- FDA Issues Guidance for New Strategy on Reuse of Single-Use Medical Devices: "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals"
- May 6, 2003
- Law Firm: Buchanan Ingersoll, Professional Corporation - Pittsburgh Office
On August 14, 2000, the Food and Drug Administration ("FDA")'s Center for Devices and Radiological Health issued "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals," a final guidance on the reuse of medical devices that had been approved by FDA as disposable devices for one-time use.
In the late 1970s, shortly after single-use devices became common, hospitals and other healthcare facilities began washing, resterilizing, and reusing these devices. Under the terms of the Federal Food Drug and Cosmetic Act, FDA had the legal authority to regulate reprocessed single-use devices; however, at least initially, there was little perceived need for FDA action with regard to these products. As single-use devices became both more common and more technically complicated, an industry of non-manufacturer, non-hospital "third party reprocessors" evolved, specializing in processing used single-use devices to make them fit for reuse. The growth of this new industry raised questions about the safety of the increased reuse of single-use devices. While there was no definitive evidence of increased risk associated with reuse, sufficient questions were raised, and FDA began to develop a strategy to regulate reuse. In November 1999, FDA released a "proposed strategy" for the reuse of disposable, single-use medical devices. This proposal was followed in December 1999 by a public meeting with industry representatives to allow the FDA to refine its position.
Under the August 2000 guidance, FDA will regulate third-party reprocessors and hospitals that reprocess single-use devices in the same manner as original equipment manufacturers. This includes registration of parties doing the reprocessing of and listing of the reprocessed devices, premarket notification and approval requirements, adverse event reporting, and labeling and manufacturing requirements.
FDA's enforcement of the premarket clearance requirements will utilize the traditional three-tier device classification system, i.e., Class I, II, and III, with Class III having the most rigorous premarket requirements for devices with the highest risk. Under the guidance, each reprocessed device will retain the same class as the original single-use device. FDA intends to enforce premarket submission requirements within six months for all Class III devices (requiring submission of safety and effectiveness data), within twelve months for all Class II non-exempt devices, and within eighteen months for all Class I non-exempt devices. (Manufacturers of Class I and II non-exempt devices must demonstrate that the device is "substantially equivalent" to one already on the market.)
Third-party reprocessors are already subject to enforcement of the other, non-premarket regulatory requirements, and will continue to be under the new guidance. However, FDA intends to phase in enforcement of these non-premarket requirements for hospital reprocessors within the next year, and will use this time to educate hospitals about the requirements.
FDA explains that such a phased-in approach for enforcement of regulatory requirements for third-party and hospital reprocessors is appropriate because:
- The health risk associated with reprocessing single-use devices varies with each device.
- It may avoid any unintended and unpredictable consequences, such as potential shortages, in certain hospitals.
- Establishments such as hospitals may be unfamiliar with FDA regulations and a phased-in approach will allow those facilities time to learn about the requirements.
While the reuse strategy has been generally well accepted as necessary for patient protection, several potential issues have been raised. A number of groups have objected to the entire system for regulation of reused devices. These opponents cite a lack of evidence of harm from reprocessed single-use devices, and believe that FDA's actions will eliminate a safe and efficient method for reducing healthcare costs. Others have objected to the apparent disparate treatment of certain reprocessors. The current guidance applies to hospitals and third-party reprocessors, but does not restrict reuse of single-use devices by other healthcare establishments, such as non-hospital clinics.
Some have criticized the use of the device classification scheme (i.e. Class I, II, or III) as a method of assessing risk, and the development of enforcement priorities. These critics state that the original classification of the single-use device may be unrelated to the possible risks associated with the device after reuse. For example, certain simple, low risk Class I single-use devices that are difficult to resterilize, may pose significant risk for infection after reprocessing. Under FDA's "proposed strategy," the Agency had proposed a risk assessment based upon actual risk after reprocessing, rather than relying on the original device classification; however, this was deemed too complicated and unwieldy.
In view of these developments, hospitals would be well advised to review their use of reused devices, the entities which reprocess them, and the regulatory requirements which are likely to be applicable.