All Wales. Annual Tonsillectomy Surveillance Report

Transcription

1 Surgical Instrument Surveillance Programme (SISP) All Wales Annual Tonsillectomy Surveillance Report 2007 (Data inclusive of 01/01/ /12/2007) The Temple of Peace & Health, Cathays Park, Cardiff, CF10 3NW Y Deml Heddwch ac Iechyd, Parc Cathays, Caerdydd, CF10 3NW Tel/Ffon: Fax:/Ffacs:

2 INDEX Page no. Introduction 3 Executive Summary 4 SECTION 1: Form feedback 5 SECTION 2: Patient demographics 8 SECTION 3: Complications 9 SECTION 4: Instrument performance 12 Conclusions 16 References 17 Acknowledgements 18 Glossary 19 2

3 Introduction In 2000 the Spongiform Encephalopathy Advisory Committee (SEAC) identified a theoretical risk of transmission of variant Creutzfeld-Jacob Disease (vcjd) from instruments used for surgical procedures 1. Tonsillectomy surgery was identified as high risk to patients due to the procedure being performed, mainly on children and young adults. In 2001, single-use instruments were introduced by the Department of Health in response to concerns by SEAC 2, but were withdrawn shortly afterwards due to major problems with their supply and quality. During this time defective products with serious design and quality issues were noted with the instruments in use through the Surgical Materials Testing Laboratory (SMTL). Following serious concerns with unmonitored single-use instruments they were withdrawn in England and then Wales 3 and both England and Northern Ireland returned to using reusable instruments 4. In Wales, adenoid and tonsil surgery ceased for all but emergency cases on the recommendation of the Chief Medical Officer (WAG) 5, until surgery with single-use instruments could be a feasible proposition. A detailed comparison of reusable instruments to instruments from the then current suppliers and other potential alternative suppliers of single-use instruments in the market place were undertaken 5, 6. By 2002 WAG advised the cessation of tonsil and adenoid surgery using the unspecified single-use instruments 7, 8. Following further detailed instrument and company analysis, a set of highly specified single-use instruments were announced in February The mechanism to deliver safe surgery in Wales, and free of risk from vcjd, resulted in the establishment of the Surgical Instrument Surveillance Programme (SISP) in The SISP was established by the WAG in collaboration with the Welsh Otorhinolaryngological Association and the National Public Health Service for Wales. In addition, this collaborative surveillance system involved SMTL and Welsh Health Supplies. The surveillance system was designed in order to monitor all surgery performed with the specified single-use tonsillectomy and adenoidectomy instruments. The initial study design and core dataset were similar to the audit established in Scotland 9 and in England and Northern Ireland 10. Wales was alone, however, in its approach to the reintroduction and subsequent monitoring of the instruments themselves. As the concerns about the risks of healthcare increase, the need for good quality systems to assure patient safety are unlikely to reduce. The collaborative systems approach based on surveillance has now demonstrated that with suitable mechanisms surgeons can be assured that single use instruments are safe for them to use, however, continuous careful monitoring of their introduction and use is essential. The SISP has been fully established for five years and during this time the surveillance has gathered information on over 200,600 single-use tonsillectomy instruments with over 21,800 operations recorded in the database (database accessed on 30 th November 2008). In addition, the programme has been utilised as a model for the set-up and deliverance of other healthcare surveillances, especially with regard to the compliance achieved and clinician ownership of the data collected. It is also important to remember that this surveillance is quite unique as it has achieved this status whilst still remaining a voluntary scheme. This is the third national report on the use of single-use tonsillectomy instruments and provides data for

4 Executive Summary This report on all Wales surveillance of single use instruments utilised for tonsillectomy and adenoidectomy surgery, includes operation data, instrument usage / instrument problems and all complications associated with operations carried out between 1 st January and 31 st December Form feedback Operation data Surgeons of Wales continue to provide accurate data with approximately 88% of the questions on the form being completed. 59% of the questions present were above 80% complete. Poor completion rates were noted for dissection instrument setting / measurement type and haemostasis measurement type. The continued support by the surgeons of Wales is required to maintain and improve the accuracy of the data. The total number of operations using single use instruments in Wales for 2007 was 3,848 with 2,769 tonsillectomy procedures carried out. On average between 220 and 400 procedures were captured per month for Wales with peaks noted in March and August. 60% of surgery was performed on female patients; 73% of patients undergoing surgery were below 20 years of age. Operation data for 2007 is comparable with the findings of the SISP in the 2005 and 2006 Annual Tonsillectomy report. Complications Bleed rates of 0.47% and 0.53% were noted for initial (R1) and readmission (R2) returns to theatre, respectively. The overall patient bleed rate (major haemorrhage) for 2007 was 1.43%. This bleed rate is utilised as a regular outcome measure within the surveillance. Levels of major haemorrhage have reduced to those found prior to the introduction of single use instruments. However, trend data shows increased rates in both 2006 and Although the bleed rate has not increased to rates obtained in 2003 / 2004, careful monitoring and investigation of this trend is required. Increased rates may or may not be explained by the increase in the use of the coblation dissection method. Instrument data Instrument surveillance continues to improve single use equipment. Continued reporting of instrument malfunctions and their return to SMTL is essential to prevent ongoing problems. Total instrument problem rates (excluding diathermy) for all Wales (2007) were 0.2%. The Meditech diathermy problem rate has decreased in 2007 with major and overall problem rates of 0.4 and 0.7%, respectively. The knot pusher was the most problematic instrument (overall problem rate of 0.9%). Overall, instrument problems have stabilised or reduced for all instruments since Removal of problematic instrument stock is, however, essential to prevent artificial inflation of instrument problem rates. 4

5 SECTION 1 1. Form feedback This section gives information about completion of data items on the forms, concentrating on the operation form (DS2). In addition a table of the number of procedures carried out since the surveillance began in 2003 is included (table 1.2) with a monthly breakdown of procedures for the current year of reporting (2007) (Figure 1.1). 1.1 Completeness of forms Table 1.1 Percentage completeness of data items on the operation form (DS2) for 2007 Data item Expected Present % Completed Hospital code Admission type Surgeon code Supervisor code * Surgeon grade Training year Operation Indication Tonsillectomy dissection type * Adenoidectomy dissection type * Dissection instrument setting Dissection measurement type Haemostasis Haemostasis instrument setting Haemostasis measurement type Gag in Gag out Total * Completion rate greater than 100% - The data item was completed on the form more times than would be expected for the number of operations carried out. 5

6 The completion of data items on the operation form (Table 1.1) is based on procedures with an operation date between 01/01/2007 and 31/12/2007. A total of 10 data items were above 80% complete for all forms returned in However, the % completion of 3 of these data items, specifically supervisor code, tonsillectomy dissection type and adenoidectomy dissection type were above 100%. This denotes that the particular data items were completed on the form more times than would be expected for the number of operations carried out. The dissection instrument setting, dissection measurement type and haemostasis measurement type were poorly completed with completion rates of 50.7%, 41.0% and 58.5%, respectively. 1.2 Operation data The following table provides details on the number of operations carried out each year since the start of the surveillance. The numbers tabulated in this report may differ from previous annual reports. Data may have been updated in the database since the previous report and the reader is advised to use the most up-to-date report when quoting such operation figures. Figure 1.1 shows the number of operations carried out by month for Table 1.2 Summary of the number of operative procedures carried out between 2003 and 2007 (up to 31 /12 /2007) Procedure Year 2003 * Total Tonsillectomy Adenotonsillectomy Adenoidectomy UPPP Unknown Total * Procedures included from 0 1/02/2003 onwards. 6

7 Figure 1.1 Number of operative procedures recorded (excluding post operative haemorrhage repairs and biopsy) by month for 2007 The number of operations carried out monthly in 2007 varied between 220 and 400. Operation numbers reached 400 in March and 350 in August Key Summary Point Data response rates were high with approximately 88% of the questions on the form completed. Poor completion rates were noted for some parts of the form, in particular, dissection instrument settings, dissection measurement type and haemostasis measurement type. The total number of operative procedures recorded by the surveillance between 2003 and 2007 (inclusive) is 18,027. For 2007 a total of 3,848 procedures were recorded. 2,769 tonsillectomy, 647 adenotonsillectomy and 346 adenoidectomy operations were carried out in On average between 220 and 400 operations were captured monthly by the surveillance system for Operation numbers peaked in March and August. 7

8 SECTION 2 2. Patient Demographics This section looks at the patient demographics for all procedure records with first operation dates in 2007, specifically on gender and age. Table 2.1 Number of operative procedures carried out broken down by gender (2007) Gender No. of procedures Female 2432 Male 1594 As previously quoted in the 2005 and 2006 annual tonsillectomy reports 6, 11, the female population attending for tonsil and adenoid surgery considerably outnumbers the male population, the cause of this difference remains unknown but has also been reported in several other studies 12. Table 2.2 Number of operative procedures carried out broken down by age group (2007) Age group No. of procedures < < < < < < < Examination of age variation shows a marked peak at 5-10 years of age. This was also noted for 2005 and 2006 Welsh surveillance data by SISP 6, 12. The majority of patients (2,902) undergo surgery by 19 years of age (as shown in Table 2.2). However, over 1,000 patients over the age of 20 also underwent surgery in Key Summary Point 60% of patients undergoing surgery in 2007 were female. 72% of patients undergoing surgery in 2007 were under 20 years of age with operation numbers peaking at the age group of 5 <10 years. The data for 2007 is comparable with the findings of the SISP in the 2005 and 2006 Annual Tonsillectomy Reports. 8

9 SECTION 3 3. Complications This section looks at major haemorrhage bleeds following tonsillectomy and adenotonsillectomy surgery. Definitions Post operative haemorrhage may be described as a major or minor complication. Major haemorrhage is defined as bleeding requiring a return to theatre for cessation of bleeding (R). Minor haemorrhage does not require surgical intervention (N). A major haemorrhage can be further categorised into a primary (R1) or secondary (R2) bleed: R1 - Primary major haemorrhage is a haemorrhage requiring a return to theatre that occurs within the first 24 hours following primary surgery. R2 - Secondary major haemorrhage, is a haemorrhage requiring a return to theatre that occurs more than 24hrs following primary surgery and up to 28 days following surgery. A minor haemorrhage can be further categorized into the following: N1 or N2 are minor haemorrhage within or following 24 hours post primary operation, respectively Table 3.1 Complications by major haemorrhage for 2007 Major haemorrhage No. of complications Bleed rate (%) * Initial returns (R1) Readmission returns (R2) * Bleed rate (%) = (no. of complications / no. of tonsillectomy + no. adenotonsillectomy operations) x 100 Note: A patient may have one or more bleeds that will be included in the above figures. The complication figures exclude patients that have post operative haemorrhage repairs identified but have no corresponding DS4 complication recorded. The initial return to theatre haemorrhage (R1) rate was 0.47% whilst the readmission return to theatre haemorrhage (R2) rate was 0.53% for These figures provide an estimation of the number of major haemorrhage captured by the surveillance system. N1 and N2 haemorrhage have not been reported due to poor reporting levels. 9

10 Table 3.2 Overall patient bleed rate for 2007 Number of complications Bleed rate (%) * ** * Bleed rate (%) = (no. of complications / no. of tonsillectomy + no. adenotonsillectomy operations) x 100 ** The bleed rate (%) is based on a tonsillectomy or adenotonsillectomy bleed occurring up to 28 days after the primary operation. This rate may differ from the individual R1 and R2 rates (table 3.1) as only one occurrence of bleeding is recorded per patient. Note: The above complications are based on completion of a DS4 form but also include patients which have post operative haemorrhage repairs identified but have no corresponding DS4 complication recorded. Instrument problems have not been associated with increased returns to theatre. From the patient dataset in 2007, only one complication record had an instrument record with an instrument problem (minor problem). The instrument was a knot pusher. The overall patient specific bleed rate was 1.43% for This specific major haemorrhage calculation is utilised when comparing bleed rates for individual Trusts in Wales in addition to the all Wales rate Patient specific bleed rate (%) Year Figure 3.1 Trend data showing yearly patient specific bleed rates (%) for The trend data shows a marked decrease in the bleed rate for 2005 compared with all other years. During 2005 a decrease in the number of DS4 complication forms returned to SISP was noted. More specifically some hospitals did not participate in the reporting of 10

11 complications. A predictive bleed rate for 2004, if all complications were returned, would be approximately 1.1%. Figure 3.1 shows that the bleed rate for 2007 is greater than for It would appear that the bleed rate has started to increase in the last two years. The latter may be as a result of a change in the dissection technique. The surveillance has identified that more surgeons are carrying out the coblation technique. However, more data is required to increase operation numbers utilising this technique and thus provide statistical evidence for this hypothesis. Key Summary Point Bleed rates of 0.47% and 0.53% were noted for initial and readmission returns to theatre, respectively in The overall patient bleed rate for 2007 was 1.43%. Trend data shows that the patient bleed rate has increased in both 2006 and 2007 but not to the same level as the rates noted in 2003 / The surveillance has also noted a change in the technique utilised for dissection. There has been an increase in the use of the coblation technique, which may, or may not explain the increase noted in the bleed rates over the last two years. 11

12 SECTION 4 4. Instrument data This section provides details of all instrument problems reported to the SISP in 2007 and includes both minor and major problems. Table 4.1 Instrument usage (excluding diathermy) for all procedures recorded for Wales (2007). The number of problems (minor and major) associated with each instrument is also shown and the percentage of problems (major and all problems) Instrument Total used Problems % Major problems Minor Major % Any problems Gag child Gag adult Blade Draffin rods < Draffin rod support Yankauer Lucs DBrowne Birkett Gwynne Evans Negus large curved < Waughs toothed Waughs non-toothed Eves tonsil snare Mollison tonsil pillar Knot pusher Metzenbaum Beckmann 75 unguarded SCT 45 unguarded Total Note: The above table includes all records with an instrument usage date for 2007 Failure rates for individual instruments used were minimal for 2007 with rates of reporting of minor and major problems below 0.5%. Only the knot pusher had a rate above 0.5% with 17 major problems (0.8%) reported in Both the Lucs and knot pusher had rates above 0.5% when considering overall problems with rates of 0.8% and 0.9%, respectively. 12

13 Table 4.2 Meditech diathermy usage for all procedures recorded in The number of problems (minor and major) associated with the instrument is also shown and the % problems (major and all problems). Instrument Total used* Problems % Major problems Minor Major % Any problems Diathermy (Meditech) Note: The above table includes all records with an instrument usage date for * Diathermy usage is based on all hospitals in Wales currently using the specified Meditech forceps only. For this reason, Royal Glamorgan and Wrexham Maelor are excluded from this report. Both hospitals have continued to use the piloted BBraun diathermy forceps. In addition, monopolar diathermy usage and any resulting problems are also excluded. A total of 13 problems were noted for the Meditech diathermy in 2007, providing instrument problem rates of 0.3, 0.4 and 0.7% for minor, major and all problems, respectively. 0.8 % problems with instrument usage minor problems major problems all problems Year Figure 4.1 Percentage of minor, major and all problems with instrument usage (excluding diathermy) (inclusive) 13

14 10.0 % problems with instrument usage minor problems major problems all problems Year Figure 4.2 Percentage of minor, major and all problems with Meditech diathermy usage (inclusive) Comments were made on many of the problematic instruments, including child and adult gags, draffin rods, yankauer, lucs, Dennis Browne, birkett, negus large curved, knot pusher, metzenbaum, needle holder and diathermy. The knot pusher cut ties / sutures and the curve was noted to be too shallow. The lucs and birkett were too stiff. The ratchet did not work (not holding) on the gags. The negus large failed to clamp properly. The Dennis Brownne cut into the tissue whilst the metzenbaum was blunt. The diathermy did not work properly, by not firing on many occasions and the ends / tips were reported as crossing. Many of the reported instrument problems occurred in clusters. Although the instrument problems are rectified, problems may still be noted in small numbers if the problematic instruments have not been removed from stock. Removal of problematic instruments is essential to prevent artificial inflation of instrument problem rates. Overall, instrument problems in general have stabilised since 2005 with minor and major problems (excluding diathermy) running at 0.1% and overall problems at 0.2%. A similar trend has been noted for the diathermy with problems reducing each year, especially for 2007 compared with all other years. A decrease in diathermy problems noted may be as a result of two hospitals now using BBraun forceps instead of Meditech. Continual reporting of problematic instruments, especially diathermy forceps (both Meditech and BBraun) is imperative. Large changes in satisfaction are detected by SISP quickly and acted on ensuring surgeons have single use instruments they can rely on. Developing a mechanism for early detection of small changes in quality of manufacturing, when the items are made to the current high standard, is problematic. Various approaches are thus currently being considered within the SISP working group. 14

15 Key Summary Point One or more problems were noted for 10 out of the 20 instruments available within the tonsils set. However, failure rates for the majority of instruments were below 0.5%. Total instrument problem rates (excluding diathermy) for all Wales (2007) were 0.2%. The knot pusher was the most problematic instrument in 2007 with an overall problem rate of 0.9%. The Meditech diathermy problem rate has decreased with major and overall problem rates of 0.4 and 0.7%, respectively. Overall, instrument problems in general have stabilised or reduced since 2005 (including diathermy). Removal of problematic instrument stock is essential to prevent artificial inflation of instrument problem rates. 15

16 Conclusions This report shows the continued support for the surveillance system within Wales. SISP has adopted a unique surveillance allowing problematic instruments to be detected efficiently without compromising patient safety. In addition, the surveillance allows for the evaluation of the procedures undertaken and provides details of any associated complications. In particular, major haemorrhage rates are monitored and compared on a regular basis. Although, major haemorrhage rates are below the rates observed prior to the introduction of single use instruments, the bleed rate captured by the surveillance has increased in the last two years. It is hypothesised that this may be as a result of the change in the dissection technique utilised, but a greater number of operations need to be captured by the surveillance using this particular technique. Any small change in the rates does however require further careful monitoring and investigation. Instrument problems will continue to occur and due to their mass production, continuing appraisal and notification of failures/errors are an essential part of preventing ongoing problems. Reporting of instrument problems and return of the problematic instrument itself to SMTL is essential to rectify the instrument fault. Diathermy forcep (Meditech) continues to be a problematic instrument. In addition, the knot pusher was problematic in 2007 due to the instrument being too sharp and cutting ties / sutures. This instrument was returned to SMTL and the design failure rectified. In general, instrument problems and failures have, however, stabilised or have continued to reduce since The continued support of the surgeons of Wales is thus essential to maintain and further improve the data collected and to reduce instrument problems. Since the analysis of the 2007 data, the SISP Working Group has amended the forms currently in use. In particular, the operation and instrument information can be captured on one form and some information / questions have been removed to simplify the forms. The surveillance system is a necessity and will continue whilst single use instruments are used. The SISP would like to thank all surgical teams and those responsible for data return for their continued interest and support for this surveillance programme. 16

17 References 1. Risk assessment for transmission of vcjd via surgical instruments: a modelling approach and numerical scenarios (2001). Department of Health, London. Guidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID= &ch k=xwy3ak (date of last access 25 Jul 2006) million for NHS equipment to protect patients against possible variant CJD risk (2001). Department of Health, London. ENT ID= &chk=59R1 /T (date of last access 25 July 2006). 3. Suspension of Diathermy in Tonsil and Adenoid Surgery (2001). Department of Health, London. fs/en?content_id= &chk=vh54c%2b (date of last access 25 May 2004). 4. Re-Introduction of Re-Usable Instruments for Tonsil Surgery (2001). Department of Health, London. fs/en?content_id= &chk=7VV%2BPw (date of last access 25 July 2006). 5. Tomkinson, A., Phillips, P. Scott, J. B., Harrison W., De Marting. S, Backhouse. S.S. et al. (2005). A laboratory and clinical evaluation of single- use instruments for tonsil and adenoid surgery. Clinical Otolaryngology 30 (2), All Wales Annual Tonsillectomy Surveillance Report (2005). Surgical Instrument Surveillance Programme, National Public Health Service for Wales. 7. Tomkinson, A., Harrison, W. and Temple, M. (2005) The protection of patients in Wales from vcjd and a guarantee of single-use instrument safety. A success in collaboration. National Leadership and Innovation Agency for Healthcare conference. Cardiff. 8. Ceilidh Gilchrist, Alun Tomkinson (personal communication) 5 April 2002, South Western Laryngological Association. 9. Scottish Tonsillectomy Audit (date of last access June 2004). 10. National Prospective Tonsillectomy Audit (2004) Tonsillectomy technique as a risk factor for postoperative haemorrhage. Lancet 364, All Wales Annual Tonsillectomy Surveillance Report (2005). Surgical Instrument Surveillance Programme, National Public Health Service for Wales. 12. Thorp, M., Isaacs, S. and Sellars, S. (2000) Tonsillectomy and tonsillitis in Cape Town age and sex of patients. South African Journal of Surgery 38 (3),

18 Acknowledgements The 2007 Annual Tonsillectomy Report could not have been produced without the continued support of the following: All members of the Welsh Otorhinolaryngology Association and all surgeons who have and continue to participate in this surveillance. Additional essential assistance provided by all theatre, nursing and administrative staff involved in the surveillance. Surgical Instrument Surveillance Programme team: Wendy Harrison, Susan Harris, Victoria McClure and Mark Temple Surgical Material Testing Laboratory, Bridgend: Peter Philips and Gavin Hughes Welsh Health Supplies: June Scott Special thanks are also provided to the Surgical Instrument Working Group. Members include: Dr Wendy Harrison Mr Alun Tomkinson Dr Mark Temple Dr Mike Simmons Dr Eleri Davies Mrs Susan Harris Miss Victoria McClure Mr David Owens Ms Sarah Farmer (New member) Mr Mike Sullivan (New member) Mrs Jan Collins (New member) Mrs Elizabeth Phillips Mr Dominic Worsey and Mr Philip Reardon Smith (New members) SISP Manager and Senior Scientist, WHAIP, NPHS Consultant ENT Surgeon (UHW), WORLA Consultant in Public Health Medicine, NPHS Director of Health Protection Director for WHAIP Senior Specialist Analyst Programmer, WHAIP, NPHS Information Assistant, WHAIP, NPHS SpR ENT SpR ENT Theatre Manager, Wrexham Maelor Theatre Manager, Princess of Wales Theatre Sister, Singleton Hospital Healthcare Standards, Quality Standards and Safety Improvement Directorate, Welsh Assembly Government 18

19 Glossary and Definitions. NPHS SEAC SISP SMTL vcjd WAG WORLA National Public Health Service for Wales Spongioform Encephalopathy Advisory Committee Single-use Instrument Surveillance Programme Surgical Materials Testing Laboratory Variant Creutzfeld-Jacob Disease Welsh Assembly Government Welsh OtoRhinoLaryngological Association Major Haemorrhage Minor haemorrhage Primary complications Secondary complications R1 R2 N1 N2 Haemorrhage requiring return to theatre to control Haemorrhage that does not require surgical intervention Complications occurring within 24 hours of the surgical procedure. Complications occurring more than 24 hours after surgery. Primary major haemorrhage Secondary major haemorrhage Primary minor haemorrhage Secondary minor haemorrhage DS2f, DS3f & DS4 Orphan instrument record Data collection Sheets used to collect the data for SISP An instrument record reporting that instruments have been used for an operation but the specific operation is not identifiable. 19

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