New Provisions for Reprocessed, Single-Use Devices: An Interview With John R. Manthei

On October 26, 2002, President Bush signed into law the Medical Device User Fee and Modernization Act (MDUFMA) of 2002. MDUFMA enacts the most significant series of regulatory reforms for the medical device industry since the 1976 Medical Device Amendments. The new requirements for reprocessed, single-use devices (SUDs) contained in Title III are perhaps the most controversial provisions of this law. It is important that healthcare professionals understand these important and complex new provisions relating to the reprocessing and reuse of SUDs. EP Lab Digest is providing this interview with John R. Manthei, a member of the FDA practice group in the Washington D.C. office of Latham & Watkins and former Majority Counsel to the House Energy and Commerce Committee, who was instrumental in helping obtain the bill s passage. He has provided additional insight into the law and its new requirements. Congress enacted the new reprocessing provisions in response to concerns regarding the safety and effectiveness of single-use devices (SUDs) following multiple cycles of reprocessing and reuse. Congress effectively concluded that the FDA s existing regulations were not adequately protecting patients, and that it needed to establish stronger regulatory controls over the reprocessing industry. Title III of MDUFMA reflects a compromise among the device industry, hospitals and third-party reprocessors. In enacting these provisions, Congress recognized that, although there are economic benefits from reprocessing and reuse of certain types of medical devices, there are also potentially significant risks of compromised safety and effectiveness. There are several. First, MDUFMA required the FDA to identify those reprocessed SUDs already subject to premarket notification requirements, for which validation data must be submitted to demonstrate substantial equivalence for the maximum number of reuses specified by the reprocessor. The FDA identified 13 such devices in the Federal Register Notice published on April 30, 2003. Electrode recording catheters, intracardiac mapping catheters and steerable catheters are included in this list. More importantly, the premarket review of this validation data supporting a specific number of reuses will eliminate the FDA s multiple single-use standard for these products. Secondly, FDA is required to review the viability of premarket exemptions for all critical and semi-critical reprocessed SUDs. The FDA is required to publish in the Federal Register a list of those critical and semi-critical reprocessed SUDs for which the exemptions should be terminated in order to provide a reasonable assurance of safety and effectiveness. Reprocessors of these devices will be required to submit 510(k)s that include validation data, which will establish the maximum number of times the device can be reprocessed. In addition, the law establishes a new premarket approval process for Class III reprocessed SUDs. Rather than a PMA, reprocessors must now submit a new Premarket Report to the FDA demonstrating the safety and effectiveness of the reprocessed device. MDUFMA also establishes new labeling requirements to ensure that reprocessed devices are properly identified for the user. Finally, the FDA was required to modify the MedWatch (Medical Device Report) mandatory and voluntary reporting forms that are used to report patient injuries and product malfunctions. Congress enacted this reform to ensure that reportable events involving reprocessed devices are properly attributed to the reprocessor, rather than to the original equipment manufacturer. There are a number of important implementation dates. On April 30, 2003, the FDA published a list of devices that will be subject to enhanced 510(k) requirements and a list of critical devices that, when reprocessed, will no longer be exempt from premarket submissions. The FDA also modified the MedWatch forms. Reprocessors now have 9 months to resubmit the enhanced 510(k)s with the additional validation data for those previously-cleared devices identified by the FDA. The enhanced 510(k) requirements are effective immediately for those listed devices that were not cleared prior to the April 30th notice. Reprocessors of critical devices for which an exemption has been removed have until July 2004 to file 510(k)s with validation data for those devices. By April 26, 2004, the FDA must publish a list of those semi-critical reprocessed SUDs that are currently exempt from filing 510(k)s for which the exemption will be terminated. 510(k)s with validation data must be submitted for these devices within 15 months of publication of the list. The new Premarket Reports for reprocessed Class III SUDs became effective on October 26, 2002, when the law was signed by the President. The Act set no formal deadline by which FDA must issue Guidance Documents for the new validation requirements, and Premarket Report submissions. FDA is expected to issue both documents shortly without a formal notice and comment period. As a result, affected parties should promptly submit comments for FDA s consideration in developing the guidance documents. On April 30, 2003, the FDA listed several categories of EP catheters as reprocessed SUDs for which 510(k)s were previously required, that now require the submission of this validation data. These EP catheters include electrode recording catheters, intracardiac mapping catheters and steerable catheters. All new 510(k)s for reprocessed version of these SUDs are now subject to the enhanced 510(k) requirements. FDA reviewed all commonly reprocessed SUDs and categorized them based upon the level of potential risk they pose to a patient-high, medium or low. FDA reserved the high risk categorization for only "those devices that pose the greatest risk of infection and inadequate performance after reprocessing." Reprocessed single use electrode recording catheters, intracardiac mapping catheters and steerable catheters were all categorized by the FDA as posing a "high risk" to the patient. Based upon this determination, therefore, FDA is requiring that additional validation data be submitted by reprocessors of these devices within the next 9 months or they must cease marketing the device. Reprocessors of previously-cleared, listed SUDs such as electrode recording catheters, intracardiac mapping catheters and steerable catheters must, by January 2004, submit validation data regarding their cleaning, sterilization and functionality to demonstrate that the reprocessed device is substantially equivalent to the single-use example. Even though these devices were previously cleared by the FDA, Congress has determined that additional validation data must be submitted. If validation data are not submitted or are not adequate to demonstrate substantial equivalence, the reprocessor can no longer legally market the reprocessed device. The new Premarket Report requirements will, at a minimum, impose the same stringent requirements that are currently applicable to PMA submission for the original single-use product. The Premarket Report requirements in MDUFMA essentially mirror those for PMAs, with the exception of certain design control information for the original device. Although reprocessors are not required to submit these data, Premarket Reports must contain extensive safety and effectiveness information and validation data which provide reasonable assurance of the devices safety and effectiveness after the maximum number of times the device will be reprocessed. As with the enhanced 510(k)s, the premarket review and approval of the device for a specified maximum number of uses will eliminate the multiple single-use paradigm for these products. In addition, the FDA will need to require additional data to compensate for the absence of design control information for the original SUD as well as methods to identify and compensate for changes to the original device after it was approved for marketing. Finally, the FDA has indicated that it will require preapproval manufacturing inspections, and clinical trials to ensure the safety and effectiveness of the devices after multiple cycles of cleaning, sterilization and reuse. The FDA should require the clinical data to support each additional use. Developing this information will be a very difficult task for reprocessors. The new law requires reprocessors to attach directly to the device a label that "prominently and conspicuously" identifies the reprocessor of the device. This requirement becomes effective on April 26, 2004, and applies only to devices introduced into commerce after that date. Also, all reprocessed devices introduced into commerce after January 26, 2004, must be labeled with the following statement Reprocessed device for single use. Reprocessed by [insert name of reprocessor]. Both of these new labeling requirements are designed to ensure that users know that the SUDs they are using were previously used and reprocessed and by whom.