«Washer Disinfector» with the European Standards

Introduction

Washer-disinfector is technological innovation that reduces the occupational risks that may bring about during the process of handling the instruments contaminated by microorganisms. The cleaning of instruments used in work environment is utmost important to safe guide the cross-infection between patients and staff in the hospital. Thus, for effective cleaning system, there is need to use automatic disinfecting washing machine. (Bergo, 2006).

Due to the awareness of dangers of cross infections in the hospitals, Health Technical Memorandum 2030 (HTM 2030), and the impending European standard of BS EN ISO 15883 have set up the guideline and legal requirements on the use of washer-disinfectors for the cleaning of all materials as well as surgical instruments in the hospital environment.

To comply with European standard for washer-disinfectors, HTM 2030 provides validation and periodic testing guideline of washer-disinfector in order to ensure the minimisation of cross infection between patients and staff. Thus, essential criteria of validation process of washer-disinfector are to use audit strategy in other to ensure that washer disinfector complies with the European Standards HTM 2030 / EN 15883.

The objective of this report is to audit validation report of the Washer-Disinfector owned by Sadexho Healthcare with the European Standards HTM 2030 / EN 15883.

The rest of the report is organised as follows:

First, the report provides general overview of Washer-Disinfector owned by Sadexho Healthcare.

In addition, the report provides method of carrying out audit of validation report of Washer-Disinfector owned by Sadexho Healthcare to check whether it complies with the European Standards HTM 2030 / EN 15883.

Finally, the report provides findings of the validation process Sadexho Healthcare’s washer-disinfector.

Overview of Washer-Disinfector owned by Sadexho Healthcare

Sadexho Healthcare is a hospital that engages in period of surgical services for patients. To ensure of minimisation of cross infection between patients and staff, the management of Sadexho Healthcare bought the Washer-Disinfector in 2002 for Sterile Service Department, which was made by HAMO with serial no 9800000011. In compliance with the legal requirements set up by European Standards HTM 2030 / EN 15883, Sadexho Healthcare provides yearly validation of the hospital’s Washer-Disinfector. The first period that the Washer disinfector passed through validation process was in 14 March 2002, and the results of the validation of a yearly test on surgical instruments confirmed, “The test results confirmed that all the requirements of HTM2030 were met and the Washer-Disinfector is fit to use on the Surgical Instrument program”. (cited from Sadexho Healthcare).

Meanwhile, the third party audit confirmed, “all the requirements of HTM 2030 were met and the Washer-Disinfectors is fit to use on the surgical instruments program. The Water System results indicated that the RO water system is not operating correctly-Further investigation is required.” (Cited from Sadexho Healthcare).

Based on the results of the third party test, it is essential to carried out the audit of validation report carried out on Washer-Disinfector owned by Sadexho Healthcare in order to show that the Washer Disinfector complies with the European Standards HTM 2030 / EN. Thus, next section provides methods of validation process.

Methods of validation of Washer Disinfector of Sadexho Healthcare

The method this report use to audit the validation report of the Washer Disinfector owned by Sadexho Healthcare is to compare all the requirements of this Washer Disinfector with the laid down legal frame work for validation process laid down by the European Standards HTM 2030 / EN 15883.

According to the laid down Washer Disinfector Washer of the European Standards HTM 2030 / EN 15883. The Washer disinfector should able to remove difficult gross contamination, which include blood, bone fragment, and solid debris. The temperature standard must not be less that 40 0 C, which is the best to prevent protein coagulation.

In addition, the mechanical and chemical process should be in line with the requirements of European norm of HTM 2030. The detergents used for the Washer disinfector should be in line with manufacturer and comply with European Standards HTM 2030 / EN 15883.

To avoid instrumental degradation, which include corrosion, staining, and discoloration, the detergent to be used for washing should be compatible with washer-disinfector. (Department of Health, 2009).

Thus, from the specification of HTM 2030 standard there should be safety door lock of the washer disinfector. The detergent range should incorporate Alkaline, pH Neutral, Enzymatic, and Acid. Moreover, the rinse aid should range between 11lt to 20lt.

The disinfector dryer should have large chamber of 180lt volume, with dental rack of 24 hand pieces. (Peacocks Medical Group).

Typically, the disinfectant solution should established independent testing or have minimum requirement designated by manufacturer, which should be 2% solution of glutaraldehyde with limit concentration of 1.5%.

In addition, the rinsing stage for the washer disinfector should be suitable which will not lead to recontamination from microorganisms, and the temperature of static water should be between 10C and 55C. (Labcaire, 2009).

As being indicated above, the methods used for audit process is to check whether Washer-Disinfector owned by Sadexho Healthcare is compatible with European Standards HTM 2030 / EN 15883.

Thus, the description of European Standards HTM 2030 / EN 15883 provided above will provide findings for the report. The findings will provide whether the Washer-Disinfector owned by Sadexho Healthcare is compatible with European Standards HTM 2030 / EN 15883.

Findings

The findings for this report is to provide the results of the audit process that reveals whether the Washer-Disinfector owned by Sadexho Healthcare is compatible with European Standards HTM 2030 / EN 15883. Audit is a third party verification to ensure report validity.

The following criteria will be based to carry out the findings of washer disinfector.

  • Yearly safety checks: According to the chapter, 2 of Validation and verification procedure of Health Technical Memorandum 2030, which states that there should be testing washer-disinfectors. The section 2.46 states that there should be periodic testing of washer disinfector. The periodic testing can be weekly, monthly of yearly. The periodic tests are to ensure that washer-disinfector performs according to the laid down procedure of European Standards HTM 2030 / EN 15883. Added to the periodic test, there should also be validation of the test carried out on the washer-disinfector. However, from the test report sheet of Washer-Disinfector owned by Sadexho Healthcare, the Sterile Services Department carried out the weekly safety check, and weekly record check, which was in line with chapter 2.46 of HTM 2030, which states that there should be periodic test of HTM 2030. However, Washer-Disinfector Yearly Test Record reveals that the yearly test of Washer Disinfector was only carried out on 14 March 2002, and since then, there was no record that another test was carried on the washer –disinfector. Meanwhile, chapter 2, section 2.46 states that there should be periodic test of washer disinfector in order to comply with European Standards of HTM 2030 / EN 15883. (NHS Estates, 1997).
  • Water Quality Test: According to chapter 14.5 of HTM 2030, which consists of Water quality for the washer-disinfector. The guideline stipulated by European Standards HTM 2030 / EN 15883 is that the water quality should be sterile water. There filtration stage should be able to retain particles of 5µm or larger. The filtration of bacteria should be 0.22 µm. ((NHS Estates, 1997, Labcaire, 2009). However, the Sadexho Healthcare’s Washer-Disinfector yearly test record revealed that the record was a little different from the laid down procedure of European Standards HTM 2030 / EN 15883. From the record, the water conductivity: RO water is 10µm, and the water conductivity: RO water for HTM 2030 is stipulated to be 5µm or larger.
  • General operating requirements: The general operating requirement provides operating system of the washer-disinfector of Sadexho Healthcare. The specification of HTM 2030 reveals that level of temperature of operating system, which specifies the temperature of flushing, should not exceed 35C, which is the maximum temperature to minimise the coagulation of protein. In addition cleaning with detergent solution should not be more than 60C, which is in line with chapter 8.18 of HTM 2030 laid down procedure. (Labcaire, 2009).

From the Washer-Disinfector Yearly Test Record of Sadexho Healthcare, the validation temperature recorded minimum of 55C and maximum of 61C. There is slight difference of 1C of washing temperature recorded with European standard.

It is essential to realise that the distribution of water system revealed that temperature could be heated at 60oC, and disinfecting at 90ºC, which is in line with HTM 2030 European standard. (Lambert, 2008).

However, Washer-Disinfector Yearly Test Record of Sadexho Healthcare provides validation for disinfecting temperature to be minimum of 91C and maximum of 92C, which also reveals the slight variation with European standard.

Conclusion

The report provides audit of validation report of Washer Disinfector with the European Standards HTM 2030 / EN 15883. The audit report reveals that the Sterile Services Department of Sadexho Healthcare validated weekly testing of washer- disinfector in order to be in guideline with European Standards HTM 2030 / EN 15883. However, the audit report reveals that the validation was not carried out yearly as being stipulated 2030 in chapter 2.46 of HTM 2030, which states that there should be periodic tests for washer disinfector. The record showed that it was only in 2002 that yearly test was carried out. Moreover, the audit report supports that the validation report that RO water system is not working properly. In addition, the audit report shows that there was slight variation of disinfecting temperature level, and temperature of distribution of water system.

The recommendation provides for the audit report is that some parts of washer disinfector are not working properly with compliance with European Standards HTM 2030 / EN 15883. Thus, washer disinfector should be repaired or the Sadexho Healthcare buys a new washer disinfector.

References

Bergo, M, C, N, C, (2006), Evaluation of Cleaning and Disinfection Performance Ofautomatic Washer Disinfectors Machines in Programs Presenting Different Cycle Times and Temperatures, Setembro-Outubro; 14(5) Pp :735-41.

Department of Health, (2009), Decontamination Health Technical Memorandum 01-05: Decontamination in Primary Care Dental Practices, UK.

Labcaire, (2009), Washer Disinfectors Health Technical Memorandum 2030 Operational Management, Labcaire Reference? UK.

Lambert, T, (2008), Purifying Water for Hospital Sterile Services, Purite Ltd, UK.

NHS Estates, (1997), Washer-Disinfectors Validation and Verification Health Technical Memorandum 2030, the Stationery Office, Department of Health, UK.

NHS Estates, (1997), Washer-Disinfectors Operational Management Health Technical Memorandum 2030, the Stationery Office, Department of Health, UK.

Peacoks Medical Group (ND), Decontamination Solutions, Peacocks Medical Group Ltd, UK.

Sadexho Healthcare (ND), Sadexho Healthcare, Certificate of Washer , Disinfector Validation, Sterile Service Department, Holby Ssd.

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