The Importance of Patient Safety with Single-use Instruments - A Collaborative Surveillance Approach in Wales

Background: In 2000 the Spongiform Encephalopathy Advisory Committee (SEAC) identified a theoretical risk of transmission of vCJD from reusable surgical instruments. Tonsillectomy surgery was identified as high risk to patients due to the procedure being performed, mainly on children and young adults. Wales opted to use single-use instruments and this resulted in the establishment of the Surgical Instrument Surveillance Programme (SISP) in 2003. The programme collaborated with the Welsh Assembly Government, Welsh Otorhinolaryngological Association, Public Health Wales and Surgical Materials Testing Laboratory.

Objective: To determine if surgery with single-use instruments could be as safe as with equivalent reusable instruments by comparing bleed rates over time. To provide reassurance to the public and healthcare professionals on the use of specified tonsillectomy instruments through continuous surveillance. To provide a surveillance system that could be utilised for monitoring the safe introduction of other surgical instruments.

Methods: A detailed laboratory audit provided a single supplier of single-use instruments. A paper-based surveillance system was established utilising a core dataset for all hospitals carrying out adenotonsillectomy surgery in Wales. Instrument safety was measured by complication rates (major bleeds). Instrument performance was based on assessment of each instrument in use by the surgeon during surgery and instrument failure was reported on the form. This information was disseminated to the supplier to ensure the original design and instrument specification was adhered to. Major bleed rates (requiring return to theatre) were monitored regularly and reported to all hospitals.

Results: All instruments were problematic on initiation with the majority occurring in the first two years of surveillance. Redesign of some instruments was required demanding further collaboration with the supplier and ENT surgeons. Instrument failure has since halved. Changes to the specification of instruments do continue but are quickly detected and resolved showing the continued need for this surveillance. Over 85% of major bleed are captured by the surveillance. Complication rates using the single-use instruments are no different from when operations were performed with reusable instruments.

Conclusions: The collaborative approach with surgical teams has demonstrated that single use instruments are safe for use but only with continuous careful monitoring. To date instrument failure has not significantly increased major bleed rates. Due to the rapid detection of problematic instruments by the surveillance and clinician ownership of data patient safety has not been compromised. This surveillance is unique as it still remains voluntary. The aim of SISP is to expand this model system to ensure patient safety with the introduction of surgical instruments in general.