FDA Finalizes Policy on Reprocessing
Single-Use Medical Devices for Reuse

By Claudia Parks-Miller, J.D., LL.M. Candidate

The Food and Drug Administration's (FDA) Center for Devices and Radiologic Health (CDRH) finalized its policy on the reprocessing of single-use medical devices for reuse through a guidance document issued on August 2, 2000. The document, "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals," details a regulatory framework subjecting hospitals and third-party reprocessors to the same regulatory requirements applicable to original equipment manufacturers, including premarket submission requirements. The guidance document represents a significant change in the FDA's philosophy and its oversight of single-use device reprocessing, and it is the first time the FDA has exercised jurisdiction over hospitals reprocessing medical devices.

Although it appears that the same regulatory requirements of the Food, Drug and Cosmetic Act (FDCA) apply to any entity reprocessing single-use devices, to date, the FDA has not regulated original equipment manufacturers, third-party reprocessors, and hospitals that reprocess single-use medical devices for reuse in the same manner. The guidance document purports to eradicate the inconsistent regulation of reprocessing entities.

When a single-use medical device is reprocessed for reuse by cleaning, repairing, or refurbishing, the FDA considers the device to be "remanufactured" and the entity reprocessing the device, whether it is the original equipment manufacturer, third-party reprocessor, or hospital, is considered to be a "manufacturer." Currently, third-party reprocessors are subject to the same requirements as original equipment manufacturers, although the FDA has not previously enforced premarket submission requirements against third-party reprocessors. None of the regulatory requirements have been enforced against hospitals reprocessing single-use medical devices in-house for reuse. Previously, the FDA has not addressed hospital reprocessing of single-use medical devices for reuse except in a FDA's Compliance Policy Guide that states that hospitals reprocessing single-use devices assume full liability and responsibility for the devices' safety and efficacy.

The final guidance document requires that third-party reprocessors and hospitals comply with all regulatory requirements of the FDCA applicable to original equipment manufacturers that reprocess single-use devices for reuse. Specifically exempted from regulation by the guidance document are: (1) opened-but-unused devices that are reprocessed; (2) reprocessors of single-use devices other than hospitals or commercial reprocessors such as physician offices and ambulatory surgery centers; (3) permanent pacemakers; and (4) hemodialyzers.

The final guidance document sets forth the intended timetable for enforcement of regulatory requirements on hospitals and third-party reprocessors. The FDA plans to take a phased-in approach to enforcement of the premarket submission requirements and the non-premarket requirements. Third-party reprocessors and hospitals will be subject to the premarket submission requirements based on the device's classification under the existing Code of Federal Regulations (CFR) classification scheme. The FDA will actively enforce premarket submission requirements for class III devices six months after issuance of the final guidance document; for class II devices in twelve months; and for class I devices in eighteen months. The FDA currently enforces non-premarket requirements against third-party reprocessors and intends to continue to enforce all non-premarket requirements against third-party processors. The FDA intends to enforce non-premarket requirements against hospitals one year following issuance of the final guidance document. However, the guidance document states that the agency intends to use the first year following issuance of the guidance document to educate hospitals about their regulatory requirements.

In the final guidance document the FDA retains discretionary authority to take enforcement action at any time without regard to the published implementation timetable if the agency determines a particular reprocessed medical device poses a significant risk to the public. To assist with the monitoring of reprocessing in healthcare facilities, the FDA is seeking collaboration with third-parties such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Health Care Financing Administration (HCFA) and state agencies. To date, neither JCAHO nor HCFA has committed to assist the FDA in this area. See http://www.fda.gov/cdrh/reuse/index.shtml.

09/11/00