THE SINGLE-USE INSTRUMENT SURVEILLANCE PROGRAMME (SISP) AS A MODEL SYSTEM FOR THE INTRODUCTION OF DISPOSABLE INSTRUMENTATION AND NEW SURGICAL PROCEDURES

Victoria McClure*, Alun Tomkinson, Mark Temple, Wendy Harrison

(*corresponding author)

The Single-use Instrument Surveillance Programme, NPHS, Abton House, Cardiff, CF14 3QX. e-mail victoria.mcclure@nphs.wales.nhs.uk

Table 1 Annual serious bleed rates for all Wales following adenotonsillectomy procedures (2003 -2005) Year Number of serious

bleeds Serious bleed rate

(%)

2003 22 1.0

2004 58 1.1

2005 31 0.8

2006 19 1.0

• In 2000, The Spongiform Enchephalopathy Advisory Committee (SEAC) identified a theoretical risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) from instruments used for surgical procedures1.

• vCJD 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instruments were introduced by the Department of Health due to high risks to patients (children and young adults) but withdrawn again shortly afterwards in England due to instrument safety concerns.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 vCJD remained unchanged3. 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 vCJD, resulted in the establishment of the Single-use Instrument Surveillance Programme (SISP) in 20023.

BACKGROUND

• 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.

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.

AIMS OF THE PROGRAMME

1. Department of Health (2001) Risk assessment for transmission of vCJD via surgical instruments: a modelling approach and numerical scenarios. CJD publications London. Available from: htttp://www.dh.gov.uk/policyandguidance/healthandsocialcaretopics/CJD/CJDGeneralInformation/fs/en [Accessed 1 December 2005]

2. 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.

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.

REFERENCES

• 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.

• Patients undergoing tonsil surgery have continued to be protected from the theoretical risk of vCJD 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 using single-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.

CONCLUSIONS

The authors would like to thank all members of the Welsh Otorhinolaryngology Association and all surgeons for their continued participation in this surveillance

Acknowledgements

Figure 1. Schematic diagram showing the surveillance system implemented

SISPSISP

(1) Questionnaire Distribution

(2) Questionnaire completion THEATRE OR WARD

OPERATION ANDINSTRUMENT FORMS

(4) Questionnaires scanned

Data fileproduced

(5) Import into All-Wales database

(7) All Wales reports

Import into hospital database by data transfer co-ordinator

Production of local reports

Surgical teams

(3) Questionnaires returned via post by local surveillance coordinator

(6) Data returned via post or email

HOSPITALHOSPITAL

WAG

COMPLICATIONFORMS

Initial complications (before patient discharged from hospital)

Readmission complications(On readmission of patientto hospital)

• 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 instruments4. Modifications to instrument design were established through working with Welsh ENT surgeons, leading to a set of specifically designed single-use steel instruments.

• 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.

• SISP is alone, however, in including a detailed assessment of each instrument in use by the surgeon at the time of surgery.

• 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.

METHODS

Figure 2. Minor, major and total instrument percentage problems noted for specified single-use instruments 2003 - 2006

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

2003 2004 2005 2006Year of surveillance

Tota

l inst

rum

ent p

roble

ms

(%) Major problems

Minor problems

RESULTSCurrently 13,209 procedures in total are present within the all Wales tonsils database. The number of procedures broken down per year are – 2,158, 5,126, 3,934 and 1811 for 2003, 2004, 2005 and until end of August 2006, respectively. Almost 9,000 are tonsillectomy and 3,000 adenotonsillectomy procedures.

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 2003 to 2006 has remained lower than with reusable instruments (1.4%).

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 and major problems have each decreased 4-fold (2006 compared with 2003).

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.

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

50.0%

Feb-03

Mar-03

Apr-03

May-03

Jun-03

Jul- 03

Aug-03

Sep-03

Oct-03

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Dec-03

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Feb-04

Mar-04

Date of Procedure

% in

stru

men

t p

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s fr

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to

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o. u

sed

Gag & BladeDraffin rodsYankauerEves SnareLucsDen. BrowneBirkettGwynne EvansNegusKnot pusherCurretteDiathermy

Figure 3. Number of reported instrument problems by month by instrument usage (first year of the surveillance)

SMTLSMTL WORLA

SISP