The importance of high-quality reusable and single-use surgical instruments has never been greater to the HealthTech Sector. With the well-publicised NHS budget constraints1, an ageing population, over 10 million operations2 performed each year in England, in just over 3,200 operating theatres3, this clearly creates significant pressure to keep instruments available and fit for use.

The variety, nomenclature and heritage of the surgical instrument marketplace is vast. It is so varied due to the complex range of procedures they feature in. Most instruments are named after their original inventor, the area of the body they are used and the type of device. For example, the Spencer Wells Artery Forceps was invented in the late 1800ʼs and is still one of the most common devices in use.

The Surgical instrument market value is estimated at more than £50m4. The challenge to retain the value and performance of devices, and the appropriate educational focus for NHS staff, is immense.

A case study presented on behalf of the ABHI SIG looked at 48 UK hospital sites of varying sizes in the UK (see page 9). An average hospital has 735 beds, 18 theatres and carries out 27,000 operations per year with an average of 1,545 surgical instrument sets on site. A typical reusable instrument set contains 48 instruments, with an approximate value per instrument of £40.00. On average a hospital has 75,000 instruments, with a value of around £3.6m. The likely number of instruments in circulation in the NHS is conservatively estimated at 17 million.

Single-use instruments are used alongside reusable instruments. In the single-use market there are common surgical areas that favour single-use devices, depending on the delicacy of the devices, safety and ability to re-clean reusable ones e.g. suction tube where cleaning and decontamination maybe difficult. Where patient outcome and diagnosis rely on, for example, a sharp device, single-use may be the only viable option.

Surgical instruments are not commodity products, they support positive surgical outcomes and shorter hospital stays. Investment in good quality equipment, strong supporting education, and high quality maintenance are essential

The sector continues to evolve, with the introduction of single-use devices which are Class IIa risk level in most cases. The imminent transition to the Medical Device Regulation will up-classify reusable instruments to Class I reusable, requiring notified body approval for the first time. Reusable instruments account for the vast majority of instrumentation, but the need for single-use devices must also be recognised.

With this up-classification, the obligation and cost for the manufacture of these devices goes up, in association with the recognition that their risk has increased. To navigate the challenges of Brexit and its interplay with the Medical Devices Regulation, the SIG has utilised its network to ensure such factors have been raised with appropriate stakeholders, particularly where it was felt these regulations could impact patient safety.

Understanding the cost and benefits of compliance with the new regulations should also be central to procurement decisions.

Surgical instruments are essential for the delivery of modern healthcare. Their use is so widespread that they are easily taken for granted, and often little attention is paid to the origin, design, materials and decontamination protocols, or the regulatory processes and associated costs that are required for their introduction.

The supplier base for instruments is diverse, sourced from small family owned businesses, through to large multinational corporations. What they have in common are complex manufacturing processes, global supply chains, broad product ranges to suit varying clinical needs and product development with the capacity to innovate and change to meet clinical requirements. By joining ABHI, members show a commitment to transparent and ethical codes of manufacturing and business conduct, raising standards of quality and professionalism, and working to meet regulatory, technical and data requirements.

In order to be placed on NHS Supply Chain frameworks, manufacturers employ standards, whether national or international, to demonstrate compliance to the regulations which are audited by notified bodies. Separately, a manufacturer will also be audited to the ethical performance matrixʼ specified in the Labour Standards Assurance System (LSAS) and adhere to the requirements of the Modern Slavery Act 2015.

Labour Standards issues have been identified within this supply chain and the SIG have worked closely with NHS Supply Chain during the introduction of the LSAS to try to address these matters through the Surgical Instruments Frameworks. Reports have shown that progress has been made, although there is more work to be done in this regard.

The Modern Slavery assessment tool will be implemented imminently in this sector and ABHI members are committed to working with stakeholders to support ethical manufacturing and supply in this sector.

ABHI members support and co-operate with the NHS and Department for Health and Social Care initiatives in other initiatives such as, Scan4Safety, Sales Person Credentialing, and National Contracting.

Value based procurement5, a very recent initiative, enables NHS buyers to find the balance between cost, quality, support and ethical supply. The SlG recently produced the ‘Surgical Instrument Purchase and Care Guideʼ, provides guidance for purchasing and caring for surgical instruments. It can be downloaded from www.abhi.org.uk.