番茄社区

What bare minimum equipment would you need to practice your specialty during a public health emergency? It depends on what the emergency is, members of an FDA advisory panel said Tuesday.

"If we have a thermonuclear war, all I need is a scalpel," said Stavropoula Tjoumakaris, MD, a professor of neurosurgery at Thomas Jefferson University in Philadelphia, during a meeting of the FDA's General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. "It would be nice to have an aneurysm clip, but I may not have that."

On the other hand, "if we had some horrible plague that was killing people, we don't need ECMO devices ... because we're going to triage those people and they're not going to get care," said Keith Allen, MD, director of surgical research at Mid America Heart & Lung Surgeons in Kansas City, Missouri.

This meeting resulted in part from a law passed by Congress in March 2020. The law, known as Section 506J, requires manufacturers to notify the agency of any discontinuation of or disruption in the manufacture of certain critical medical devices during -- or in advance of -- a public health emergency, FDA staff noted . A later law, part of an amendment to the Coronavirus Aid, Relief, and Economic Security (CARES) Act, requires the FDA to issue or revise guidance regarding the Section 506J requirements.

The Device List

One of the questions the FDA must address is which devices should fall under 506J, which defines "critical" medical devices as those that are "critical to public health during a public health emergency, including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery."

Once the agency is notified of a shortage, it can conduct an assessment of the supply chain for that particular device and develop a strategy to mitigate the shortage, which might include regulatory actions such as emergency use authorization, enforcement discretion, and letters to providers, as well as other actions like priority request letters or transportation prioritization.

The FDA issued draft guidance on Section 506J in November 2023. The draft guidance included a that would be subject to the notification requirement, and noted that the agency is accepting comments on the list through February 15.

The FDA has classified more than 1,700 distinct types of devices and organized them into 16 medical specialty panels, such as "cardiovascular devices" or "ear, nose, and throat devices." Within the panels, each type of device is given its own product code; the proposed list includes 284 product codes. The cardiovascular panel has the most product codes at 57, while physical medicine has the least, with only two.

Panel members expressed concerns about the product codes. "The broadness of these codes may become problematic," said Barbara Van Der Pol, PhD, MPH, of the University of Alabama at Birmingham. "Some subsets may be important and others may not ... Are there subcodes that we can subdivide any of these by?"

Linda Ricci, deputy director of the Office of Strategic Partnerships and Technology Innovation at the FDA's Center for Devices and Radiological Health, said the agency was constrained by what the law told the agency to do. "The legislation that directs us to create this list specifically talks about product codes," she said, adding that "we do understand that there can be some challenges associated with the broad nature of some of the product codes."

What to Add?

Members also had specific devices they felt needed to be added to the list. Jason Dominitz, MD, MHS, executive program director for gastroenterology and hepatology at the Veterans Health Administration in Seattle, mentioned carbon dioxide regulators. "And I don't know if this is a drug or a device but ... we had a shortage of isopropyl alcohol during the pandemic for drying the endoscopes," he said, noting that another device that has also been in short supply in the past is large vacuum bottles used for abdominal paracentesis.

Lisa Jennings, PhD, of the University of Tennessee in Memphis, said she would add continuous positive airway pressure (CPAP) machines and the supplies associated with them. Also, "stretchers were [listed] there but wheelchairs were not ... And there's really nothing associated with complete blood counts, such as automated hematology analyzers," she added.

The FDA also wanted panelists to weigh in on whether the resiliency of the supply chain for a particular product should be considered when deciding whether to put it on the list.

"Were you to be aware that there are not particular vulnerabilities with respect to market share or other issues, and that there is sufficient resilience in the supply chain, would that in any way alter your decision in terms of whether they belong or not on the 506J list?" asked Suzanne Schwartz, MD, MBA, director of the Office of Strategic Partnerships and Technology Innovation.

John Carrino, MD, PhD, of Weill Cornell Medical College in New York City, said the resiliency consideration only made things more confusing for panelists trying to figure out what to recommend for the list. "I see that MRIs aren't on the list ... Should I presume that it wasn't on the list because the FDA feels MRIs are resilient enough devices that don't need to be on this 506J list?" he asked. "And how would I have known that a priori to the meeting?"

Broad or Narrow?

Allen seemed to feel the discussion had gotten too granular. "I'm going to take a contrarian view," he said. "What the FDA wants is a concise list of what is essential. If we had a thermonuclear war ... you're not going to be doing elective cases where you're using a biologic mesh to fix elective bigger hernias. That isn't realistic. And we can't ask the FDA -- and we certainly can't ask industry -- to have a list like that. So we need to be realistic about what we're asking for and what really is mission critical to care for patients in a national emergency."

But Charity Morgan, PhD, of the University of Alabama at Birmingham, disagreed. "We have a broad scope of possible public health emergencies; they're not all going to be COVID," she said. "Sometimes it's an earthquake or a train derails, cars carrying toxic chemicals ... I vote for the broader list just because it seems like that's the world we're in. Shortages pop up quickly, and by the time they fix one emergency, something else is coming up."

"You want to know about the shortages that are happening so the healthcare systems can be notified, even if the response is going to be 'just keep an eye on your stock,'" she added.

Carrino proposed a framework for how the FDA might consider whether to add an item to the list: "If we have one of these emergencies, what is desired, what is required, what's the resiliency, and what's the contingency [plan]?" he said. "That might be something the FDA can use to work with."

Another question for panel members was whether "convenience kits" -- items packaged together because they're frequently used together -- should be put on the list.

Hugh Cassiere, MD, of South Shore University Hospital at Northwell Health in Bay Shore, New York, gave an example of two convenience kits he felt should be included. "Central line kits and arterial catheter kits -- those are the things that are our go-to procedures in the ICU that need to be done meticulously, flawlessly, and in sterile technique, and not having a so-called convenience kit would be a big detriment to that," he said.

Comment