Health Canada’s Surveillance Process Found Lacking
Canada’s Office of the Auditor General has found Health Canada’s medical device surveillance and inspection processes unsatisfactory, according to The Montreal Gazette.
The regulator’s poor review stems from its inadequate response to problems found in two previous audits as far back as 2004, the Gazette reports. Health Canada’s audit in October 2010 revealed that the regulator lacks awareness of what levels of surveillance and inspection are necessary to effectively monitor the Canadian medical device market and adequately support public safety. In addition, Health Canada doesn’t know if device risks its inspections have identified have been properly handled by manufacturers.
Auditors have recommended that Health Canada define levels of post-market activities required to properly safeguard public health, including establishment inspections, incident report reviews and keeping abreast of latest clinical and scientific literature.
But post-market shortcomings were not the only problems at Health Canada noted by auditors: The regulator has also failed to meet pre-market device review timelines in 45% of cases, delaying public access to new devices and technologies. While the regulator has contended that lack of proper funding has largely caused these delays, the Office of the General Auditor counters that Health Canada could more cost-effectively carry out its pre-market activities for devices previously approved in other markets by using data from those prior reviews in its assessments.