Introduction
For automated cleaning, thermal or chemical disinfection, and drying of reusable general surgical instruments prior to sterilization in outpatient/same-day surgery departments, surgical centers, and ambulatory care centers, a variety of Washer-Disinfectors (WS) are in use. This audit report reviews a ‘Yearly Validation And Re- Performance Qualification Tests’ on a Getinge Decomat 8666 Washer-Disinfector (WD), Serial No. 80338, Unit Number 3, for Sterile Services Department of Holby City Hospital. The reviewed test program was required by senior management to demonstrate compliance with published HTM 2030, BS EN ISO 15883, BS EN ISO 13485 and ISO TR 14969:2005 standards and other relevant standards or guidance documents. The review includes reporting perceived deficiencies of the tests, recommendation of necessary additional investigation or testing, and consideration of whether the data reported would justify the use of the WD for processing the instruments for laparoscopic cholecystectomy.
Details and Analysis of the Yearly Validation and Re-Performance Quantification Tests on the Getinge Decomat 8666 Washer-Disinfector (WD)
In Declarations, it is stated that the Washer-Disinfector (WD) met the requirements of HTM 2030 Validation and Verification except for any limitations detailed. However, limitations should not be acceptable in reports dealing with medical devices (see and ISO TR 14969:2005). The declaration statements “it has been tested in accordance with the HTM 2030 and did/did not perform satisfactorily automatic test cycles giving accurate/inaccurate temperature recordings. It meets/fails to meet the test requirements of HTM and can/cannot be returned to service” are vague and meaningless since the words “did not”, “inaccurate”, “fails”, “cannot” were not crossed out or deleted from the report to indicate that the Washer-Disinfector (WD) actually passed (or did not pass – whichever is the case) the Yearly Validation and Re-Performance Qualification Tests. Furthermore, no Limitations/Remarks, etc, are given in the report (the space is left blank) though the Washer-Disnfector (WD) test person signed the declaration form.
In the Test Report Sheet dated 28th February 2002, it is reported that “the results of the test confirmed that all the requirements of HTM 2030 were met and the Washer-Disinfector (WD) was fit for use on Surgical Instruments program”, The requirements of HTM 2030 carried out, i.e., yearly safety checks, automatic control tests, verification of calibration of WD instrument, water system, drainage, doors and door interlocks, water vapor discharge tests, aerosol discharge tests, chemical additive dosing tests, load carriers, tests for air quality, cleaning efficacy tests, over-temperature cut-out tests, thermometric tests for thermal disinfection, load dryness tests, and process residues” are simply listed under observations without stating that the detailed test results are given in another specified section of the report.
For the water systems, it is stated that a “third party carried out the tests” without giving appropriate details of the “third party”. Though it is stated that “the test report showing results are included in “Plant History Record File”, the details or location of the file is not mentioned in the report for easy cross-reference.
In the Conclusions section of the Test Report Sheet, it is stated that “the Water System results indicated that the RO water system was not operating correctly – further investigations were required” and yet the details of the required further investioations is not given and when they were to be done not stated.
The givenTest Report Sheets for Anaesthetic Accessories and Surgical Instruments, respectively, are more or less similar. The only differences are that for Anaesthetic Accessories, Performance Quantification Tests are reported to have been carried out by the user, and also as expected there were differences in Automaic Control Tests and Thermostatic Tests.
In the Test Sequence Sheets for Anaesthetic Accessories and Surgical Instruments, respectively, it is clear that the tests were done and the WD equipment passed the yearly safety checks, automatic control tests (wash time 1m 06s, wash temp 60oC, disinfect time 3m 2s and disinfect temp 75oC for Anaesthetic Accessories; and wash time 1m 04s, wash temp 60oC, disinfect time 1m 02s and disinfect temp 93oC for Surgical Instuments), cleaning efficiency tests (photos were attached to show actual cleaning efficiency of the Surgical Instruments, Anaesthetic Accessories and the WD cabinets), thermostatic tests (measured temp 75.2oC, indicated temp 74.0oC, recorded temp 74.0oC, carrier temp [U] 75.4oC, carrier temp [M] 75.2oC, and carrier temp [L] 75.4oC for Anaesthetic Accessories; and measured temp 94.9oC, indicated temp 93.0oC, recorded temp 93.8oC, carrier temp [U] 94.7oC, carrier temp [M] 94.5oC, and carrier temp [L] 94.7oC for for Surgical Instruments), load dryness tests, and process residues and performance qualification tests (stated for the Anaesthetic Accesories to have been carried out by the user). For aerosol discharge and over-temp cut out tests, it is indicated that they were Not Applicable (N/A) though reasons should have been given in the report.
In page 1 of the Yearly Records Sheets for week 48, it is shown that the following tests were carried out: maintenance, weekly safety checks (7.8 to 7.9 – the meaning of these figures are not explained in the report), and weekly record cheeks.
Water quality tests showed that water harness (soft water) was 4mg/l (max limit 210mg/l), water hardness (RO water) was 0mg/l (max limit 210mg/l), water conductivity (soft water) was 764uscm-1 (max limit 300uscm-1) meaning that the tested water conductivity value was higher than the max limit – yet no explanation is given for this in the report, water conductivity (RO water) was 7.7uscm-1 (max limit 10uscm-1), and that the system analysis failed, and also that water system results indicated that the RO water system was not working correctly and further investigation was required. It would have been better to give details of these required further investigations.
On pages 2 to 4 in the Yearly Records Sheet, detailed results of the tests are also given and sentinel logger charts are provided for temperatures and pump pressure validation test records. Certificates of Calibration for high-temperature loggers are also given and showed that they were in good working condition.
Compliance with Published HTM 2030 and BS EN ISO 15883 Standards
In HTM 2030 requirements for validation and verification of washer-disinfectors, there are statutory and personnel requirements (e.g. safety, training and competency aspects) (EN 554:1994) which seemingly were not addressed in the report indicating noncomplete compliance. As per BS EN ISO 15883-1: 2009, part 1, which covers general requirements, terms and definitions and tests (ISO 15883-1: 2006), certificate of validation and requalification for the WD was authorized and done appropriately and signed by relevant staff which is commendable. However, in annexes C and D of BS EN ISO 15883-1: 2009, part 1, which covers general requirements, terms and definitions and tests (ISO 15883-1: 2006), there are tests for the detection and assessment of residual proteinaceous contamination and also assessment of microbial contamination of WD (ISO 11737-2: ISO 11737-1) which should have been carried out.
As per BS EN ISO 15883-3: 2009 which cover requirements and tests for WDs employing thermal disinfection for human waste containers (ISO 15883-3: 2006) in annex A, drain seal integrity, flushing of non-absorbent materials, flushing of absorbent materials, and safety of loading and emptying of containers tests were either not done or if they were done then the report has not adequately explained them.
Consideration of Whether the Data Reported Would Justify the Use of the WD for Processing Instruments for Laparoscopic Cholecystectomy
The surgery to remove the gallbladder is called a cholecystectomy. An incision of about 5 to 8 inches long or an abdominal cut is used to remove the gall bladder. Open cholecystectomy involves making a cut on the right side just below the ribs which extends to the area just below the waist (Kapoor, 2001). However, laparoscopic cholecystectomy which is performed through many small incisions as opposed to one large incision uses a laparoscope which is able to show the inside of the body and presents a less invasive way of removing the gall bladder. (Kapoor, 2007). The data reported for the WD may not justify its use for some of the instruments for laparoscopic cholecystectomy such as veress needle, suction-irrigation devices and the thin tubular laparoscope which may contain thermo-labile components and may need chemical disinfection unless the tested WD has specific software or program for chemical disinfection as well – details which are unfortunately not given in the report (see BS EN ISO 15883-4:2009, part 4: requirements and tests for WDs employing chemical disinfection for thermolabile endoscopes [ISO 15883-4:2008]; PINEAU et al., 1997). Chemical disinfection also requires additional microbiological tests for efficacy of chemical disinfection of the load and microbiological evaluation of disinfection of liquid transport systems (see BS ISO 15883-4: 2009 – ISO 15883-4: 2008).
Compliance with Published BS EN ISO 13485 and ISO TR 14969:2005 Standards, and Conclusions
In BS EN ISO 13485 (CEN ISO/TR 14969): medical devices – quality management systems – a requirement for regulatory purposes, the WD equipment can be categorized as a medical device since it is used for disinfection of medical devices or equipment. In that case, its cabinet and the instruments that have been disinfected should meet the requirements for sterility. In that case, also, microbiological contamination and the presence of proteinaceous materials tests should have been done. Also, the presence and poof of use of relevant manuals and documents, and records of use, for the WD operation should have been determined as part of the validation and verification tests and evaluation. The report should have also contained information on infrastructure and wok environment pertaining to the location and use of the WD. There should also have been mention of quality management systems in place for operation and use of the WD.
References
BS EN ISO 15883-1: 2009, part 1, which covers general requirements, terms and definitions and tests (ISO 15883-1: 2006)
BS EN ISO 15883-3: 2009 which cover requirements and tests for WDs employing thermal disinfection for human waste containers (ISO 15883-3: 2006)
BS EN ISO 15883-4: 2009 (ISO 15883-4: 2008). Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for a thermolabile endoscope.
EN 554:1994, Sterilization of medical devices — Validation and routine control of sterilization by moist heat.
Health Technical Memorandum 2030, Washer-disinfectors — Validation and verification — The Stationery Office, London. 1997 ISBN 0-11-322071-5
ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products.
ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process.
ISO 13485:2003 (BS EN ISO 13485; CEN ISO/TR 14969), Medical devices — Quality management systems — Requirements for regulatory purposes
KAPOOR VK. Bile duct injury repair – When? What? Who? ‘Journal of HBP Surgery’ 2007; 14: 476-9.
KAPOOR VK. Incidental gall bladder cancer. ‘American Journal of Gastroenterology’ 2001; 96: 627-629.
PINEAU, L., ROQUES, C., LUE, J., MICHEL, G. Automatic WD for flexible endoscopes — A new valuation process endoscopy. 1997; 29, pp. 372-377