Singapore: Provisional authorization pathway open to devices for single-use respirators

With the outbreak of the COVID-19 pandemic, there has been a high demand and critical shortage of respirators all around the world. Generally, respirators are intended for single usage as manufacturers have insufficient scientific evidence to prove their decontamination and reusage. Thus, there is a need to innovate practical methods to effectively decontaminate used respirators. A provisional authorization pathway has been introduced by the Health Sciences Authority (HSA) for the approval of Class C medical devices used to decontaminate respirators intended for local supply in Singapore. Via the provisional authorization pathway, HSA will facilitate access to safe and effective decontamination devices, which will then facilitate access to respirators during the pandemic. Parties that are interested in this provisional authorization pathway will have to email HSA (hsa_md_info@hsa.gov.sg) with the following information on the subject of “Provisional Authorization for Medical Devices for Decontamination of Respirators”:

1. Description of the medical device, including the principle of operation, design, and description of relevant controls (e.g. chemical indicators)

2. Evidence that the medical device is effective in reducing the number of pathogens (e.g. sporicidal and viral inactivation studies)

3. Evidence that the respirator’s design (e.g. fit, material) and performance (e.g. filtration) specifications remain intact post reprocessing

4. Evidence that there are no residual chemicals (e.g. hydrogen peroxide) on the respirators from the decontamination

5. 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)

• The 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

A risk-calibrated review process will be done by HSA to dictate the safety, quality, and effectiveness of the decontamination process using these devices. The integrity of the respirator and its ability to perform its intended functions after the decontamination process will also be reviewed. After attaining authorization, submission of periodic reports to HSA on any defects or performance issues pertaining to the decontamination devices will be necessary. If there is a need to import and/or supply these devices, the entity would have to hold the Importer’s and/or Wholesaler’s license from HSA and comply with the Good Distribution Practice for Medical Devices (GDPMDS). There are also guidelines set out for healthcare institutions and other facilities that decontaminate respirators. They are as follows:

1. Only use devices that are evaluated and authorized by HSA.

2. Refer to the user manual/information for use/technical specifications/fact sheet of the device and closely follow the instructions and recommendations presented.

3. HSA also strongly recommend some additional measures on top of its regulatory measures, they include:

• 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 a 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 ongoing basis and to rule out any potential impact from environmental factors, use errors, or other human factors.

Source: Guidance on Medical Devices for Decontamination of Single Use Respirators during the COVID-19 (Coronavirus Disease 2019) Situation Contact us at info@arqon.com for more information.