Medical devices for decontamination in Singapore – new guidance issued

2020-06-19T16:51:43+08:00 June 19th, 2020|Insight, Medical Regulation Updates, News & Events|
OSCAR system

Critical shortages of respirators have been observed globally during this challenging time of the COVID 19 pandemic. To tackle this situation, there has been significant effort in developing practical methods to decontaminate used respirators effectively. Respirators are generally intended for single use as manufacturers have not validated or developed scientific evidence to support their decontamination and reuse.

Medical devices for decontamination of other previously used medical devices fall under the ‘’Moderate – High’’ risk class and have to be reviewed and approved by Health Science Authority (HSA) prior to their supply in Singapore.  In view of the increasing demand for respirators and the global supply constraints, HSA will facilitate access to safe and effective medical devices for decontamination of single use respirators via the provisional authorisation pathway.

This 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 aims to verify the integrity of the respirators and that their ability to achieve their intended functions such as filtration efficiency and fit is maintained following decontamination. As a post authorisation requirement, periodic reports on any defects or performance issues related to medical devices used for decontamination would have to be submitted to HSA to ensure their continued performance.

Documentary Requirements for the Provisional Authorisation

  • Device Description
  • 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 and performance 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

The guidance allows makes recommendations for healthcare institutions, hospitals and other user facilities on implementing additional measures to ensure the safety, quality and efficacy of these medical devices for decontamination. Click here to read the full guidance document.

If you have any queries regarding medical devices for decontamination or our services for medical device registration and representation in Singapore, please contact us at contact@andamanmed.com.