Key Message

What Is the Issue? 

Reprocessing a medical device includes cleaning, reconditioning, testing, and disinfection to ensure the device can safely be reused. In contrast to reusable medical devices, manufacturers are not required to provide instructions for properly cleaning and sterilizing single-use medical devices (SUMDs). 

Health Canada regulates third-party device reprocessors and requires they meet the same requirements as new device manufacturers. Health Canada does not provide oversight for hospital onsite reprocessing, deferring to the oversight provided at the provincial and territorial levels. Given the potential economic and environmental benefits of using reprocessed SUMDs, there is a growing interest in determining the clinical safety of reprocessed SUMDs. 

Current standards for reprocessing medical devices use definitions for sterilization and disinfection based on measurement of bioburden, but not necessarily clinical outcomes such as infection.

What Did We Do? 

To inform decisions about the appropriate use of reprocessed critical and semicritical SUMDs, CADTH sought to identify and summarize literature evaluating the clinical safety of reprocessed SUMDs, defined as infections, mortality, or other adverse events, compared with nonreprocessed (new) SUMDs. Microbiological outcomes, such as bacterial colony counts, were not included. An information specialist searched for peer-reviewed and grey literature sources. 

This report does not provide a comprehensive list of device reprocessors in Canada or recommend any specific methods of reprocessing medical devices.

What Did We Find? 

We identified 8 studies, including one study based in Canada, which evaluated the use of reprocessed SUMDs compared with new SUMDs; most did not report statistically significant differences in patient outcomes between groups. 

Most of the included studies were of very low to moderate quality, which limits confidence in the observed outcomes resulting from the reuse of these devices. Half of the included studies were published before the year 2005, which may limit applicability given potential improvements and changes over time in reprocessing standards, surgical approaches, device specifications, and patient care protocols. 

Most of the studies evaluated a different type of reprocessed single-use medical device for different surgical populations, so there is very limited evidence for the use of a specific device in a specific population or intervention of interest. All included studies evaluated SUMDs classified as critical, and all were conducted in surgical settings; however, it is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings.

What Does it Mean? 

Given various devices, clinical applications, and reprocessing methods, it is difficult to draw broad conclusions about the appropriateness of reprocessing SUMDs. 

While the evidence base in this review was insufficient to conclude whether reprocessed critical SUMDs in surgical settings affect patient outcomes, Canadian standards and other resources exist to help inform decisions around medical device reprocessing based on infection risk. 

To ensure patient safety, any reprocessing of SUMDs should meet standards for safety, effectiveness, and labelling that follow Health Canada regulations.

Key Message

What Is the Issue?

• Accumulating research has demonstrated that subanesthetic doses of ketamine have rapid and sustained antidepressant effects. In 2019, the US FDA approved the S-enantiomer of ketamine (esketamine) for the treatment of patients with treatment-resistant depression.
• Since then, there has been interest in the development of ketamine for the treatment of a broad range of mental health conditions beyond depression, including substance use disorders (SUDs).
  Decision-makers want to know if there is any evidence to support the use of ketamine for treating SUDs in adults.

What Did We Do?

• To inform decisions about using ketamine for treating SUDs, we sought to identify and summarize the literature comparing the clinical and cost-effectiveness of ketamine with placebo or no treatment, with alternative interventions, or among ketamine administered via different routes for SUDs. We also searched for evidence-based recommendations for the use of ketamine for SUDs.
• A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2018, and November 28, 2023. One reviewer screened citations for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings.

What Did We Find?

• We found 2 systematic reviews (SRs) and 1 randomized controlled trial (RCT) on the use of ketamine for the treatment of patients with alcohol use disorder (AUD), cocaine use disorder (CUD), and opioid use disorder (OUD).
• Evidence from 2 SR suggests that a combination of ketamine infusion and psychotherapy treatment may be effective in promoting abstinence and reduced consumption of alcohol and cocaine use. There were mixed results regarding the effect of ketamine on withdrawal and craving.
• The effects of ketamine on OUD were inconclusive as the results were derived from a single study with a small sample size. Similarly, the effects of ketamine on health care utilization (e.g., hospital readmission, emergency department visit) in patients with severe AUD reported in a RCT were also inconclusive due to the small sample size.
• Adverse events associated with ketamine treatment included the dissociative and psychotomimetic effects and nondissociative effects. The authors of the included SR reported that these events were mild and transient.
• We did not find any studies on the cost-effectiveness or evidence-based guidelines of ketamine for treating SUDs that met our criteria for this review.

What Does It Mean?

• The conclusions on the positive effects of ketamine for AUD and CUD should be interpreted with caution due to the high risk of bias of the studies included in the SRs.
• There is a need for more robust clinical trials with larger sample sizes, blinding, and low risk of bias to provide more accurate findings on clinical efficacy, dosing strategies, and safety profile of ketamine for the treatment of AUD, CUD, and OUD.
• Additional studies on other substances of abuse (e.g., nicotine, amphetamines, and cannabis) may provide important insights into the overall efficacy of ketamine in the treatment of SUDs.