Unbelievable Leading-edge Medical Precision

2010-10-14

The notion of robots performing surgeries may not be as far-fetched as it once seemed.

Given the size of the Canadian medical devices market, which is valued at approximately $7.1 billion (2007, Global Markets Direct), combined with Canada’s federal commitment to support scientific research, create jobs and stimulate economic growth, the momentum and buzz for projects emanating from this sector becomes increasingly believable.

Ian Smith, the Director General of the National Research Council (NRC) Institute for Biodiagnostics in Winnipeg, is excited to be a part of Canada’s leading-edge medical devices sector. “It’s a very fascinating field right now,” he says. The NRC Institute conducts research on innovative diagnostic methods such as stem cell research, MRI procedures and robotic surgery, all of which are advancing at a rapid pace.

“That’s our goal is to invent something, commercialize it and make jobs to hire people who are graduating from our universities instead of shipping them off to other countries,” says Smith. He explains that the institute’s Calgary location already has the prototype for a mechanical device that performs various surgeries, while the human surgeon guides it along.

“An increased use of internationally recognized standards, such as those listed on the Medical Devices Bureau website, ensures that patients in Canada have timely access to safe, effective and quality devices,” says Stephane Shank, a senior advisor for Media Relations at Health Canada.

“You know exactly where you’re going, you know exactly what you’ve done as soon as you’ve done it and you’ve taken (away) any uncertainty due to wobbly hands,” he says, praising the device’s usefulness for neural surgery where even the smallest mistake can lead to severe brain damage.

Medical robots have a surgical accuracy of less than 1 millimetre. The da Vinci robot, which is being used for cardiac surgery at the London Health Sciences Centre, in London, Ontario, is just one example of this field’s sophistication. “I think this is going to go lots of places because of the accuracy,” says Smith.

As with any field experiencing rapid growth, the need for standards and testing becomes acute, in particular with regards to product safety and quality assurance.

In Canada, the sale of medical devices is regulated by Health Canada. Federal regulations specify that class 1-4 medical devices must be manufactured or distributed under a certified quality management system (QMS) that meets the criteria of the international quality management systems standard for medical devices (ISO/IEC 13485:2003). The program operated by the Therapeutic Products Directorate of Health Canada for Canadian Medical Devices Conformity Assessment System (CMDCAS), requires organizations that certify the management systems of medical device manufacturers or distributors to be accredited by the Standards Council of Canada.

“An increased use of internationally recognized standards, such as those listed on the Medical Devices Bureau website, ensures that patients in Canada have timely access to safe, effective and quality devices,” says Stephane Shank, a senior advisor for Media Relations at Health Canada.

Since these regulations were introduced in 1998, Canadian efforts to harmonize medical device regulations with those of our international trading partners have continued. By requiring that medical devices sold in Canada be designed and manufactured under a certified QMS that conforms to international standards (ISO/IEC 13485:2003), there is greater assurance of product safety in terms of the import and export of these types of products.

“Harmonization of standards is important when technologies change rapidly and when manufacturers supply markets around the world, as well as in Canada,” says Shank.

The complexity of these devices combined with their impact on the health of Canadians further enhances the need for harmonization. “Standardization establishes internationally recognized, essential safety and effectiveness criteria, to ensure users of the safety and quality of the device,” adds Shank.

Part of Health Canada’s role is to monitor technology compliance of medical devices with Canadian regulations and guidelines before allowing these products to become available on the Canadian market.

“In addressing leading-edge devices, standards must avoid setting restrictions on design or application that would impede the advancement of the new technology,” says Mary Jo Haddad, President and CEO of the Hospital for Sick Children (SickKids).

Advances in technology are certainly being put to good use at SickKids, which received an investment of $10 million in March of 2010 from the federal government to strengthen its position as a leading centre for medical research in Southern Ontario.

“This is a prime example of how research and technology can be transformed into clinical application, which leads to improved health outcomes for our children,” says Haddad. Surgical robots, medical imaging and simulation technologies are being developed for the care of children and babies thanks to the federal grant.

The astounding potential of medical devices is obvious from the rapid pace of the industry and the many innovative applications being proposed. Robots performing delicate surgery, biosensors used to detect bioterrorism agents in food and water, as well as new optical imaging techniques that could greatly improve procedures such as angioplasty are a few examples.

As the application of leading-edge medical devices continues to expand, Canadians will witness an array of ground-breaking technologies that would not be possible without the application of standards.

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This article first appeared in Volume 37 of CONSENSUS Magazine, 2010. The information it contains was accurate at the time of publication but has not been updated or revised since, and may not reflect the latest updates on the topic. If you have specific questions or concerns about the content, please contact the Standards Council of Canada.

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