Polly Varnado looks at her daughter’s Medtronic insulin pump in Destin, Fla. Medical device manufacturers and experts say insulin pumps are safe. 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 some other countries. File photo by THE ASSOCIATED PRESS

Ottawa unveils plan to make medical devices like insulin pumps, pacemakers safer

TORONTO — 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 some other countries.

A recent Toronto Star-CBC investigation found that at least 1,400 Canadians have died since 2008 in incidents involving various types of medical devices, while another 14,000 reported injuries over that 10-year period.

The plan released Thursday includes a number of steps aimed at boosting the safety, quality and efficacy of medical devices, including improving how the products get onto the market strengthening follow-up monitoring of those already in use and providing more information about devices to patients.

Part of that plan involves hiring an additional eight inspectors and two investigational analysts, bringing the total number to 90 by March, and raising the number of inspections of foreign medical device manufacturers from 80 to 95 by April.

The strategy also involves putting in place regulations that will mandate that all hospitals across the country report serious adverse incidents related to medical devices to Health Canada with “prescribed timelines,” Dr. Supriya Sharma, the federal department’s chief medical adviser, told a media briefing from Ottawa.

Under the proposed beefed-up regulations, hospitals would be required to report adverse incidents in writing within 30 days, a period designed to allow sufficient time for institutions to validate required information and provide clinical documentation.

However, that reporting requirement will not include private health clinics or long-term care facilities that also can provide medical devices to patients, because of the varying provincial and territorial definitions of what constitutes a hospital, Sharma said.

Adverse incidents are those serious enough to cause a person to be admitted to hospital or to have their hospital stay extended, for instance if a diabetic’s insulin pump were to malfunction.

“So even if people have had a procedure in a private facility or something in a long-term care facility and there is an incident that brings them into a hospital,” any problem with a device would be captured through the new reporting system mandated for those health-care institutions, she said.

Meanwhile, Health Canada is exploring the idea of expanding the scope of mandatory reporting of adverse incidents to private clinics and long-term care facilities, but any new regulations would have to follow consultations with the provinces and territories.

Currently, a program known as the Canadian Medical Device Sentinel Network covers more than 260 health-care facilities, which have voluntarily committed to report any adverse events experienced by patients related to the products.

“Health Canada will aim to expand this network to include facilities outside the hospital setting, including long-term care facilities and private clinics,” the online document says.

The plan also includes proposing draft regulations, by June, that 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.

Currently, information from clinical studies about medical devices is made available to the public only through Access to Information requests to the federal government. Health Canada will make that process easier by creating a web portal that will allow members of the public to directly search for information about various devices.

Health Canada also plans to create an expert advisory committee on women’s health issues for drugs and medical devices by January. The committee, which has not yet been formed, will begin by looking into devices such as breast implants, vaginal meshes for supporting the urinary tract, and contraceptive implants, Sharma said.

The regulator has also proposed allowing health professionals to conduct “investigational testing” of medical devices by June of next year. Researchers would submit an application for human trials to Health Canada without having to go through the products’ manufacturers.

That would align testing of medical devices with the way in which medications have long been regulated, Sharma said.

Online:

Action Plan: https://www.canada.ca/en/health-canada/services/publications/drugs-h https://www.canada.ca/en/health-canada/services

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