The US Food and Drug Administration (FDA) has issued a statement outlining steps to improve protections to prevent medical device shortages.
Citing supply chain disruption as the primary threat to medical device shortages, which may be caused by natural disasters, limited manufacturing capacity for niche devices, or manufacturing and quality problems, Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), said that as the global regulatory environment continues to evolve, the US may be at risk of falling behind in its ability to protect patients by assuring device availability.
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On 10 January 2025, new European Union (EU) regulations that mandate that medical device manufacturers must flag up any anticipated supply shortages at least six months in advance took effect.
Tarver commented: “Now, the European Commission and member countries will have access to vital information about medical device shortages that could impact their population.
“In contrast, there are no mandatory reporting requirements for potential medical device shortages in the US except, as required, during or in advance of a public health emergency.”
To address this vulnerability, the agency has requested new statutory authority to amend Section 506J of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) – which was signed into law in 2020 in response to the economic fallout of the pandemic in the US – to remove the current temporal limitation that ties device shortage reporting requirements to public health emergencies. It is also calling for increased funding for existing measures that the Center for Devices and Radiological Health (CDRH) Supply Chain Program takes to identify and mitigate device shortage issues.
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By GlobalDataTarver said: “These changes are essential for enabling proactive responses to prevent supply chain disruptions before they impact patient care, and the future of our healthcare system.
“In recent years, Congress has provided resources to support CDRH’s efforts to respond to supply chain disruptions, and while these resources have been helpful, additional funding will be needed to sustain and enhance our abilities to help identify, prevent, and mitigate shortages.”
With the US’s lack of comparable transparency, the EU’s new regulation to provide critical information to healthcare providers, giving them the chance to act accordingly to mitigate the impact of device shortages, Tarver added that US hospitals and healthcare systems are left “ill-prepared to address shortages, forcing them to rely on unpredictable or ad-hoc solutions”.
Tarver noted that safeguarding measures for patients around possible medical device shortages are particularly consequential for neonatal and paediatric patient populations.
She stated: “When shortages arise, there are few options that may accommodate children – compelling clinicians to adapt adult-sized equipment, which can lead to suboptimal outcomes and increased risks for patient safety.”
In closing, Tarver said the FDA remains committed to working with the relevant authorities and resources to strengthen the domestic supply chain and address vulnerabilities: “Together, the FDA, healthcare providers, patients, hospitals, and Congress can work to ensure that paediatric and other patient populations receive the care they need without interruption.”
