Over the weekend and continuing into today, there have been numerous reports in the press about alleged problems with medical devices in Canada, the U.S., the UK, and elsewhere. The press reports come out of an investigation called The Implant Files, which was carried out by the International Consortium of Investigative Journalists. The press reports have been covered extensively on CBC radio and in the Toronto Star, The Guardian, and other international publications. The reports allege that patients are experiencing pain or other adverse effects, including death, from inadequate medical devices that have made their way into the market due to poor regulation, inadequate device testing rules, and a lack of transparency. Among the devices that they discuss are replacement hips, pacemakers, hernia mesh, and spinal disc replacements, though these are only a few examples.
These press reports are likely to continue and to result in various inquiries for hospitals. Hospitals are likely to receive inquiries from patients asking for information about what specific devices (make, model, serial number) they have had implanted in them and whether those devices are among the ones alleged in the press reports to be sub-standard. Media inquiries, while less likely, are also possible. Hospitals are urged to be prepared for such inquiries and to have a system in place for responding to them.
The following resources may be helpful to hospitals who want to know more about devices that have been subject to recalls or similar action:
- The Health Canada register of recent health product recalls and alerts
- The International Medical Devices Database built by the International Consortium of Investigative Journalists and used in the research that forms the basis of these press reports
- HIROC Risk Note: Responding to Medical Device Issues
- HIROC Multi-Patient Lookback and Notification Guide