Dear Mr. Waite,
It is important to note that no device incidents related to the safety of the DRX 9000 were reported. Health Canada requested evidence to support the success rate of pain reduction claimed by the manufacturer. The manufacturer did not respond to this request. Therefore, the licence was then suspended as of May 5, 2010.
Pursuant to the Medical Device Regulations, the notice of suspension, and any correspondence related to licence suspension, is sent directly to the manufacturer of the device. It is the responsibility of the manufacturer to notify current owners of the device. However, there is no regulatory requirement for the manufacturer to send a notification to its Canadian customers that the device they have is now unlicensed, so Health Canada could not compel the manufacturer to do this. The decision to continue to use the device is the responsibility of the healthcare professional.
Canadians can find information on the status of medical licences on www.mdall.ca. Prior to purchasing medical devices, health care providers should ensure that the devices are appropriately licensed. Health Canada has posted notices on our website in this regard as recently as December 14, 2009.
Notices have also been sent out directly to health care facilities providing this reminder.
Health Canada uses a risk-based approach and increases the nature of its communications pursuant to the perceived risk to users. Where there are concerns regarding the safety of Canadians, Health Canada communicates actively with Canadians to inform them of the risks associated with the use of a medical device.
Sincerely,
Nancy Shadeed
Device Licensing Division |
