The American Hospital Association is urging the Federal Emergency Management Agency to form an agreement with the private sector covering the “extraordinarily wide” range of medical products needed in the response against COVID-19 — including dialysis devices, cardiac monitors and IV pumps, not just personal protective equipment.
The AHA comments came ahead of a FEMA meeting slated for Thursday to discuss use of the Defense Production Act’s voluntary agreement clause. The clause allows private companies to enter into agreements with the government on mutually acceptable terms and gain immunity from antitrust liability.
FEMA is proposing a 5-year voluntary agreement "effective as soon as possible," as well as formation of a committee to spur the best "coordination, planning, information sharing, and distribution of health and medical resources." Medical devices trade group AdvaMed had reached out to FEMA in March saying it would welcome centralized guidance on distribution of ventilators.
Governments and medtech companies spent the first few months of the COVID-19 outbreak trying to ensure hospitals had enough PPE such as gowns, gloves and masks, in addition to mechanical ventilators. The availability of those devices is essential to effective responses against the coronavirus as they enable hospitals to protect frontline staff and keep patients with respiratory failure alive.
However, as the crisis has gone on AHA has found COVID-19 is placing strains on other parts of the medical supply chain.
“In contrast to prior infectious disease outbreaks, COVID-19 has placed a strain on an extraordinarily wide range of medical supplies, equipment and medications. For the health care system to sustain its response, it will need the private sector’s support in addressing the full range of these needs, and not just narrow segments like PPE,” AHA wrote in a letter Wednesday.
AHA wants the voluntary agreement FEMA forms with the private sector to reflect the breadth of products its members are using in the care of COVID-19 patients. The list, which only covers some of the products AHA wants to see addressed in the agreement, includes intubation equipment, pulse oximeters, nasal cannulas and laboratory testing equipment.
AHA also noted the agency "may need to consider including additional supplies or services that support these changes in health care delivery, such as devices to help patients connect to care virtually."
FEMA will discuss its plans for the voluntary agreement at a virtual public meeting Thursday afternoon that will feature a 90-minute so attendees can address comments to the federal agency. The meeting, which FEMA expects major medtech manufacturers to attend, is intended to enable the agency to identify companies that can enter into deals and collect technical advice on the “scope and substance” of the agreement.
AHA is supportive of the approach outlined by FEMA so far, saying it's in favor of the proposed 5-year duration of the agreement on the grounds that the U.S. may be affected by the coronavirus for “an extended timeframe.”
The next steps will depend on what happens at the meeting Thursday. If necessary, FEMA will hold a second meeting next week. Otherwise, FEMA will use information gathered at the meeting to start working toward a voluntary agreement.
Correction: A previous version of this story mischaracterized the focus of AdvaMed's March letter, which concentrated solely on ventilators.