Mr. Speaker, a glaring lack of federal oversight exists in a little known but nonetheless important aspect of our health care system. I am referring to the reprocessing and reuse of medical devices designed and intended for single-use only.
The federal government has undisputed jurisdiction for regulating the manufacture of both pharmaceutical products and medical devices. I have already asked the government why it has been remiss in regulating drug compounders, those entities that are not strictly speaking drug manufacturers or pharmacies as the oversight and regulation of the latter is the responsibility of the provinces and the former of Health Canada.
In regard to the reprocessing of singe-use medical devices, in 2004 the Auditor General urged Health Canada to consider regulating these devices in the same manner as it regulates new medical devices. However, the department concluded that the Food and Drugs Act, from which the medical devices regulations derive their authority, was not intended to apply to the use of a device after its sale.
The issue was subsequently raised by a witness at the health committee last spring during the committee's hearings on Bill C-17, Vanessa's Law.
Suddenly, this past July, Health Canada announced that it was encouraging, although apparently not requiring, reprocessors to apply for and obtain a licence for reprocessed single-use devices in Canada. The government went on to say that one reprocessor had, in fact, obtained a licence from Health Canada for one reprocessed single-use device out of 200 or so in commerce in Canada. This device was a non-invasive device, an inflatable compression sleeve, which is clearly not an example of the riskiest reprocessed single-use device.
Why will the government not act decisively and follow the Auditor General's 2004 recommendation to begin strict regulatory oversight of the market for reprocessed single-use medical devices?
What prompted the government to move away from its earlier view, that it lacked jurisdiction in the matter, to a more confused position that reflects a half-hearted commitment to ensuring the safety of patients undergoing invasive procedures with reprocessed devices?