Abstract :
ISSUE: Along with the popularization of endoscopic surgeries, the reuse of single-use devices (SUDs), which may cause various risks, has become a considerable issue globally. In Japan, there has been no nationwide surveillance about the practices and problems for the reuse of SUDs in endoscopic surgeries. We conducted two-step surveys using questionnaires and laboratory functional tests of reprocessed devices.
PROJECT: First, we implemented the questionnaire survey in 2224 general facilities accommodating more than 200 beds in 2000. The second survey was done in 2003 in 460 hospitals that indicated on the first survey they would accept the follow-up. To find changes in handling of SUDs, we altered some items of the questionnaire used for the second survey. In addition, we carried out laboratory functional tests to evaluate the quality of the reprocessed trocars and endoscopic clips which had already been used for patients one time. The tests consisted of two parts: the gross inspection by appearance and overhaul inspection for contamination and corrosions or damages of metal and non-metal parts. The functional evaluation was done for penetrating power of the trocars and holding power for the clips. The control data were obtained from the same manufacturerʹs unused new products from a different lot number.
RESULTS: Comparisons were made between the re-use rates in the 2000 and 2003 surveys among hospital that replied to both. The second survey demonstrated an overall decline in re-use frequency to 86.2%. The decreased frequency of re-use was significant in national or public hospitals. In terms of size, the decrease in re-use was significant only in those with over 500 beds (p = <0.05). Sample tests for the quality assessment of reprocessing of SUDs demonstrated the following: for trocars, 60% showed incomplete cleaning and drying; for clips, tensile strength showed a drop after reprocessing and the holding performances also decreased (p = <0.001 for both).
LESSONS LEARNED: Surgeons and nurses have to realize that the reprocessed SUDs may have quality problems related to sterility and function. Healthcare workers appear to have positive attitudes toward adopting safety management steps to reduce the re-use of SUDs. To promote the single use of SUDs, it will be necessary to develop multidisciplinary and composite approaches that include regulation and education programs.
