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

The hospital has been dealing with Intermittent shortages of sodium chloride and its related ingredients As manufacturers and distributors have focused on the production of COVID-19 vaccines since late last year, some suppliers have qiut the market The rest have experienced Production delays.

About 60 percent of hospitals’ requests for sodium chloride were not being met as of Thursday, according to group buying and consulting agency Premier. Under normal circumstances, less than 10% of hospital requests go unmet.

Sodium chloride, also known as brine, is an important tool for suppliers that have historically been prone to shortages. Clinicians and paramedics use it to replenish fluids, irrigate wounds, compound medications, deliver intravenous medications, and stabilize patients during surgery.

Vials and syringes used in hospitals to inject saline are classified as medical devices, while bags and solutions are classified as pharmaceuticals. The FDA has more power over the drug supply chain than the medical device sector.

Supply chain experts say fragmented regulatory frameworks make it harder to collect data, implement workarounds and guide conservation strategies.

“During a drug shortage, there are many levers the FDA can use to bring a product to market,” said Soumi Saha, vice president of advocacy at Premier, adding that the FDA can extend the expiration date of a drug or expedite the approval of a new product. “These similarities don’t exist in the device space. place. “

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

A provision in the act requires certain medical device manufacturers to provide the FDA with information about product availability and supply chain disruptions. This is the first time the agency has power over medical device manufacturers, agency said.

It enables regulators to “better understand and monitor the complex supply chain network that feeds the medical device industry, and be more proactive”, especially as the 2021 Texas winter storm and supply disruptions for COVID-19 diagnostic tests lead to of resin shortages, the FDA wrote in a recent article briefly.

The agency said in its briefing that before the CARES Act, the FDA contacted more than 1,000 device manufacturers for supply chain information, but only about a third responded, and often incompletely, because the FDA The request is voluntary.

“Without a more comprehensive authorization, our equipment supply chain and U.S. public health remain at risk,” the agency wrote.

Given that some devices have more than 100 components, some device manufacturers oppose these requirements due to administrative burdens. AdvaMed, the medical device association, did not immediately respond to a request for comment.

Regulators should look at certain devices and drugs with finished products 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 could have unintended consequences on the finished product,” he said. “In the case of medical products and devices, that means starting with the finished product, and developing appropriate regulations for those before considering the components used in the manufacture or assembly of medical devices and products.”

Sharp HealthCare, a San Diego-based integrated health system, said that for now, all saline is still being distributed closely with manufacturers and distributors. A spokesman said the neck was the tightest for a 100ml bag.

Hospitals hope the FDA will develop specific conservation strategies, repackaging of saline into smaller bags and extended use-by-date information, but its latest suggestion Just focus on the syringe. Experts say this may be due to different regulations on devices and drugs.

“Unfortunately, the FDA recommendation is to use vials because those vials are also very short,” said Erin Fox, director of senior pharmacy at the University of Utah Health.

Saline, similar to other sterile injectables, is Easily out of stock Because of its high production and storage costs.Manufacturers often stop production and switch to higher-margin products, making Supply chains are more fragile. The war in Ukraine limits the supply of plastic. Similar to other healthcare industries, the medical device and pharmaceutical industries face staffing shortages that limit their output.

“Most of this shortage should be alleviated over the next 90 days, however, it will depend on the shortage of downstream plastics and resins and all components,” Saha said.

In a new move, the FDA should disclose procurement, quality, quantity and capacity information for all medical products sold in the U.S. as manufacturers, hospitals and other stakeholders work to increase production capacity. Report Recommendations from the National Academies of Sciences, Engineering, and Medicine.

Stephanne Hale, director of clinical solutions at group buying group Vizient, said hospitals should maintain interdisciplinary teams to keep track of saline supply levels, not just during a crisis. Providers should also adjust the amount of saline they give each patient based on their weight and other characteristics, she said.

Similar recommendations were made after Hurricane Maria In 2017, many related brine manufacturers in Puerto Rico were eliminated, Saha said. While the FDA has extended product expiration dates and eased policies on saltwater imports, not enough long-term solutions have been implemented.

“One of the prime minister’s biggest goals is to learn from the past and move on. I thought we’d done it after Hurricane Maria, but we’re here today. That’s what keeps me up at night, we haven’t learned yet. ,”she says. “Of course, we need to correct this by adding redundancy and other solutions. It could be as simple as making sure there’s no regulatory disconnect between the device and the drug.”