Guidance on Medical Devices for Decontamination of Single Use Respirators during the COVID-19 (Coronavirus Disease 2019) Situation

UPDATE: The following regulatory measures will be discontinued with immediate effect. All standard regulatory controls for medical devices will apply. For an overall understanding of processes and requirements for product registration and licensing of dealers, you may refer to our Quick Guide available at: http://www.hsa.gov.sg/medical-devices/regulatory-overview

 

Respirators are generally intended for single use as the manufacturers have not validated and developed scientific evidence to support their decontamination and reuse. However, given the critical shortages of respirators globally, there have been significant efforts to develop practical methods to decontaminate used respirators effectively.

In Singapore, medical devices used for decontamination are classified under Class C and would require review and approval by the Health Sciences Authority (HSA) before being supplied locally. In view of the increasing demand for respirators and the global supply constraints, HSA will facilitate access to safe and effective^[1] medical devices intended for decontaminating used respirators via the provisional authorisation pathway. Provisional authorisation is an interim measure to facilitate access to essential medical devices during this COVID-19 situation.

This guidance covers the key regulatory requirements for the Provisional Authorisation for decontamination devices for respirators and also presents certain good practices for healthcare institutions and other user facilities to take note of when deploying and using these devices. The medical devices that have received provisional authorisation for decontamination of respirators are listed at the end of this page and will be updated periodically.

^[1] As SARS-CoV-2 is a novel virus, there is currently limited data to support the effectiveness of decontamination methods against this virus specifically, although some methods have successfully reduced similar or related viruses. The criteria for review and approval of these decontamination devices may be updated if and when new scientific evidence or data emerges.

Provisional Authorisation

The provisional authorisation is based on a risk-calibrated review process that considers the safety, quality and effectiveness of the decontamination process using these medical devices. The review will also verify that the integrity of the respirators and their ability to achieve their intended functions (e.g. filtration efficiency, fit) are maintained following decontamination. Periodic reports on any defects or performance issues related to the decontamination devices will be required to be submitted to HSA post authorisation to ensure continued performance of these devices.

How to submit an application for Provisional Authorisation to HSA

Email hsa_md_info@hsa.gov.sg with the subject “Provisional Authorisation for Medical Devices for Decontamination of Respirators” with the following information:

• Description of the medical device, including the principle of operation, design and description of relevant controls (e.g. chemical indicators)
• Evidence that the medical device is effective in reducing the number of pathogens (e.g. sporicidal and viral inactivation studies)
• Evidence that the respirator’s design (e.g. fit, material) and performance (e.g. filtration) specifications remain intact post reprocessing
• Evidence that there are no residual chemicals (e.g. hydrogen peroxide) on the respirators from the decontamination
• Comprehensive instructions on safe and effective use of the medical device for users, including:

• Device operation instructions, settings, including control measures (e.g. chemical and biological indicators) and essential warnings and precautions
• Validated decontamination conditions and methods (e.g. disinfectant concentration, dwelling time, temperature, density, number of respirators per cycle)
• Residual chemicals or gases at the end of the decontamination cycle and recommended aeration time, if any
• Validated facility specifications (e.g. room dimensions or size), where applicable
• Respirators compatible with the decontamination method (e.g. respirator materials that are safe to be decontaminated without damage)
• 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

Any entity importing and/or supplying these devices should comply with the requirements of Good Distribution Practice for Medical Devices (GDPMDS) and is required to hold Importer’s and/or Wholesaler’s licence from HSA.

Licensing requirements for commercial facilities offering decontamination services

Decontamination of respirators intended for use in healthcare settings is considered a medical device manufacturing activity. Any local commercial facility performing this activity should implement and comply with quality management system requirements based on ISO 13485, and is required to hold a Manufacturer’s licence from HSA.

Guidelines for healthcare institutions and other facilities that decontaminate respirators

i. Hospitals or other local facilities intending to decontaminate used respirators should use the medical devices that have been evaluated and authorised by HSA. They are listed at the end of this page and will be updated periodically.

ii. Users in these facilities should duly refer to the user manual/information for use/technical specifications/fact sheet that accompanies the medical device and closely follow the instructions and recommendations presented. This includes specifications such as the disinfectant concentration, respirator type, maximum size of the room or containment where the disinfection is performed, number of respirators per cycle and aeration time where applicable.

iii. While HSA's regulatory measures would reasonably ensure that these medical devices are safe, of good quality and effective for decontamination of respirators, we strongly recommend that the HCIs, hospitals and other user facilities decontaminating their used respirators implement the following additional measures:

• Perform a qualitative mask fit check prior to each reuse of the decontaminated respirator
• Implement a reasonable oversight (e.g. internal audit) to ensure that users comply with the necessary use instructions, warnings and precautions
• Implement a documented procedure for users (e.g. SOPs) to diligently verify that the decontamination process is complete (e.g. checking the chemical or biological indicators in the device) before releasing the respirators for use
• Adopt a track and trace system to mark the used respirators to identify the number of decontamination cycles for each respirator and also to identify the original user of the respirator to enable re-use by the same user for better fit (e.g. use of RFID tags)
• Consider periodic sampling and testing of decontaminated respirators from the facility to monitor the effectiveness of the process on an on-going basis and to rule out any potential impact from environmental factors, use errors or other human factors.  

The Table below lists the Decontamination system that have received provisional authorisation to date. It will be updated as more devices are authorised.

No.	Applicant	Product Owner	Name of Device	For more information

 

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