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The US Food and Drug Administration says in a new immediately-in-effect guidance that it will temporarily allow limited modifications of medical-use ventilation equipment during the coronavirus public health emergency to bolster supplies of ventilators to treat patients during the coronavirus pandemic.
The FDA also would allow use of anesthesia gas machines, and continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), to treat COVID-19 patients with respiratory insufficiency, it said in its enforcement policy for ventilators, accessories and other respiratory devices for the COVID-19 crisis.
“FDA does not intend to object to limited modifications … to the hardware or software of agency-cleared ventilators or devices used to support patients with respiratory failure.” – James Lee
The March 22 FDA guidance applies to many different types of ventilators, anesthesia gas machines, oxygen conservers and other devices similar to ventilators – as well as conventional ventilators – and was issued “to help expand the availability of ventilators, as a well as other respiratory devices and their accessories during the pandemic,” the agency wrote.
“FDA does not intend to object to limited modifications … to the hardware or software of agency-cleared ventilators or devices used to support patients with respiratory failure,” FDA device center respiratory assistant director James Lee said in the guidance.
The 13 types of ventilators under the policy, all of which are listed as class II, are:
|
Device Type |
Product Code |
|
Ventilator, continuous, facility use |
CBK |
|
Ventilator, continuous, minimal ventilator support, facility use |
MNT |
|
Ventilator, continuous, home use |
NOU |
|
Ventilator, continuous, minimal ventilator support, home use |
NQY |
|
Ventilator, continuous, non-life-supporting |
MNS |
|
Mechanical ventilator |
ONZ |
|
Ventilator, emergency, powered (resuscitator) |
BTL |
|
Gas-machine, anesthesia |
BSZ |
|
Ventilator, non-continuous, (respirator) including masks and interfaces under the same product code |
BZD |
|
Conserver, oxygen |
NFB |
|
Devices, positive pressure breathing, intermittent |
NHJ |
|
Resuscitator, manual, non-self-inflating |
NHK |
|
High flow/high velocity humidified oxygen delivery device |
QAV |
|
Source:Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during the COVID-19 Public Health Emergency, Guidance for Industry and FDA Staff, March 2020 |
|
In the guidance, FDA provided a couple of examples of the flexibility it would apply to its regulations for ventilator manufacturing. One was changes to the ventilator motor, to let an alternate supplier meet design specifications; another was changes to the ventilator tubing, which would allow more flexible material sourcing.
“We believe this approach will help manufacturers that want to add production lines or manufacture at alternate sites with different manufacturing equipment to increase manufacturing capacity,” the agency wrote. The flexibility should also reduce supply chain interruptions and “manufacturing bottlenecks,” according to the FDA.
American auto giant General Motors Co. announced late on 20 March that it has teamed up with Seattle-based Ventec Life Systems to manufacture much-needed medical ventilators as the US braces for a strained health care system from COVID-19.
The agency also pointed out that use of ventilators outside their cleared environment of use – such as employing a home-use ventilator in a health care facility – would also be permitted. Sleep apnea devices, including CPAP and BiPAP, could also be pressed into service to treat patients with respiratory insufficiency, the agency noted, “as long as appropriate design mitigations are in place to limit aerosolizations.”
The FDA provided a list of modifications to agency-cleared hardware and software that it believes “would not create undue risk,” during the coronavirus public health emergency. A few examples of these modifications include:
Modifications to motors, batteries and other electrical components;
Material changes to components in the gas pathway or with other patient tissue contact;
Introduction of filtration to minimize aerosolization; and
Software modifications to modify ventilation parameters including inspiratory pressure, tidal volumes, and flow rates.
The agency said it won’t object to firms making modifications or adding to the hardware/software architectures to allow for increased remote monitoring, such as the addition of wireless or Bluetooth capability.
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