The Healthcare Safety Investigation Branch (HSIB) has today published its latest report,highlighting why current measures aren’t effective in preventing the insertion of an incorrect intraocular lens (IOLs) and setting out three recommendations aimed at national improvement. 

The removal of a cataract and insertion of an intraocular lens is the most common surgical procedure undertaken by the NHS*. In 2017, it was one of the most commonly reported ‘Never Events’ within the NHS.**

Initially the investigation focused on the hospital where the reference incident took place. During planned cataract surgery an 86-year old woman had the wrong strength lens implanted into her left eye. Her vision was not impaired as a result, but the case presented an opportunity to analyse local working practices, processes and pressures to identify the key areas for wider investigation.  

The broader investigation examined the usability of specialist ophthalmology systems and looked at how IOLs are selected, retrieved and identified across organisations. The use and value of both international and national standards and guidance were also considered. 

Keith Conradi, Chief Investigator said: “Having the wrong lens implanted during cataract surgery is something that any one of us or our family members could experience. Data from national reporting shows that, despite existing procedures and guidance, the insertion of the wrong lens is still happening.

“This investigation was a great example of where we’ve aimed to understand why current measures aren’t working and moved the focus from individual actions to strong systemic barriers. The use of technology and the role of human factors and system design are often at the top of our list when we are looking at developing effective and impactful recommendations.

“We worked closely with the Royal College of Ophthalmologists, Department of Health and Social Care and MHRA. We recognise the work being done and the resource needed to implement recommendations. We trust that our report provides strong evidence for those organisations to take forward at a national level and improve outcomes.”

Recommendations 

The report states that good equipment design should take human factors into account and that usability testing is key to understanding interaction. None of the ophthalmology electronic patient record systems (OEPR’s) seen by the investigation had been subject to this testing.  A recommendation has been developed with the Medicines and Health products Regulatory Agency (MHRA), who are due to reclassify OEPR’s under new medical device regulations, to encourage manufacturers to use their human factors engineering and usability guidance.

Variance in practice was a key finding from the investigation. This relates to checking processes, use of technology and existing guidance. An example is the World Health Organisation Surgical Safety Checklist (WHOSCC) and how it is adapted and used within different organisations. Recognising funding, resource and expertise required to support this work, a recommendation has been made to the Royal College of Ophthalmologists (RCOphth) to set up an expert working group to examine issues of variance and where processes could be standardised. 

The investigation identified that some Trusts are using scanning technology to track prostheses and implants and that this could be extended to verification of IOLs. If an OEPR or other system was able to verify the scanned data, and provide an alert if there was a mismatch, this could put an additional barrier in place to prevent errors. Building on the work of the Scan4Safety programme, a recommendation has been made to the Department of Health and Social Care (DHSC) focusing on setting standards on digital alerts for the NHS. 

Over the course of the investigation, the team observed cataract surgery in multiple operating theatres across three Trusts. They also worked with relevant experts, and analysed a range of data, reports and other literature.

The report is now available on the HSIB website and responses to the recommendations will be published by the end of the year. 

ENDS

Notes to Editors  

Never Events are serious incidents that the national Serious Incident Framework define as ‘entirely preventable because guidance or safety recommendations providing strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers.’ 

The patient and family mentioned in this report have chosen to remain anonymous. 

References from report 

* Page 11, Section 1.3.15 of the report: Managing the demand for cataract surgery 

**Section 5.2 of report: Review of reported incidents 

Recommendations, safety observations and safety actions 

Safety recommendations 

1.    The Medicines and Healthcare products Regulatory Agency should strongly recommend the manufacturers of ophthalmology electronic patient record systems (including systems for making and storing ocular biometry measurements),where they fall under the remit of the Medical Device Regulations, undertake an assessment against the MHRA Human Factors and Usability Engineering guidance and this should form part of the documents assessed by a Notified Body as part of any declaration or assessment of conformity with the requirements of the Medical Device Regulations.

2.    The Department of Health and Social Care commissions a set of standards for the NHS that utilises appropriate technologies to provide digital alerts when incorrect intraocular lens’ are selected.

3.    The Royal College of Ophthalmologists establish an expert working group to evaluate the variance of practice for cataract surgery, and subsequently establish standardised and workable processes to minimise the risk that a patient will receive an incorrect intraocular lens.

Safety observations 

1.    The National Ophthalmology Audit could be a useful vehicle for capturing the relevant information for the insertion of an incorrect artificial intraocular lens. The resulting data, when analysed, may improve understanding of why these events continue to occur and provide supporting evidence for further safety measures to prevent them.

About HSIB 

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 liability. 

Media contacts 

Please contact media@hsib.org.uk or phone 07710114191 or 07453283931 for interviews and other queries