Many surgeons will have encountered the scissors that would not cut, and the artery clip that comes off in a deep difficult location, but it would be reasonable to assume that new instruments should be of assured quality. This study reports the surprising findings of a local quality control exercise for new instruments supplied to a single trust.
MATERIALS AND METHODS
Between January 2004 and June 2004, all batches of new 5MM surgical instruments ordered by the Central Sterile Supplies Department of St Bartholomew's and the Royal London Hospitals were assessed by three clinical engineers, with reference to British Standards (BS) requirements.
Of 4800 instruments examined, 15% had potential problems. These included 116 with machining burrs and debris in the teeth of the tissue-holding regions, 71 defects of ratcheted instruments, 34 scissors with deficient cutting action, and 35 tissue forceps protruding guide pins. In addition, 254 instruments did not have a visible manufacturer's mark.
This study demonstrates the value of local quality control for 10MM surgical instruments. This is of importance in an increasingly hazard-conscious environment, where there are concerns over instrument sterilisation, surgical glove puncture and the potential for transmission of blood-borne and prion diseases.
A surgeon performing a surgical procedure should be able to assume that the instruments used are safe and reliable – particularly if they are new. To ensure the quality of these instruments, the Health Care Standards Policy Committee directed the British Standards Institution to produce requirements for the materials, design, dimensions and other features of surgical instruments. As a result, British Standards (BS), incorporating International Organisation of Standardisation (ISO) standards, were published.1 Each year, large numbers of new instruments are ordered by healthcare facilities across the UK, and those ordering them should be able to rely on these standards. This study reports the results of local quality control by the clinical engineering department of all new instruments supplied to a single NHS trust.
Over a 6-month period between January 2004 and June 2004, all new batches of disposable surgical instruments delivered to the Barts and the London NHS Trust, from a variety of manufacturers, were assessed by three clinical engineers. The suppliers and manufacturers were informed beforehand. Where large numbers of identical instruments were delivered in a single batch, samples of these were examined as follows: 25–49 instruments 50%, 50–74 instruments 30%, 75–99 instruments 20%, and 100+ instruments 15%. In total, 4800 instruments were inspected, where necessary under magnification, for flaws as defined under BS quality assurance requirements.
In total, 730 (15%) instruments failed the inspection. Table 1 shows the flaws that were identified. Figure 1 shows shows33 views of the jaws of vascular clamps: a well-finished instrument on the left, an instrument with machining burrs in the teeth in the middle view and right views. Figure 2 shows a crack in the securing screw of scissors on the left, a crack though the end of the jaws of a needle holder in the middle view, and a major soldering fault in the surface of a wire bending forcep on the right. Figure 3 demonstrates protrusion of a sharp guide pin on gentle closure of tissue forceps.
The commonest fault identified was lack of a maker's mark. BS states that ‘the instrument shall be marked with the name or registered trade mark of the manufacturer or supplier’.1 This may seem like a minor infringement, but in fact it is highly important. If an instrument fails in service, it is essential that the supplier and manufacturer can be notified, so that any potential problem can be rectified, to ensure the safety of the patient and theatre staff. In addition, there is the question of liability and insurance.