The US Food and Drug Administration has contacted dozens of medical device manufacturers whose facilities in China may be at risk of creating shortages in the supply chain — and indeed, some facilities have already been disrupted by the coronavirus outbreak.
The agency reached out to 63 companies with a total of 72 facilities in China that make essential medical devices, according to a statement late Thursday by FDA Commissioner Dr. Stephen Hahn.
Hahn said that “several of these facilities in China are adversely affected” by the epidemic. Their workforces have taken a hit from the outbreak, including employees being quarantined.
While the agency reported its first drug shortage due to the outbreak, Hahn says there are no widespread device shortages to report at this time. However, the FDA “has heard of spot shortages of some medical devices,” an agency spokeswoman told CNN in a statement Wednesday.
It may not be a question of if, but when. On Tuesday, Hahn told reporters that “the outbreak will likely affect the medical product supply chain.”
Of particular concern is personal protective equipment such as masks, respirators, gloves and surgical gowns. “The FDA has heard reports of increased market demand and supply challenges for some of these products,” Hahn said.
Orders are up, he added, as US hospitals “are preparing for potential future need if the outbreak were to become more severe.”
While there may be no widespread shortages yet in the US, the global picture may be more dire. Earlier this month, World Health Organization Director-General Tedros Adhanom Ghebreyesus told reporters “the world is facing severe disruption in the market for personal protective equipment.” At the time, he reported backlogs of four to six months, demand that was up to 100 times greater than usual and prices up to 20 times higher.
“This situation has been exacerbated by widespread inappropriate use of [personal protective equipment] outside patient care,” Ghebreyesus said.
Health officials do not recommend the use of face masks for the general public.
According to Dr. Mike Ryan, executive director of the WHO’s Health Emergencies Programme, the organization has been working with supply chain partners to protect respirator stores in light of a shortage internationally. The organization has also asked countries with larger stockpiles of protective equipment to share with other countries in need.
“There are fierce strains on protective equipment around the world,” Ryan told reporters Friday.
Earlier this week, US Health and Human Services Secretary Alex Azar said some of the requested $2.5 billion in supplemental funds would be used to funnel personal protective equipment into the national stockpile. Correcting an earlier figure, he told a House Appropriations subcommittee Wednesday that there are 12 million N95 respirators in the Strategic National Stockpile that meet national standards, an additional five million that “may have expired” and that the US would need roughly 300 million additional masks for health care workers.
But Azar cautioned that manufacturing these supplies domestically and getting them into the stockpile won’t happen overnight.
“It will take time because China … does control a lot of the raw materials as well as the manufacturing capacity,” he said.
On Saturday afternoon, President Trump revealed the administration has added to the nation’s supply of masks, though he did not specify which type of mask.
“Tremendous amounts of supplies are already on hand,” he said during a White House briefing. “We have 43 million masks … and a lot more are coming.”
Following what Trump described as a two-and-a-half-hour meeting of the White House Coronavirus Task Force, Pence told reporters that those masks were “available today.” He also revealed the administration has now contracted with 3M to produce 35 million additional masks per month. “We’re also going to be working with other manufacturers,” Pence said.
He added, “The average American does not need to go out and buy a mask.”
‘Seriously under threat of shortage’
Some doctors say they are already seeing an impact, and their hospitals may be in danger of using up protective equipment like masks and respirators.
“We are basically out,” said one emergency doctor in California, who requested that CNN not use his name. “There are no more large [respirators] available, and I have a large head.”
Doctors in various states told CNN they had received hospital-wide communications about current or anticipated shortages, especially when it comes to N95 respirators — a tightly fitting face mask that filters out airborne particles.
A shortage of N95s was also echoed in an emailed message from the New York State Department of Health obtained by CNN.
The email, shared by a council that coordinates emergency medical services in New York City, said the state health department “is aware that some hospitals, EMS agencies and other providers are experiencing shortages of N95 respirators and we are strongly recommending that this type of respirator should only be utilized when necessary.”
On Wednesday, New York Mayor Bill De Blasio said the city had distributed about 1.5 million face masks and asked for at least 300,000 more. The city plans to ask for federal assistance to get that need met from private manufacturers, he said.
In some cases, doctors have been asked to reuse masks and take boxes off the wall so people can’t steal them.
The US Centers for Disease Control and Prevention says doctors can extend supplies by reusing the same respirator if they’re seeing multiple patients with the same illness — a call usually made by individual institutions, not the CDC itself. The agency says hospitals may also decide to use these masks beyond their shelf life and limit the number of staff who need that level of protection in the first place.
Some medical centers have been taking preventive measures for weeks in order to stretch their supply.
“We’re not at a shortage right now. But we are seriously under threat of shortage,” said Dr. Emily Landon, a hospital epidemiologist at University of Chicago Medicine. “We are not able to receive some of our regular shipments of N95 masks, and we’re not able to up-stock.”
Similarly, Amanda Chawla, vice president of supply chain for Stanford Health Care, told CNN that high demand and lower supply is why Stanford is “working proactively” to make sure it has what it needs down the line.
Landon said her institution is stocked for the “foreseeable future” — anywhere from one to six months, depending on how they make use of what’s in stock. “But that’s assuming regular use. And if we start to see many more cases, then we’d have to use a lot more. So we’re certainly in need of more masks. We would like to have a more reliable supply chain of masks.”
She added that things might look different for a large, well-resourced medical center like hers versus a smaller hospital.
“We are aware of some rural member facilities reporting personal protective equipment supply … shortages at this time,” Alan Morgan, chief executive officer of the National Rural Health Association, said in an email. “We are currently assessing how widespread this situation [is] among rural facilities.”
When it comes to smaller rural hospitals, “we don’t have large stocks of anything,” said Alison Page, CEO of Western Wisconsin Health.
Page is now faced with suppliers whose products are either on backorder or allocation — a practice in which purchases are limited to deter hoarding, based on what hospitals have ordered in the past. In Page’s case, however, a recent increase in surgeries means her medical center needs more gowns than it’s allocated.
Page said her hospital should be OK for a couple of months, but she’s taking no chances with her protective masks and has removed them from the entryway.
“We’ve heard from other hospitals that people are coming in the doors and stealing them.”
‘Lack of transparency’
Health care company Premier Inc., whose members include more than 4,000 hospitals and health care systems around the country, says that 44% of their members’ N95 orders over the last 45 days have yet to be fulfilled — which company officials described as “very” abnormal. Under normal circumstances, they’d expect nearly all of their usual orders to be fulfilled within a day or two.
The company is in a “unique position” in the supply chain as a group purchaser, which may make it aware of shortages before the FDA, according to Soumi Saha, senior director of advocacy at Premier.
Saha said that the manufacturers of medical devices like N95s aren’t necessarily reporting shortages to the FDA — but unlike drug manufacturers, they don’t have to by law.
“There is a lack of transparency,” Saha said.
A representative for Vizient, which negotiates contracts with manufacturers on behalf of hospitals, said she was unaware of widespread shortages, but echoed Saha on the level of transparency within the industry. In an email, spokeswoman Angie Boliver said the company struggles with a “challenging industry-wide lack of transparency into manufacturing processes and raw materials,” and where those materials are sourced.
Companies like Premier and Vizient are among those that have cooperated with the FDA as it works to recognize trends and possible vulnerabilities in the pipeline.
In recent budget proposals, the agency has sought the authority to require similar information from medical device companies as it does from pharmaceutical ones.
“The FDA does not have the same authorities for medical device shortages as it does for drugs,” Hahn said Thursday.
The agency nonetheless urges hospitals and manufacturers to voluntarily report any device shortage concerns, he added.
“Enabling the FDA to have timely and accurate information about likely or confirmed national shortages of essential devices would allow the agency to take steps to promote [their] continued availability,” he said.
‘Surge in demand’
Shortages can — and have — led to delays in treatment.
Last month, surgeries were postponed in some cases when manufacturer Cardinal Health voluntarily recalled more than 9 million gowns. Though related to one of the company’s suppliers in China, the recall was not apparently due to the novel coronavirus.
Cardinal Health declined CNN’s request for comment.
But other manufacturers said they are already feeling the pressure over increased demand.
Honeywell, for example, says it’s “experiencing a surge in demand for our protective face masks in North America, Europe and China.” The company is increasing production globally, according to an emailed statement.
Prestige Ameritech, which says it is the largest domestic manufacturer of surgical masks and respirators in the United States, says it doesn’t have the capacity to fulfill orders from individuals while it works to meet “high demand from our current hospital customers.”
“If you are looking for a one-time, high volume order of masks, we cannot help you at this time,” the company responds to those seeking information via email. Prestige urges hospitals and purchasing groups with standing contracts to reach out “once the market settles and the crisis is over.” The company declined CNN’s request for further comment.