High quality care essentially describes care which achieves good outcomes for patients through the provision of evidence based healthcare delivery (clinical effectiveness), which minimises harm (patient safety) and which provides the patient with a positive, personal experience of care (patient experience).
The College promotes quality and safety in all aspects of ophthalmology and produces many standards and guidelines to support this as well as the following clinical governance guides.
Safety Alerts
- Opioids in pregnancy – are we losing sight of the child?
Opioids prescribed as part of a drug maintenance programme (eg. Methadone) have been widely associated with visual pathology in children exposed in utero, as well as with MRI brain changes in volume and myelination. Foetal Opioid Spectrum Disorder includes nystagmus, squint, refractive error, impaired smooth pursuit, reduced visual acuity and poor binocular vision.Recently we have become aware in Scotland, of cases of Foetal Opioid Spectrum Disorder in children exposed to opioids prescribed for pain relief in pregnancy (eg. Tramadol, Dihydrocodeine and Morphine), given for back pain or pelvic girdle pain for instance. These include children with long-term nystagmus. The SPROGS group have informed the Chief Medical Officer’s office (Scotland) and are currently submitting Yellow Cards to MHRA. A policy change to ensure that all women of child-bearing age prescribed an opioid have a warning of potential visual effects is indicated and efforts to ensure this are being made. Please consider submitting a Yellow Card for suspected cases.
- Update to the Burkholderia cenocepacia novel cluster with suspected association with carbomer containing lubricating eye gel As of 21 March 2024, UKHSA, MHRA and the College are satisfied that the risk associated with this outbreak has reduced such that there is no longer need to avoid use of carbomer-containing lubricating eye products. Therefore, the recommendation to avoid use of all carbomer-containing eye products in individuals with cystic fibrosis, patients being cared for in critical care settings, the severely immunocompromised and patients awaiting lung transplantation has been stepped down.
- DORC Directional Laser Probes
A series of batches of Dutch Ophthalmic Research Center (DORC) directional laser probes has been identified as being faulty and posing a potential risk to patient safety. The impacted product codes are 7220.xxx, 7223.xxx, 7225.xxx and 7227.xxx, where xxx can be ALC, DORC, or IRI.
- Burkholderia cenocepacia novel cluster with suspected association with carbomer containing lubricating eye gel ( Nov 2024)The UKHSA is investigating a novel cluster of Burkholderia cenocepacia involving 20 cases across the UK. Preliminary epidemiological and microbiological investigations have identified a potential association with carbomer containing lubricating eye gel.
The MHRA has released a National Patient Safety alert regarding cases of high intraocular pressure (IOP) following cataract surgery using preloaded EyeCee One and EyeCee One Crystal lenses. The College has worked with some of the departments affected to develop some consensus points regarding implementing the alert and managing patients experiencing high IOPs.
- Strategic Executive Information System (StEIS) reports of 100% v/v alcohol used during corneal cross-linking surgery (Dec 2022)
The patient safety team at NHS England and Improvement have noted a series of cases of 100% v/v alcohol used during corneal cross-linking surgery. These incidents have occurred when the full-strength solution of alcohol has been selected instead of the 18% or 20% v/v solution. We would encourage members performing corneal cross-linking surgery to evaluate their use of alcohol during corneal cross-linking surgery and whether suitable 18% or 20% alcohol preparation solutions can be sourced from a specials manufacturer.
- Mydriasert ophthalmic pellet for pupil dilation (Nov 2022) – Recent evaluation of National Reporting and Learning System (NRLS) data has shown a significant number of reports to the system related to the use of the Mydriasert ophthalmic pellet for pupil dilation. This includes reports of the Mydriasert pellet being left in situ post-surgery and not being found during post-operative checks.
- Retinal vein occlusions post COVID vaccination (May 2021) – The College had considered the recent reports of an increased incidence of Central Venous Sinus Thrombosis (CVST) in the UK and anecdotal cases of retinal vein occlusion (RVO) in the immediate period (28 days) subsequent to COVID vaccination.
- Boron additives in Chloramphenicol drops safety alert (April 2021) – In response to an Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (Reference: EMA/CHMP/302620/2017), manufacturers have updated product information to include specific warnings possible effects of boron-containing excipients on fertility.
- Cataract related CFTER for cystic fibrosis – Advice for clinicians. At this time, based on the data received, there is no evidence to support a recommendation for wholesale adoption of a hospital eye service screening programme for cataracts in children who are prescribed CFTR modifiers containing Ivacaftor.
- Lucentis® 10 mg/ml pre-filled syringe – plunger on syringe too stiff – Direct Healthcare Professional Communication (DHPC) Lucentis® (ranibizumab) 10 mg/ml pre-filled syringe – Updated November 2019
- Particulate matter in syringes for intravitreal injections – July 2019
The College has been approached by a unit concerned about particulate matter discovered in syringes for intravitreal injections. - Zeiss Lucia 611P intraocular lens safety alert – April 2019
The College has been made aware of two ophthalmic units with a run of a small number of cases of fibrin membrane deposition in association with the Zeiss Lucia 611P intraocular lens. - Do not use apraclonidine in infants below six months of age – February 2019
The College has recently received a report from NHS Improvement of a severe adverse reaction in a six month old child with anisocoria who had been administered apraclonidine 1% to help exclude Horner syndrome. - Do not use nitrous oxide when there is gas in an operated eye – December 2018
The patient safety team at NHS Improvement has reported an incident involving a patient who had undergone retinal detachment repair and had a gas bubble in their eye while the anaesthetist did not seem to be aware that the use of nitrous oxide was contraindicated. - Detachment of cannulas during ophthalmic surgery – April 2018
The NHS Improvement national patient safety team have informed the College of the continued trend of incidents involving issues with detachment of cannulas during ophthalmic surgery (cannula-associated ocular injury, COI). - Intracameral cefuroxime – May 2018
The College recommends that for those using a non licensed product, users should check the SmPCs and avoid use of any product which specifically cautions against intraocular use. - Diabetic control and safe cataract surgery – May 2018
The College has received queries from members to clarify whether there is a specific cut off for glycaemic control, either measured via HbA1C or a blood glucose level on the day, beyond which it is unsafe to proceed with cataract surgery.
