Ottawa unveils plan to make medical devices like insulin pumps, pacemakers safer
Posted December 20, 2018 11:31 am.
This article is more than 5 years old.
Health Canada has announced an action plan to improve the safety of medical devices such as pacemakers and breast implants following media reports of Canadians receiving risky products pulled from the market by other countries.
The plan released Thursday includes a number of steps, including improving how medical devices get onto the market; strengthening follow-up monitoring of devices already in use; and providing more information about those devices to consumers.
Health Canada chief medical adviser Dr. Supriya Sharma says the federal department will boost the number of inspections of foreign medical device manufacturers by April.
The action plan also involves putting in place regulations that will mandate that hospitals across the country report adverse incidents related to medical devices to Health Canada.
Sharma says proposed regulations would require manufacturers to notify Health Canada within 72 hours if foreign regulatory agencies issue a warning about serious risks related to a medical device.
A recent Toronto Star-CBC investigation found that at least 1,400 Canadians have died since 2008 in incidents involving various medical devices, while another 14,000 reported injuries.
