The Royal College of Ophthalmologists responds to the Healthcare Safety Investigation Branch report and recommendations into the insertion of an incorrect intraocular lens
15 November 2018
The Royal College of Ophthalmologists (RCOphth) welcomes the Healthcare Safety Investigation Branch (HSIB) report i2017/012 ‘Investigation into the insertion of an incorrect intraocular lens’1.
Cataract surgery is the most commonly performed operation in the NHS with over 400,000 being carried out every year in the UK. It greatly enhances quality of life by restoring sight. As a result of major advances in technology, the procedure has evolved from one of simply removing a cloudy lens from within the eye to one whereby a replacement lens is inserted in to the eye, the power of which is selected to achieve a patient selected refractive outcome. In most cases patients chose to have, where possible, good distance vision without glasses, and to rely on reading glasses for near work because this is what they are used to doing at the time they develop their cataracts.
Correct intraocular lens selection is essential to achieve the desired outcome. As described in the HSIB report, this is a process that begins with accurate biometry and a discussion with patients about their desired refractive outcome and ends with the appropriately selected intraocular lens (IOL) being inserted into the correct eye of the correct patient.
The primary cause of the index case sited in the report, was the surgeon selecting an IOL from a list related to the patient’s other eye. Fortunately, as is often the case, the patient’s eyes were similar in shape and the insertion of the wrong IOL did not significantly affect the patient’s post-operative need for glasses. Never-the-less, the incident was correctly raised as a serious event and, when considered in the context of 74 reported cases of incorrectly implanted IOLs, it was clearly an appropriate subject for investigation by the HSIB.
The report is expertly written and the findings are presented in a way that should be understood by clinicians, managers and, most importantly, patients. It highlights variations in practice and evidence of a failure to adopt recommended best practice. It is essential reading for all NHS staff involved in the provision of cataract surgery.
Response to the recommendations
The HSIB report includes the following specific recommendation to the RCOphth:
‘Recommendation 2018/016: 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.’
Responsibility for patient safety and ensuring that clinicians adopt best practice guidance and standards rests with individual hospital Medical Directors. The RCOphth is not a regulatory body and does not have any powers to compulsorily inspect the quality of services delivered in individual eye departments. However, it does have considerable expertise in performing service reviews when invited by hospitals to do so. Such assessments are expensive both financially and in terms of time commitment by appropriately experienced individuals. The RCOphth would be prepared to set up an expert working group as suggested by HSIB recommendation 2018/016 provided it receives authority to do so from NHSE or NHSI, together with sufficient resources to complete the task.
As noted in the report, the National Institute for Health and Care Excellence (NICE) has relatively recently published a full guideline on adult cataract surgery (NG77) that includes recommendations on how to avoid incorrect IOL implantation. It is unclear whether the lessons to be learned from the guideline had reached both the surgeon and the eye department involved with the specific case in the HSIB report. However, the RCOphth recommends that the report is reviewed by NICE and any identified deficiencies in NG77 recommendations are corrected by an urgent revision of the guideline.
The HSIB report includes the following additional recommendations:
‘Recommendation 2018/014: 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.’
‘Recommendation 2018/015: 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.’
The RCOphth would be willing to provide expert assistance to both the Medicines and Healthcare Products Regulatory Agency and the Department of Health and Social Care should they decide to undertake this work.
Other issues raised in the HSIB report
The RCOphth notes a number of significant patient safety issues identified in the case report that were not the subject of specific recommendations. These include:
- The fact that the operating surgeon was a locum. Whilst many ophthalmology consultant locums provide a safe and effective service for their patients, it is undoubtedly true that any change in working environment adds risk. Locum consultants, by their very nature are unlikely to undergo the extensive induction process experienced by newly appointed permanent consultants. The RCOphth strongly recommends that eye department clinical service leads take steps to ensure that locums receive an adequate induction process that includes all standard operating procedures, and that the locum is a competent surgeon.
- The use of a general operating theatre. Running operating lists in an unfamiliar environment inherently adds risk. Furthermore, unless appropriate steps are taken to appropriately schedule lists, there is a risk that patients undergoing eye surgery will be exposed to increased risk of infection as a result of preceding operations that are associated with high levels of infection.
- The lack of an ophthalmology trained theatre nurse. This is a highly significant safety issue. It is possible that an appropriately trained ophthalmology nurse might have been able to explain the systems used in the hospital to the locum. More importantly, it is vital that the theatre staff know immediately what to do in the event of a per-operative complication. The RCOphth strongly recommends that all ophthalmic surgical lists are staffed by appropriately trained individuals and will discuss with the Royal College of Nursing the setting up of an expert working group to develop a national programme of theatre staff training and accreditation.
The NSIB report includes the following safety observation:
‘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 Royal College of Ophthalmologists agrees that the National Ophthalmology Database Audit (NOD)2 could be used in this way and welcomes the HSIB’s support. However, sustainable funding for the NOD is urgently required, as the current NOD funding stream will end in August 2019.
Michael Burdon
President, The Royal College of Ophthalmologists
References
- HSIB, Insertion of an incorrect intraocular lens https://www.hsib.org.uk/investigations-cases/insertion-incorrect-intraocular-lens/
- The NOD currently runs the National Cataract Audit to collect and analyse a standardised, nationally agreed data set from all centres providing NHS cataract surgery in England and Wales. The audit forms part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP). https://www.nodaudit.org.uk/resources/publications-annual-report