Quality Assurance
Size matters: quality control for surgical instruments
Sojin Mappidecheri, Tom Brophy and Jonathan Reeves discuss the findings of an in-house quality assurance programme at Barts Health NHS. They highlight the importance of ensuring the correct sizing of surgical instruments and discuss the need to move to a standardised approach to measuring instrument dimensions, across the industry.
The quality of surgical instruments plays a pivotal role in ensuring patient safety, improving surgical outcomes, enhancing operational efficiency, and maintaining the reputation of healthcare institutions. Since 2000, all new surgical instruments enter our in-house quality assurance (QA) programme within Barts Health NHS, prior to being accepted by the Trust. We test against BS 5194 (parts 2,3 and 4), as it plays a vital role in ensuring that surgical instruments are safe, reliable, and easy to manage. This directly supports the quality of patient care and operational efficiency. All instruments that fail the QA process are returned to the manufacturer or supplier, with replacements returned to the Trust, which re- enter the QA process. Typical reasons for instruments failing the
QA process include burrs, no traceability (no logo or trademark), fragments on serrations, scissors not cutting as defined in recommended standards. To date, ≈147k instruments have entered this process, with an overall failure rate of 5.8%. In the initial years of the setting up the QA programme, the instrument failure rate was 20%. However, over the duration of the programme, this has significantly improved and is currently 4.3% for 2024 (≈ 5000 instruments). The primary focus of our QA process is on the active part of the surgical instrument that directly performs the intended action and comes into contact with the patient. These checks are to determine that the instrument operates as intended. Historically, we had previously not undertaken rigorous checks on the sizing of instruments in the QA process, unless there were obvious differences between the instrument labelling and the instrument undergoing the QA process. To get a better understanding of the sizing
of surgical instruments entering the Trust, we carried out a study on the tolerance of all new general instruments entering our QA
programme. Between 24 January and 24 July, 606 new general instruments entered the Trust. This study excluded specialised instruments, such as endoscopic instruments, orthopaedic instrument for prosthesis and plating systems. The length of each instrument was measured using a 300mm digital caliper (RS components, UK) and compared against the ‘very coarse’ tolerance class for linear dimensions using ISO 2768 (table 1). ISO 2768 is a general tolerance standard primarily intended for mechanical engineering and manufacturing industries but is not specific to medical devices. Compliance to ISO 2768 ensures that a standardised approach to dimensioning and tolerance is undertaken. The aim of this standard is to simplify mechanical tolerance specifications in engineering drawings. It provides guidelines for tolerances on dimensions and geometrical properties of parts where specific tolerances are not explicitly defined. Within this standard, there are four
tolerance classes: fine, medium, coarse and very coarse, with increasing tolerance levels. This ensures that all parts meet the same quality standards, which leads to consistent performance and reliability. It reduces variability in production, which helps in maintaining consistent quality in the final product. When compared to the very coarse class of ISO
2768 (table 1), it was observed that 19.8% of the instruments would be rejected and returned to the manufacturer or supplier. This included: 43.2% of scissors, 28.4% of clamps and 9.9% of forceps. The largest oversized instruments that we received were Maxilla retractors that were oversized by 16mm compared to the package label. The largest undersized instruments we received were a pair of Potts 90° scissors that were undersized by 8.3mm and Doyen intestinal forceps by 4.9mm. The size of surgical instruments is a critical
factor in ensuring that surgeries are performed with the utmost precision, safety, and efficiency. It also enables surgeons to adapt their techniques
April 2025 I
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