As Michigan manufacturers shift course to join the growing “arsenal of health,” federal regulators have responded to the COVID-19 outbreak by reducing potential liability that typically comes with making medical supplies.
But experts say manufacturers that now produce equipment like face shields and ventilator parts should partner with companies more experienced in the space and ensure they are not making health claims about their new products.
“Even if a ventilator or facemask looks simple — or simpler than the product you usually manufacture — you need to make sure you get it right, for the good of the patients and caregivers and to avoid later liability,” said Steven Cernak, a Detroit-based partner at the law firm Bona Law PC.
The U.S. Food and Drug Administration has issued emergency procedures and instructions for manufacturers that are now producing personal protective equipment (PPE) and other health care devices. These rules allow the agency “a little extra power” to permit new clearances for medical equipment that might otherwise take weeks or months to meet compliance requirements, according to Nicholas Werner, director of regulatory policy and education at Network Partners LLC, a medical device and pharmaceutical consulting and contract staffing agency in Jackson.
Regulations can be an overwhelming hurdle when moving products through the medical device industry.
However, since the first confirmed cases of COVID-19 hit the country and the ensuing danger of overwhelmed hospital systems emerged, the FDA has been working to facilitate the rapid development and availability of medical products and equipment “as quickly and safely as possible,” according to Werner.
Manufacturers making medical devices and equipment for the first time should be most wary of making claims about the products that they are producing — especially as they relate to the coronavirus — and leave the specifics for usage up to hospitals and medical staff, Werner said.
Specifically for the new production of face shields and masks, FDA issued certain guidelines to manufacturers, including recommendations for proper labeling and materials. For example, the labeling cannot state that the use of the face shield alone will prevent infection from microbes or viruses.
“FDA does not regulate the practice of medicine,” Werner said. “All that they’re regulating is what the manufacturers do, how they make the product and what they say about their product. Once it gets to the hospital, once it gets to the doctor, they reserve the right to use it however they want.”
One best practice for manufacturers entering the medical space for the first time is to partner with another company that is already a part of the medical supply chain, according to Werner.
“In that case, they essentially become a supplier or a contract manufacturer to any existing medical device company,” Werner said.
Through its enforcement discretion, FDA has given many of those medical device companies the ability to add in new manufacturing lines that would normally require review by the agency.
As with all agreements, manufacturers need to confirm “who is responsible for what,” in these partnership agreements, Cernak said. Design responsibility and intellectual property are important discussions to hash out before production.
Working with competitors within an industry also can make sense during the current crisis and “probably is fine under the antitrust laws,” so long as the cooperation is limited, customers will benefit and there are limits to the information shared, according to Cernak.
“While an automotive manufacturer is used to making a complicated product that must be done right or people die, it is not easy to switch to a completely different product that must be made right for the same reason,” he said.
‘We are in this together’
During public health emergencies, the FDA can use emergency authorities, including Emergency Use Authorizations (EUA), to allow unapproved medical products to reach patients, physicians and health care systems when FDA-approved alternatives are unavailable.
During the coronavirus pandemic, a number of supply disruptions have created obstacles to obtaining diagnostic tests and supplies, like swabs, and personal protective equipment, such as facemasks.
In response, West Michigan manufacturers rapidly countered the crisis with new products.
Kalamazoo-based Stryker Corp. was recently approved through EUA for a product that uses vaporized hydrogen peroxide to “decontaminate” the respirators attached to coveted N95 face masks for reuse by health care workers.
To help meet critical shortages of vital medical equipment, a local network of additive manufacturers calling themselves 3Dc19 is ramping up the industrial printing of face shields and other medical devices for nursing homes, hospices, police departments, doctors and nurses.
Allendale-based Perception Engineering LLC is part of the group of individuals and companies that have access to additive technology and are able to rapidly have parts running for those in need. To date, the group has 3-D-printed and donated more than 32,000 face shields, ear savers and ventilator parts, according to Stephen Wierenga, president of Perception Engineering.
“When we look back on this time, we want to know that we did everything with the skills and resources that we were blessed with to be part of the solution,” Wierenga told MiBiz. “The attitude of everyone involved in 3Dc19 is one of ‘what can I do to help,’ and with this mindset, big change can happen.”
However, designing and making parts for a chair or filing cabinet is much less of a liability for manufacturers than producing parts for a ventilator.
The 3Dc19 group is protected under the Public Readiness and Emergency Preparedness Act, which allows the U.S. Secretary of Health and Human Services to issue a declaration to provide “liability immunity to certain individuals and entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures.”
Plastic face shields are used by medical staff as secondary personal protective equipment. The accessibility of designs and materials for the face shields have made the product an ideal alternative for otherwise idled 3-D printers, particularly for manufacturers in the automotive industry.
“I am encouraged after watching the business community in Michigan rapidly step up in this way,” Wierenga said. “We are in this together.”
Members of the 3Dc19 network are using a free, open-source ventilator design and partnered with Ford, GM and Boston Scientific to get FDA clearance to make ventilator parts, according to the group.
Werner is unconcerned about what comes after the temporarily loosened liability requirements.
“These manufacturers want to help because they’re here and there’s a shortage,” he said. “The likelihood that when this is all over that FDA is going to come out and start just hammering manufacturers with warning letters, fines or telling people that they’re wrong for this is slim to none.”