Key Message

What Is the Issue?

It is estimated that 23% of adults in Canada have hypertension. About 1/3 of this population have uncontrolled hypertension, a condition in which (BP) blood pressure levels continue to remain high despite treatment. People with high BP despite being prescribed 3 or more blood pressure-lowering (antihypertensive) medicines are considered to have uncontrolled resistant hypertension. Renal denervation is a therapy that involves disrupting activity in the sympathetic nerves in the renal artery using a minimally invasive catheter-based procedure to treat high BP. We wanted to know if renal denervation would effectively and safely reduce BP in people with uncontrolled hypertension.

What Did We Do? 

We identified and summarized the literature comparing the clinical effectiveness and safety of renal denervation in individuals with uncontrolled hypertension to help guide decisions on the use of this intervention. An information specialist searched for peer-reviewed and grey literature sources published between January 1, 2019, and February 5, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings.

What Did We Find? 

The evidence for this report was based on 2 systematic reviews and 3 randomized controlled trials (RCTs). Renal denervation could lead to a reduction in BP compared to sham in adults with uncontrolled nonresistant hypertension. It is uncertain if renal denervation is an effective treatment for resistant hypertension and suspected hypertensive heart disease due to the methodological limitations of the included studies. Serious side effects of renal denervation were rare.

What Does This Mean? 

Our findings agree with evidence-based guidelines and real-world evidence that suggest renal denervation can be considered a treatment option for patients with uncontrolled nonresistant hypertension. Other factors, including costs and resources, equity, acceptability, and patient selection, should be considered when implementing renal denervation in Canada, where it remains an emerging medical technology. Future research should assess important patient outcomes, such as quality of life.

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, Canada's Drug Agency 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? 

• Mechanical ventilation helps individuals breathe when they cannot do so on their own. During mechanical ventilation, aerosol therapy is used to deliver medication to the lungs of the person who is using the ventilator. 
• High doses of aerosol therapy administered via metered dose inhaler for adults and older adults who are mechanically ventilated is common clinical practice. However, the reasoning behind this practice, and whether it has clinical benefits compared to no doses and standard doses, is unclear.

What Did We Do? 

• To inform decisions about high doses of aerosol therapy delivered with metered dose inhalers in adults and older adults receiving mechanical ventilation, we sought to identify and summarize literature comparing the clinical effectiveness of inhaled high doses of aerosol therapy versus no aerosol therapy. We also sought to identify and summarize literature comparing the clinical effectiveness of inhaled high doses of aerosol therapy versus standard doses. 
• A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2004, and January 25, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included study, and narratively summarized the findings.

What Did We Find? 

• We found 1 retrospective chart review that compared the clinical effectiveness of 2 different doses of inhaled high doses of aerosol therapy. The findings from this study suggest that, compared to lower doses, higher doses of salbutamol are associated with more days alive and free of acute lung injury and more days alive and free of indicators of acute respiratory distress and respiratory failure. 
• We did not find any studies that compared the clinical effectiveness of inhaled high doses of aerosol therapy to no aerosol therapy for adults and older adults receiving mechanical ventilation that met inclusion criteria for our review.

What Does It Mean? 

• The available evidence with methodological limitations suggests that high doses of aerosol therapy with salbutamol may be associated with better clinical respiratory outcomes when compared to low doses in patients with acute lung injury who are mechanically ventilated. To inform future clinical practice, decision-makers may want to consider the potential risks and benefits and environmental implications of aerosol therapy, as well as implementation factors (e.g., resource needs, risk of contamination).
• Additional clinical studies would help provide a better understanding of the optimal dosage and clinical effectiveness of aerosol therapy for patients who are mechanically ventilated.