AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports

Friday, March 27, 2020

Source: MassDevice

Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today.

AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech production and the possible invocation of Defense Production Act (DPA) to boost needed medical supplies.

“They’ve both made it very clear as have others, that want to be careful about invoking the DPA,” AdvaMed president & CEO Scott Whitaker told reporters in a conference call. “They don’t want to signal, at least as they’ve told us, to other countries that they should limit their own production and exports. I think we’ve made that point and I think they’re very aware of it as well.”

However, President Trump yesterday decided to use the Korean War-era act, which enables extraordinary government actions to boost needed supplies, to order General Motors to proceed with a plan to manufacture ventilators with Bothell, Wash.-based Ventec Life Systems.

“They have agreed that they don’t want to get in the way of the supply chain and they don’t want to impose unnecessary burden, but we understand why they have chosen to invoke this and we will work with them going forward,” Whitaker added. “I think if anything changes, moving forward without DPA continues to be the best course of action, but we’re prepared to adjust as we need to in the days ahead.”

AdvaMed is also working closely with Vice President Mike Pence’s coronavirus task force “to open global supply chains, which is a challenge for us right now,” Whitaker said.

The U.S. Trade Representative, the Federal Trade Commission, the FDA and other federal officials have been helping the trade group push foreign governments to keep from limiting exports of critical medical devices and make sure that medtech workers in those countries can get to work, he added. AdvaMed belongs to the Global Medical Technology Alliance, which today called upon governments around the world to collaborate on opening global trade in response to the pandemic.

Production of personal protective equipment (PPE) for front-line healthcare workers has topped 100% manufacturing capacity, Whitaker noted. Even with peak production, however, those workers continue to report widespread shortages of PPE at hospitals and fears of greater need as coronavirus cases are expected to continue climbing in the U.S. and abroad.

PPE manufacturers are running three shifts, repurposing production lines, hiring new workers and retraining existing employees to increase the supply of masks, gloves, gowns, face shields and other equipment to protect healthcare workers from getting or spreading the virus, Whitaker said.

The shortage of ventilators, which aid patients’ breathing, continues to be top-of-mind, with healthcare providers pleading for more. A group calling itself #GetUsPPE said today that it has published an article in the New England Journal of Medicine on the critical need for PPE and ventilators.

Ventilator manufacturers are also ramping up production with non-medtech companies offering to help. General Electric Healthcare (NYSE:GE) this week announced that it is  doubling its production capacity for ventilators and expanding its Madison, Wis., production line to 24-hour operation. Zoll Medical Corp. announced on Tuesday that it is increasing its manufacturing capacity to 10,000 ventilators per month in response to the COVID-19 pandemic. Last week, Medtronic (NYSE:MDTannounced that it would double its capacity to manufacture and supply ventilators.

Developing a ventilator is not a simple task, according to Whitaker. “Ventilators have upward of 700 separate parts and can contain millions of lines of software code, which can be very challenging,” he said.

Whitaker lauded the FDA for temporarily loosening its enforcement on ventilators and some related devices to address manufacturing limitations and supply shortages during the coronavirus pandemic.

“We have to make sure new manufacturers getting into the ventilator business don’t over-stress the supply chain,” he cautioned. That situation will improve as the medtech industry talks with automakers over the next few weeks.

Whitaker pointed out a few highlights of medtech’s response to the coronavirus on diagnostic tests, ventilators and personal protective equipment (PPE).

Since the outbreak began, companies began racing to develop and distribute diagnostic tests to laboratories. The FDA has so far issued emergency use authorization (EUA) for a dozen of them. “To get a single one on the market would typically take a year,” Whitaker said. “But we’ve gotten 12 tests on the market within a matter of weeks.”

Millions of tests will be available by the end of the month and these companies will deliver millions more per week, Whitaker said.

“It’s a real credit to our industry and our work with the FDA,” he added. “It’s an amazing accomplishment.”

This article has been updated with information from The Associated Press.

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