Medical device manufacturers start disclosing COVID-19 shortages through FDA list

Erin McCallister Senior Manager, Health Research Institute, PwC US August 20, 2020

The FDA unveiled the first medical device shortage list as part of a requirement under the Coronavirus Aid, Relief and Economic Security (CARES) Act. The list, which does not disclose company names involved, reveals that disruptions persist months into the pandemic.

The list, posted on Aug. 14, includes 20 products with an estimate of the duration of the shortage. Three ventilators are listed, and the remainder of device shortages are split between personal protective equipment (PPE) and testing supplies and equipment.

Testing supply shortages have resulted in numerous headaches since the COVID-19 outbreak, including delays in returning results.

The agency also released a list of discontinued devices on Aug. 14 with one item, an infusion pump (and accessories), which was produced at a now-closed facility.

The CARES Act gives the FDA the authority to require manufacturers to report potential supply interruptions or product discontinuations during a public health emergency.

HRI Impact Analysis

Supply chain disruptions have occurred since the onset of the pandemic. To address the shortages, the FDA has issued numerous guidance documents and Emergency Use Authorizations (EUAs). In fact, the agency has issued more guidance documents during the COVID-19 pandemic than in the past few years of public health emergencies. Additionally, the FDA has quickly approved generic versions of drugs in shortage.

While the intent of the medical device shortages list is to increase transparency and help government officials plan for replenishment and seek additional procurement channels, uncertainty remains around how often the agency will update the list, which could evolve as vaccines are released, potentially creating new supply shortages. The Trump administration recently announced a primary distributor for vaccines and logistics providers are building out capacity.

During the H1N1 pandemic more than a decade ago, spiking demand and supply shortages hampered the efforts to quickly mobilize and immunize a significant portion of the US population. As pressure builds in preparation for a massive vaccination campaign, supply chain transparency and central leadership could prove critical as testing and vaccinations likely would exceed typical demands on the healthcare supply chain. 

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Ingrid Stiver

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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