Study: COVID pandemic triggered spike in device shortages

Regulatory NewsRegulatory News | 08 December 2022 |  By 

COVID-19-related demand for medical devices, including personal protective equipment (PPE) and diagnostics, was the main driver of the 22 device shortages reported in the first half of 2020, according to a new analysis published in Health Affairs.

The analysis, led by Trinidad Beleche, PhD, of the US Department of Health and Human Services, and co-authored by officials at the Food and Drug Administration (FDA), examined the number and characteristics of medical device shortages in the US from January 2006 to July 2020. Overall, there were 61 device shortages reported during the study period. There was at least one medical device shortage each year during the study period, with an average of five shortages per year from 2010 to 2019, followed by a jump to 22 shortages in the first half of 2020.

The researchers suggested that devices shortages detailed in the study may have been an underestimate. For instance, the study does not include shortages that were averted. Additionally, before passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which provided the FDA with early notification of discontinuations and manufacturing interruptions, the agency received limited information about likely shortages. (RELATED: FDA seeks comment on device shortage reporting guidance, Regulatory Focus 10 January 2022)

“Before the CARES Act, the FDA worked with device manufacturers to prevent shortages, but manufacturers shared shortage information on a voluntary, case-by-case basis, if at all,” the researchers wrote in Health Affairs.

While 2020 was marked by a significant increase in device shortages, the drivers behind those shortages were also different than in the pre-pandemic period. From January to July 2020, the majority of device shortages were triggered by increased demand, with a small portion caused by product discontinuation. In contrast, during the pre-pandemic period, device shortages were triggered mainly by regulatory actions, such as recalls or seizures that were related to product quality or manufacturing issues. Other common contributors were natural disasters and product discontinuance.

The types of devices involved in shortage also differed between the pandemic and pre-pandemic time periods. Other than ventilator-related product shortages, which occurred during both periods, there was no other overlap. Shortages during the COVID-19 pandemic in early 2020 were related to PPE, diagnostic testing supplies and equipment and vital sign monitoring. Before the pandemic, however, shortages were related to infusion pumps, devices used in dialysis treatment, needles/syringes and sterilization products.

The underlying structure of the medical device market likely had a role in shortages, the researchers suggested. They pointed to the non-competitive markets for medical devices, with one or fewer producers, as contributing to shortages “in the event of a shock.” The lack of substitute devices or familiarity with alternatives also prevent providers from choosing another device when one device is unavailable.

“More research is needed to increase understanding of the relationship between the proximate causes of shortages and these underlying features of medical device markets, as well as how lessons learned from other markets vulnerable to shortages might apply to this context,” the researchers wrote.

Health Affairs study


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you