The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a specification for a “Rapidly Manufactured Ventilator System” (“RMVS”), setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the “RMVS Specification”). The purpose of the RMVS Specification is to meet the UK healthcare system’s increased demand for ventilators to support patients suffering with Acute Respiratory Distress Syndrome (“ARDS”) caused by COVID-19.
Summary of the RMVS Specification
MHRA accepts that full compliance with current standards for ventilators (namely ISO 80601-2-12:2020) is unrealistic in the emergency timeframe. MHRA has weighed patients’ need for immediate access to ventilators against the necessity for compliance with all applicable standards. The Agency accepts that RMVS will not be CE marked and instead will be subject to approval by the MHRA through the “Exceptional use of non-CE marked medical devices” route. The “exceptional use” route is primarily aimed at “the treatment of a single named patient”. This route also allows the MHRA to grant approval to manufacturers to supply non-CE marked devices without prior identification of a named patient or to hold as emergency stock for use at short notice. The UK’s Medical Devices Regulations 2002 also allow the Secretary of State – presumably acting through the MHRA – to authorise, where appropriate for a specified period, “the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with)….”
Whatever the legal basis, manufacturers of RMVS must demonstrate compliance with essential standards for patient safety. Once the current COVID-19 emergency has passed, RMVS will no longer be useable in hospitals, unless they have been CE marked in accordance with the EU medical devices regulations.
The RMVS Specification sets out both mandatory and optional requirements. These include, amongst others:
- It is proposed that RMVS would be for short-term stabilisation for a few hours, but this may be extended up to 1-day use for a patient in extremis as the bare minimum function.
- The ventilator must have at least one mode of ventilation, but optionally 2 modes of ventilation, which can support patients in critical condition.
- The user must be able to control the percentage of oxygen in the gas being breathed in by the patient.
- The ventilator must have infection control. This means that the ventilator must be cleanable by healthcare workers and all parts coming into contact with patients’ breath must be capable of decontamination or disposable.
- The ventilator must alarm, for example, in response to gas or electricity supply failure, or if the ventilator is switched off while in mandatory ventilation mode.
- Displays on the ventilator should allow healthcare workers to monitor certain activity.
- The ventilator must be useable by qualified healthcare professionals, for example, doctors with some experience of ventilator use should not need more than 30 minutes training.
- Manufacturers must test the ventilator at prototype and final production stage. This should be done as a short Formative Usability Test to ISO 62366 in a realistic environment, where possible.
- Manufacturers must produce the ventilators from materials and parts readily available in the UK supply chain. This requirement anticipates an increase in international restrictions on freight movement.
The RMVS Specification will be a welcome measure to manufacturers wanting to help produce ventilators for the outbreak. Manufacturers should, however, note that some points of clarification are still outstanding:
- The MHRA recognises that flexibility is needed and will lead an exercise to define which standards can be ‘safely’ relaxed for this emergency situation. However, the outcome of this exercise has yet to be determined.
- The RMVS Specification highlights several “unknown issues” caused by reduced requirements. One example is whether the RMVS must have a backup battery. MHRA flags that all current ventilators have backup batteries in case of mains electricity failure or to allow healthcare workers to unplug it from the wall to, for example, manoeuver the patient. MHRA still has to consider the balance between the risk to the patient and the potential burden to manufacturers to source huge numbers of large, heavy batteries in a short space of time. The latter may defeat the RMVS Specification’s purpose to support the UK’s healthcare system with as many ventilators as possible.
MHRA has not provided a timeline for when it will provide further guidance on these points. It is, however, continuing to seek advice from experts such as anaesthesia and intensive care medicine professionals, medical device regulators and electronic engineers to finalise the RMVS requirements.