Amid the coronavirus disease 2019 (COVID-19) pandemic, the United States is struggling with supplies. Reports of mask and other personal protective equipment (PPE) shortages have been common but as reports of US hospitals resorting to concerning practices becomes more common, many wonder how they can help.
For those health care workers caring for patients with SARS-CoV-2 infection, the ability to protect themselves is paramount right now. New York City is under siege, reporting an enormous spike in cases and hospitals across the country are seeing this as a warning siren to prepare. Fortunately, there are those offering assistance in helping hospitals re-supply with critical PPE like N95 respirators.
Unfortunately though, this poses unique challenges for hospitals that many may not realize. N95 respirators require fit testing to ensure the person wearing it has the appropriate size and it forms a seal to ensure aerosols are kept out. The Occupational Safety and Health Administration (OSHA) requires fit testing to confirm the fit of respirators and until recently, required annual fit testing
. Temporary enforcement guidelines were issued recently and allow noncompliance with annual fit testing as long as the health care employer uses respirators certified by the National Institute of Occupational Safety and Health (NIOSH) and other basic measures.
Unfortunately, this does not alleviate the issue that for every new brand or style of N95 respirator, staff need to be re-fit-tested to ensure it adequately protects them. These efforts require time and additional masks and supplies, which can be challenging. This is not to say that such efforts can’t be done but simply that supply chain issues extend well beyond the acquisition of masks.
In addition to the efforts to acquire additional masks necessary for patient care, many have considered the usage of masks that fall outside NIOSH approval. Several times in recent weeks I’ve heard questions regarding KN95s, which are Korean-made masks. Moreover, several European options have been found online, so this has begged the question: in desperate times, can we go beyond NIOSH-approved masks?
On Thursday though, the US Food & Drug Administration (FDA) released insight
into non-NIOSH approved respirators under the Emergency Use Authorization (EUA). “As mentioned in CDC's strategies for optimizing respirator supply, other countries approve respirators according to standards. These devices are evaluated using methods similar to those used by NIOSH, and are still expected to provide adequate protection for healthcare personnel, given shortages of FFRs resulting from the COVID-19 pandemic. Under these circumstances, FDA believes these devices may serve as suitable alternatives for personal respiratory protection during this period of shortage caused by the COVID-19 pandemic.”
The site gives further information regarding importing respirators if the country is not listed as criteria eligible for use under the EUA.
These are just some of the nuances and regulatory changes that have occurred and become that much more important in recent weeks. As hospitals wrestle with acquiring additional supplies, these regulatory requirements and the roll-out of the supplies should be incorporated into processes. Acquisition of new ventilators will require coordination with biomedical programs within hospitals, just as new N95 respirators require fit-testing for staff.
We must account for these delays or process changes as part of the response efforts.