Of all the supply chain challenges brought on the by the COVID-19 pandemic, the procurement of high-quality respiratory protection – most notably N95 respirators, sometimes called “masks” – has been one of the most vexing. Not every health care worker requires the level of protection afforded by an N95. But for individuals at high risk of being exposed to droplets and aerosols from COVID-19 patients, personal protective equipment (PPE) that provides reliable, N95-level respiratory protection is essential.
Procuring N95 (or equivalent) respirators during the pandemic has required an unnerving amount of energy, inventiveness, money … and luck. With increased global demand depleting the inventories of traditional N95 suppliers, hospitals have had to scramble to identify alternate sources for these mission-critical, PPE items.
Unfortunately, working with non-traditional suppliers can be fraught with risk. Some shipments may never arrive; and some may include products that do not offer the level of protection advertised.
N95s are a type of filtering facepiece respirator. They fit over the wearer’s mouth and nose like a mask. But unlike surgical masks and some other types of face coverings, N95 respirators (1) are intended to form a tight seal against the wearer’s face, and (2) are made of materials that offer a high level of filtration. When fitted properly – so that a tight seal is formed – an N95 respirator allows air to pass, but blocks at least 95% of airborne particles under specified test conditions.
N95s are designed to be worn once and then discarded; but shortages experienced during the pandemic have prompted extreme measures. N95s are being reused, or their “single use” is being extended. In addition, health care facilities are engaging with non-traditional suppliers, often to procure N95 alternatives – products promoted as offering the same level of performance as N95 respirators, but that have not been certified to meet that standard. KN95 respirators from China are one example.
All these options pose risks. The danger for health care workers and health systems alike is that wearers may not be getting the level of protection they expect. If a poor quality respirator is used while conducting an aerosol-generating procedure on a COVID-19 patient, the wearer is at heightened risk for exposure to the virus.
“During the pandemic, we’re finding that most hospitals are turning to non-traditional suppliers out of necessity,” explains Kristina Cybularz, manager of comparative analytics for ECRI’s Supply Guide service. “Their traditional suppliers simply do not have enough supply to meet demand.”
ECRI’s data illustrates the changes, particularly for N95-like products. With the caveat that the incoming data has been a little messy – an expected consequence of health care organizations scrambling to meet the challenges brought on by the pandemic – Cybularz notes increases of approximately 200% in terms of the number of vendors being engaged and the number of distinct items. Further, she adds that “the increase in total spend has been even more dramatic: over 1,500%.”
During an August 2020 webcast on the topic of N95 respirators, ECRI polled viewers to gauge the prevalence of using non-traditional suppliers. Nearly two-thirds of the 60 organizations that responded specified that they are obtaining at least some PPE from non-traditional suppliers.
That’s not to say that there aren’t concerns, specifically about product quality. During that same ECRI webcast, nearly two-thirds of the respondents specified that they had at least some concerns about the quality of the N95s they were purchasing.
Too often, those concerns are well-founded.
N95 respirators, as certified by the U.S. National Institute for Occupational Safety and Health (NIOSH), will block at least 95% of airborne particles under specified test conditions. Products promoted as being equivalent to N95s need to offer that same level of protection. What we’re seeing during the COVID-19 pandemic, however, is that alternative respirators in some cases fall short of that goal.
ECRI’s Chris Lavanchy, engineering director for the organization’s device evaluation group, explains that anticipated increases in global demand have prompted a surge of new or repurposed overseas companies to start making respirators, which in turn has led to concerns about deficient quality control processes. Lavanchy notes that the KN95 respirators from China have attracted particular scrutiny, and with good reason: “NIOSH started examining these models and found that about half of the products tested did not offer the level of protection required.”
Testing conducted by ECRI confirmed what NIOSH was seeing: many of these products simply did not function as well as an N95. “Our member hospitals expressed concerns about the quality of alternatives like the KN95 respirators from China, so we added capabilities to test those products for them,” explains Lavanchy. ECRI examines models for filtration efficiency, inhalation resistance and exhalation resistance. Some of the models it has tested perform acceptably, while others fail to meet the criteria. “Most often there’s no easy way to tell just from looking at a product whether it will perform as expected.”
For hospitals and health care workers, that’s troubling.
ECRI’s N95 test findings are described in its publicly accessible alert: “Use of Imported N95-Style Masks, without NIOSH Certification or Independent Lab Validation, May Put Healthcare Workers and Patients at Risk during the COVID-19 Pandemic.” Additional resources on this topic are available to members of ECRI programs through their membership web pages.
To learn more about ECRI’s technology decision support solutions, including its Supply Guide service for optimizing the supply chain through pricing expertise and product testing, visit https://www.ecri.org/solutions/technology-decision-support, or contact ECRI at (610) 825-6000, ext. 5891, or by e-mail at firstname.lastname@example.org.
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