The FDA Expects N95, Surgical Mask and Other PPE Supply Shortages to Last for the Duration of the Pandemic
Since March, we've been closely watching the PPE market, reporting on the promo industry's newfound role as mask provider and on broader PPE supply shortages faced by health workers across the U.S. For most of that time, information on shortages has primarily come from hospitals and health workers themselves, with the Federal Emergency Management Agency, in charge of the national stockpile, providing few concrete details. Now, we may have a clearer picture, though not a pretty one.
Under the CARES Act, the FDA was given authority to collect and publish data on medical device shortages during the COVID-19 public health emergency. The agency published its first list on August 14, coming in at 20 total items in three categories: PPE, testing supplies and equipment, and ventilation-related products. Nine of the 20 items fall under the PPE category. The items, listed by FDA product code, include FXX surgical masks, FME examination gowns and FYA surgical gowns. They also include, notably, MSH surgical respirators—N95 masks.
The data backs up the vast and growing body of anecdotal evidence that certain types of PPE are in critically short supply. Dr. Lisa Lattanza, who by day is chair of orthopedics and rehabilitation at Yale School of Medicine and chief of orthopedics at Yale New Haven Hospital, and by night the head of the hospital's DIY PPE sourcing efforts, has been sounding the alarm about this since March.
"All I can tell you is that I’ve been trying to get the standard 3M medical masks—medical N95s that we use, that I’ve used for my entire 25-year career—and I can’t get a single one in the door," she told Promo Marketing.
In the FDA's data table, all nine PPE items are listed as "demand increase for the device" under the "reason for interruption" column (surgical masks also include "delay in shipping of the device" and "shortage or discontinuance of a component or part" as reasons). And in the "additional information" column, all nine items are listed as "availability: limited supply."
This more or less confirms what we already know. But the most telling information is the "estimated shortage duration" column, which appears to have been added a few days after the list was originally published. In this column, all nine PPE items on the list—and all 20 items in total—are listed as "duration of COVID-19 PHE" (public health emergency). In other words, the FDA expects these shortages to last as long as the pandemic does.
With coronavirus infections still surging in large parts of the country, that's troubling news—especially considering the measures many hospitals are already taking to stretch the life of PPE designed for one-time use.
"An N95 mask is supposed to be a single-use mask, so we’re saying we have shortages when we’re not even following normal, non-pandemic guidelines for how to wear a mask, which is you wear it once, for one patient, and you throw it away," Dr. Lattanza said. "People in hospitals were running out of masks when they were giving a doctor or nurse one mask and saying ‘put it in a brown paper bag and wear it tomorrow, too.’ Or ‘wear it for two or three days.’ I can’t even fathom how many masks and gowns we would need if we were using them how they’re supposed to be used.”
The FDA's data does not include specific manufacturers for each item, with the agency noting that "disclosure of the manufacturer’s name of the devices determined to be in shortage during the COVID-19 PHE will adversely affect the public health by increasing the potential for hoarding or other disruptions in device availability to patients." Under the CARES Act, manufacturers are required to notify the FDA about supply interruptions or device discontinuations.
In the promo industry, much of the demand has shifted to branded masks and away from medical PPE, though many distributors still count hospitals and other health care organizations as clients. This news from the FDA figures to complicate some of those distributors' sourcing efforts.