The FDA is ramping up efforts to address medical device shortages that are increasingly threatening patient care, particularly for pediatric and neonatal populations.
In a Jan. 16 news release, Michelle Tarver, MD, PhD, director of the FDA's Center for Devices and Radiological Health, emphasized the need for systemic changes to ensure better availability of critical devices.
Here are four notes:
- The shortage of specialized devices for pediatric care is particularly concerning. Devices such as pediatric tracheostomy tubes and oxygenators are in limited supply, forcing clinicians to adapt to adult-size equipment, which increases risk for young patients.
- The U.S. does not require manufacturers to report device shortages proactively. The FDA has had to rely on voluntary reports from healthcare providers, often learning of shortages too late to take effective action, the release said.
- To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least six months notice of potential disruptions allowing the agency to better prepare.
- Dr. Tarver called for legislative changes to remove restrictions that tie shortage reporting to public health emergencies.