Guidance for Manufacturers on Sterilization of Reusable Medical Devices – Health Canada Overview

Purpose and Scope

This guidance document assists manufacturers in meeting regulatory requirements for reusable medical devices that are intended to be reprocessed (cleaned, disinfected, and/or sterilized) between uses. It outlines expectations for sterilization process validation, sterility assurance, labelling, and instructions for use under the Medical Devices Regulations. The guidance applies to devices labelled as reusable or requiring reprocessing, including surgical instruments, endoscopes, and other critical or semi-critical devices. Guidance Document: Information for Manufacturers on Sterilization of Reusable Medical Devices - Canada.ca

Key Sterilization Expectations

Sterilization Methods

Acceptable methods include:

• Steam (moist heat) sterilization.
• Ethylene oxide (EO).
• Hydrogen peroxide (vapor or plasma).
• Dry heat (limited applications).
• Liquid chemical sterilants (e.g., glutaraldehyde, peracetic acid) when validated for the device.

Manufacturers must justify the chosen method based on device materials, design, and compatibility.

Validation Requirements

Sterilization validation must demonstrate:

• SAL of 10⁻⁶ (Sterility Assurance Level) for critical devices.
• Overkill approach or bioburden-based cycle with supporting data.
• Half-cycle validation using biological indicators (e.g., Geobacillus stearothermophilus spores for steam).
• Physical, chemical, and biological monitoring data.
• Worst-case loading configuration and device orientation.

Labelling Requirements

Reusable device labelling must include:

• Clear statement that the device is reusable.
• Detailed reprocessing instructions (cleaning, inspection, packaging, sterilization method, and cycle parameters).
• Recommended sterilization method(s) and any restrictions.
• Sterility assurance level (SAL) if claimed.
• Warnings on single-use components or limits on reprocessing cycles.

Instructions for Use (IFU)

IFU must provide step-by-step guidance on:

• Point-of-use cleaning.
• Manual and/or automated cleaning.
• Inspection for damage or wear.
• Packaging for sterilization.
• Storage conditions after sterilization.
• Maximum number of reprocessing cycles (if applicable).

Practical Considerations

• Compatibility testing with common cleaning agents, disinfectants, and sterilization methods.
• Material degradation studies (e.g., corrosion, embrittlement) over multiple cycles.
• Risk management file updates per ISO 14971 to address reprocessing-related hazards.
• Post-market surveillance for reprocessing failures or device deterioration.

This guidance ensures reusable medical devices maintain safety and performance throughout their intended lifecycle. Detailed validation protocols, acceptable SAL approaches, labelling examples, and common deficiencies are provided in the official Health Canada reusable device sterilization guidance document. Guidance Document: Information for Manufacturers on Sterilization of Reusable Medical Devices - Canada.ca