Thursday August 13, 2009
More Reaction to Our Show on Hospital Infections
As part of this week's rebroadcast of a White Coat, Black Art show that looked at hospital infections, we aired an interview with Dr. Michael Gardam, an infectious disease expert, on the growing process of reusing medical equipment meant to be used once and discarded. That interview prompted an email from J.R. Cocchio, an engineer from Edmonton. He writes:
Greetings Dr. Brian Goldman;
The program discussed the re-use of "single use only" medical instruments and devices. One of the guests (Dr. Michael Gardam) indicated that there was no legislative framework in Canada that applied to this practice, and that this lead could to gaps in policies, processes, and practices in the health services.
There is, in fact, a regulation in Alberta that I believe does apply. I refer you to the "Alberta Occupational Health and Safety Code 2009", and specifically "Part 3 Specifications and Certifications". (See "OHS Code 2009)
The OH&S Code is intended to protect the safety of workers and the safety of the public. It has wide-reaching impact, probably more than the legislators originally intended.
To paraphrase Section 12(d) of Part 3, an employer (the hospital, the clinic, etc.) must ensure that equipment is used "in accordance with the manufacturer's specifications or the specifications certified by a professional engineer."
So, if medical staff choose to re-use "single use only" devices after sterilization (or other means of re-processing the device to make it acceptable to re-use) contrary to the manufacturer's specifications (regardless of whether this is motivated by commercial / sales or is a true technical limitation), such a method would need to be reviewed and certified by a professional engineer who is knowledgeable and competent in that particular field. Be assured that if there were true technical limitations that could not be overcome by the re-processing means, a professional engineer would not certify the re-use of the medical device.
Thank you for your email. I read the sections as outlined. They do seem to put the onus on the hospital to have a profeessional engineer sign off on the technique followed to re-use the device ordinarily designated for one use only. It would be important for hosptials (at least in Alberta) to make certain they comply with provincial regulations before embarking on a plan to reuse disposable medical devices.