Medical device supply chain problems plague hospitals

Scripps Health has about eight times more medical devices and supplies on backorder than the integrated nonprofit health system had in 2019.

San Diego, California-based Scripps has been managing shortages in ligatures and oxygenators that stop bleeding, catheters used in heart surgery and urology and custom procedure trays and surgical packs, among other things.

While providers, distributors and manufacturers have grappled with supply chain disruptions for critical devices, supplies and pharmaceuticals for years, health systems administrators say this latest round is more challenging. Supply chain managers must frequently use the fourth, fifth or sixth option in their list of substitute products, requiring a new workflow for nurses and physicians.

“This is by far the worst supply chain disruption I have ever experienced,” said Joshua Spangler, associate vice president of supply chain procurement, strategic sourcing and accounts payable at Scripps, who has been working in healthcare supply chain roles for about 26 years.

As health systems move further down the list of their lists of preferred substitutes, clinicians are spending more time adjusting, increasing the likelihood of mistakes as they work with less-familiar products. 

“The secondary and tertiary substitutes are frequently unavailable and providers have to change protocol,” said Mittal Sutaria, senior vice president of pharmacy contracting and program services at the group purchasing organization Vizient. “When you have to use a product you are not as familiar with or one that is suboptimal, that can increase the chance of errors or negative outcomes.”

The range and severity of shortages have gotten progressively worse since the COVID-19 pandemic, said health system administrators, citing a lack of transparency between manufacturers and providers that continues to plague the system. Supply chain shortages are expected to continue well beyond the end of the public health emergency. 

Scripps saw the number of items on backorder triple from 2019 and 2020, largely related to personal protective equipment, Spangler said. The number of products on backorder swelled five-fold in 2021 compared with pre-pandemic levels as emergency care supplies, plastics used in medical equipment circuitry and ventilators and related supplies ran short, he said.

“We were hoping to see some light at the end of the tunnel in 2022, but we are now at an eight-fold increase compared with 2019,” Spangler said.

The number of alternative suppliers, particulalry of low-cost generic drugs and medical supplies, continues to wane as pharmaceutical and device manufacturers prioritize more profitable items. That often leaves one or two sources for items hospitals use daily, industry observers said. 

Sioux Falls, South Dakota-based Sanford Health is dealing with similar supply chain snags. The number of items on backorder have tripled in recent months, ranging from trash liners to intra-aortic balloon pumps, which help hearts pump more blood. The nonprofit health system manages a list of between six and 16 substitute devices that are different enough from the preferred option that they require training or workflow adjustments, Sanford Chief Physician Dr. Jeremy Caulwels said.

“It is remarkable the number of things in shortage that you would never thought you would run out of,” he said.

Eye drops, for instance, have been in short supply for months. Akorn Pharmaceuticals discontinued production of eye drops used to treat glaucoma in early 2022, and other manufacturers have struggled to keep up with the demand. Akorn, which did not reply to a request for comment, filed for Chapter 7 bankruptcy in February and is shutting down U.S. operations after struggling through years of quality and financial issues.

Akorn also stopped production in February of liquid albuterol, which is used to treat asthma and for patients on ventilators. It was the sole domestic manufacturer of a large dose of albuterol, and one of two main suppliers globally.

That means Sanford clinicians have to administer doses more frequently because only smaller sizes are available, said Nate Leedahl, manager of the health system’s pharmacy operations.

“It requires more communication, more space to store smaller vials and an appreciable amount of astuteness from bedside practitioners,” he said. “More manufacturers are bowing out of the market perhaps because the cost of making the supply outweighs the return on investment.”

Before the COVID-19 pandemic, Sanford supply chain managers could count on one sheet of paper how many drugs were made by one or two manufacturers. “That list is growing,” Leedahl said.

The number of active drug shortages reached 301 by the end of the first quarter, the highest level since 2014, according to data from the American Society of Health-System Pharmacists. Chemotherapy drugs, which often do not have alternatives, are increasingly in short supply, according to ASHP. 

The prevalence of drug shortages prompted a March report from Senator Gary Peters (D-Mich.), chairman of the Homeland Security and Governmental Affairs Committee. It found that drug shortages increased by nearly 30% between 2021 and 2022, noting that more than 90% of generic sterile injectable drugs for critical care rely on ingredients from China and India. While the average drug shortage lasts about 18 months, more than15 critical drug products have been in shortage for more than a decade, according to the report.

“There is a lack of transparency of where products are manufactured, where the raw material is sourced from and how many suppliers are in the market,” Sutaria said.

Health systems like Scripps and Sanford have not had to delay or cancel any procedures as a result of the shortages. Providers are asking for more robust reporting requirements from manufactures and an increase in production of vital, widely used devices and drugs to prevent potential care disruptions.

“Prompt reporting can help hospitals know to institute rationing plans, but reporting alone can’t improve supply [levels],” said Erin Fox, senior pharmacy director at University of Utah Health.

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