e-1422 (Medical devices)
- Keywords
- 8545-421-210-01 Government Response to petitions concerning medical devices
- Implants
- Patient registries
- Plastics
- Surgical procedures
Original language of petition: English
Petition to the House of Commons
- Inadequate regulation for synthetic surgical mesh products has exposed thousands of Canadians to unnecessary harms;
- All implantable medical device materials and devices can be more readily tracked, patterns of use monitored, and patients later judged to be at risk more easily identified;
- International Standars Organization (ISO) agreements between countries allows substantially similar products to be cleared for sale instead of approved for sale, which means that biocompatibility testing may not be required for 510k cleared implant products to be licensed;
- Implant mesh materials substantially the same as previously cleared mesh materials in the USA are considered to have met biocompatibility requirements, even though the approved predicate mesh may have been recalled; and
- No mechanism is in place to recall 510k cleared products.
- Open for signature
- December 21, 2017, at 2:28 p.m. (EDT)
- Closed for signature
- April 20, 2018, at 2:28 p.m. (EDT)
- Presented to the House of Commons
-
Martin Shields
(Bow River)
April 26, 2018 (Petition No. 421-02274) - Government response tabled
- June 11, 2018