Abstract
OBJECTIVES: Estimate the safety, financial and environmental impacts of reprocessing low and moderate risk single-use medical devices (SuMDs). METHODS: Systematic review (PROSPERO ID: CRD42022365642) of primary studies of patients receiving reprocessed low and moderate risk SuMDs (non-critical and semi-critical medical devices a and b) versus first use of otherwise identical SuMDs. Items were sourced via database and supplemental searching. Results were reported by device risk class, included studies were quality appraised, and primary outcomes: direct patient safety; direct and indirect financial costs; environmental impacts, were Grade of Recommendation, Assessment, Development and Evaluation (GRADE) assessed following narrative synthesis. RESULTS: Ten studies examined 10 devices across three categories of risk class I devices: external fixator devices (n=3 studies), compression sleeves (n=2), and pulse oximeters (n=1) and three categories of risk class II devices: ophthalmic devices (n=1), surgical instruments for grasping and cutting (n=1) and endoscopic and laparoscopic devices (n=5 studies, 5 devices). There were no significant differences in the odds of primary safety outcomes across the two device types contributing data. The only study contributing primary financial impact data reported no statistically significant difference in savings for new versus reprocessed devices (p=0.340). Reprocessing reduced global warming (n=2 studies) and increased human health impacts (n=1) across the four device types contributing data. The certainty of safety and cost evidence was very low. CONCLUSIONS: Safety monitoring systems where SuMD reprocessing is permitted are required. Reprocessing costs should be estimated using appropriate methodologies and research is needed to ensure that life cycle assessment study designs can be better utilised to inform decision-making.