COVID-19: Usage of Penlon Anaesthesia Devices for Long-term Ventilation

Dear Users of Penlon Anaesthesia machines,

The pandemic has created unprecedented demand for patient ventilation systems that may exceed the number of available ICU ventilators.
Recently many customers and health care professionals around the globe have enquired about using anaesthesia machines and ventilators as a substitute for ICU ventilators when the ICU equipment is not readily available in our hospitals whilst treating patients with COVID 19.
In response to this request, we need to address the applicable medical device regulations and assess that the benefits to user and patients outweigh the risks.

Legal and Regulatory Perspective

The following guidance is limited to the requirements under European Union (EU) medical device legislation, which has been transposed into UK law under Statutory Instrument.
The intended use for all Penlon devices are described within the relevant user manual. Any use of a device outside of the intended use specified within the user instructions constitutes 'off-label use' e.g. anaesthesia ventilator substituted for ICU ventilator. Penlon cannot protect against unqualified non-authorised users, therefore It cannot be stressed strongly enough that the clinical professionals using the Penlon equipment must be trained and familiar with the unique Penlon device interface, alarm system and performance features of our devices.

If a device is used 'off-label' the clinical user then recognises that it is not the intended use of the device and does so at their own liability and risk. A risk /benefit assessment needs to be undertaken by the user and a decision taken as to whether that use is beneficial to a positive patient outcome on a case by case basis. Please consult legal counsel for detailed guidance.
Penlon cannot protect against unqualified non-authorised users.

If Penlon are made aware of such 'off-label' use, it is the responsibility of the Manufacturer to re-evaluate the device risk assessment and update user instructions if necessary under intended use and/or contraindications, warnings and cautions.

In particular, the use of Anaesthesia Machine Ventilators as substitutes for ICU ventilators: User and Medical Professionals using medical devices must be trained and familiar with the unique performance characteristics of those devices. This is the same for changing between different models of ICU ventilator and definitely applies to the use of an Anaesthesia machine ventilator. The different features between the two types of device must be understood and taken into account during ventilation therapy. This may include the availability of humidification and the features such as CPAP.

In addition to being fully conversant and trained on the device User Instructions, Penlon recommends the use of appropriate single-use breathing circuits and filters for the protection from biocontamination and the rigorous application of sterilisation procedures to protect both the patient and user.