THE SINGLEUSE INSTRUMENT SURVEILLANCE PROGRAMME SISP AS A

THE SINGLE-USE INSTRUMENT SURVEILLANCE PROGRAMME (SISP) AS A MODEL SYSTEM FOR THE INTRODUCTION OF DISPOSABLE INSTRUMENTATION AND NEW SURGICAL PROCEDURES Wendy Harrison*, Alun Tomkinson, Mark Temple (* corresponding author) SMTL WORLA SISP The Single-use Instrument Surveillance Programme, NPHS, Abton House, Cardiff, CF 14 3 QX. e-mail wendy. harrison@nphs. wales. nhs. uk INTRODUCTION RESULTS • In 2000, The Spongiform Enchephalopathy Advisory Committee (SEAC) identified a theoretical risk of transmission of variant Creutzfeldt. Jakob Disease (v. CJD) from instruments used for surgical procedures 1. Currently 10, 816 procedures in total are present within the all Wales tonsils database. The number of procedures broken down per year are – 2, 160, 5, 129 and 3, 527 for 2003, 2004 and 2005, respectively. Almost 7, 000 are tonsillectomy and 2, 000 adenotonsillectomy procedures. • v. CJD is a disease due to the same infectious agent as BSE, a fatal disease with a long incubation period, associated with the presence of pathologic prions. These abnormal proteins cannot be removed from surgical instruments by standard sterilisation methods raising concerns for transmission from patient to patient 2, • In January 2001, single-use tonsillectomy instruments were introduced by the Department of Health due to high risks to patients (children and young adults) but withdrawn again shortly afterwards in England due to instrument safety concerns. Advice from SEAC regarding v. CJD remained unchanged 3. The Welsh Assembly Government elected to remain with single-use instruments but launched an independent investigation. Work was also in collaboration with Welsh ENT surgeons via the Welsh Otorhinolaryngology Association (WORLA), the National Public Health Service for Wales (NPHS), The Surgical Materials Testing Laboratory (SMTL) and Welsh Health Supplies. • In summary, the mechanism to deliver safe surgery in Wales, free of risk from v. CJD, resulted in the establishment of the Single-use Instrument Surveillance Programme (SISP) in 20023. Table 1. Serious bleed rate = postoperative haemorrhage repair. It denotes those bleeds that require a return to theatre, either after an initial complication or on readmission to hospital. The serious bleed rate for both 2003 and 2004 remained constant, but almost halved for 2005. This is lower than with reusable instruments (1. 4%). AIMS OF THE PROGRAMME • To set up a specific surveillance programme in Wales to determine if surgery with single-use instruments could be as safe as with their equivalent reusable instruments. • To demonstrate with successful implementation of this surveillance system that evidence-based reassurance of safe practice could be provided to the public and healthcare professionals. 50. 0% % instrument problems from total no. used OBJECTIVES • Estimating the postoperative haemorrhage rate complications (serious bleed rates) associated with adenotonsillectomy procedures. • To monitor the performance of the single-use instruments themselves in order to provide early warning and investigation of the problems. • To critically evaluate the system by external and internal auditing to ensure capture of all required data. METHODS • All hospital surgical teams (NHS and private) carrying out adenotonsillectomy surgery in Wales have participated in surveillance since 2003. • A detailed supplier and laboratory audit was conducted to provide a single supplier of single-use instruments 4. Modifications to instrument design were established through working with Welsh ENT surgeons, leading to a set of specifically designed single-use steel instruments. Figure 1. Schematic diagram showing the surveillance system implemented Data file produced (5) Import into All-Wales database (2) Questionnaire completion THEATRE OR WARD OPERATION AND INSTRUMENT FORMS COMPLICATION FORMS Initial complications (before patient discharged from hospital) Readmission complications (On readmission of patient to hospital) 25. 0% 20. 0% 15. 0% 10. 0% Feb 03 Mar 03 Apr- May- Jun- Jul 03 03 Aug- Sep 03 03 Oct 03 Nov- Dec 03 03 Jan 04 Feb- Mar 04 04 Date of Procedure Figure 3. Example of how the surveillance identifies problematic instruments in Wales. In 2003, the gag and blade were identified, and reported to SMTL. Modification of the instrument specification rectified this problem immediately. The diathermy has proved most problematic overall but has undergone less scrutiny (different supply company). Evaluation of the system – External and internal validation was conducted independently using the Patient Episode Database for Wales. The surveillance was above 95% efficient at recording the desired surgical procedure and more than 90% of both initial and readmission serious bleeds have been identified. CONCLUSIONS • In Wales, postoperative haemorrhage rates with single-use tonsillectomy instruments are similar to reusable instruments if appropriately specified and monitored in use. • The SISP has adopted a unique surveillance allowing problematic instruments to be detected quickly and efficiently without compromising patient safety. SISP (3) Questionnaires returned via post By local surveillance coordinator 30. 0% Figure 3. Number of reported instrument problems by month by instrument usage (first year of the surveillance) • All complications associated with the procedure are recorded (up to 28 days after the initial procedure). Initial complications (e. g. bleeds, pain occurring before the patient is discharged from hospital) and readmission complications (e. g. bleeds, pain occurring after discharge of the patient, requiring a readmission to hospital). Complications both requiring and not requiring a return to theatre are recorded. HOSPITAL Gag & Blade Draffin rods Yankauer Eves Snare Lucs Den. Browne Birkett Gwynne Evans Negus Knot pusher Currette Diathermy 35. 0% 0. 0% • SISP is alone, however, in including a detailed assessment of each instrument in use by the surgeon at the time of surgery. (1) Questionnaire Distribution 40. 0% 5. 0% • A paper-based surveillance was set-up utilising questionnaires for data capture. Number of procedures, related post operative complication(s) and performance of the instruments are monitored. In addition, information on patient and surgeon characteristics, other operative / postoperative details and method of tonsillectomy chosen by the surgeons are collected. (4) Questionnaires scanned 45. 0% Figure 2. Minor instruments denote those that are problematic but can be continued for use. Major problems, those that must be replaced immediately. Minor problems have decreased 6 -fold, whilst major problems have decreased 3 -fold (2005 compared with 2003). (6) Data returned via post or email Import into hospital database by data transfer co-ordinator WAG (7) All Wales reports • Patients undergoing tonsil surgery have continued to be protected from theoretical risk of v. CJD transmission during surgery. • The high standard of care and safety has been, and continues to be achieved mainly through the continued cooperation of ENT surgical teams in Wales with support from NPHS and The Welsh Assembly Government. Surgeons in Wales agree that the system must be in place if they are to continue usingle-use instruments in Wales. • This surveillance system is equipped for introduction of further surgical instruments and procedures, an excellent example to be followed by the rest of the UK. LESSONS LEARNT: This surveillance demonstrates that clinician-led systems are essential in order to achieve valuable and quality data, with emphasis on clinician ownership of data. Surgical teams Production of local reports REFERENCES 1. Department of Health (2001) Risk assessment for transmission of v. CJD via surgical instruments: a modelling approach and numerical scenarios. CJD publications London. Available from: htttp: //www. dh. gov. uk/policyandguidance/healthandsocialcaretopics/CJDGeneral. Information/fs/en [Accessed 1 December 2005] 2. Tomkinson, A. , Harrison, W. and Temple, M. (2005) The protection of patients in Wales from v. CJD and a guarantee of single-use instrument safety. A success in collaboration. National Leadership and Innovation Agency for Healthcare conference. Cardiff. 3. Tomkinson, A. , Harrison, W. , De Martin, S. Backhouse, S. and Temple, M. (2005) The surveillance of single-use instruments in tonsil and adenoid surgery – postoperative haemorrhage and operative technique. Clinical Otolaryngology and Allied Sciences. In press. 4. Tomkinson, A. , Phillips, P. Scott, J. B. et al. (2005) A laboratory and clinical evaluation of single-use instruments for tonsil and adenoid surgery. Clinical Otolaryngology and Allied Sciences 30 (2), 135 -142. Acknowledgements The authors would like to thank all members of the Welsh Otorhinolaryngology Association and all surgeons for their continued participation in this surveillance