This article was originally published in the Medical Device User Facility Bulletin, Issue No. 36, 2001
FDA SENDS ANOTHER LETTER TO HOSPITALS
ABOUT REUSE OF SINGLE-USE DEVICES
Recently, FDA sent a letter to hospitals explaining the change in its enforcement approach for hospital SUD (single-use device) reprocessors. At the discretion of Department of Health and Human Services Secretary Tommy Thompson, hospital SUD reprocessors were granted another year before FDA actively enforces the non-premarket requirements with the exception of registration and listing. Premarket requirements are still being actively enforced. The complete text of the September 25th letter is below.
Changes in Enforcement of FDA's Requirements on
Reprocessing of Single-Use Devices
(You are encouraged to copy and distribute this information)
September 25, 2001
Dear Hospital Administrator and Hospital Risk Manager:
The purpose of this letter is to alert you to a change in FDA's policy on the reuse of single-use devices (SUDs) that will affect all hospital SUD reprocessors. Specifically, FDA is extending the deadline for active enforcement to August 14, 2002, for the following postmarket requirements: medical device reporting, tracking, corrections and removals, quality system, and labeling. FDA's schedule for enforcement of other requirements remains unchanged. As previously announced, FDA plans to begin inspecting hospital SUD reprocessors shortly. FDA will immediately enforce the requirements for establishment registration and device listing. FDAs actively phasing-in enforcement of its premarket requirements (as described below). Change in enforcement approach to hospital SUD reprocessors. Beginning this fall, FDA intends to inspect hospital SUD reprocessors. These inspections will cover all three classes (I, II, and III) of medical devices. The change in FDA's reuse policy concerns the focus and possible outcomes of these inspections. The focus will be to assess hospitals' compliance with the Agency's postmarket regulatory requirements. However, the Agency does not intend to take enforcement actions against hospitals if they are found not to be in compliance with these requirements. Rather, FDA plans to spend the next year educating hospitals on complying with the postmarket requirements. This policy will remain in effect until August 14, 2002, provided that the hospitals are taking steps to correct the violations noted during the inspection and that the violations do not pose a serious public health risk. This revised policy does not apply to third party reprocessors. FDA will still enforce requirements for registration and device listing. As stated in the Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (SUD enforcement guidance),1 which was published by FDA on August 14, 2000, the Agency will actively enforce registration and device listing requirements for all hospital SUD reprocessors. These requirements remain unchanged and will be actively enforced by FDA immediately.
1 A copy of the SUD enforcement guidance is available on FDA's Internet site:
www.fda.gov/cdrh/reuse/index.shtml or by calling CDRH Facts on Demand at 1-800-899-0381 or by calling
301-827-0111, specify number 1168 when prompted for the document shelf number.