1. The Importance of Patient Safety with Single-use Instruments - A Collaborative Surveillance Approach in Wales W. Harrison, A. Tomkinson, V. McClure*, S. J. Harris (*corresponding author) 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 (WORLA), Public Health Wales and Surgical Materials Testing Laboratory (SMTL). OBJECTIVES To provide reassurance to the public and healthcare professionals on the use of the specified single-use tonsillectomy instruments through continuous surveillance. To determine if surgery with single-use instruments could be as safe as equivalent reusable instruments by comparing major bleed rates over time. 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 (fig. 1). Forms are completed in theatre and returned to SISP. Data is held in a central database and reports are produced for surgical teams every 6 months and as requested. Instrument performance is based on assessment of each instrument in use by the surgeon during surgery and is reported on the form (fig 1). Information regarding problematic instruments is disseminated to the supplier to ensure the original design and instrument specification are adhered to. Instrument safety is measured by complication rates. Post-operative event forms are used by surgeons to record complications which occur within 24hrs of surgery and those that require readmission to hospital. Major bleed rates (requiring return to theatre) are monitored regularly and reported to all hospitals. RESULTS There are currently 26251 procedures and 916 post-operative events (major and minor) in the SISP database. Data has been validated by comparison with the Patient Episode Database for Wales (PEDW) and shows that over 95% of operations and 85% of major bleeds are captured by the surveillance. The majority of instrument problems occurred in the first two years of surveillance (fig. 2). In the first year of the surveillance (2003) the overall rate* (excluding diathermy**) of instrument problems was 0.7%. Further collaboration with the supplier and ENT surgeons resulted in the redesign of some instruments. From 2004 to 2009 the overall instrument problem rate has remained steady between 0.2% and 0.3% (fig. 2). Fig. 3 shows the quarterly rate of major and minor*** problems for the knot pusher. In 2007 the number of major problems associated with the knot pusher rose significantly. This increase was identified by the surveillance and reported to the Surgical Materials Testing Laboratory (SMTL). It was revealed that the supplier had altered the specifications of the instrument. This was resolved and the rate of major problems for the knot pusher fell. Small peaks have been noted since and are being monitored, but it is thought that these peaks may be a consequence of theatres failing to completely dispose of faulty batches of instruments. Changes to the specification of instruments do continue to occur but are quickly detected and resolved showing the continued need for this surveillance. The major bleed rate for 2009 is 1.11% (fig. 5). 2009 Complication rates using the single-use instruments are no different from when operations were performed with reusable instruments were the rate was estimated range was between 1.0% and 2.0%. 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. Further work needs to be done to ensure all problematic instruments are returned by theatre teams to SMTL for assessment and identified faulty batches are disposed of completely. This surveillance is still voluntary but participation by surgical teams remains high. The aim of SISP is to expand this patient safety system so it can be utilised as a surveillance model for the introduction of new surgical instruments. Fig 1. Surveillance forms (version 2, 2008) Fig 4. All Wales instrument problems** report 2009 * Overall rate of instrument problems = Number of major +Number of minor instrument problems/Total number of instruments used ** The diathermy is supplied by a different company and is therefore monitored separately. *** Minor = the instrument is problematic, but can be used Major problems = the instrument is problematic and must be replaced immediately **** Major bleed rate (one per patient) = Major bleeds reported on a post-operative events form (fig. 1) + Post-operative haemorrhage repairs reported on an operation form that do not have a matching post-operative events form/Number of tonsillectomy and adenotonsillectomy procedures*100 Fig 5. All Wales major bleed rate**** 2003 - 2009 Fig 3. All Wales quarterly rate of major and minor*** problems for the knot pusher 2006 – 2009 Fig 2. All Wales annual rate of major and minor*** problems for all instruments 2003 – 2009 Surgical Instrument Surveillance Programme, Public Health Wales NHS Trust, Temple of Peace and Health, Cathays Park, Cardiff, Wales CF10 3NW e-mail: victoria.mcclure@wales.nhs.uk Tel: 029 20402473victoria.mcclure@wales.nhs.uk WORLASMTL