Reuse of single use medical devices in Canada: Clinical and economic outcomes, legal and ethical issues, and current hospital practice
Bibliographic record
Abstract
OBJECTIVES: The aim of this study was to assess the evidence that reuse of medical devices marketed for single use only (SUDs) is safe, effective and cost-effective, and to consider the use and health services impact of this practice in Canada. METHODS: A systematic review was performed of studies that reported clinical or economic outcomes following reuse of SUDs in humans. Direct costs of adverse health events associated with SUD reuse and indications of budget impact were obtained using data for devices for laparoscopic cholecystectomy and coronary angioplasty. Legal and ethical issues were reviewed, drawing on material relevant to Canada. Data on current reuse of SUDs were obtained through a survey of Canadian acute care hospitals. RESULTS: Studies of variable quality suggested that SUD reuse could be safe and effective, and would give cost savings, if there were no adverse events. Eliminating reuse of SUDs for laparoscopic cholecystectomy and coronary angioplasty would add less than 0.1 percent to costs of the procedures over 1 year. Adverse health events associated with device reuse create liability risks; patients should be informed of any known or foreseeable risks of reuse. Most of the 28 percent (111/398) of acute hospitals that reprocess SUDs do so in-house. Some do not have a written policy or an incident reporting mechanism. CONCLUSIONS: There is insufficient evidence to establish the safety, efficacy and cost-effectiveness of reusing SUDs. Legal and ethical issues require attention to minimize liability and maintain patient safety and trust. Some hospitals that reprocess SUDs do not have adequate documentation. These findings do not support the reuse of SUDs in Canadian hospitals.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.089 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.007 | 0.018 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.005 | 0.001 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".