Patient safety incidents involving medical devices occur every day in the NHS. Although the vast majority of incidents result in no harm to patients, in 2013, over 40,000 incident reports relating to medical devices were submitted to the National Learning and Reporting System (NRLS). The actual number of incidents is even higher due to reporting and coding issues.
The term ‘medical device’ covers a broad range of products, used every day in healthcare settings to support the diagnosis, treatment and care of patients. The definition of a medical device in European and UK law is:
‘any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
- investigation, replacement or modification of the anatomy or of a physiological process; and,
- control of conception,
and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.’
The range of medical device products is very wide: it includes dressings, tubing, syringes, infusion pumps, heart valves, surgical instruments, resuscitators, radiotherapy machines, wheelchairs, walking frames or other assistive technology products.
Patient safety alerts relating to medical devices
The analysis of NRLS reports has enabled new risks to be identified and communicated to the NHS through the use of Patient Safety Alerts. Examples of NHS England alerts relating to medical devices include:
- Risk of hypothermia for patients on continuous renal replacement therapy (February 2014)
- Patient safety alert on non-Luer spinal (intrathecal) devices for chemotherapy (February 2014)
- Risk of associating ECG records with wrong patients (March 2014)
- Risk of using vacuum and suction drains when not clinically indicated (June 2014)
- Risk of inadvertently cutting in-line (closed) suction catheters (July 2014)
View all NHS England Patient Safety Alerts.
The National Medical Device Safety Network
NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) are working together to minimise harm from medical devices. A joint Patient Safety Alert, Improving medical device incident reporting and learning, was issued in March 2014 requesting large healthcare provider organisations to identify a Medical Device Safety Officer (MDSO).
A national network for MDSOs has now been established to improve communication and feedback on reported safety issues, and enable safer practice to be discussed and shared through monthly webinars and conferences.
New designs for small bore connectors
Wrong route errors have occurred in the UK and worldwide arising from the use of the Luer connectors in medical devices for all routes of administration. NHS England has set up a Small Bore Connector Clinical Advisory Group to advise NHS England on the safe introduction of medical devices with new small bore connectors into use in the NHS.
Following initiatives from the former National Patient Safety Agency and NHS England, new devices with ‘non-standardised’ small bore (non-Luer) connectors for oral/enteral and neuraxial routes of administration have already been introduced into use, to minimise risks of wrong route errors in practice.
Read more on small bore connectors.
Questions and comments
For questions, comments and feedback on patient safety incidents involving medical devices please email the NHS England medical devices patient safety team email@example.com.