Health and Sciences Authority (HSA) published a guidance last June 11, 2020 on the decontamination of single use respirators in line to COVID-19 response. Respirators are among the most important personal protective equipment (PPEs) that are currently being used and practical methods are being developed to decontaminate used ones effectively.
Respirators are considered under the Class C of medical device risk classification in Singapore and will require review and approval from HSA prior to local distribution. However, due to the recent increasing demands for such, the HSA implements provisional authorization pathway which facilitates access to safe and effective medical devices intended to decontaminate respirators. The guidance covers the important regulatory requirements for provisional authorization, as well as good practices for healthcare institutions and other facilities.
Provisional Authorization
The provisional authorization is a risk – calibrated review process that covers the safety, quality and effectiveness of medical devices. This guideline will particularly focus on devices for decontaminating other medical devices. Prior to granting the authorization, HSA reviews the integrity and the ability of the respirators to achieve their intended use (e.g. filtration efficiency, fit, etc.). Post – authorization will require periodic reports of any defects or performance issues related to these devices.
To apply for a provisional authorization, an email must be sent to hsa_md_info@hsa.gov.sg bearing the subject “Provisional Authorization for Medical Devices for Decontamination of Respirators”, including the following information/evidences regarding the device:
- - Description of the Medical Device (principle of operation, design, description of relevant controls)
- - Pathogen Reduction Effectiveness (sporicidal and viral inactivation studies)
- - Preservation of Intended Use of Respirators (e.g. fit, filtration, etc.) Post – Decontamination
- - Tests for Residual Decontaminants
- - Instructions for Safe and Effective Use for Users:
- Device Operation Instructions (e.g. settings, control measures, essential warnings and precautions)
- Validated Decontamination Conditions and Methods
- Tests for Residual Decontaminants
- Validated Facility Specifications (e.g. room size)
- Decontaminant – Respirator Compatibility
- Respirator Decontamination Cycles
- Recommended Specifications of Decontamination Pouches
- Device Specific Limitations or Residual Risks
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An importer/wholesaler’s license with HSA and compliance with Good Distribution Practice for Medical Device (GDPMD) are required for suppliers and/or importers. For establishments offering decontamination services, a manufacturer’s license from the HSA and an ISO 13485 certificate is required.
HSA Guidelines on Healthcare and Other Facilities that Decontaminate Respirators
- - Hospitals or other local facilities will use the decontaminating products that have been evaluated and authorized by HSA.
- - User manuals/information for use/technical specifications/fact sheet must be followed strictly by the users in these facilities.
- - Implementation of the following additional measures by the hospitals:
- Reasonable oversight (e.g. internal audit)
- Documented procedures for verification of completion of the decontamination process prior to releasing of the respirators
- Track and trace system to identify the number of decontamination cycles for each used respirator.
- Periodic sampling of decontaminated respirators to monitor process effectiveness.
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