Skip to main content

Single-Use Devices

Definition​

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 requirements​

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 — 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 matters​

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 devices​

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 implications​

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)