Recommendations for health services
- Distribute this information to relevant staff.
- Advise staff not to adjust the headband straps on the BYD N95 respirator.
- Ensure all staff carry out a fit check every time they use a P2/N95 respirator.
Risk of strap tear in BYD N95 respirators
There have been reports from other jurisdictions that small tears may occur when pulling/adjusting the headband straps through the staple points on the BYD N95 respirators.
These small tears at the staple entry point are not always noticeable, but have the ability to compromise the integrity of the respirator seal.
Pulling/adjusting the headband straps through the staple points is not recommended in any of the product information manuals and doing so is not in line with product specifications.
NIOSH approval of BYD respirators
We are following up on concerns from the sector about NIOSH approval of BYD respirators.
When contacted by Health Purchasing Victoria, BYD confirmed there have been no changes in design, raw materials or construction of BYD respirators (Product Model DE2322):
- between lodging the application and receiving NIOSH approval
- since NIOSH testing of respirators began, including the NIOSH test reports dated 23 April 2020.
These products are listed on the Australian Register of Therapeutic Goods as safe for use. The Department is now seeking clarification with the Therapeutic Goods Administration.
NIOSH approved respirators have been cleared by the Food and Drug Administration (FDA) for use. Further information on BYD testing results and NIOSH approval process can be found here.