Health Canada upbraided for inspections of medical devices
The health of Canadians could be at risk because Health Canada doesn't know if it is doing enough surveillance and inspections to ensure medical devices are safe and effective, the Office of the Auditor General says.
The audit found that overall the department's progress on regulating medical devices was "unsatisfactory" because it has failed to adequately address concerns raised in two previous audits dating back to 2004.
Under the Food and Drugs Act, Health Canada regulates the safety and effectiveness of all medical devices marketed in Canada. But according to the audit, completed last October, the department doesn't know what level of inspection activities and surveillance are needed to protect the health and safety of Canadians.
Health Canada also does not know whether the risks that inspections and incident reports are designed to identify have been adequately addressed.
There are currently more than 1.4 million different medical devices on the Canadian market, ranging from low-risk items such as bandages and reusable surgical scalpels to high-risk devices such as HIV test kits and pacemakers.
"Health Canada should complete program baselines for post-market activities by defining the level of activities necessary to meet its obligation of protecting the health and safety of Canadians," the audit states.
These activities include inspections of establishments, review of incident reports and keeping up with clinical and scientific literature.
The audit also looked at how Health Canada is doing on the front-end before medical devices are approved for sale, and found that in 45 per cent of cases, the department does not meet the timeliness standards agreed upon with industry for its pre-market review. This delays Canadians' access to the health benefits of these devices, the audit states.
"According to Health Canada, this problem is due to a funding shortfall caused by rapid growth in medical device technology and increasingly complex submissions."
But the audit also notes that medical devices are often approved for use in other countries before companies apply to Health Canada for approval. Yet the department does not use these foreign reviews as part of its pre-market assessments.