Setting sights on higher standards for eye surgery
National Eye Health Week (20 – 26 September)
A review of data sets for liquid endo-ocular tamponade agents has led to a higher specification of manufacture to increase patient safety.
Various tamponades are currently used during complicated vitreoretinal surgery and minimum data sets have been sought for some time by eye surgeons and suppliers.
Following concerns over possible toxicity and impurity, a collaborative review was facilitated by NHS Supply Chain, between the Orthopaedics, Trauma and Spine, and Ophthalmology Category Tower Service Provider (CTSP) and the Clinical and Product Assurance (CaPA) function, in partnership with the British and Eire Vitreoretinal Surgeons (BEAVRS).
As a result of this collaboration, a higher specification for the manufacture of tamponades has been developed and it has been agreed that all suppliers who meet the new specification will be highlighted on the NHS Supply Chain framework for customers to see.
Linda Saunders, Ophthalmology Clinical Engagement and Implementation Manager with NHS Supply Chain, said: “It has been a privilege working with the experts at BEAVRS who have provided minimum data requirements and enabled us to share these with manufacturers and suppliers. We have had a fantastic response as they all share our joint aim of improving patient care. Our suppliers already meet all the minimum requirements and this is just an opportunity, entirely voluntary, to raise the bar even higher in terms of safety.
“It has been a great opportunity to self-regulate standards and show that we are all working together on behalf of patients.”
Fay Allen, Product Assurance Specialist with the Clinical and Product Assurance (CaPA) team, said: “Working alongside BEAVRS as an expert reference group to produce and approve an essential specification ensures we are placing the quality of our products and safety of our patients at the forefront of our procurement.”
The essential specification process is a cross-functional programme led by CaPA, who will work closely with CTSPs to carry out due diligence and address the key lines of enquiry. CaPA will also be working closely with national expert reference groups to ensure that specifications have appropriate expert clinical input.
Areas covered by the new standards include the range of molecular mass distribution, silanol content and endotoxins. The new data requirements also spotlight methodology for toxicity tests, cytotoxicity limits, silanol content and specific gravity of products.
Liquid tamponade agents such as perfluorocarbon liquids, silicone oil and heavy silicone oils are a crucial intraoperative and postoperative tool in vitreoretinal surgery, in particular for the management of complex vitreoretinal diseases.
Professor David Steel, President of BEAVRS, said: “An up-to-date knowledge on research findings and potential risks associated with the use of intraocular liquid compounds is essential. This is not only important for vitreoretinal surgeons but also for any ophthalmologist involved in managing patients who have received these agents.
“These new requirements will provide clinicians with a comprehensive characterisation of the tamponades used in our NHS, in terms of physical and chemical properties, allowing surgeons to be confident in their use and reducing the risk of complications. Our focus is on the safety of these compounds for our patients, within the framework of existing regulations and standards, and using best available evidence on their biocompatibility.”
The essential specification now includes manufacturers supplying the method of quality assurance for batch variability and individual batch listing; stating the range of molecular mass distribution.
Relevant academic literature:
Steel DHW, Wong D, Sakamoto T. Silicone oils compared and found wanting. Graefes Arch Clin Exp Ophthalmol. 2021 Jan;259(1):11-12.
Januschowski K, Irigoyen C, Pastor JC, Srivastava GK, Romano MR, Heimann H, Stalmans P, Van Keer K, Boden K, Szurman P, Spitzer MS. Retinal Toxicity of Medical Devices Used during Vitreoretinal Surgery: A Critical Overview. Ophthalmologica. 2018;240(4):236-243.
Chen Y, Kearns VR, Zhou L, Sandinha T, Lam WC, Steel DH, Chan YK. Silicone oil in vitreoretinal surgery: indications, complications, new developments and alternative long-term tamponade agents. Acta Ophthalmol. 2021 May;99(3):240-250.
About NHS Supply Chain’s role in the Covid-19 response
- The Government has set up new PPE Dedicated Supply Channel which is a parallel supply chain to the normal NHS Supply Chain service. It has been set up by Government to meet the urgent volume requirements for core personal protective equipment (PPE) items, allowing NHS Supply Chain to focus on ensuring the supply of medical devices and clinical consumables to our NHS.
- The Government has set up a dedicated unit to focus on securing supplies of PPE led by the government’s commercial function. This unit is identifying PPE suppliers from across the globe to meet the increasing demand for a growing list of PPE products. NHS Supply Chain’s PPE buying teams have been seconded to the unit which is led by the government.
- NHS Supply Chain has expanded its operations to support the stand up of seven NHS Nightingale Hospitals set up across the UK, including NHS Nightingale London, Birmingham, North West (Manchester), Yorkshire and the Humber (Harrogate), Bristol, North East (Washington) and Exeter. Equipment and consumables supplied include ventilators, patient monitors and CT scanners.
About NHS Supply Chain
NHS Supply Chain manages the sourcing, delivery and supply of healthcare products, services and food for NHS trusts and healthcare organisations across England and Wales.
Managing more than 4.5 million orders per year, across 94,000 order points, 17,465 locations and delivering 25 million lines of picked goods to the NHS. NHS Supply Chain system consolidates orders from over 800 suppliers, saving trusts time and money and removing duplication of overlapping contracts.
Lord Carter’s report into efficiency and productivity in the NHS, published in 2015, identified unwarranted variation in procurement across the NHS, resulting in the need to improve operational efficiencies to transform a fragmented procurement landscape. To undertake this transformation the Department of Health and Social Care established the Procurement Transformation Programme (PTP) to deliver a new NHS Supply Chain.
The new NHS Supply Chain was designed to help the NHS deliver clinically assured, quality products at the best value, through a range of specialist buying functions. Its aim is to leverage the buying power of the NHS to negotiate the best deals from suppliers and deliver savings of £2.4 billion back into NHS frontline services by the end of the financial year 2022/23.
The new model consists of eleven specialist buying functions, known as Category Towers, delivering clinical consumables, capital medical equipment and non-medical products such as food and office solutions. Two enabling services for logistics and supporting technology and transactional services which underpin the model.
Key benefits the NHS Supply Chain will bring NHS trusts and suppliers include:
- Savings channelled back to frontline services
- Releasing more time for core clinical activities
- Greater NHS clinical involvement in purchasing decision
- More effective introduction of new products.
- Lowering sales and marketing costs
- Single route into the national market
- A joined-up approach across the NHS
- Clear route for innovative products.
On 1 April 2018, a new commercially astute management function of the new NHS Supply Chain called Supply Chain Coordination Limited (SCCL) went ‘live’. The management function is responsible in driving strong commercial capability, providing a relentless approach to creating value, gain competitive advantage, become the strategic procurement partner of choice for the NHS, manage the delivery and performance of the Category Tower Service Providers and its enabling logistics and technology services whilst overseeing continuous improvement. SCCL is a limited company, wholly owned by the Secretary of State for Health and Social Care, SCCL is part of the NHS family. For more information on our category service tower providers go to https://www.supplychain.nhs.uk/categories/.
The Clinical and Product Assurance (CaPA) team of NHS Supply Chain is key to ensuring that all the products we supply are safe and reflect the needs and preferences of all our NHS partners.
This includes working with our NHS partners such as NHS England, NHS Improvement and the National Institute for Health and Care Excellence (NICE) to support the introduction of new technology and innovation into the supply chain that provides demonstrable benefits for our patients and users.
The CaPA team is responsible for three key areas of expertise:
- Assurance framework
- Patient safety