Impact of FDA policy change on the reuse of single-use medical devices in Michigan hospitals.

BACKGROUND: Reuse of single-use devices (SUDs) was a common practice in many health care centers in the United States. In August 2000, the FDA presented a guidance document indicating their policy change that meant the FDA would regulate centers that reprocess SUDs.
OBJECTIVE: Our objective was to survey Michigan health care centers to determine the level of action that has been taken regarding this policy change and determine whether there has been a shift in the extent of reuse of SUDs.
METHODS: We developed a telephone survey tool and contacted the infection control personnel in the 54 Michigan hospitals that had more than 200 beds.
RESULTS: The response rate to the telephone survey was 48 of 54 (89%). Prior to the FDA policy change, 46%, 17%, and 37% performed on-site, third-party, or no reprocessing of SUDs, respectively. Currently, 21%, 35%, and 44% performed on-site, third-party, or no SUD reuse, respectively. The major shift has been to utilization of third-party reprocessors as opposed to stopping reuse of SUDs. In the 27 centers that currently reprocess SUDs, the most common items included the following: compression sleeves, 13 of 27; pulse oximeters, 8 of 27; PTCA cardiovascular catheters, 7 of 27; and biopsy forceps, 5 of 27. There were 61% (11/18) that resterilized open but unused SUDs with an equal split between on-site versus third-party resterilization. There were 3 sites that stopped reprocessing SUDs completely as a result of the FDA policy change and 4 that previously did not reprocess SUDs that started using a third-party reprocessor.
CONCLUSIONS: The FDA policy change has impacted how SUD reprocessing is being performed in Michigan. Few centers (1/48) reprocessing any high or medium-risk SUDs on-site at the time of the survey. There has been little overall reduction in SUD reprocessing, but there has been a shift to use of third-party reprocessors.