Central Service - Issue 6/02

EDITORIAL

Norms and Directives in the Light of 10 New Countries accessing the EU

NEWS UPDATE

What's New in Standardisation: Large Steam Sterilizers
Regulations on Reuse of Single-Use Medical Devices to be Reviewed in 2004
Infection Risks Posed by Returned Medical Devices: BVMed Recommends an Approach
3rd Schleswig Holstein CSSD Forum on 26 October in Ostseebad Dam

MAIN ARTICLES

A.W. van Drongelen*, A.C.P. de Bruijn, J.F.M.M. Huys, B. Muis:
Optimisation of the Process for a Manually-Operated Jacketed Steam Steriliser
(Zentr Steril 2002; 10 (6): 373-384)

Abstract
The objective of this study was to improve the sterilisation process for a manually-operated jacketed steam steriliser of a type that is mainly used in developing countries. The experiments were focussed on steam penetration and drying for both a standard textile test pack and a full load of three sterilisation drums filled with textiles, while keeping the power and water consumption as low as possible. The process should fulfil the requirements for steam penetration and drying specified in European standards.

Hardly any steam penetration was observed in a standard textile pack during the sterilisation process as recommended by the manufacturer. The process could not be considered sterilisation. For the improvement of the steam penetration, most attention was paid to steam flushing and steam pulsing.

A full load of textiles in three sterilisation drums proved to be the most difficult to sterilise textile load. This load could be sterilised with the use of a modified sterilisation cycle. This cycle consisted of 20 minutes steam flushing at atmospheric pressure, three times a slow pressure build-up to 300 kPa followed by a pressure reduction to 100 kPa and finally a slow pressure build-up to the sterilisation pressure and sterilisation for four minutes.

The vacuum created with the standard steam ejector proved to be insufficient to dry the load and the use of water ring pumps was considered to be inappropriate. An external condensation vessel was developed. This vessel proved to be a low cost means to create an effective drying vacuum.

M. Pfeifer:
Validation of SonoCheck for the Monitoring of Ultrasonic Energy of Ultrasonic Cleaners
(Zentr Steril 2002; 10 (6): 386-391)

Abstract
SonoCheck, a new test for monitoring the ultrasonic energy in ultrasonic cleaner used for reprocessing surgical instruments was successfuly validated. In the validation tests it was shown that SonoCheck will indicate ultrasonic energy needed to induce cavitation and give additional informations regarding the energy level. Thermal disinfection will not influence the result of SonoCheck. Due to the design of the product no residue will be left in the bath when performing the test and therefore SonoCheck can also be used to check the ultrasonic energy during the actual reprocessing of surgical instruments for load safety.

PRACTICAL TIPS

Sterilisation Section of the German Society for Hospital Hygiene (DGKH): The Problems Arising from Non-Condensable Gases (NCGs) in Steam Sterilisation Processes with a Pulsed Vacuum Procedure/Instructions for Interpreting the Inert Gas Value of 3.5% in DIN EN 285

RECOMMENDATIONS

P. Hooper
Choosing the Right Cycle

DISCUSSION

W. Renders:
Can chemical indicators replace biological ones?

U. Kaiser:
Which Sterilant is the Active Component in a Steam Sterilisation Process? Steam? No, it's water!

N. Ghassemieh:
Reprocessing Medical Devices - New Regulations for Ensuring Safety and Economic Efficiency

MAILBOX

Textile Filters/Demonstration of Cleaning Results

RECOMMENDATIONS BY THE QUALITY TASK GROUP (AK »QUALITÄT«)

Water for Operating Washer-Disinfectors