In rapid response to the current COVID-19 pandemic, the government has published specifications on the minimum clinical acceptance of ventilator standards to be used in hospitals throughout the UK.
These clinical requirements outline the acceptable performance standards of devices used for therapeutic purposes, in those circumstances where urgent ventilation is needed. The guidelines have been regulated by the UK government alongside medical device regulators and medical professionals.
The government specifications are a necessity because any ventilator below minimum specifications is thought to cause more harm than good, which is deemed clinically unacceptable. Manufacturers across the UK rising to the challenge need to strike the balance between speedy production and the stringent standards that need to be met to ensure the products are ready to enter the healthcare system.
The purpose of the ventilators is for short-term stabilisation and in more severe cases, a full day’s operation is vital. Ideally, ventilators will be able to operate for number of days, when cases are extreme.
An exhaustive list of specifications is available within the recent government publication. To summarise, ventilators will have to provide two modes of ventilation, with an incoming gas and electricity supply which meet biological safety and low pressure oxygen safety standards. Infection control is crucial: breathing apparatus on the machine must be disposable, avoiding contamination between patients. All parts of the machine must be manufactured to withstand disinfection practices from healthcare professionals, should the outer casing come into contact with bodily fluids.
In terms of reliability, ventilators must be able to last 14 days and be robust as possible (theoretically speaking, if it were dropped accidentally, could it still function). Design, quality and testing processes must be completely transparent and of sufficient standards for the Medicines & Healthcare Products Regulatory Agency to deem the product appropriate for use in exceptional circumstances. This latest publication suggests that any ventilation systems which meet these minimum acceptance standards could be in high demand in the coming weeks, conceivably months.
Are you a UK Manufacturer with the resource and capability to either source parts or produce ventilators?
If so, complete the gov.uk form here for ‘Readiness to supply ventilators and ventilator components’.
Futures Manufacturing is able to support manufacturing companies approaching this challenge who may require skilled candidates across the industry. Please feel free to get in touch with any requirements you may have.