Guidance

Rapidly manufactured
ventilator system
specification
Published 20 March 2020

United Kingdom Department of Health & Social Care

Contents
1. Ventilation
2. Gas and electricity
3. Infection control
4. Monitoring and alarms
5. Miscellaneous
6. Unknown issues
This is a specification of the minimally (and some preferred options)
clinically acceptable ventilator to be used in UK hospitals during the
current SARS-CoV2 outbreak. It sets out the clinical requirements
based on the consensus of what is ‘minimally acceptable’
performance in the opinion of the anaesthesia and intensive care
medicine professionals and medical device regulators.

It is for devices, which are most likely to confer therapeutic benefit

on a patient suffering with ARDS caused by COVID-19, used in the
initial care of patients requiring urgent ventilation. A ventilator with
lower specifications than this is likely to provide no clinical benefit
and might lead to increased harm, which would be unacceptable for
clinicians and would, therefore, not gain regulatory approval.

It must be borne in mind that 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. Where
these impinge on the specification they are mentioned below.
 It is proposed these ventilators 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. Ideally it would
also be able to function as a broader function ventilator which could
support a patient through a number of days, when more advanced
ventilatory support becomes necessary.

Ventilation
At least 1, optionally 2 modes of ventilation:

 must have mandatory ventilation (for the deeply sedated and

paralysed). The user can set a tidal volume and the output is a
pressure regulated flow to achieve this volume, for example,
pressure regulated volume control (PRVC), SIMV-PC
 optional pressure support mode for those patients breathing to
some extent themselves, for example, BIPAP. The user sets an
inspiratory pressure and an expiratory pressure. The ventilator can
sense when a patient starts to breathe in and apply the inspiratory
pressure, then sense when the patient starts to breathe out and
apply the expiratory pressure (this pressure is still positive but lower
than the inspiratory pressure)

If the patient stops breathing in pressure support mode, it must

failsafe automatically onto mandatory ventilation.

Inspiratory airway pressure, the higher pressure setting that is

applied to make the patient breathe in:

 plateau pressure should adapt to achieve volume and be limited to

35 cmH2O
 peak pressure should be no more than 2 cmH2O greater than
plateau pressure
 ideally there should be a mechanical failsafe valve that opens at 40
cmH2O
 Positive End Expiratory Pressure PEEP (usually called EPAP during
pressure support mode). The lower pressure applied to the patients
airway to allow them to breathe out, but not too much:

 range 5 to 25 cm H2O adjustable in 5 cmH2O increment

 patient breathing system must remain pressurised to at least the
PEEP level setting at all times

Inspiratory:Expiratory ratio (I:E) (note, confusingly, it is actually E/I

time). The proportion of each breathing cycle that is spent breathing
in compared to breathing out:

 2.0 (i.e. expiration lasts twice as long as inspiration)

 optionally adjustable in the range 1.0 to 3.0

Respiratory Rate. The number of breathing cycles every minute:

 range 10 to 30 breaths per minute in increments of 2 (only in

mandatory mode) can be set by the user

Tidal Volume (Vt). The volume of gas flowing into the lungs during
one inspiratory cycle:

 must have at least one setting of 400ml +/- 10 ml

 ideally 350ml and 450 ml options
 optionally Range 250 to 600 ml in steps of 50ml
 even more optionally up to 800 ml
 optionally the ability to input body weight and have volume
calculated as, for example, 6ml/kg of ideal body weight

Gas and electricity

Incoming gas supply:
 all gas connectors and hoses must use standard non-
interchangeable connectors and be colour coded according to
current standards
 must connect to wall pipeline oxygen supply via Schrader valve
connector (BS 5682, not the bicycle wheel version). If hose not
permanently fixed to machine, then must connect with NIST (Non-
Interchangeable Screw Thread – ISO 10802). Oxygen pipeline
pressure is 4 to 5 Bar
 optionally can incorporate a backup oxygen cylinder connected via
either Schrader valve or Pin Index System
 must be able to be operated on any attached cylinders. Oxygen
cylinder pressure is either 1 to 137 bar if no regulator is fitted, or 4
bar if the cylinder incorporates a pressure regulator. The ventilator
must be able to work with either. The ventilator must include a
pressure regulator to decrease 137 bar cylinder pressure to 4 bar
working pressure. Working pressure inside the ventilator may be up
to 4 bar, but it must be impossible to expose the patient to any
pressure above 40 cmH2O
 optionally can connect to wall pipeline medical air via Schrader
valve (NB ‘medical air’ is 4 bar. Must not connect to ‘surgical air 7
bar’ supply)
 optionally can connect to Anaesthetic Gas Scavenging System
 optionally can operate using an oxygen concentrator device for
input oxygen

Electricity supply:

 should connect to 240V mains

 battery backup – see below. Must have 20 minutes backup battery
in case of mains electricity failure
 optionally hot swappable batteries so that it can be run on battery
supply for an extended period, for example, 2 hours for within
hospital transfer
 must avoid harmful RF or EM emissions that could interfere with
other critical machinery

Gas supply to patient:

 user must be able to control inspired oxygen proportion (FiO2). The
percentage of oxygen in the gas being breathed in by the patient.
Room air is 21% oxygen
 at least 50% and 100% options
 very preferably ideally variable between 30 and 100% in 10% steps
 patient breathing system connections: the ventilator must present
22mm outside diameter (OD) ‘male’ standard connectors for
connection to user supplied 22mm ‘female’ connectors on the
breathing system

All elements in the gas pathway must meet biological safety and
oxygen safety standards, especially to minimise risk of fire or
contamination of the patient’s airway.

Infection control
All parts coming into contact with the patient’s breath must be either
disposable or decontaminatable between patients.

All external surfaces must be cleanable in the likely event that they
get respiratory secretions or blood splatter on them. Cleaning would
be by healthcare workers manually wiping using an approved
surface wipe with disinfectant or cloths and approved surface
cleaning liquid.

There will be a separately sourced HMEF-bacterial-viral filter

between the machine and patient which may impact on resistance
within the system, which may need to be accounted for with some
designs. The pressure being delivered to the patient is the specified
pressure. If the filter has a resistance of, say 2 cmH2O, the ventilator
needs to output 37 cmH2O to achieve a set 35 cmH2O at the
patient. This will need further detailed consideration. Usually HMEF
filters have negligible resistance, but the viral filtering filters may
have much higher resistance that may be clinically relevant.
 Optionally include facility for ultrasonic humidifier-warmer to be
included.

Monitoring and alarms

Must alarm at:

 gas or electricity supply failure

 machine switched off while in mandatory ventilation mode
 inspiratory airway pressure exceeded
 inspiratory and PEEP pressure not achieved (equivalent to
disconnection alarm)
 tidal volume not achieved or exceeded

Monitoring
The following should be continuously displayed so the user can
verify:

 current settings of tidal volume, frequency, PEEP, FiO2, ventilation

mode
 actual achieved rates of tidal volume, breathing rate, PEEP, plateau
pressure, FiO2
 if it exists, in pressure support mode there must be real-time
confirmation of each patient breath and an alarm if below
acceptable range
 optionally CO2 monitoring included
 Miscellaneous
Must be reliable. It must have 100% duty cycle for up to 14 days.

Optionally it can be used beyond 14 days, the expected durability

must be specified.

Can be floor standing.

Ideally small and light enough to mount on patient bed and

orientation-independent functioning.

Should be as robust as possible. For example, it may be dropped

from bed height to floor.

It must be intuitive to use for qualified medical personnel, but these

may not be specialists in ventilator use:

 must not require more than 30 minutes training for a doctor with
some experience of ventilator use
 must include instructions for use
 ideally instructions for use should be built into the labelling of the
ventilator, for example, with ‘connect this to wall’ etc
 must include clear labelling of all critical functions and controls using
standard terms, pictograms and colours that will be readily
recognised by UK healthcare staff

Must 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.

Must not be excessively cumbersome so that it would impede

hospital operations or prevent easy movement within hospital
premises.

Must be made from materials and parts readily available in the UK

supply chain (anticipating increasing global restrictions on freight
movement).
 Standards
There are many standards that exist in this area. Below is a list of
the most relevant ones. They are not formal regulatory requirements
but many are harmonised against regulatory requirements. Consider
them as helpful advisory standards for now. MHRA will lead an
exercise to define which can be ‘safely’ relaxed for this emergency
situation:

 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 to
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)
 BS ISO 19223:2019: Lung ventilators and related equipment.
Vocabulary and semantics

Unknown issues
How plentiful is 4-bar oxygen supply?

 absolute minimum oxygen requirement is the human consumption

of about 250 ml/min. However, achieving this is only possible if
certain breathing system designs are used and ‘driving’ gas is done
by air. Specifically, would have to use circle breathing system with
active CO2 absorption
 if consumption in the range 1 to 2 l/min is acceptable, then a wider
range of designs is possible, but some very basic designs are not
 if consumption in the range 10l/min is acceptable, then any possible
design can be considered
 What is the resistance of HMEF-bacterial-viral filters that are to be
used with the ventilator? Is it clinically relevant?

Is there any need to consider running from only low pressure

oxygen, for example, from a concentrator? This makes design more
complex.

How plentiful is the supply of syringe drivers and drugs for sedation?

 if limited, then a vaporiser could be used to vaporise Isoflurane for

sedation
 this would need certain breathing system designs, mandatory AGSS
and a supply of vaporisers

If monitoring can be done by another machine, it could be left out of

the ventilator, but essential parameters must be available to the
clinician.

Battery backup
Every current ventilator used inside hospitals has a battery backup,
so users will expect it to be there and will behave as if it is, for
example, unplug it from the wall in order to rearrange cables or while
manoeuvring the patient. However, this needs very careful thought
to balance the risks. Including this in the spec means instantly trying
to source 30,000 large, heavy batteries. Specifying a DC voltage (ie
12VDC) may well be the most sensible for the machine working
voltage. Need the advice of an electronic engineer with
military/resource limited experience before specifying anything here.
It needs to be got right first time.