FDA has relaxed the regulation of extracorporeal membrane oxygenation, or ECMO, devices and cardiopulmonary bypass devices to help hospitals cope with the COVID-19-driven surge in patients with health problems stemming from the sudden acute respiratory syndrome.
In guidance posted late Monday, FDA gave the green light to hospitals to use cardiopulmonary bypass devices outside of their authorized indications. The guidance permits some changes to ECMO and cardiopulmonary bypass devices without an otherwise required notification to the agency.
FDA also put out a call to manufacturers of ECMO and cardiopulmonary bypass devices not currently authorized for use in the U.S. The agency is open to granting emergency use authorizations to the manufacturers of such devices.
With the U.S. braced for what may be its worst week of the COVID-19 pandemic, FDA is lifting certain regulatory barriers to use of equipment that could help hospitals manage their spiraling workloads. That effort initially focused on ventilators and other respiratory devices, but has now expanded to cover other equipment that can play a role in the care of respiratory-compromised COVID-19 patients.
If a patient suffers acute respiratory or cardiopulmonary failure, clinicians typically use ECMO devices to provide long-term extracorporeal oxygenation. The devices provide cardiac and respiratory support when the heart and lungs are unable to supply enough oxygen. Cardiopulmonary bypass devices perform a similar role to ECMO devices, yet are only authorized for use for up to six hours. Medtronic and Getinge are among the companies that make the devices.
Amid rising demand for external oxygenation, FDA has created a list of cardiopulmonary bypass devices it says are okay to be used for longer than six hours without creating undue risks. FDA said the devices are “technologically capable of being used for ECMO therapy,” despite not being authorized for use in that context.
For the duration of the COVID-19 public health emergency, hospitals can use cardiopulmonary bypass devices in ECMO circuits beyond six hours. FDA is also permitting changes to the dimensions of ECMO and cardiopulmonary bypass device accessories, provided the modifications do not affect the rate of blood flow.
The regulator is permitting those changes without filing a premarket notification as it thinks the modifications do not create an undue risk. FDA reached a different conclusion about other changes, leading it to prohibit modifications to device coatings and other tweaks that may have a negative effect on gas transfer.
Even with those restrictions, the guidance gives hospitals access to a larger pool of devices for extracorporeal oxygenation. Yet, FDA thinks there may still be concerns that demand will outstrip supply. If that happens, FDA hopes hospitals will be able to fall back on devices granted EUA.
To make that happen, FDA has established and communicated its intended approach to EUAs for ECMO and cardiopulmonary bypass devices. FDA wants manufacturers of devices that are not legally marketed in the U.S. to email it information about their products, such as performance data and their authorization status in other countries.
The guidance on extracorporeal oxygenation devices, implemented without a prior public comment period, was the fourth set of COVID-19 medtech guidelines issued by FDA in a three-day window. The other guidance documents shared by FDA in recent days covered ophthalmic assessment devices, infusion pumps and electronic thermometers.