What's New Advancing Healthcare Through Innovative Technologies and Devices
Significant change in the healthcare system is ongoing. Over the last year regional transformation within the provinces, increased reliance on technology assessment, province-to-province agreements to a new and aggressive approach to provincial and hospital tendering practices have all arisen in multiple jurisdictions. These changes should not focus on commoditization of medical technologies and services, or downplay the value of innovation in the healthcare system, rather change should be an enabler for patients to access the medical technologies and diagnostics they require.
Health System Reform and related issues are being addressed by MEDEC and its member committees in a number of way including:
Health Technology Assessment position paper
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Healthcare systems in Canada use tendering processes for the procurement of medical technology. This tendering process has become increasingly complex and is requiring a significant allocation of resources. The medical technology industry is concerned about the direction of the complexity, lack of transparency in the process and the variation in clauses contained in the tenders.
In all cases, competitive tendering should support and recognize the value of innovation in medical technologies to patients, clinicians and healthcare systems, and should reward features that bring new capabilities and options to the clinical pathway.
Tendering for Medical Technologies: Core Principles position paper
Delays at the MDB began in 2007, first generating a backlog in applications for IVDD and cardiovascular devices; since then the backlog has spread evenly over all application classes. In fact, the current delay for Class III and Class IV devices are on average between 2-3 times the target times.
MEDEC is working with Health Canada and MDB to find solutions to the issues related to declining performance.
MEDEC (Canada's Medical Technology Companies) is dedicated to advancing healthcare by delivering innovative technologies and devices. Because the relationships between MEDEC's Members ("Members") and healthcare professionals are so important, they must be guided by the highest ethical standards.
For this reason, MEDEC members have designed and adopted a Code of Conduct to promote ethical business practices and socially responsible industry conduct to govern their interactions with healthcare professionals.
MEDEC's voluntary Code of Conduct was adopted January 1, 2005 to guide interactions between healthcare professionals and Members. The Code of Conduct was revised and scheduled for release the first quarter of 2010.
MEDEC Code of Conduct
The reuse of single use medical devices (SUMeDs) is a great paradox. Healthcare institutions that once asked for SUMeDs are routinely reprocessing, cleaning, sterilizing and reusing these devices, or employing the services of third party reprocessors.
Despite manufacturers' strict instructions, the practice is widespread in the Canadian healthcare system. Industry studies have shown that reprocessing by either hospitals or third party reprocessors does not result in safet products.
Therefore patients are being exposed to needless risks on a daily basis. Reuse of SUMeDs brings legal and ethical ramifications that may be overlooked.
Hospitals are potentially liable to a patient population that is unaware these devices are being used contrary to manufacturers' instructions. The economic arguments for reuse have not been demonstrated especially now that third party reprocessors are reprocessing more and more SUMeDs.
There are no laws in Canada requiring the reprocessor to validate safe reuse, despite laws that require the original equipment manufacturer to validate safe one time use of the product.
Third party reprocessors are free to operate in Canada with no regulatory oversight and devices that would not be approved by the US FDA may still come to Canada raising questions of concern for safety of the patient.
Position Papers:
Cause for Concern: The Reuse of Single Use Medical Devices
Cleaning and Sterilizing Reusable Medical Devices
