Fragmented regulations exacerbate saline shortage

Different regulations for pharmaceuticals and medical devices are complicating the sodium chloride shortage.

Hospitals have been dealing with intermittent shortages of sodium chloride and its related components since late last year, as manufacturers and distributors have been focused on COVID-19 vaccine production, some suppliers have pulled out of the market and those that remain have experienced production delays.

About 60% of hospitals' requests for sodium chloride were not being filled as of Thursday, according to the group purchasing and consulting organization Premier. In normal times, less than 10% of hospital requests go unfulfilled.

Sodium chloride, also known as saline, is an essential tool for providers that's historically been prone to shortages. Clinicians and caregivers use it to replenish fluids, flush wounds, compound drugs, deliver intravenous medications and stabilize patients during surgery.

The vials and syringes that hospitals use to administer saline are classified as medical devices while the bags and solution are regulated as drugs. The Food and Drug Administration has more authority over the pharmaceutical supply chain than the medical device sector.

The fragmented regulatory framework has made it harder to collect data, implement workarounds and guide conservation strategies, supply chain experts said.

"During a drug shortage, there are a lot of levers the FDA can utilize to get products to market," said Soumi Saha, vice president of advocacy at Premier, adding that the agency can extend a drug's expiration date or expedite the approval of new products. "Those parallels don't exist in the device space."

The FDA hopes to change that by extending provisions in the CARES Act beyond the public health emergency.

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A provision in the act required certain medical device manufacturers to provide information to the FDA on product availability and on supply chain disruptions. It was the first time the agency had that authority over medical device manufacturers, the agency said.

It allowed regulators to "better understand and monitor the complex web of supply chains that feed the medical device industry and to be more proactive," particularly during the resin shortage that stemmed from the 2021 Texas winter storm and the COVID-19 diagnostic test supply disruptions, the FDA wrote in a recent brief.

Before the CARES Act, the FDA contacted more than 1,000 device manufacturers to request supply chain information, but only about one-third responded, and often incompletely, because the FDA's requests were voluntary, the agency said in the brief.

"Without more comprehensive authority, our device supply chain and U.S public health remain at risk," the agency wrote.

Some device manufacturers have opposed the requirements because of the administrative burden, given that some devices have more than 100 components. AdvaMed, the medical device association, did not immediately respond to a request for comment.

Regulators should view certain devices and drugs with the finished product in mind, said David Dobrzykowski, an associate professor of supply chain management at the University of Arkansas.

"It is certainly conceivable that regulations affecting specific components can have unintended consequences on finished goods," he said. "When it comes to medical products and devices, this means starting with finished goods and crafting appropriate regulations for those prior to thinking about the components that are used in the manufacturing or assembly of medical devices and products."

Currently, all saline remains on tight allocations with the manufacturers and distributors, said Sharp HealthCare, an integrated health system based in San Diego. The bottleneck is the tightest for 100 milliliter bags, a spokesperson said.

Hospitals were hoping the FDA would have specific conservation strategies around repackaging saline into smaller bags and extended date use information, but its latest recommendations focused solely on syringes. That was likely because of the differing regulations for devices and drugs, experts said.

"It's unfortunate that the recommendation from FDA is to use vials because those are extremely short as well," said Erin Fox, senior pharmacy director at University of Utah Health.

Saline solution, similar to other sterile injectables, is prone to shortages because it is expensive to produce and store. Manufacturers often stop making it and shift to higher-margin items, rendering the supply chain more vulnerable. The war in Ukraine has constrained the supply of plastics. The medical device and pharmaceutical sectors, similar to the rest of the healthcare industry, are also facing staffing shortages that have limited their output.

"Much of this shortage should be alleviated over next 90 days, however, it is going to depend upon those downstream shortages of plastic and resin and all of the componentry," Saha said.

While manufacturers, hospitals and other stakeholders work to increase production capacity, the FDA should make sourcing, quality, volume and capacity information publicly available for all medical products sold in the U.S., a new report from the National Academies of Sciences, Engineering and Medicine recommends.

Hospitals should maintain interdisciplinary teams to constantly track saline supply levels, not just during crises, said Stephanne Hale, director of clinical solutions at the group purchasing organization Vizient. Providers should also adjust how much saline they give each patient based on their weights and other characteristics, she said.

Similar recommendations were made after Hurricane Maria wiped out many of the related saline manufacturers in Puerto Rico in 2017. While the FDA extended product expiration dates and loosened saline importation policies, not enough long-term solutions were implemented, Saha said.

Read more: Saline supply hamstrung by Puerto Rico disaster

"One of Premier's biggest goals is to learn from past experiences and move forward. I thought we had done that post-Hurricane Maria, but here we are today. That's what keeps me up at night, that we haven't learned," she said. "Of course we need to correct this by increasing redundancy and other solutions. It could be as simple as making sure there is not a regulatory disconnect between devices and drugs."