With the continual rise of COVID-19 cases, the healthcare facilities are witnessing shortage of respirators. Assessing the critical shortage and enormous demand for respirators, the global Regulatory agencies are swiftly initiating significant efforts to develop practical methods for decontaminating used respirators effectively. Accordingly, Singapore’s Health Sciences Authority (HSA) has issued guidance on facilitating access to safe and effective medical devices, intended for decontaminating used respirators through provisional authorization pathway.
The provisional authorisation pathway is implemented as an interim measure to facilitate access to essential medical devices during the current pandemic. Based on a risk-calibrated review process, this pathway considers the safety, quality and effectiveness of the decontamination process using the medical devices. It also verifies that the integrity of the respirators and their ability to achieve their intended functions (e.g. filtration efficiency, fit) are maintained following decontamination. Assuring continued performance of the devices, any periodic reports, defects, or performance issues related to the decontamination devices have to be submitted to the HSA post authorization.
Application for HSA provisional authorisation can be submitted via email email@example.com with “Provisional Authorisation for Medical Devices for Decontamination of Respirators”, as the subject line and it should contain the following information:
- Description of the medical device (principles of operation, design and chemical indicators)
- Evidence of medical device being effective in reducing the number of pathogens
- Evidence of respirator’s design and performance specifications that must remain intact post reprocessing
- Evidence of no residual chemicals on the respirators from the decontamination
- Comprehensive instructions on the safe and effective use of the medical device for users, including:
- Device operation instructions, settings, including control measures, essential warnings and precautions
- Validated decontamination conditions and methods
- Residual chemicals or gases at the end of the decontamination cycle and recommended aeration time, if any
- Validated facility specifications, where applicable
- Respirators compatibility with the decontamination method
- Maximum number of times the respirator can be decontaminated using the device
- Recommended specifications of decontamination pouches or packaging material into which the respirator is to be placed prior to loading into the device, where applicable
- Any other device-specific limitations or residual risks
Licence Requirements: Any commercial facility offering decontamination services to healthcare settings should implement and comply with the quality management system requirements based on ISO 13485, and hold a manufacturer’s licence from the HSA. Entities supplying or importing the devices should comply with the Good Distribution Practice for Medical Devices (GDPMDS) requirements and hold importer’s and/or wholesaler’s licence from the HSA.
Manufacturers offering decontamination services are expected to keep a track of the HSA’s guidelines and approach the right Regulatory assistance for a compliant market-entry. Stay safe. Stay informed. Stay compliant.