Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -8

Accepted - Volume 5

Comment Record
Commentor Ms. Patti Grant Date/Time 2002-09-10 11:46:44
Organization RHD & Trinity Medical Centers
Category Health Professional

Comments for FDA General
1. General Comments BACKGROUND ON CURRENT PRACTICES: Had an experience in 1992 regarding Opened-But-Unused, Single-Use Medical Devices related to aneurysm clips (not my current institution). A neurosurgeon was in the habit of not opening an aneurysm clip package until the moment needed -- when he determined the correct size of aneurysm clip, because didn't know what size was needed until patient opened on the table. This was not an issue until the manufacturer changed packaging, and it was difficult to enter (took too long and dangerous to patient outcome); therefore, surgeon had 3-5 sizes opened before the procedure (literally, the new packages could not be opened quick enough during the actual procedure). When infection control was consulted, we stated 'cannot do this unless the manufacturer can give specific instructions on reprocessing of the opened/unused aneurysm clip'. The manufacturer responded with specific sterilization instructions; however we can only guarantee five reprocessing events because the 'integrity' of the material cannot be guaranteed after 5 reprocessing/sterilization events. At this point, infection control passed along this reprocessing request to Risk Management, because, in truth, the reprocessing of the aneurysm clip(s) was no longer an infectious but a material risk circumstance. Since our OR could not guarantee 100% that they could devise a tracking mechanism that prevented a 6th sterilization of an opened/unused aneurysm clip, the hospital forbade the practice. COMMENT/CONCLUSION: The 'integrity' not necessarily the 'sterility' (as that is a given) is the issue with reprocessing of opened/un-unused single-use medical devices. This reality must be included, and guidelines provided for, this reality. CURRENT PRACTICE: As the FDA final guidance did not address the issue of opened/unused single-use medical devices in their Final Guidance, we do not allow this practice, as the 'community/gold standard' is silent on this very critical issue. POTENTIAL FUTURE PRACTICE: When the FDA includes a final guidance on this issue, we will add it to our policy -- I feel the 'science' of reprocessing opened/un-used SUD's is appropriate if the proper check/balances are in place, up and above the 'infectious' risks involved. Below is a copy of our succinct policy regarding the issue of reprocessing of SUD's. =============================== REPROCESSING/REUSE OF DISPOSABLE DEVICES I. POLICY A. Single-use disposable items -- as defined by manufacturer labeling -- which have been utilized, may not be reprocessed for reuse within the medical center. B. Single-use disposable items that have not been used on patients, but contaminated due to loss of packaging integrity, may not be reprocessed in the medical center. C. Contract and/or external agencies will not reprocess single-use disposable items for use within the medical center healthcare system. D. Any exception under consideration against this policy must be brought before the infection control program for consideration, and 1) The single-use device (SUD) product must have a 510(k) and/or PMA awarded to the 3rd Party Outsourced/Contracted provider by the FDA, according to the 08/02/00 FDA Final Guidance Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals 2) No reprocessing of SUD's will occur by hospital staff, on or off campus

EC -8