Safety recommendation
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.
Response:
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 undertake this work.
Response received on 14 November 2018.