The reuse of single-use cardiac catheters: safety, economical, ethical and legal issues. Conseil d'évaluation des technologies de la sante du Québec.
OBJECTIVE
To evaluate the risks, economic benefits, and ethical and legal aspects of reuse of diagnostic and angioplasty catheters intended for single use only.


METHODS
Four approaches were used: first, a comprehensive review of the literature relating to risks of infection, pyrogen reactions, toxicity, particulate contamination and catheter breakage; second, experimental studies involving deliberate bacterial contamination and resterilization of catheters; third, experimental studies of the mechanical properties of catheters; and fourth, acquisition of legal opinions.


CONCLUSIONS
Diagnostic and angioplasty catheters intended for single use can be reused without putting patients or personnel at increased risk if effective cleaning, sterilizing and quality control procedures are adhered to. An average of five uses for each diagnostic catheter and three uses for each angioplasty catheter may save approximately $5000 and $100,000 respectively, per 100 procedures. The measures necessary to achieve safe reuse, including the steps to assure adequate training of the responsible personnel, should be precisely identified and formally approved by any institution before catheters are reused. Evidence that this has been done and that protocols are being followed should be kept updated and available.
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D002170:Canada; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D004209:Disposable Equipment; D017743:Equipment Reuse; D004992:Ethics, Medical; D006801:Humans; D016365:Liability, Legal