HyperClear Partners with Rook Quality Systems to Offer Remote Quality Auditing of PPE
As many experts foresee the second wave of COVID-19 pandemic (evidently, Beijing reported the first COVID-19 case in almost two months on June 11st), the need to ensure qualified medical devices being deployed to clinical environments is a high priority for regulatory agencies such as the FDA.
The FDA reversed decisions to allow the emergency use of dozens of N-95 masks made in China, according to a recent press release back in early May . The masks “may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19”, according to a letter released to health-care providers .
It is advised that health care facilities with these respirators in inventory should review the considerations listed in the letter :
Respirators that no longer appear in Appendix A of the EUA may not reliably provide a minimum percent particulate filtration efficiency of 95 percent.
A complete list of Respirator Models No Longer Authorized is available on our website.
NIOSH regularly updates its list of testing results.
If you have respirators that were removed from Appendix A based on the May 7, 2020, update to the third criterion and you want NIOSH to test their filtration efficiency, you can request NIOSH testing by submitting the International Respirator Assessment Request.
HyperClear is partnering with Rook Quality Systems to help healthcare facilities and distributors, who have purchased respirators or other PPEs, identify potential product-related issues and avoid unforeseeable risks to first responders. Rook Quality Systems offer contractual, remote auditing service for reviewing the following records. Our branch office in Taiwan can also serve as a point of contact on behalf of our clients for communicating with China-based manufacturers in Mandarin.
Quality Assurance records (e.g. lot release records, product-specific testing records, packaging validation records, manufacturing process validation records, sterilization record… etc) issued by the manufacturers
Manufacturer establishment and device listing records
Product labeling (e.g. product labeling, instructions for use)
Evaluate potential product specification deficiency leveraging recommendations by the FDA (e.g. NIOSH assessment, or relevant medical device testing standards)
Please reach out to HyperClear if you are in need of this quality assurance service and we will put you in touch with our Rook Quality Systems partner to meet your needs.
 Anna E., U.S. Pulls Authorization for Use of Face Masks Made in China, Bloomberg News, retrieved from: https://www.bloomberg.com/news/articles/2020-05-07/u-s-pulls-authorization-for-use-of-face-masks-made-in-china
 FDA Issued Letter, Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers, retrieved from: https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter?utm_campaign=2020-05-07%20Concerns%20with%20Filtering%20Facepiece%20Respirators%20from%20China%20-%20Letter%20to%20HCP&utm_medium=email&utm_source=Eloqua