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FDA cautions MedTech manufacturers about reverting to old business practices

Manufacturers and healthcare providers are reverting to old business practices that could jeopardize medical device supply chains in the event of another public health emergency (PHE), according to a US Food and Drug Administration (FDA) official, who said companies must learn from the pandemic and prepare for potential shortages.

Speaking at the AAMI/FDA neXus medical device standards conference hosted by the Association for the Advancement of Medical Instrumentation (AAMI) on 21 February, Tammy Beckham, associate director of the Centers for Devices and Radiological Health’s (CDRH) Resilient Supply Chain and Shortages Prevention Program, said that stakeholders are reverting to their pre-pandemic habits, which could have dire consequences. She said they need to reconsider how to balance their financial interests against risks to their supply chain.

“We learned a lot during the public health emergency, but then sometime after the public health emergency, folks moved back to pre-pandemic business practices,” said Beckham. “I’m hoping that we don’t have another one of those emergencies again, but we’re seeing some of these business practices jeopardize patients and national security.”

She emphasized that it’s important for stakeholders to think about the total product lifecycle (TPLC) of their products, how to diversify their suppliers, maintain risk management plans, understand their potential vulnerabilities, manage their inventories, and make sure they strengthen their transportation and logistics capabilities.

“During the public health emergency, there were investments made by the government for various things like [Personal Protective Equipment (PPE)],” Beckham told Focus. “Now that the contracts have come to an end, we’re seeing those manufacturers and distributors sourcing back overseas.”

She added that it’s not just manufacturers that have reverted to sourcing their critical materials and components from foreign sources but the whole healthcare ecosystem.

“I’m talking about hospitals and others doing sole source contracts, so it’s much more difficult for them to pivot when there is a supply chain issue,” said Beckham. “We saw during the public health emergency that it really did help if hospitals had multiple contracts, whether it was for N-95 masks or other critical supplies, and now we’re seeing people go back to those pre-pandemic business practices.”

While Beckham empathized with the fact that stakeholders must consider their own financial interests, she also warned that they must remember the difficulty manufacturers, physicians, and patients faced during the pandemic due to supply chain shortages caused by single-sourcing products, materials, and components and sourcing them from abroad.

“We need to learn from that and find that happy medium and that space in the middle where we have some domestic manufacturing here because that’s definitely a patient health and healthcare delivery issue, and also understand how important it is to look at vulnerabilities in your supply chain and diversify your suppliers,” she said.

Beckham noted that during the public health emergency, the healthcare system not only faced supply chain shortages in areas such as PPE, but also ran into issues with finding enough semiconductors and circuit boards to repair hospital equipment. She said it’s important to take a TPLC approach to the supply chain and think about how it can be strengthened from end-to-end.

“Know where your raw materials and your components are coming from; build that in as you’re starting to think about the development of those medical devices,” Beckham told attendees. “Think about resiliency, risk management plans, and understand where your vulnerabilities are.”

“Medical devices can consist of a number of tier of suppliers. Think about some of the packaging of the components, the paper, even down to the sterilization and pre-plan that as you are designing the product,” she added. “Also, think about the product after it goes to market and make sure that there are components and raw materials available for that after-market repair and servicing.”

Beckham noted that governments are considering further restrictions against the use of per- and poly-fluoroalkyl substances (PFAS), leading some PFAS manufacturers to exit the market. She said the medtech industry should think about what that means for their products and their supply chains.

“These fluoropolymers are absolutely critical for medical devices for a variety of traits that they have that they bring to medical devices,” said Beckham. “With these manufacturers exiting, that could lead to some disruptions in the supply chain…. This is a very complex supply chain with many, many, many tiers that will take some time to map as these manufacturers exit.”

“I think the key thing here is, how does the medical device community communicate the importance of PFAS and fluoropolymers and their use in medical devices in manufacturing and the supply chain… and the amount of safety data that we have on the use of those in medical devices,” she added.

Similarly, Beckham noted that as regulations are being developed around the use of ethylene oxide (ETO), which is used to sterilize medical devices, it has caused capacity constraints and potential supply chain disruptions. She also added that FDA is trying to do its part to help manufacturers become less dependent on ETO to sterilize products and has an ongoing innovation challenge to encourage development of alternative sterilization methods.

Besides specific supply chain considerations, Beckham said manufacturers should consider everyday threats that may affect their supply chains, such as recalls, labor shortages, extreme weather, transportation issues, and geopolitical conflicts. She encouraged stakeholders to share supply chain concerns early with FDA so they can help mitigate them.

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