CDRH Director Jeff Shuren spoke to attendees at the 2022 annual Medtech Conference in Boston, MA. (Source: Ferdous Al-Faruque)
The head of the US Food and Drug Administration’s (FDA) device center says he will continue to work with Congress and the medtech industry to pass legislation to prevent potential medical device shortages before a public health emergency must be declared.
Jeff Shuren, Center for Devices and Radiological Health (CDRH) director, spoke with Focus about his center’s performance last year and priorities for this year.
The FDA recently published the CDRH 2022 Annual Report, which states that while the excess workload from the COVID-19 pandemic is starting to alleviate, it is still tackling pandemic-related work on top of its normal day-to-day activities.
“Although COVID-19 has been an odyssey that we are returning home from – albeit battle-scarred – we have emerged a bit wiser and more prepared for the future to ensure we are best responding to public health needs,” Shuren wrote in the report.
One of the key takeaways from the pandemic, according to the report, is how vulnerable the US medical products supply chain is to trade disruptions. The crisis led to shortages in critical devices such as personal protective equipment (PPE) and ventilators needed to prevent and treat COVID-19.
While the Coronavirus Aid, Relief, and Economic Security (CARES) Act gave the FDA new authority to require supply chain reporting from manufacturers, that authority may only be used during a public health emergency. The information the agency was able to collect under the authority allowed it to better understand and monitor the medical device supply chain and take proactive measures to prevent product shortages or at least find alternative solutions.
Despite the new authorities, Shuren said the agency needs to do better and wants the additional authority to spot a shortage before a public health emergency needs to be declared. Such authority would allow regulators to detect potential shortages even sooner.
“What’s most important for the authorities [that we are seeking] is that we receive advance notice of potential shortages in circumstances outside of a public health emergency,” Shuren told Focus.
He acknowledged that industry is wary of being subjected to onerous reporting requirements, but he argued that the FDA’s interest is to only ask for “limited information under limited circumstances,” which is essential for regulators to take proactive steps to prevent or mitigate shortages.
“We continue to remain open to working with Congress and the industry on rational authorities that best meet the needs of patients in the least burdensome manner,” Shuren said. He added that he’s not asking to get data on all medical devices and diagnostics but rather a subset of products that the FDA deems critical to public health.
“Device shortages happen all the time and they don’t respect the boundaries of a public health emergency,” Shuren said. “We think this could be crafted with minimal burden on the industry but have a significant beneficial impact on patients.”
In the latest CDRH annual report, the center noted that it has significantly reduced the backlog of reviews caused by the COVID-19 pandemic. Over the past year, it has shifted its focus to addressing the impact of new SARS-CoV-2 variants on device safety and effectiveness, developing strategies to transition existing COVID-19 devices, converting devices from emergency use authorization (EUA) to traditional marketing authorization, bolstering the supply chain, and preparing for future public health emergencies.
In 2022, CDRH authorized 765 medical devices to address COVID-19, bringing the total number of such devices authorized to address the public health emergency to 2,831. It also gave breakthrough designation to 135 devices, bringing the total to 752 devices since the breakthrough program began in 2015, according to the report.
The report also addresses FDA’s work to require Philips to recall its Respironics ventilators, as well as bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. It was noted that the polyester-based polyurethane (PEPUR) foam used in the devices could break down and potentially cause serious injury to patients.
After informing the company of the need to notify healthcare providers and patients about the risk of the devices, FDA determined Philips’ response was inadequate, forcing the agency to take additional steps to ensure the recall notification was publicized.
As part of that effort, Shuren said that his center for the first created a CDRH Recall Response Team in CDRH’s Division of Industry and Consumer Education (DICE). The group of FDA staff were tasked with ensuring patients and providers were kept abreast of the recall.
“Because we were receiving so many inquiries from patients and others, often because they felt they were not getting the answers they needed from Phillips, we had a group of individuals dedicated to responding to those inquiries,” Shuren said. “This is an unusual step, and it reflects the problems that we have seen with Phillips adequately and effectively responding and communicating with the public.”
Jeff Shuren, Center for Devices and Radiological Health (CDRH) director, spoke with Focus about his center’s performance last year and priorities for this year.
The FDA recently published the CDRH 2022 Annual Report, which states that while the excess workload from the COVID-19 pandemic is starting to alleviate, it is still tackling pandemic-related work on top of its normal day-to-day activities.
“Although COVID-19 has been an odyssey that we are returning home from – albeit battle-scarred – we have emerged a bit wiser and more prepared for the future to ensure we are best responding to public health needs,” Shuren wrote in the report.
One of the key takeaways from the pandemic, according to the report, is how vulnerable the US medical products supply chain is to trade disruptions. The crisis led to shortages in critical devices such as personal protective equipment (PPE) and ventilators needed to prevent and treat COVID-19.
While the Coronavirus Aid, Relief, and Economic Security (CARES) Act gave the FDA new authority to require supply chain reporting from manufacturers, that authority may only be used during a public health emergency. The information the agency was able to collect under the authority allowed it to better understand and monitor the medical device supply chain and take proactive measures to prevent product shortages or at least find alternative solutions.
Despite the new authorities, Shuren said the agency needs to do better and wants the additional authority to spot a shortage before a public health emergency needs to be declared. Such authority would allow regulators to detect potential shortages even sooner.
“What’s most important for the authorities [that we are seeking] is that we receive advance notice of potential shortages in circumstances outside of a public health emergency,” Shuren told Focus.
He acknowledged that industry is wary of being subjected to onerous reporting requirements, but he argued that the FDA’s interest is to only ask for “limited information under limited circumstances,” which is essential for regulators to take proactive steps to prevent or mitigate shortages.
“We continue to remain open to working with Congress and the industry on rational authorities that best meet the needs of patients in the least burdensome manner,” Shuren said. He added that he’s not asking to get data on all medical devices and diagnostics but rather a subset of products that the FDA deems critical to public health.
“Device shortages happen all the time and they don’t respect the boundaries of a public health emergency,” Shuren said. “We think this could be crafted with minimal burden on the industry but have a significant beneficial impact on patients.”
In the latest CDRH annual report, the center noted that it has significantly reduced the backlog of reviews caused by the COVID-19 pandemic. Over the past year, it has shifted its focus to addressing the impact of new SARS-CoV-2 variants on device safety and effectiveness, developing strategies to transition existing COVID-19 devices, converting devices from emergency use authorization (EUA) to traditional marketing authorization, bolstering the supply chain, and preparing for future public health emergencies.
In 2022, CDRH authorized 765 medical devices to address COVID-19, bringing the total number of such devices authorized to address the public health emergency to 2,831. It also gave breakthrough designation to 135 devices, bringing the total to 752 devices since the breakthrough program began in 2015, according to the report.
The report also addresses FDA’s work to require Philips to recall its Respironics ventilators, as well as bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. It was noted that the polyester-based polyurethane (PEPUR) foam used in the devices could break down and potentially cause serious injury to patients.
After informing the company of the need to notify healthcare providers and patients about the risk of the devices, FDA determined Philips’ response was inadequate, forcing the agency to take additional steps to ensure the recall notification was publicized.
As part of that effort, Shuren said that his center for the first created a CDRH Recall Response Team in CDRH’s Division of Industry and Consumer Education (DICE). The group of FDA staff were tasked with ensuring patients and providers were kept abreast of the recall.
“Because we were receiving so many inquiries from patients and others, often because they felt they were not getting the answers they needed from Phillips, we had a group of individuals dedicated to responding to those inquiries,” Shuren said. “This is an unusual step, and it reflects the problems that we have seen with Phillips adequately and effectively responding and communicating with the public.”
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