With an urgent need for the rapid manufacture of life-saving ventilator systems for hospitals to fight the current pandemic, the Medicines and Healthcare products Regulatory Agency (MHRA), along with their international counterparts, have outlined how they intend to expand the availability of such devices.
In the UK, the MHRA has published a minimum specification for ventilators for use during the COVID-19 pandemic. The US Food and Drug Administration (FDA) have produced an enforcement policy for ventilators and other respiratory devices. The European Commission (EC) have created the first ever “rescEU” stockpile of medical equipment to help EU countries. They have also adopted revised harmonised standards to speed the relevant devices to the market.
“Intensive care medicine is a whole system of care, and ventilators cannot be safely used on any patient without trained staff and other equipment and medicines.”
The minimum specifications from the MHRA are based on the views of anaesthesia and intensive care medicine professionals and medical device regulators. These specifications are intended to help with the supply of devices which are most likely to impose a therapeutic benefit on a patient suffering with acute respiratory disease symptoms caused by SARS-CoV-2 in the shortest possible time.
The ventilators are proposed for short-term stabilisation for a few hours, extending up to one day as a bare minimum. Ideally they should be able to support patient for more than one day.
The specifications detail the following criteria:
- Ventilation capability, with at least one, if not two modes of ventilation.
- Gas and electricity supply connectivity
- Infection control, such as the need for disposable parts and cleanable surfaces which come into contact with patients’ breath.
- Monitoring and alarms for supply failure, exceeding inspiratory pressures and other malfunctions.
- Other miscellaneous criteria such as reliability, size, weight and design.
In addition to this minimum requirements specification, the MHRA has referenced some helpful advisory standards for the manufacture and supply of such ventilators:
- BS EN 794-3:1998 +A2:2009 Particular requirements for emergency and transport ventilators
- ISO 10651-3:1997 Lung Ventilators for Medical Use – Emergency and Transport
- BS ISO 80601-2-84:2018 Medical electrical equipment. Part 2-84. Particular requirements for basic safety and essential performance of emergency and transport ventilators – especially the parts on ‘patient gas pathway’ safety (very similar to IEC 60601)
- ISO 80601-2-12:2020 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- BS ISO 19223:2019 Lung ventilators and related equipment. Vocabulary and semantics
According to the MHRA, it is not anticipated that devices will be CE marked and approval will go through the “Exceptional use of non-CE marked medical devices” route. The MHRA, FDA and EC have all urged that essential safety standards must still be demonstrated to maintain patient safety.
Our regulatory affairs consultancy team, who specialise in medical devices, are ready and willing to help new manufacturers of ventilators to ensure they meet these minimum specifications for rapidly manufactured ventilator systems which could save many lives.
For our assistance or just to have an initial conversation, please contact our medical devices team for expert advice.