FDA: Medical Device Supply Chains Under Pressure

Medical device shortages are becoming an increasingly urgent issue, according to the US Food and Drug Administration (FDA), particularly in paediatrics, where specialised equipment for neonatal and young patients is vital.

These shortages expose significant vulnerabilities in the supply chain, risking the safety and care of patients who rely on devices such as ventilators, hemodialysis catheters and tracheostomy tubes.

As the US lags behind global counterparts in addressing these supply challenges, the pressure to reform and strengthen resilience has never been greater.

Critical challenges in paediatric medical device shortages

Paediatric patients face unique risks during medical device shortages. They require devices specifically designed for smaller, fragile bodies, making adult-sized alternatives unsuitable and often dangerous.

Neonatal intensive care units (NICUs) and children requiring long-term interventions are among those most affected. A lack of appropriately-sized equipment forces healthcare providers to adapt adult-sized devices, which can result in higher rates of complications, suboptimal care and increased safety risks.

Supply chain vulnerabilities are not new, but their impact is growing. Shortages stem from a variety of sources, including natural disasters, limited production capacity for niche devices, manufacturing quality issues and insufficient investment in paediatric device innovation.

For example, sterilisation constraints related to ethylene oxide—a chemical used to sterilise many medical devices—have already caused significant disruption in the availability of critical devices.

The COVID-19 pandemic starkly exposed these weaknesses, with shortages in ventilators and personal protective equipment (PPE) dominating headlines.

For paediatric patients, the problem was even more acute due to the smaller production runs of specialised devices. This often left hospitals scrambling to find alternative solutions, which sometimes exposed patients to greater risks.

How the FDA is addressing the crisis

The FDA has taken steps to improve supply chain resilience, but gaps remain. One of the biggest differences between the US and other regions, such as the European Union (EU), is in the approach to shortage reporting.

Since January 2025, the EU has required mandatory reporting of potential medical device shortages, providing governments with early warnings to manage risks. In contrast, the US only mandates such reporting during public health emergencies, leaving hospitals and healthcare providers poorly prepared to anticipate or address shortages.

The FDA’s reliance on voluntary notifications related to disruptions hasn't been plain sailing, resulting in shortages only discovered after healthcare providers report them, often at the point of care—too late to take preventive action.

Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health (CDRH), sums it up: “While the vulnerabilities in the medical device supply chain are not new, we're growing increasingly concerned that the rise in shortages is having a significant adverse impact on neonatal and paediatric patients.”

To address these challenges, the FDA has established the Office of Supply Chain Resilience (OSCR) within its CDRH.

OSCR monitors risks, assesses vulnerabilities and works with manufacturers, healthcare providers and government agencies to prevent and mitigate disruptions.

Its efforts include maintaining a real-time medical device shortage list, conducting supply chain impact assessments and using regulatory tools such as the Defence Production Act to secure raw materials and prioritise production.

For instance, during the 2022 shortage of Bivona tracheostomy tubes, the FDA worked with manufacturers and raw material suppliers to ensure timely production. This included issuing public safety communications and recommending alternative devices and conservation strategies. Although these measures helped reduce the impact, paediatric patients remained disproportionately affected.

Trump, RFK Jr and the future of FDA supply chain disruptions

Political dynamics have added complexity to the FDA’s ability to respond to medical device shortages.

President Donald Trump’s policies, such as the possible imposition of tariffs on imports, could significantly affect the availability and affordability of medical devices.

Tariffs on goods from countries such as China and Mexico – key suppliers of medical devices and components – have previously led to price increases and occasional supply chain disruptions. For example, the American Society of Health-System Pharmacists recorded the highest number of drug shortages in 2023 since it began tracking in 2001, with tariffs exacerbating the issue.

Stakeholders in the medical sector have long raised concerns about the effects of such trade policies on generic drugs and device components, which are critical to healthcare systems.

Arthur Wong, Healthcare Managing Director at S&P Global Ratings notes: “Generics account for roughly 90% of all US prescriptions and tariffs would potentially raise costs for a significant portion of the market.”

Meanwhile, Robert F. Kennedy Jr., US Secretary of Health and Human Services (HHS), has taken an aggressive stance on reforming the FDA.

RFK Jr.’s criticisms of the agency include its regulatory authority and its reliance on user fees from pharmaceutical and device manufacturers, which accounted for US$3.5bn of the FDA’s US$7.2bn 2025 budget request. His calls for changes to the Prescription Drug User Fee Act (PDUFA) have placed the FDA’s funding model under scrutiny, raising fears of weakened regulatory oversight.

Critics worry this approach prioritises cost-cutting over patient safety, potentially leaving the US healthcare system ill-prepared for future crises.

Despite these challenges, the FDA remains focused on its mission. The agency is actively advocating for expanded authorities to mandate early shortage reporting and additional funding to address systemic vulnerabilities. 

The path to a resilient future

While the FDA has made progress, long-term solutions require legislative and financial support.

The agency has called for amendments to Section 506J of the CARES Act to remove the limitation that ties shortage reporting to public health emergencies. By implementing proactive reporting requirements and expanding funding for supply chain programmes, the FDA hopes to prevent shortages before they occur.

Congress has allocated additional resources to the CDRH in recent years, but more funding is needed to address systemic vulnerabilities. The agency continues to advocate for a strengthened supply chain programme that would support early detection of disruptions and facilitate the development of risk mitigation strategies.

Broader collaboration with international partners, healthcare providers and manufacturers will also be critical. Leveraging data and communication channels to anticipate risks and improve responsiveness can create a more resilient system that ensures patients, particularly the youngest and most vulnerable, receive uninterrupted care.

As the FDA continues to prioritise supply chain resilience, its commitment to safeguarding patient health remains steadfast. Michelle reinforces this: “The FDA recognises that early awareness of supply chain disruptions is essential to mitigating the impacts of potential medical device shortages on patient care and protecting the public health.”

By addressing these challenges, the US has the opportunity to build a supply chain that protects patients, supports healthcare providers and ensures critical devices are available when they are most needed.

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