Dozens of questionable companies have emerged during the pandemic, hoping to capitalize on the skyrocketing demand in personal protective equipment (PPE), CNN reports. And because of this situation, fraudulent medical supplies have become a growing problem in recent months.
Millions of used, substandard nitrile gloves enter the US
One of the most affected medical supplies is medical grade nitrile gloves, which are primarily produced in South and East Asia. According to CNN, tens of millions of counterfeit and secondhand nitrile gloves have been imported into the United States over the past year.
The situation is so problematic that Douglas Stein, an industry expert, said nitrile gloves are the "most dangerous commodity on Earth right now."
"There's an enormous amount of bad product coming in," Stein said, "an endless stream of filthy, second-hand and substandard gloves coming into the US of which federal authorities, it seems, are only now beginning to understand the enormous scale." While Stein said it likely that some of these fraudulent gloves have ended up in medical settings, it's currently unclear whether they've harmed any U.S. health care provider or patient.
Many of these fraudulent nitrile gloves have been linked to facilities in Thailand, where health authorities have uncovered workers dyeing used gloves to make them appear new again. One prominent Thai-based company is Paddy the Room, which has sold millions in substandard gloves to U.S. businesses, CNN reports.
For example, Tarek Kirschen, a Miami-based businessperson, ordered around $2 million in gloves from the company, only to discover that they were completely unusable.
"These were reused gloves. They were washed, recycled," Kirschen said. "Some of them were dirty. Some of them had bloodstains. Some of them had markers on them with dates from two years ago... I couldn't believe my eyes."
Louis Ziskin, CEO of AirQueen, also had a similar experience with Paddy the Room. He purchased $2.7 million of nitrile gloves, but later discovered that most of them were made of lower-grade latex or vinyl and many were already used and soiled. As a result, Ziskin was not able to sell the gloves to hospitals, calling it a "total safety issue."
US authorities have been slow to act
According to CNN, import regulations for protective medical equipment, which were initially suspended during the height of the pandemic, have yet to be reinstated, a situation that has contributed to the flow of fraudulent materials entering the country largely unchecked.
FDA, in a statement to CNN, said that under these suspended regulations, companies were permitted to import gloves as long as they "conform to the consensus standards and labeling cited in the guidance and where the gloves do not create undue risk." However, there are few physical review points in place to examine the gloves or other supplies shipped into U.S. ports, CNN reports, which means fraudulent or contaminated supplies are often not identified until they reach their destination.
And regulators have been slow to respond to the issues, according to CNN. In February, Kirschen and Ziskin filed separate complaints about Paddy the Room to both FDA and Customs and Border Protection. However, their complaints did not prevent the company from continuing to import gloves, CNN reports—with more than 80 million gloves from the company entering the United States between February and July.
"[T]o me the fact that these companies were never blacklisted is shocking," Ziskin said.
It wasn’t until August that FDA issued an alert saying shipments from Paddy the Room should be held without physical inspection at all U.S. ports, CNN reports—five months after initial complaints were made to the agency. (Separately, the Department of Homeland Security said it is conducting an ongoing criminal investigation into the company.)
Although FDA said it could not comment on ongoing investigations, a spokesperson for the agency said it has taken "a number of steps to find and stop those selling unapproved products by leveraging our experience investigating, examining, and reviewing medical products, both at the border and within domestic commerce."
High demand allows the fraudulent glove trade to continue
It's unknown how many million more substandard nitrile gloves remain in warehouses at ports in the United States, CNN reports, particularly as overseas facilities continue to produce these substandard supplies largely unchecked—and the demand for supplies continues to skyrocket.
According to the Thai FDA, health officials have struggled to keep up with the fraudulent nitrile glove trade in the country. "Under this outbreak situation, the demand is enormous both from hospitals and the general public," said Supattra Boonserm, deputy secretary-general of the Thai FDA. "The volume of illegal gloves we have found is enormous."
In recent months, the agency has carried out raids on 10 different facilities producing substandard or counterfeit gloves, CNN reports, but several of the companies, including Paddy the Room and SkyMed, remain in business.
"[The companies] just moved to another location, to another warehouse," Boonserm said. "And why is that? Because the demand for gloves is still high. There are still customers waiting out there." (McLean et al., CNN, 10/25; Beals, The Hill, 10/25, Rosa-Aquino, "Intelligencer," New York Magazine, 10/24)