FDA Panel Mulls Which Devices Are Critical in a Public Health Emergency

— “If we have an atomic war, all I require is a scalpel,” one panel member stated

by
Joyce FriedenWashington Editor, MedPage Today
February 6, 2024

What bare minimum devices would you require to practice your specialized throughout a public health emergency situation? It depends upon what the emergency situation is, members of an FDA advisory panel stated Tuesday.

“If we have an atomic war, all I require is a scalpel,” stated Stavropoula Tjoumakaris, MD, a teacher of neurosurgery at Thomas Jefferson University in Philadelphia, throughout a conference of the FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. “It would be great to have an aneurysm clip, however I might not have that.”

On the other hand, “if we had some awful afflict that was eliminating individuals, we do not require ECMO gadgets … since we’re going to triage those individuals and they’re not going to get care,” stated Keith Allen, MD, director of surgical research study at Mid America Heart & & Lung Surgeons in Kansas City, Missouri.

This conference led to part from a law gone by Congress in March 2020. The law, called Section 506J, needs makers to alert the firm of any discontinuation of or disturbance in the manufacture of particular important medical gadgets throughout– or in advance of– a public health emergency situation, FDA personnel kept in mind in an instruction fileA later law, part of a change to the Coronavirus Aid, Relief, and Economic Security (CARES) Act, needs the FDA to provide or modify assistance relating to the Section 506J requirements.

The Device List

Among the concerns the FDA should attend to is which gadgets need to fall under 506J, which specifies “crucial” medical gadgets as those that are “vital to public health throughout a public health emergency situation, consisting of gadgets that are life-supporting, life-sustaining, or planned for usage in emergency situation healthcare or throughout surgical treatment.”

When the company is informed of a lack, it can perform an evaluation of the supply chain for that specific gadget and establish a method to reduce the lack, which may consist of regulative actions such as emergency situation usage permission, enforcement discretion, and letters to companies, in addition to other actions like concern demand letters or transport prioritization.

The FDA provided draft assistance on Section 506J in November 2023. The draft assistance consisted of a list of gadgets that would go through the alert requirement, and kept in mind that the company is accepting talk about the list through February 15.

The FDA has actually categorized more than 1,700 unique kinds of gadgets and arranged them into 16 medical specialized panels, such as “cardiovascular gadgets” or “ear, nose, and throat gadgets.” Within the panels, each kind of gadget is provided its own item code; the proposed list consists of 284 item codes. The cardiovascular panel has the most item codes at 57, while physical medication has the least, with just 2.

Panel members revealed issues about the item codes. “The broadness of these codes might end up being bothersome,” stated Barbara Van Der Pol, PhD, MPH, of the University of Alabama at Birmingham. “Some subsets may be essential and others may not … Are there subcodes that we can partition 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, stated the company was constrained by what the law informed the company to do. “The legislation that directs us to develop this list particularly discusses item codes,” she stated, including that “we do comprehend that there can be some difficulties connected with the broad nature of a few of the item codes.”

What to Add?

Members likewise had particular gadgets they felt required to be contributed to the list. Jason Dominitz, MD, MHS, executive program director for gastroenterology and hepatology at the Veterans Health Administration in Seattle, discussed co2 regulators. “And I do not understand if this is a drug or a gadget however … we had a lack of isopropyl alcohol throughout the pandemic for drying the endoscopes,” he stated, keeping in mind that another gadget that has actually likewise remained in brief supply in the past is big bottle utilized for stomach paracentesis.

Lisa Jennings, PhD, of the University of Tennessee in Memphis, stated she would include constant favorable air passage pressure (CPAP) devices and the materials related to them. “stretchers were [listed] there however wheelchairs were not … And there’s actually absolutely nothing connected with total blood counts, such as automated hematology analyzers,” she included.

The FDA likewise desired panelists to weigh in on whether the resiliency of the supply chain for a specific item ought to be thought about when choosing whether to put it on the list.

“Were you to be conscious that there are not specific vulnerabilities with regard to market share or other concerns, which there suffices strength in the supply chain, would that in any method change your choice in regards to 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, stated the resiliency factor to consider just made things more complicated for panelists attempting to determine what to suggest for the list. “I see that MRIs aren’t on the list … Should I presume that it wasn’t on the list due to the fact that the FDA feels MRIs are resistant adequate gadgets that do not require to be on this 506J list?” he asked. “And how would I have actually understood that a priori to the conference?”

Broad or Narrow?

Allen appeared to feel the conversation had actually gotten too granular. “I’m going to take a contrarian view,” he stated. “What the FDA desires is a succinct list of what is important. If we had an atomic war … you’re not going to be doing optional cases where you’re utilizing a biologic mesh to repair optional larger hernias. That isn’t practical. And we can’t ask the FDA– and we definitely can’t ask market– to have a list like that. We require to be sensible about what we’re asking for and what truly is objective important to care for clients in a nationwide emergency situation.”

Charity Morgan, PhD, of the University of Alabama at Birmingham, disagreed. “We have a broad scope of possible public health emergency situations; they’re not all going to be COVID,” she stated. “Sometimes it’s an earthquake or a train thwarts, cars and trucks bring hazardous chemicals … I elect the more comprehensive list even if it looks like that’s the world we’re in. Scarcities turn up rapidly, and by the time they repair one emergency situation, something else is turning up.”

“You wish to know about the lacks that are occurring so the health care systems can be informed, even if the reaction is going to be ‘simply watch on your stock,'” she included.

Carrino proposed a structure for how the FDA may think about whether to include a product to the list: “If we have among these emergency situations, what is preferred, what is needed, what’s the resiliency, and what’s the contingency [plan]” he stated. “That may be something the FDA can utilize to deal with.”

Another concern for panel members was whether “benefit sets”– products packaged together due to the fact that they’re regularly utilized together– must be placed on the list.

Hugh Cassiere, MD, of South Shore University Hospital at Northwell Health in Bay Shore, New York, offered an example of 2 benefit sets he felt must be consisted of. “Central line packages and arterial catheter packages– those are the important things that are our go-to treatments in the ICU that require to be done thoroughly, perfectly, and in sterilized method, and not having a so-called benefit package would be a huge hinderance to that,” he stated.