Reprocessing of single-use medical devices

The literature often forms more of a theoretical basis for these concerns than any firm scientific evidence.1 The report also noted that the reliability of the results was limited because of the diversity of SUDs and methods used to evaluate reprocessing and re-use. [...] The re-use of SUDs was considered in a 2004 report by the Auditor General of Canada.2 In July 2004, a letter was issued from the Therapeutic Products Directorate presenting Health Canada’s recommendations to health care facilities on the reprocessing of re-usable and single-use medical devices.3 The letter described Health Canada’s 1996 collaboration with the Canadian Healthcare Association (CHA) [...] A higher incidence of initial balloon failure was observed in the re-use group compared with the single-use group (10.2% versus 3.3%).11 A re-analysis of the data, controlling for baseline clinical characteristics, found that adjusted rates were similar for the two centres, suggesting that catheter re- use was not associated with an increased rate of in-hospital complications.22 The quality of the [...] Duration of observation The best quality of study would include observation of the patient until there is no longer a risk of an adverse event because of the re-use of SUDs. [...] Common reasons for the exclusion of articles were the same as those for the clinical review and included the absence of data on patients’ outcomes.