Medicines and Healthcare products Regulatory Agency
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.
Combined response to these recommendations and safety recommendations as a result of our Design and safe use of portable oxygen systems investigation
These recommendations overlap with each other and so I [Dr Ian Hudson, Chief Executive, Medicines and Healthcare products Regulatory Agency] intend to respond to all of them together. Please also note your report, I2017/010, Implantation of wrong prostheses during joint replacement surgery, didn’t specifically direct recommendations for us, however it did prompt actions by us relevant to the response to these recommendations.
Overall, we agree these are good recommendations and are areas we have also identified where further systemic safety improvement effort should be directed. We intend to implement them as fully as we can, within the constraints of our regulatory abilities. We supplied a considerable amount of information to your investigators during these investigations and I am confident this contributed to the recommendations being as well targeted as they are.
We think the recommendations you have made are logical conclusions from the specific investigations you have undertaken. However, we think these are examples of wider problems, and so we intend to implement improvements to the whole category of problem we identify, rather than concentrate on the specific examples you give. For example, we suspect usability of all medical devices can be an issue and following our human factors guidance would help improve all medical devices, so we will work to improve this whole issue rather than focus on improving it just for ophthalmology electronic patient record systems that include an ocular biometry module that is a medical device. In support of this, the usability and human factors design of labelling of orthopaedic implants was identified as an issue by your report on that area.
I will set out some of the things we have done already and have planned, indicating where they contribute to enacting your recommendations:
- In September 2017 we published Guidance on applying human factors to medical devices. This is aimed at all manufacturers of medical devices, Notified Bodies and users of devices. It was promoted at the time with a news story.
- We have planned to evaluate how this guidance has been received (recommendation 2018/021)
- We had identified usability of labelling as an area of interest and report I2017/010 helped us focus this on labelling of orthopaedic implants. We planned a study of these labels to see whether they follow our guidance, have started gathering data for that study and plan to analyse and publish the results by the end of 2019.
- We intend to expand our evaluation to include other methods such as a survey of Notified Bodies and manufacturers to ascertain awareness and use of the guidance. This is planned to occur during 2019.
- This evaluation will include whether sufficient weight is given to post market surveillance of devices within the guidance (recommendation 2018/023) and whether the strength of our recommendation that this guidance be used is understood (recommendation 2018/014).
- Further actions, such as specific action on recommendation 2018/14, depend on the results of this evaluation. Therefore, we will plan and take action as necessary after we have completed the evaluation and have a clear picture of what action would be most helpful.
- We consider we have made good progress toward recommendation 2018/024 because it is already widespread practice to consider whether field safety corrective actions planned by manufacturers are likely to be effective, and weak barriers are likely to be ineffective. We have limited power here because the field safety notice and corrective actions are determined by the manufacturer of the affected device and our role is supervisory. We also plan to make further progress on the related point of actions that we recommend in our own publication of Medical Device Alerts. The procedure for MDA writing is due for revision in September 2019, and during this review we will consider whether an extra step to explicitly consider strength of actions recommended is needed.
- We consider we have met recommendation 2018/022. For the last two years, such requirement has been implemented in new marketing authorisation applications for drug-device combination products that are regulated as medicinal products. Results of summative human factors and usability testing studies, or other evidence of usability for such products, are actively requested for review during the assessment process. For example, for oxygen cylinders with integral valves the usability study of the CE marked integral valves is reviewed to ensure that the study is appropriate with respect to the medicinal product as a whole. If it is not sufficient further results of usability testing are requested to support the use of the integral valves with the oxygen cylinders under assessment. We have not received any applications for oxygen cylinder and integrated valve combinations in this time.
Response received on 5 February 2019.
Department of Health and Social Care
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 Department of Health and Social Care accepts Recommendation 2018/015 as formulated and commits to work with NHS Improvement, NHS England and the MHRA in conjunction with other relevant organisations to develop and agree an implementation strategy.
The resulting strategy will set out proposed standards and next steps for the NHS to utilise appropriate technologies to provide digital alerts when an incorrect intraocular lens is selected.
DHSC commits to completing the strategy within six months from the date of this response and to reporting back to HSIB on progress periodically until this work is complete.
The DHSC notes the work currently underway in response to a previous HSIB recommendations (2018/004 and 2018/005) to implement a similar system of alerting in theatre environments to identify wrong protheses prior to implantation in a patient and will utilise the remit and experience of this work prior to creating a similar system for IOLs.
Response received on 5 February 2019.
The Royal College of Ophthalmologists
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 undertake this work.
Response received on 14 November 2018.