Mock up image of the report investigating the design and safe use of portable oxygen systems

Design and safe use of portable oxygen systems

Summary

The national investigation

NHS Improvement issued a patient safety alert on medical devices in January 2018. It highlighted 400 incidents - including six deaths - over three years that involved the incorrect operation of oxygen cylinder controls. This investigation reinforces that alert and makes further safety recommendations.


Investigation summary

The reference event in this investigation is an 83-year-old man who failed to receive oxygen from a portable system whilst having cardiopulmonary resuscitation (CPR) for approximately 10 minutes. The lack of oxygen is thought unlikely to have affected the outcome for this man, but it was recognised that oxygen is widely used throughout the NHS and we found clear evidence of an ongoing risk to patient safety. 

This investigation focuses on:

  • Reviewing how the design of portable oxygen systems is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Reviewing the design of portable oxygen systems used in other industries to determine if there are appropriate lessons for healthcare.

The investigation also looks at the design and regulation of medical devices in general, in particular looking at how people interact with systems and devices (referred to in the report as human factors) in both the pre and post-market regulatory stages.