FDA, MHRA Seek to Boost Ventilator Supply

Regulatory NewsRegulatory News | 23 March 2020 |  By 

Credit: NIAID-Rocky Mountain Laboratories

As hospitals face an influx of patients needing mechanical ventilation due to coronavirus disease (COVID-19), regulators including the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are loosening their requirements for ventilators to boost supply of the devices.
While medical device makers including Medtronic and GE have said they working to increase production, global demand for the devices is expected to outstrip supply.
FDA Guidance
On Sunday, FDA issued an immediately effective guidance setting out its enforcement policy to increase the availability of ventilators and other respiratory devices by allowing device makers to make modifications to already cleared products without submitting a premarket notification (510(k)) during the public health emergency.
FDA says the move will give companies flexibility to make changes such as sourcing components or materials from alternate suppliers. The move comes as automakers around the world, including Ferrari, Fiat Chrysler, Ford, General Motors, McLaren, Nissan and Tesla, say they are looking into manufacturing ventilators to boost production.
While President Donald Trump on Sunday tweeted that “Ford, General Motors and Tesla are being given the go ahead to make ventilators and other metal products, FAST,” it is unclear how rapidly automakers could begin making ventilators or their components. General Motors on Friday said it is working with Ventec Life Systems to try to increase their ventilator production, while Medtronic and Tesla discussed ventilator engineering over the weekend.
In anticipation for the soaring demand for the devices, FDA says it will allow certain modifications to the devices and their use, including alternate parts or materials, design changes to reduce aerosolization and software changes.
In addition to modifications to the devices themselves, FDA says it does not plan to object to changes to the indications of ventilators or other respiratory devices without a 510(k) submission “where the modifications will not create an undue risk in light of the public health emergency.” FDA provides four examples of modified indications it believes would not pose an undue risk, including the use of ventilators “outside their cleared environment of use” or the use of sleep apnea devices to treat respiratory insufficiency.
FDA provides a list of devices that may be used beyond their indicated shelf life and duration of use without a 510(k) submission.
The guidance also provides a list of FDA-recognized consensus standards manufacturers should consult when designing, evaluating and validating changes made to the devices and provides labeling recommendations to help users understand any modifications.
While FDA emphasizes its preference for using “conventional/standard full-featured ventilators” when possible, the agency says it will also consider granting emergency use authorizations for ventilators that have not yet been cleared by the agency.
“FDA is interested in interacting with manufacturers of ventilatory support devices that are not currently legally marketed in the US as well as manufacturers who have not previously been engaged in medical device manufacturing with capabilities to increase supply of these devices,” FDA writes.
Alongside the guidance, FDA sent a letter to healthcare providers advising them of the new policy surrounding ventilators and recommending steps for treating patients with modified or alternate devices.
MHRA Specifications
On Friday, MHRA took its own steps to increase the availability of “rapidly manufactured” ventilators by providing a set of specifications to meet “minimally acceptable” performance criteria for the devices during the outbreak.
The specifications include recommendations for ventilation functionality; gas and electricity supply; infection control; and monitoring and alarm features.
MHRA says the specifications are meant for devices “used in the initial care of patients requiring urgent ventilation” and used for short durations ranging from a few hours to one day.
The agency says it plans to authorize the devices through its exceptional use of non-CE marked medical devices route and that the devices will not be considered useable outside the current emergency unless they are CE marked.
FDA, Statement, MHRA


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