The Food and Drug Administration published an FAQ confirming CPAPs and BiPAPs are on its medical device shortage list. The inclusion, however, is not obvious to consumers. DME suppliers cannot simply point to the list when explaining equipment backorders to frustrated patients and referral sources. In fact, searching the list for the terms CPAP or BiPAP returns no results.
The shortage list uses technical product classification codes. Fortunately, the FAQ acts as an objective bridge between familiar language and the less-than-helpful product classification. It reads:
The shortage list uses technical product classification codes. Fortunately, the FAQ acts as an objective bridge between familiar language and the less-than-helpful product classification. It reads:
| Q: Are the product codes for CPAP and BiPAP machines on the FDA’s device shortage list? A: Yes, all the product codes under which CPAP and BiPAP machines are classified are on the device shortage list due to device availability issues. These include product codes BZD, NOU, CBK, MNT, and MNS. The majority of these devices are classified under product code BZD [emphasis added]. |
Curiously, the BZD product code description reads “ventilator, non-continuous (respirator).”
MiraVista requested the FDA add another column of data to the device shortage list for common terms recognizable to the average consumer. Given the agency’s efforts to produce consumer-driven FAQs, we are hopeful they will consider a modification to the existing format.
In the meantime, suppliers can use the combination of the FAQ and the medical device shortage list as authoritative evidence that suppliers are not hoarding inventory.
SOURCE LINKS
https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recall-frequently-asked-questions
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency
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