FDA, MHRA Continues to Facilitate Access to Ventilators Supply

As hospitals are in need of mechanical ventilation for an influx of patients due to coronavirus disease 2019 (COVID-19), regulatory bodies including the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are committed to enhance the supply of ventilators.

FDA Guidance:

Food and Drug Administration (FDA) issued this guidance to provide a strategy to help increase the availability of ventilators or other respiratory devices, during this pandemic to support patients with respiratory failure or difficulty breathing.

This guidance allows more flexibility to manufacturers that can make modifications to device including alternate parts or materials, design changes to increase manufacturing capacity and supply and to reduce supply change interruptions and manufacturing bottlenecks.

FDA says it does not intend to object to limited changes to the FDA-cleared devices without prior submission to premarket notification under section 510(k), where modification does not create an undue risk considering public health emergency.

The FDA’s approach applies to health care facilities that use ventilator support devices beyond their indicated shelf life and duration of use, which should increase ventilator capacity.

FDA will work interactively with manufacturers of ventilator support devices that have not yet been cleared by the agency through its Emergency Use Authorization (EUA) process.

FDA interested to encourage other manufacturers not previously engaged in medical device manufacturing with interest and capability to ventilators or respiratory support devices.

The FDA also provides recommendations for other alternatives that should be considered such as devices for treating sleep apnea, continuous positive airway pressure (CPAP), devices.

Along with this guidance, FDA sent a letter to healthcare providers advising them of the new strategy surrounding ventilators and recommending steps for treating patients with modified or alternate devices.

MHRA Specifications:

Medicines and Healthcare products Regulatory Agency (MHRA) provided a set of specifications to meet minimally acceptable performance criteria for the devices to increase the availability of rapidly manufactured ventilators during this pandemic.

These specifications include recommendations for:

• Ventilation functionality
• Gas and electricity supply
• Infection control
• 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 1 day.

The agency says it plans to authorize the ventilator support 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.