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MHRA Grants off-label use for Anaesthesia machines with built in ventilation as stand alone ventilators

Posted on 9th April 2020

Anaesthesia machines with ventilators – MDA granting off-label use for sole use of ventilator granted 8/4/20

On Thursday the 8th of April, a Medical Device Alert (MDA) was issued that allowed the ventilation only use of anaesthesia machines that had ventilator functionality for the duration of COVID-19 outbreak.

Using any equipment outside of it’s intended use is considered ‘off-label, however during the COVID-19 outbreak, all anaesthesia machines with ventilators used in the treatment of critical illness, outside its intended use is considered off-label, but may be essential due to ventilator availability.

The use of an anaesthesia machine as a (long-term) ventilator in a health care setting when it has only received regulatory clearance as an anaesthetic machine is considered as off-label use.

It is the responsibility of the clinicians/end user to make the decision to use a device off label, but the MHRA recognises it is essential in these times.

Subject to following the guidelines below, off label use of these anaesthetic machines will increase the number of ventilators available to our NHS in the fight against COVID-19:-

  • Carry out an appropriate risk assessment and document the reason for off-label use.
  • Healthcare professionals using these machines off-label must be trained and familiar with the unique performance characteristics of the device, including the device interface and alarm systems.
  • Follow the instructions for use (IFU), and the additional off-label use information from the manufacturer. This may include more regular maintenance, testing or calibration.
  • Monitor carbon dioxide levels in the breathing system. If levels are rising, replace the soda lime according to the manufacturer’s instructions. This is because most anaesthesia machines have a carbon dioxide absorber which needs to be regularly replaced or replenished whereas ICU ventilators do not.
  • Regularly check for condensate build-up, which may affect functionality. This is because most ICU ventilators include advanced condensate management, anaesthesia machines do not.
  • When suctioning, monitor for drops in pressure, which can exacerbate atelectasis. This is because ICU ventilators have autocompensation when inline suction is used, anaesthesia machines do not.
  • Ensure appropriate infection control is undertaken using local and national guidelines.
  • Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: EnglandScotlandNorthern IrelandWales. You should also report directly to manufacturers if your local or national systems do not.

Some manufacturers have now issued statements on this issue:

Check relevant manufacturers’ websites for their statements.

This alert is intended to remain in effect only for the duration of the COVID-19 pandemic.

Full MDA can be read here Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)

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