Central Service - Issue 4/02

EDITORIAL

Never Forget the Basics

NEWS UPDATE

What's New in Standardisation: Pressure Equipment
Matters Made Easier for Medical Device Manufacturers
Patient and User Protection - MedInform Conference on 13 June 2002 in Mainz
KHK Foundation Prize - Prizewinner and Call for Papers
Study Visit to the Virga Jesse Hospital Hasselt
BVMed Adopts New Image

MAIN ARTICLES

Y. Uetera, H. Saito, Z. Baba, N. Kumada, M. Morikawa:
A Simple Method of Locating Air Leakage Points in Prevacuum Autoclaves Failing the Bowie-Dick Test
(Zentr Steril 2002; 10 (4): 218-224)

Abstract
Air leaking into the steriliser chamber, inefficient air removal and the presence of non-condensable gases in the steam supply are the main causes of Bowie-Dick test failure. Inefficient air removal is easily detected by means of monitoring the pressure in the steriliser chamber. Non-condensable gases can be detected directly by measurement in the steam supply.

Air leaking into the chamber is detected by an air leak rate test. However, this test cannot locate air leakage points in the prevacuum autoclave. Furthermore, there are few reports regarding the methods of locating air leakage points in the prevacuum autoclave. The purpose of the present study was to establish a simple means of locating air leakage points using a gas leakage detecting aerosol in prevacuum autoclaves with Bowie-Dick test failure.

Materials and methods: In the present study, air leakage points were located three times using the gas leakage detecting aerosol method in our two prevacuum autoclaves with Bowie-Dick test failure. With this aerosol spray method, the chamber is pressurised to 2000 mbar absolute. Then, the gas leakage detecting aerosol is sprayed on the valve seats, joints and fatigued parts of the connecting pipework to locate air leakage points. Failure to detect air leakage points with this aerosol spray method raises the possibility of insufficient door seal gaskets.

Results: One prevacuum autoclave failed to pass the Bowie-Dick test twice. The aerosol spray method detected an air leakage point at an insufficient joint in the first case and at an insufficient door seal gasket in the second case, respectively. In the other prevacuum autoclave, the aerosol spray method detected air leakage at six points. In all cases, the prevacuum autoclave passed the Bowie-Dick test after repair of the air leakage points.

Conclusion: The present results suggest that our aerosol spray method is a simple and reliable means of locating air leakage points in a prevacuum autoclave with Bowie-Dick test failure.

RECOMMENDATIONS

Variant Creutzfeld-Jacob Disease (vCJD). Final Report from the vCJD Task Force

STERILIZATION BASICS

Peter Hooper.
What is Sterilization?

ASHCSP

Intro and Update

B. Broder.
President's Report from the ASHCSP

B. Broder.
Strategic Partnering: New Variations on an Old Theme for the 21st Century

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

Classifying Medical Devices before Processing (Part 2)