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.