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Canadian Providers: Access to equipment may decrease in 2018/2019

Discussion in 'EMS-Related News' started by ThadeusJ, Apr 6, 2018.

  1. ThadeusJ

    ThadeusJ Forum Lieutenant

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    Greetings all,

    I wanted to reach out to Canadian EMS providers to inform them that access to some equipment may decrease throughout the rest of 2018 and 2019 due to changes in Health Canada's regulatory program. The MDSAP program is a well-intentioned auditing program where a third party auditor goes through the quality assurance program of a manufacturer. The MDSAP program is optional in the USA, Brazil, Australia and Japan, but will be mandatory as of January 2019. If you want to sell in Canada, then you have to have the certification.

    The issue is that the MDSAP program replaces the previous CMDCAS system that would normally cost a company $3,000 annually. Companies have received estimates between $35,000-50,000 for an annual audit. I have spoken to 4 Canadian distributors that have told me that some of their foreign-based manufacturers are withdrawing from the Canadian Market as a direct result these increased costs. Also, a colleague spoke with a US-based auditing company and they reported that 80% of their foreign manufacturing clients plan on withdrawing from Canada.

    Although this directly affects Canadian manufacturers and distributors, but when you take into account the services that will be told that the product they currently use will no longer be available as well as the impact on patient care, these changes are significant to Canadian healthcare.

    This message is to inform EMS services in Canada of what is currently taking effect. If you require additional information, it can be found through a Google search ("MDSAP") or you can contact me directly.
     
  2. Summit

    Summit Critical Crazy

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    That is pretty nuts. Squeezes out the little guys
     
  3. E tank

    E tank Caution: Paralyzing Agent

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    The program’s goals include:

    1.Development of an international coalition to improve medical device safety and oversight on an international scale

    2.Creation of a single audit program that provides confidence to international regulators

    3.A minimized regulatory burden on the medical device industry

    4.Enabling government regulatory authorities to focus on critical/problematic manufacturers, allowing notified bodies to conduct inspections on their behalf

    5.More efficient and less burdensome regulatory oversight of medical device manufacturers’ quality management systems

    6.More effective use of regulatory resources through work-sharing and mutual acceptance among regulators

    7.Better global alignment of regulatory approaches, and technical requirements based on consensus standards and best practices

    Some of these goal look like they contradict each other. Like all of them contradicting #3. An international regulatory body on private industry? Color me skeptical. There's a reason something like that doesn't exist for food and drug on an international scale. Sounds like an absolute disaster.
     
    Summit likes this.
  4. ThadeusJ

    ThadeusJ Forum Lieutenant

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    I agree. The goals are lofty but (as in many things bureaucratic) the execution is problematic. I once assisted the first regulatory body for my profession in Ontario, Canada. The council was half professional registrants and half public member appointees. As we were discussing the annual dues, one of the public members stated quite clearly that our mandate shouldn't concern the impact on the registrant. In fact, we could charge $10,000/year and they would have to pay it in order to practice in Ontario. What they failed to recognize was that market forces would prevail and people would leave the profession. The public member didn't see that as an issue (how many paramedics would stay in the field if the government instigated a $10,000 annual due and how would that impact healthcare?). Lunatics running the asylum.

    One of the program's goals is for the industry to provide objective evidence that the quality program was being fulfilled. I ask for objective evidence that patient care will improve with this program.
     

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