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Hospitals struggle with surgical gown recall amid other supply chain woes

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Trine K. Tsouderos HRI Regulatory Center Leader, PwC US January 31, 2020


The new year already features a new headache for many hospital supply chain managers—this time affecting surgical gowns. On Jan. 21, a supplier of medical products to hospitals issued a voluntary recall of 9.1 million Level 3 surgical gowns, 7.7 million of which had been distributed to nearly 3,000 facilities since September 2018.

The gowns, made by a Chinese contract manufacturer, were produced in unapproved locations that did not maintain proper environmental conditions, were not registered with the FDA, and were not qualified by the company, the company said in its recall notice.

HRI impact analysis

The recall comes as hospitals continue to deal with the fallout from the controversy that arose last year, reported in the Chicago Tribune and other newspapers, over the public health threat posed by emissions of ethylene oxide, a chemical used in medical device sterilization, and the resulting closure of some large US sterilization facilities.

The FDA is closely monitoring effects of the plant closures on the supply chain. The agency also is working with companies interested in developing sterilization procedures that don’t involve the chemical and has launched a pilot project aimed at speeding approval of plant relocations and changes that reduce ethylene oxide use, it announced in a Nov. 25 statement.

The medical products supplier recall came after the company received a tip in December that the manufacturer was using two unauthorized sites to produce the gowns, which are used for procedures such as open-heart surgery and knee replacement. An on-site investigation found open windows, a lack of appropriate hand-washing stations, and food in the manufacturing area, according to a Modern Healthcare article.

Because of concerns about potential contamination, the supplier quarantined the gowns, placed a hold on their distribution and started communicating with customers to ensure that the affected gowns and surgical procedure packs that include them were removed from use, the company said.

The FDA said on Jan. 16 that it was not aware of any patient harm caused by the problem. However, the recall caused several hospitals across the country to briefly halt elective surgeries. To help address shortages, the supplier has increased production of similar products and in many cases has been working with firms that offer competing products.

Situations like the gown recall could continue to occur as more manufacturing takes place overseas, Dr. Marcus Schabacker, CEO of the ECRI Institute, told Modern Healthcare. The more US healthcare suppliers rely on imported products, the harder it is for them and the FDA to monitor their safety.

But as the medical device sterilization problem shows, supply chain troubles don’t always arise from issues outside the US. The two disruptions could spur healthcare supply chain executives to become more active and demand more transparency from suppliers about how and where their products are made.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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