Dive Brief:
- Health Canada released an anticipated action plan Thursday that lays out steps to strengthen the nation's regulation of medical devices ranging from pacemakers to insulin pumps.
- The plan proposes improvements to the premarket device approval process and to monitoring systems for those already in use. The safety overhaul also intends to provide the public with more information including clinical data and reports on incidents involving medical devices.
- The action comes on the heels of an extensive investigation by the International Consortium of Investigative Journalists (ICIJ) that took aim at both regulators and manufacturers for poor testing of medical devices and underreporting of injuries and deaths resulting from the implants.
Dive Insight:
The ICIJ report, called the Implant Files, prompted Canadian Minister of Health Ginette Petitpas Taylor last month to pledge to accelerate efforts to improve the country’s regulation of devices. The investigation, also led by CBC/Radio-Canada and the Toronto Star, found problems with how medical devices are approved and monitored in many countries.
An analysis in Canada specifically found that medical devices were suspected to have contributed to more than 14,000 reported injuries and 1,416 deaths over the past 10 years.
Health Canada has its work cut out for itself next year, as the 10-page action plan lays out a 2019-focused timeline for implementing an ambitious list of measures for improving medical device safety, effectiveness and quality, including:
January: Publish more information about decisions made on medical devices and expanding Health Canada's use of outside scientific expertise, including patient participation. This includes creation of a new expert advisory committee on women's health issues for drugs and medical devices.
February: Begin expanding Canadian Medical Devices Sentinel Network, an adverse event reporting group.
March: Increase staff bandwidth by hiring additional inspectors and investigational analysts.
April: Increase the number of inspections of foreign medical device manufacturers.
June: Advance final regulations to require hospitals to report medical device incidents to Health Canada, and propose draft regulations 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. The government also plans to introduce a proposal to allow healthcare professionals to conduct investigational testing of medical devices, as well as decide how to use real-world evidence for regulatory decision-making.
December: Make clinical information and data about medical device incidents more easily available through a searchable database.
