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The permissible re-use of medical devices requires that they can be efficiently cleaned and disinfected and/or sterilised.  Equipment used to decontaminate reusable medical devices is carefully controlled to ensure the effectiveness of the decontamination process.

The HTM 01-06 (formerly CFPP 01-06) Guidelines issued by the Department of Health and the now archived standard HTM2030, cover the testing of Endoscope Washer Disinfectors (EWD’s) to ensure that they are operating within the required parameters for effective decontamination of medical devices.  HTM 01-01 (formerly CFPP 01-01) and HTM2031 cover the requirements for sterilising re-useable medical devices using heat and steam.

Routine and periodic testing of both the equipment during use and of the final rinse water is designed to highlight where failure may occur which could result in the ineffective decontamination of re-useable devices putting patients at risk.

Weekly Water Testing

Weekly water testing of the rinse water used in an Endoscope Washer Disinfector ensures a rapid response to emerging problems of deteriorating water quality.  Weekly water testing includes a Total Viable Count (TVC) by membrane filtration, Hardness and Electrical Conductivity.  As a UKAS accredited laboratory (4236), 20/30 Labs hold are accredited for both the HTM 01-06 (formerly CFPP 01-06) weekly water TVC method and the HTM2030 (withdrawn) weekly water TVC method.  The main difference between the two methods is a change in temperature and incubation time.  HTM2030 TVC method incubates samples at 35C for a minimum of 48 hours, whereas the HTM 01-06 TVC method incubates at 30C for 5 days.

Quarterly Testing

Quarterly testing includes a wider range of tests than those carried out on a weekly basis.  In addition to the TVC water testing and chemical analysis, the presence of clinically important Environmental Mycobacteria and Pseudomonas aeruginosa is also tested.  This aims to prevent recontamination of equipment during the rinse stage of the decontamination process with opportunistic pathogens that can be potentially harmful to immunocompromised patients.  20/30 Labs are a UKAS accredited laboratory (4236), able to carry out water testing for the enumeration of Environmental Mycobacteria.

Annual-PQ-surrogate-scopes-disinfection-efficacy

Annual Performance Qualification (PQ) Testing+

To assess the performance of Endoscope Washer Disinfectors to suitably decontaminate re-useable medical devices, performance qualification of the EWD is undertaken on an annual basis by qualified personnel.  Analysis includes the determination of disinfection efficacy using surrogate devices inoculated with a range of organisms including Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Geobacillus stearothermophilus, Mycobacterium terrae and Escherichia coli.  Microbiological analysis of rinse water, the ability of the washer to remove test soil and effective chemical dosing is also established.

Chemical Analysis*

The chemical purity of water used for the decontamination of medical devices is critical to the efficacy of detergents and disinfectants used in the process and the potential for mineral deposits affecting the optimum operating parameters of the equipment used.  Chemical water testing includes, but is not limited to conductivity, hardness, pH and levels of Chloride, Iron, Silicate, Nitrates and Lead.  Read more

Drying Cabinets+

Prior to the release of ISO 16442, in the absence of an official standard, 20/30 Labs provided various methods for routine monitoring of Controlled Endoscopy Storage Cabinets, including sterile surrogate devices, settle plates, contact plates and swabs and the subsequent microbiological analysis of the test media..  Following the release of ISO 16442, and HTM 01-06 which includes guidance for routine testing, 20/30 Labs can provide the routine test consumables described within the guidance, now also including those for Dryness Testing.  Please contact us for more information or for guidance on the implementation of the new standards.

Tests denoted with * are not UKAS Accreditation.  Tests denoted with + have partial UKAS Accreditation

Hospital Analysis

A vast suite of standard and specialist analyses are available. Read More

Potable Water Testing

A range of tests available as required by the MODW and HTM 04-01. Read More

Pseudomonas Aeruginosa

The detection and enumeration of Pseudomonas aeruginosa according to HTM 04-01 and the MODW. Read More

Legionella Testing

Accredited to ISO 11731-2:2008 to carry out detection and enumeration of Legionella. Read More

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