Frist (R–TN), who is by training a cardiac surgeon, questioned Feigal on abstracts of several unpublished studies that raise doubts about the safety of some reprocessed devices used in surgery. Feigal said he was aware of such studies and that FDA intends to expand its research efforts on reused SUDs and the effects of reprocessing.
In his prepared testimony, Feigal said FDA's proposed new strategy on SUD reuse focuses on the establishment of priorities for enforcing existing regulatory requirements for third-party and hospital reprocessors. To carry out the new policy, he said FDA proposes to develop a list of commonly reused SUDs, as well as a list of factors that determine the degree of risk associated with reprocessing devices. Based on these lists, the commonly reprocessed SUDs will be divided into high-, moderate-, and low-risk categories. Priorities will then be assigned, according to the level of risk, for the enforcement of regulatory requirements for third-party and hospital reprocessors.
FDA intends to begin enforcing premarket notification (510(k)) and premarket approval application requirements within six months of issuing a final guidance for devices in the high-risk category, Feigal said. These requirements will be imposed within 12 months for products categorized as moderate risk, and within 18 months for those considered low risk.
General Accounting Office (GAO) associate director Janet Heinrich reported on a GAO study requested by committee chairman Jeffords and Richard Durbin (D–IL) to support their legislation (S.1542), which would require recycled medical devices to meet the same safety standards as new devices. It also would require hospitals to inform patients when they are being exposed to a reused device.
Heinrich said the GAO study indicated that some SUDs can be safely reprocessed if appropriate cleaning, testing, and sterilization procedures are carefully followed. Although GAO found the risks associated with reprocessing to be small, there is scant hard data on the subject. Heinrich agreed with critics who say that SUD reprocessing is not invariably safe and that relatively little is known about the practice of SUD reprocessing in healthcare facilities.
Heinrich pointed out that the fact that third-party reprocessors do not currently have to seek premarket approval from FDA means that the agency is unable to identify all third-party reprocessors— leaving some firms unregistered with FDA, and thus operating without inspection. She endorsed the steps FDA is taking to increase its oversight of SUD reprocessing, but also suggested that the proposed new framework is cumbersome and may be difficult to implement.
Testimony from other witnesses offered a range of viewpoints regarding the practice of medical device reprocessing. Association of Disposable Device Manufacturers president Josephine Torrente said FDA must not "turn a blind eye to the reality of reprocessing" by allowing reprocessed devices onto the market without data supporting a prespecified number of uses.
On behalf of the Association of Medical Device Reprocessors, Vern Feltner asserted that the proper reprocessing of some SUDs poses no threat to public health and can save hospitals up to 50% of the cost of new devices.
Speaking for the American Hospital Association, John Clough, MD, chair of the Cleveland Clinic Foundation (Cleveland) cited decades of hospital experience in reprocessing both reusable devices and those labeled "for single use." He said that in the absence of evidence that reprocessing and reuse of medical devices are a threat to patient safety, treating hospitals that engage in reprocessing as manufacturers adds costs without any clear benefits such as increased patient safety or improved outcomes.
FDA Expands List of Class II Devices for Third-Party Review
Disappointed in the low utilization of the third-party review program for 510(k)s, FDA says it will expand the list of moderate-risk (Class II) devices that accredited third parties can review. In the draft Guidance for Staff, Industry, and Third Parties: Implementation of Third-Party Programs under the FDA Modernization Act of 1997–June 2000, the agency reports that in the first 17 months that the FDAMA third-party program has been in effect, only 28 companies used third parties to review a total of 54 510(k) submissions.
During that time, nearly 2000 510(k) submissions from approximately 800 companies were eligible for third-party review. FDA says the approach typically has yielded rapid marketing clearance decisions. In fiscal year 1999, the average total elapsed time between a third party's receipt of a 510(k) submission and FDA's substantial equivalence determination was 57 days; the portion of that time between FDA's receipt of the third party's recommendations and its determination averaged just 15 days.
Current policy permits third-party review of only those Class II devices for which some device-specific guidance or recognized consensus standard exists. FDA says it instituted that policy at the outset to ensure consistency among third-party reviewers and to expedite the agency's review process once a third party submits a recommendation.
In an effort to expand the use of the program, FDA proposes to initiate a pilot program that will allow third-party review of any device that is not prohibited under the statute. In the expanded pilot, an accredited person may review a Class II device that does not have a device-specific guidance under three conditions: one, if the accredited person has previously completed three successful 510(k) reviews under the third-party program, with at least one review in the same or a similar medical specialty area as the device to be reviewed; two, if the accredited person contacts the appropriate CDRH Office of Device Evaluation (ODE) branch chief to confirm that he or she has the required experience and can identify pertinent issues and review criteria related to the device in question; and three, if the accredited person prepares a summary documenting the discussions and submits that summary to the ODE.
FDA says the expanded pilot program will start after it reviews comments (which were accepted for 45 days following the June 12 publication) and finalizes the guidance. The expanded pilot program will be reviewed 12 months after it begins to determine if the number of 510(k)s reviewed has increased significantly and if the timeliness of reviews has been maintained, and to consider whether particular divisions within ODE are devoting disproportionate staff time to pre-submission discussions with accredited persons.
FDA says it can stop or reevaluate the pilot program if it determines that the additional workload compromises FDA's ability to review other applications, or if the agency has reason to believe the quality of the reviews is diminished by a lack of device-specific guidance. FDA also stresses that the expansion of the program does not reduce an accredited person's obligation to consult all FDA-recognized guidance documents and standards, when available, to confirm the requirements.
A list of eligible devices is available on the CDRH Web site (in PDF).
Airway Devices Receive Down-Classification
In June, CDRH reclassified devices designed to relieve upper airway obstruction from Class III to Class II (special controls). The predicate device is the Maet Industries (Mississauga, ON, Canada) Quickair choke reliever, Model 59-001A. FDA placed that device in Class III last December; the company petitioned for down-classification, and the agency granted it in February. The special control is a labeling and design control guidance document, Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices.
In a Federal Register notice, FDA said the guidance document, covers the following:
(1) Labeling that includes instructions for reporting complications resulting from the use of the device directly to the manufacturer, as well as any applicable medical device reporting requirements (21 CFR part 803).
(2) Labeling for the lay user that includes adequate instructions for use including: (a) A clear identification of the minimum victim size threshold (weight), as well as any device-specific limitations identified through application of design controls; and (b) Instructions for use of the Heimlich maneuver.
(3) Design controls that satisfactorily evaluate: (a) The potential for excessive generation and application of pressure to the abdomen that can result in damage to the internal organs; (b) The generated pressures and their distributions over the abdomen as compared with the Heimlich maneuver in a variety of victim sizes and user strengths; (c) The initial and peak airway pressures and the duration of pressure application of the device as compared with the Heimlich maneuver; (d) Bench testing to include static load, mechanical shock, fatigue, and intraabdominal pressure simulation; and (e) Human factors testing to demonstrate that the lay user is able to understand and follow the device instructions for use with respect to device placement and applied force. The testing should include a range of rescuers' sizes, ages, and educational levels, as well as an appropriate range of victim size and position.
The guidance is accessible via CDRH's Web site.
Cal-Test to Destroy Inventory, Cease Distribution
FDA signed a consent decree of permanent injunction in June with in vitro test-kit maker Cal-Test Diagnostics Inc. (Chino, CA) over long-standing GMP violations and marketing of unapproved products. Under the decree, Cal-Test will destroy all of its inventory and stop marketing and distributing its products in the United States and overseas until all test kits have been cleared by FDA and all manufacturing deficiencies have been corrected. FDA said it will supervise the destruction of inventory, and Cal-Test will reimburse the agency for all associated costs.
In a talk paper, FDA said the consent decree had been signed in Los Angeles federal court by Judge Christina A. Snyder. The test kits included several types of HIV, hepatitis, and pregnancy kits sold to laboratories, medical facilities, and distributors in the United States and overseas. Cal-Test had been in violation of GMP and product approval/clearance requirements for four years, and had repeatedly promised to make corrections which it did not make, FDA said.
CDRH Offers Leveraging Page on Web Site
CDRH has established a new page on its Web site, entitled "Outside Leveraging: Creating Relationships through Partnerships with Stakeholders." The page is intended to keep industry abreast of the agency's activities regarding optimization of its resources through collaborative partnerships with federal and state agencies, as well as with professional, consumer, and academic organizations.
The Web page whimsically describes the concept of leveraging— which resource-starved FDA has adopted as a key strategy—in the following terms:
Archimedes, the gifted Greek scientist, mathematician and inventor, once said, "Give me a place to stand and rest my lever on, and I can move the earth." The "lever" allows the amount of effort required moving the mass to remain constant while the mass to be moved can grow in size and/or weight. We are here today seeking to create the philosophical levers, those strategic alliances that will allow us to move the mass of work more easily and effectively. Outside leveraging is one concept which we believe will help [CDRH's Office of Surveillance and Biometrics] realize its mission and improve the public health in the United States in tangible ways.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.
Back to the MDDI August table of contents | Back to the MDDI home page