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FDA: Coronavirus Could Lead to Shortages of Critical Medical Products

Coronavirus test tube
FDA is closely monitoring the situation and has been in contact with 63 manufacturers, which represent 72 facilities in China that produce essential medical devices.

The potential impact of the novel coronavirus COVID-19 on the medical product supply chain was addressed yesterday by FDA Commissioner Stephen M. Hahn. Noting that “FDA has been closely monitoring” the situation, Hahn went on to say in his statement that the outbreak could lead to “potential disruptions to supply or shortages of critical medical products in the U.S.”

In addition to providing updates on the supply of human and animal drugs and biologics, Hahn’s statement noted that the agency is “aware of 63 manufacturers, which represent 72 facilities in China that produce essential medical devices.” Essential devices are defined by FDA as those that may be prone to a potential shortage if there is a supply disruption.

FDA has contacted all of the manufacturers, said Hahn, adding that several of the facilities in China are adversely affected by COVID-19, including by quarantined workers. However, no shortages for essential medical devices have been reported within the U.S. market, according to FDA.

While there have been reports of increased market demand and supply challenges for personal protective equipment—a category that includes surgical gowns, gloves, masks, and respirator protective devices—FDA said that it is currently unaware of specific widespread shortages of those medical devices. “We are aware of reports from [the Centers for Disease Control] and other U.S. partners of increased ordering of a range of human medical products through distributors, as some healthcare facilities in the U.S. are preparing for potential needs if the outbreak becomes severe,” added Hahn in his statement.

FDA cautions, however, that medical device manufacturers currently are not required by law to notify the agency if they become aware of a situation that could lead to a potential shortage, nor are they required to respond when FDA requests information about potential supply chain disruption.

This is something that Hahn would like to see changed. He has called on Congress to require medical device firms to notify the agency of an anticipated meaningful interruption in the supply of an essential device, a request that has been included in President Trump’s budget. Also included in the request is a requirement that all manufacturers of essential devices periodically provide FDA with information about their relevant manufacturing capacity and authorization to temporarily import devices in cases where it could mitigate a shortage.

In the meantime, FDA reiterates that it has taken proactive steps to establish and remain in contact with medical device manufacturers and others in the supply chain. It also encourages manufacturers and healthcare facilities to report any supply disruptions to the device shortages mailbox, [email protected].

Delays and faulty test kits

The outbreak of the pandemic has also exposed weaknesses on the ground. The Los Angeles Times reported today that it took four days to test a patient in northern California who was suspected by doctors at the UC Davis Medical Center of having contracted the coronavirus. Protocol apparently prevented the patient from being tested immediately.

“Until Thursday, the Centers for Disease Control and Prevention restricted coronavirus testing to patients with clear symptoms of infection who had either traveled to China recently or been in contact with someone who had tested positive for the virus,” reported the Los Angeles Times. The patient in question fell through the cracks because he or she appears to be the first one to get the virus through community contact. “During [those four days], others in the area could have been exposed to the virus,” noted the Times. The CDC has now expanded the criteria for testing.

There have also been reported problems with the test kits distributed by the CDC. One of the ingredients led to inconclusive test results, according to some labs. And most health officials were required to send specimens to the CDC in Atlanta for testing, a process that can take up to 48 hours, according to the Times.

Business disruption

In addition to the human toll, the coronavirus has already disrupted businesses and the world economy, as reflected by the stock market’s precipitous decline this week.

Major international trade shows—Chinaplas in Shanghai and JEC World in Paris—have been postponed. On a smaller scale, injection mold machine maker Arburg has cancelled its annual International Technology Days event, which typically attracts 6,000 guests.

As Stephen Moore reported in PlasticsToday earlier this month, the outbreak has had a significant impact on the automotive sector in China. “Wuhan, in Hubei Province, is home to automakers including GM, PSA Group, Honda and Nissan, as well as local giant Dongfeng Motor,” noted Moore.

The impact on the plastics industry writ large could be substantial. On Feb. 11, Perc Pineda, Chief Economist of the Plastics Industry Association, wrote on the association’s blog: “While we cannot confirm today that the coronavirus has already impacted the U.S. plastics industry supply chain, it is reasonable to expect that if the coronavirus crisis in China continues and escalates, it will negatively impact the U.S. plastics industry. For business continuity reasons, U.S. plastics companies need to look at their current supply chain involving China and—as a precautionary measure—examine alternative supply sources."

Medical device manufacturers doing business in China are feeling the economic pinch. Boston Scientific expects to lower its first-quarter revenue by $10 million to 40 million, according to sister brand MD+DI. Medtronic CEO Omar Ishrak said that he expects the virus also to have a negative impact on financial results, but stopped short of calling out any numbers, said MD+DI.

Image: Cendeced/Adobe Stock

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