RE:RE:RE: 60 MinutesCBC is doing a series of programs this week on problems with medical devices, particularly implants. Here's the link to the data base they put together. If you try and see what reports to Health Canada there have been regarding contaminated endoscopes, you will find very few and the nature of the problem will not be clear in most cases, but nothing whatsoever resembling the number of contamination issues and patient injuries that have occurred. As CBC outlines, OEM's or importers are responsible for reporting problems. This is sort of like having the fox in charge of keeping track of eggs and hens. And, as we know, the OEM's are all in complete and total denial (despite Olympus setting aside 100 M for anticipated duodenoscope claims in NA) that their instruments and scopes are in any way responsible for any patient injuries or deaths related to use of their contaminated scopes, on advice of their lawyers. There is a gross lack of proper reporting in Canada as it is not done by the hospital, physcian, patient, or user. Patient injury issues or deaths would be reported at a Mortality Morbidity Rounds or during an internal Central Supply audit, but generally users are loath to have bad news about their provision of health care reported and they try to keep problems to themselves. Reporting of any device issues to Health Canada is, believe it or not, entirely voluntary, though Health Canada encourages input. Really. See the responses below to CBC questions! Does anyone in their right mind think doctors or hospitals are going to report contamination issues, injuries, and deaths (for which the physician, hospital, OEM may be legally at risk and liable) voluntarily?? This is one of the main topics of this CBC investigative series this week.
Perhaps, someone at CBC should do an investigation and try to determine the extent of the contamination issue in Canada, including demanding mandatory monitoring of endoscopes, particularly duodenoscopes, gastroscopes, bronchoscopes, cystoscopes, colonoscopes, for contamination because Health Canada is doing next to nothing on their own.
https://www.documentcloud.org/documents/5253370-Health-Canada-Response-MDI-Database.html
There is a group that monitors adverse medical device events and reports of these, for example regarding the Custom Ultrasonics HLD failures a few years ago, https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/56104a-eng.php , called the Canadian Medical Devices Sentinal Network https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html But, again, reporting to this group remains voluntary despite Health Canada's stated plans to create better reporting and surveillance, and the OEM's are in 'deny, deny, deny' mode and will continue to be for legal and marketing reasons.
IPAC (Infection Prevention and Control Canada) do try to monitor some problems and groups like CAMDR (Canadian Association of Medical Device Reprocessing) try to educate and lead but these groups need more teeth and strict manditory surveillance and reporting needs to be the norm otherwize we will never know the extent of the problem and demand use of the VP4 to solve it.
https://ipac-canada.org/photos/custom/Members/CNISPpublications/CNISP%202013-2017%20Report_Final_EN.pdf
I hope this gives a bit of view of the lack of knowledge of the extent of the contamination problem in Canada.
BUT, while we try to determine how bad the situation is, WE DO HAVE A SOLUTION: TSO3'S COST EFFICIENT AND EFFECTIVE TERMINAL LOW TEMPERATURE STERILIZER, THE VP4