A new report published today has highlighted the high patient risk – with even possible risk of death - associated with some medical devices used within the NHS for patient care and treatment.
The report from the Healthcare Safety Investigation Branch (HSIB) puts
forward a number of key recommendations to improve patient outcomes, focusing
on how medical devices are designed, and better understanding of how clinicians
interact with them when treating patients.
The report arises from an investigation that was launched following the
death of an 83-year-old man who failed to receive oxygen from a portable
system, whilst having CPR for approximately 10 minutes. The lack of oxygen is
thought unlikely to have affected the outcome for this man, but the report
recognises that oxygen is widely used throughout the NHS and found clear
evidence of an ongoing risk to patient safety.
The focus of the investigation was on portable oxygen systems and found
that there were several design issues and flaws within current systems and
products used within the NHS. The report found these issues were a contributing
factor for clinicians who had misinterpreted that oxygen was flowing to a
patient during treatment, when it was in fact not doing so.
The investigation went further than this, looking at the broader themes
of design and regulation for 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.
Back in January, NHS Improvement issued a patient safety alert on
medical devices where they mentioned 400 incidents - including six deaths -
over three years that involved the incorrect operation of oxygen cylinder
controls. This report reinforces that alert and a number of further
recommendations have been issued by the HSIB.
Four recommendations are being made to the Medicines and Healthcare
products Regulatory Agency (MHRA) by HSIB:
- Review and update guidance for medical device manufacturers and Notified Bodies on how to correctly include how people interact with devices as part of their design process
- Require all oxygen manufacturers to submit evidence of how they have considered how people use and interact with a device during pre-market assessment
- Once in use, ensure the design of a device is considered as a possible contributory factor where an ‘adverse event’ has happened, and include this in the investigation
- Discourage the use of weak design barriers (e.g. putting a label on the product) as a long-term solution to improve safety.
Keith Conradi, Chief Investigator at 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. Our
report has found that regulation and system design have more to do here.
“During our investigation we looked at other areas of industry to see what could be learned by the
healthcare sector, and how serious incidents could be prevented by changing
something at the early testing and approval stage for devices. Our
recommendations and observations to the MHRA reflect this, with the overall aim
of tackling the real patient safety risks associated with design and making
life easier for staff working in busy environments.”
HSIB worked with a range of health professionals, industry bodies and
reviewed academic literature. Since the investigation started, the team have
had interest in this report from colleagues across the world including the
Netherlands and Australia.
The report is now available on the HSIB website and responses to the recommendations will be published.
bodies are ‘organisations
designated by an EU Designating Authority to assess the conformity of products
before they are placed on the market. The MHRA is responsible for appointing
Notified Bodies in the UK.’ (Page 28, section 5.3.16)
to the International Ergonomics Association, Human Factors (also known as
ergonomics) is: “… the scientific discipline concerned with the
understanding of interactions among humans and other elements of the
system, and the profession that applies theory, principles, data and methods to
design in order to optimise human well-being and overall system performance.” (International
Ergonomics Association, n.d.)
Recommendations, safety observations and safety
- It is recommended that the Medicines and Healthcare products Regulatory Agency evaluate how its Human Factors guidance document is used in practice by manufacturers and by Notified Bodies. Based on the review, the MHRA should make any changes necessary to the document or use other mechanisms to improve the implementation of Human Factors in the pre-market approval process.
- It is recommended that the Medicines and Healthcare products Regulatory Agency require oxygen manufacturers to submit evidence of Human Factors summative testing of the complete product as part of the market authorisation process for medicinal licence.
- It is recommended that the Medicines and Healthcare products Regulatory Agency review its documentation to determine whether more specific guidance is required on how to incorporate Human Factors into post-market adverse event investigations.
- It is recommended that, when reviewing manufacturers’ Field Safety Notifications, the Medicines and Healthcare products Regulatory Agency discourages the use of weak barriers as defined in ISO 14971 (Risk Management for Medical Devices) particularly as long-term solutions.
- Staff working within Notified Bodies should have relevant competencies to review Human Factors Engineering reports submitted during the premarket approval process.
- It would be beneficial if the Medicines and Healthcare products Regulatory Agency initiates market surveillance activities based on a variety of intelligence, and not necessarily require a serious incident.
- It would be beneficial if the Medicines and Healthcare products Regulatory Agency reviews its processes regarding post-market surveillance of drug-combination products to ensure device design is considered.
- Flow indicators have the potential to improve patient safety and provide a clear visual cue that oxygen is flowing to a patient. It may be beneficial if further research, testing and evaluation is conducted to consider these products for use in a healthcare setting.
- Human Factors testing and evaluation criteria should be included as part of the selection methodology used in NHS procurement processes.
may be beneficial if single action portable oxygen systems are considered
as part of the tendering process within the healthcare market.
The formation of HSIB is a world-first and
represents a landmark moment for the NHS in England. HSIB’s purpose is to help
improve safety in the healthcare system by developing recommendations and
sharing lessons from investigations. HSIB will improve patient safety through
effective and independent investigations that do not apportion blame or
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