Single-Use Devices
Definitionā
A single-use device (SUD) is a device intended to be used on a single patient during a single procedure and then discarded. After use, the device must not be reprocessed and reused.
Labelling requirementsā
If a device is intended for single use, the label must clearly indicate this. Accepted labelling:
- The international symbol for single use (a circle with the number 2 and a diagonal line through it ā per ISO 15223)
- The words "Single Use Only" or "Do Not Reuse" in English and French
- Both the symbol and text are recommended for maximum clarity
Why single use mattersā
Single-use designation is a safety-critical labelling element. It informs:
- Healthcare professionals not to reuse the device
- Reprocessors that the device is not validated for reprocessing
- Inspectors and auditors whether a device has been reprocessed inappropriately
Reprocessing of single-use devicesā
Some hospitals and third-party reprocessors reprocess and reuse SUDs to reduce costs. In Canada, reprocessing of SUDs is a regulated activity. See Reprocessed Single-Use Devices for Health Canada's requirements for reprocessors.
Device Licence implicationsā
The single-use designation is part of the device's intended use as licensed by Health Canada. If a manufacturer adds a single-use claim to a previously multi-use device (or vice versa), a Device Licence amendment is required.
Legislative source: Medical Devices Regulations, SOR/98-282, s 21 (labelling); ISO 15223-1 (symbols)
Why single use mattersā
"Establishing Single-Use Status\n\nWhen designating a device for single use, manufacturers must provide scientific and technical rationale demonstrating that:\nā¢ The device's materials degrade or deteriorate after use in a manner that cannot be reliably reversed\nā¢ Reprocessing and re-sterilization would compromise device integrity, safety, or effectiveness\nā¢ Residual contamination or material breakdown cannot be adequately removed by standard cleaning and sterilization methods\nThis justification becomes part of the Device Licence application and must be reviewed by Health Canada."