FDA revokes umbrella EUA for infusion pumps due to lack of industry use

UPDATE: Sept. 24, 2020: An umbrella emergency use authorization issued in May by FDA for infusion pumps and accessories to treat COVID-19 patients has been revoked due to a lack of use by industry. "Based on information and experience since issuance of the umbrella EUA, FDA has determined that circumstances support revocation of the umbrella EUA," the agency wrote in a Sept. 21 letter to manufacturers, noting that no pumps have been added to the list of authorized devices in the appendix to its original letter of authorization.

Jesse Ambrosina, COO at pump maker Ivenix, said that when the umbrella EUA was issued in May, FDA made it clear that modifications to existing products would still need to go through the traditional 510(k) process when the authorization was lifted. "Infusion pumps are complex medical devices and we suspect most manufacturers decided to follow the traditional design, validation and regulatory processes to ensure that new features are safe and effective," Ambrosina observed.

FDA said that as a result of the revocation it may grant individual EUAs for infusion pumps and accessories going forward to "allow for tailored indications and scopes of authorization" for the devices. While pump maker B. Braun would not speculate on why the agency took this action, a spokesperson said the medtech is the "only company with an individual infusion pump EUA" and it is not affected by the umbrella revocation.

Dive Brief:

FDA said Thursday it issued an emergency use authorization to spur availability of infusion pumps as the lifesaving machines and accessories are in short supply for COVID-19 patients.
The agency in early April issued guidance targeted at increasing access to breathing devices for patients who may require continuous infusion of medications, nutrition, and other fluids. But this week's EUA takes the effort a step farther by allowing the manufacture, distribution, and use of pumps and accessories not otherwise cleared or approved for sale, or that require a modification that would ordinarily prompt a new premarket notification to FDA.
The EUA in part covers infusion pumps with remote monitoring, remote manual control features, administration sets and other accessories with increased length designed to help maintain a "safe physical distance" between healthcare professionals and COVID-19 patients.

Dive Insight:

FDA said it's concerned there are not sufficient quantities of infusion pumps and accessories available to meet America's needs during the public health emergency. The EUA letter says the supply chain for products that meet the agency's regulatory requirements has been "substantially stressed, with shortages already being observed in United States healthcare institutions, with demand exceeding the available supply."

That assessment tracks with a warning last month by the Institute for Safe Medication Practices, an affiliate of the nonprofit ECRI Institute, that some healthcare organizations are "already experiencing unprecedented shortages of smart infusion pumps and dedicated administration sets, while others are still anticipating such shortages."

The EUA, addressed to manufacturers, healthcare providers, hospital purchasing departments, and distributors, makes the case that there are "no adequate, approved, and available alternative" to the emergency use of the authorized pumps and accessories to treat COVID-19 patients.

In comments emailed to MedTech Dive, ECRI CEO Marcus Schabacker, observed that the EUA "allows for temporary strategies by manufacturers to respond to COVID-19 outside the traditional 510(k) process in several ways, like bringing in certain pumps and accessories sold outside the U.S., allowing modifications to existing products, and specifically permitting PPE-conserving remote control features."

While the EUA is meant to mitigate shortages of pumps and accessories, Schabacker recommended that healthcare facilities also "consider the post-EUA viability of products when negotiating a purchase."

Nonetheless, George Gray, chief technology officer for infusion pump maker Ivenix, said the EUA has the potential to bring capabilities to the marketplace not generally available.

"Capabilities such as automating the delivery of infusions, automatically flushing medications through those long extension sets and a large, touchscreen that is easy to clean and can be seen from outside the room will make a big difference in the care of these patients,” Gray wrote to MedTech Dive.

However, Karen Giuliano, associate professor at the University of Massachusetts at Amherst's College of Nursing & Institute for Applied Life Sciences, has concerns about the EUA's manufacturer requirements for providing data on flow rate accuracy under various clinical conditions.

“To optimize the safety of IV medication administration during this emergency use authorization, it is imperative for IV infusion pump manufacturers to base their requested flow rate accuracy specifications on realistic clinical use scenarios," said Giuliano, noting that providing complex care to COVID-19 patients is far from ideal.

Giuliano pointed out that some hospitals are currently placing infusion pumps in hallways, rather than in patient rooms, and using long tubing to help reduce nurses' exposure to the virus and conserve PPE.

"Various methods for increasing the length of IV tubing are now being used so patients can continue to receive important medications," Giuliano said. But increasing the tubing length between the pump and the patient increases resistance, she added, likely causing an unknown and non-detectable decrease in flow rate.

Increasing the length of IV tubing also presents other challenges, including a significant increase in tubing dead space and additional opportunities for air-in-line, Giuliano said. "All of these factors can lead to portions of medication doses being left non-administered, representing various safety concerns for the patient."