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.”
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
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
The report is now available on the HSIB website and
responses to the recommendations will be published by the end of the year.
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.
Page 11, Section 1.3.15 of the report: Managing the demand for cataract surgery
of report: Review of reported incidents
safety observations and safety actions
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
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.
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.
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.
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
Please contact firstname.lastname@example.org or phone 07710114191 or 07453283931 for interviews and other queries