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Review uncovers need for safer oxygen device regulation

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Design flaws with NHS portable oxygen systems have contributed to clinicians misinterpreting that oxygen was flowing to a patient during treatment, when it was in fact not, according to a review.

An investigation by the Healthcare Safety Investigation Branch into portable oxygen systems used within the NHS found clear evidence of an ongoing high risk to patient safety.

“There should be no margin for error around the use of medical equipment”

Keith Conradi

Its report, published today, revealed evidence that some medical devices were associated with a high safety risk, including with possibility of death.

The HSIB put forward key recommendations to improve patient outcomes, which focused on how medical devices were designed and how clinicians worked with them when treating patients.

The branch launched the investigation following the death of an 83-year-old man who failed to receive oxygen while having cardiopulmonary resuscitation (CPR).

It was found that 10 minutes of CPR had been given before it was recognised that the reservoir bag was not inflating between breaths and so he was not receiving oxygen, noted the HSIB report.

The report outlined that during CPR, the resuscitation team concluded that the oxygen cylinder was empty and so it was replaced. However, despite further CPR, the patient remained unresponsive and so CPR was stopped, and subsequently, the patient died.

“Our report has found that regulation and system design have more to do here”

Keith Conradi

Though the lack of oxygen was thought unlikely to have affected the outcome, the issues raised ultimately led the HSIB to decide to progress to a national investigation.

It found several design issues and flaws with current systems and products were a “contributing factor for clinicians who had misinterpreted oxygen was flowing to a patient, when it was not”.

The investigation also looked at the broader themes of design and regulation for medical devices in general and how clinicians interacted with them in both the pre- and post-market regulatory stages.

In January, NHS Improvement issued a patient safety alert on 400 incidents – including six deaths – over three years, where the incorrect operation of oxygen cylinder controls was involved. The HSIB have said its report reinforced the regulator’s alert from earlier in the year.

In addition, it has made four recommendations to the Medicines and Healthcare products Regulatory Agency to ensure the design of portable oxygen equipment was appropriate.

For example, it recommended a review and updated guidance for medical device manufacturers on how to correctly include the way “people interacted with devices as part of the design process”.

It also said all oxygen manufacturers should be required to submit evidence of “how they had considered how people use and interact with a device during pre-market assessment”.

Once in use, manufacturers should ensure the design of a device was “considered as a possible contributory factor where an ‘adverse event’ has happened, and include this in the investigation”.

In addition, the HSIB discouraged the use of weak design barriers – such as putting a label on the product – as a long-term solution to improve safety.

Keith Conradi, chief investigator at the HSIB, said: “Patient safety is of the highest priority to the NHS and there should be no margin for error around the use of medical equipment and devices that are designed to save lives and support clinicians to deliver medical care.”

He noted that the report’s recommendations and observations aimed to tackle the “real patient safety risks associated with design and making life easier for staff working in busy environments”.

“Our report has found that regulation and system design have more to do here,” said Mr Conradi.

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