Single-use medical devices are those labelled by their manufacturers to be used only once. For many years hospitals have been reprocessing some medical devices originally labelled for single use for cost savings. Reprocessing includes cleaning, sterilising and disinfecting.
However more and more hospitals are outsourcing reprocessing to outside companies. Although hospitals will continue to be permitted to reprocess some medical devices, commercial reprocessing companies will be held to the same requirements as manufactures of new devices.
Companies which provide this service to hospitals must meet requirements for licensing (device and establishment), quality system management, labelling, investigating and handling complaints, maintaining distribution records, conducting recalls, reporting incidents and informing Health Canada of any changes to the information in their license application.
By September 1, 2017, all commercially reprocessed devices are expected to be in compliance with the Regulations, whether they are reprocessed domestically or outside Canada. Non-compliant devices and activities will continue to be subject to risk-based compliance enforcement.
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