Central Service - Issue 1/07

EDITORIAL

NEWS UPDATE

What's New in Standardisation: Hollow Devices
The EAMDR Introduces Itself
Sterilization Education in Indonesia
ASHCSP Annual Conference
Working Group Instrument Preparation 30 Years On
Validators of (Steam) Sterilisation Processes in the Healthcare Sector

MAIN ARTICLES

T. Friedrich, K. Roth, J. Gauer, P. Heeg:
Sensitivity of Detection Methods for Assessment of Residual Contamination on Reprocessed Surgical Instruments
(Zentr Steril 2007; 15 (1): 29-38)

Abstract
Background:
EN DIN 15883 defines minimum cleaning requirements for reprocessing surgical instruments in washer-disinfectors.

Objective:
To ascertain detection limits for the following residual-contamination detection methods.

Methods:
The Bradford, modified OPA, biuret, BCA, ninhydrin, Combur, HemoCheck-S and radionuclide methods were compared with each other using a blood dilution series.

Results:
The Combur 9 test as well as the HemoCheck-S test (qualitative/semi-quantitative) showed the most sensitive detection limits, followed by the modified OPA and BCA methods (quantitative), the radionuclide (RNM) (quantitative) and ninhydrin (qualitative) methods and, lastly, the biuret reaction (semi-quantitative).

D. Harding, L. Harding:
Review of Current Relevant Legislation and Standards Affecting Sterile Barrier Systems for the European Medical Device Market
(Zentr Steril 2007; 15 (1): 39-45 )

Abstract
Sterility and its maintenance, together with the prevention of cross-infection, are at the top of any list of critical factors in patient care. The packaging around medical devices that allow those devices to be sterilised, provides a microbial barrier and maintains sterility effectively up to the point of use is known as a sterile barrier system. A sterile barrier system is an essential part of a sterile medical device.
Manufacturing medical devices and their sterile barrier systems in a highly regulated environment can be extremely challenging and traceability throughout the whole life cycle is essential.
The article describes medical device regulation in Europe and gives Examples of other relevant standards.

U. Kaiser:
Which Chemical Indicators Should Be Used in a Processes Challenge Device System (PCD; BMS; MDS)?
(Zentr Steril 2007; 15 (1): - )

Abstract
* no abstract available *

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

Decontamination of Plastic Medical Devices or of Devices with Plastic Components (Part 1)