Ventilator manufacturers - urgent call
The UK Government are currently seeking assistance with the mechanical ventilation equipment which is so vital for our NHS.
Published on 18 March 2020
We are urging all Companies who may be able to assist with the urgent supply of components and manufacture of the Rapidly Manufactured Ventilation System (RMVS) project to make contact.
The indicative specification for the project follows alongside manufacturers and engineers, of particular interest are companies with medical accreditation, plus the nuclear, oil and gas sectors.
As the situation is ever evolving, the key operating parameters for manufacture are subject to change, although they are not expected to significantly alter from the guidelines.
If you believe that your organisation may be able to assist, or would like to discuss any specific questions, then please contact:
The Department for Business, Energy and Industrial Strategy
tel: 0300 456 3565 or email email@example.com
Indicative Specification for a Rapidly Manufactured Ventilation System (RMVS)
The following information outlines the key requirements for a Rapidly Manufactured Ventilation System (RMVS). It is intended to enable manufacturers to start the process of considering how they may be able to meet these requirements.
Working with manufacturers and clinicians we would expect to iterate this specification before finalisation. Whilst the key operating parameters are subject to change, they are not expected to differ significantly from those set out here.
We do not attempt to provide a comprehensive list of requirements as manufacturers are already familiar with UK operating environment (for example, power), acceptable materials and standard device safety considerations.
The information assumes that the reader is already familiar with the concepts and basic mechanics of Mechanical Ventilation devices.
A description of a simple ventilator.
A proposed system for a rapidly deployable ventilator.
Core technical parameters
The RMVS must:
- be reliable - it must work continuously without failure (100% duty cycle) for blocks of 14days - 24 hours a day. If necessary, the machine may be replaced after each block of 14 days x 24 hours a day use
- provide at least two settings for volume of air/air O2 mix delivered per cycle/breath. These settings to be 450ml +/- 10ml per breath and 350ml +/- 10ml per breath
- provide this air/air O2 mix at a peak pressure of 350 mm H2O
- have the capability for patient supply pipework to remain pressurised at all times to 150mm H20
- have an adjustable rate of between 12 and 20 cycles/breaths per minute
- deliver at least 400ml of air/air 02 mix in no more than 1.5 seconds. The ability to change the rate at which air is pushed into the patient is desirable but not essential
- be built from O2 safe components to avoid the risk of fire and demonstrate avoidance of hot spots
- be capable of breathing for an unconscious patient who is unable to breathe for his or herself. Ability to sense when a patient is breathing, and support that breathing is desirable but not essential
- be able to supply pure air and air O2 mix at a range of concentrations including at least 50% and 100% Oxygen. Oxygen shortages are not expected, but the ability to attach a Commercial Off The Shelf (COTS) portable O2 concentrator machine may be a useful feature
- support connections for hospital Oxygen supplies - whether driven by piped or cylinder infrastructure
- be compatible with standard COTS catheter mount fittings (15mm Male 22mm Female)
- fail safe, ideally generating a clear alarm on failure. Failure modes to be alarmed include (but are not limited to) pressure loss and O2 loss
The RMVS must:
- be intuitive to use for qualified medical personnel familiar with ventilator use. Must not require extensive training to use effectively. Relevant usage instructions must be attached / intrinsic to the device.
- be capable of being easily cleaned / decontaminated using readily available materials
- have successfully been subjected to a testing and assurance process that is appropriate for the exceptional circumstances
- have transparent design, supply chain, manufacture and testing processes that are of sufficient quality to enable MHRA officials to deem appropriate for usage in exceptional circumstances
- not be excessively cumbersome so that it would impede hospital operations or prevent easy movement within hospital premises
- be made from materials and parts readily available in the UK supply chain (anticipating increasing global restrictions on freight movement)