Dr. Gagliardi
Dr. Anna Gagliardi, Scientist at Toronto General Hospital Research Institute, is the lead author of this study, which identifies the factors that influence whether physicians identify and report medical device incidents.(Photo: UHN)

As many hospitals deploy initiatives to reduce preventable harm, the key goal is to strive to minimize errors and improve patient safety.

While medical devices such hip, knee and cardiovascular implants are essential to the treatment and well-being of patients — they extend life and improve quality of life — they sometimes don't work as intended and those incidents may result in harm to the patient.

New research from TGHRI Scientist Dr. Anna R Gagliardi reveals that hospitals may need to improve the systems by which physicians, the healthcare professionals who implant medical devices, identify and report medical device incidents.

Previous work by Dr. Gagliardi and colleagues analyzed data from Health Canada on medical device recalls over a 10-year period (2005 to 2014) and found that five per cent of more than 7,200 medical devices recalled were due to problems with the device that could cause harm to patients. Thus, while medical device incidents might be rare events, it is crucial to quickly identify and report such problems.

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To further explore the underlying reasons for this underreporting of medical device incidences, Dr. Gagliardi, along with collaborators at UHN, the University of Toronto and across Canada, conducted a qualitative study — one in which detailed information is gathered from a small group of individuals who represent the views and experiences of a larger group. In this case, detailed interviews were conducted with a diverse group of 22 physicians from across Canada.

medical devices
Collage of various medical devices. Of the 22 physicians interviewed in the study, 10 discussed their experience with cardiovascular devices, such as pacemakers, and 12 discussed orthopaedic devices, such as artificial hip or knee joints. (Image: UHN StRIDe Team)

During the 30-minute interviews, physicians were asked to describe a recent event in which a medical device malfunctioned, the implications, and how they reported it, including any factors that influenced reporting.

The findings showed that there are two factors that could be addressed at the health system level: physician beliefs and healthcare system capacity. Reporting may be limited by physicians' understanding of what is and is not a medical device incident.

It is further limited by a lack of administrative tools at hospitals to capture the information or bypass purchasing agreements with medical device manufacturers in order to purchase alternative devices.

"Taken together, the results of our study suggest that effective solutions to the under-reporting problem must be multifaceted," says Dr. Gagliardi. "Rather than simply educating physicians on how and when to report incidents, we need to create the right environment for reporting.

"This includes the right policies at hospitals, including information systems and incentives to encourage reporting. It may also include establishment of national and international systems to broadly capture and publicly share information about medical device incidents."

Read more on the 10-year incident analysis and the qualitative interviews with physicians.

This work was supported by the Canadian Institutes of Health Research and the Toronto General & Western Hospital Foundation.​


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