Central Service - Issue 6/03

EDITORIAL

Training - The Key to Success

NEWS UPDATE

What's New in Standardisation: Steam Boilers
Erratum
Quality Assurance Measures in Sterile Supply. 4th Schleswig-Holstein CSSD Forum.
ASHCSP Advances the Central Service/Sterile Processing Profession at 2003 Conference
Association for Applied Hygiene Founded

MAIN ARTICLES

B. Peláez*, I. Redondo, N. Kayali, M.C. Gaspar, L.M. Polo, J. Fereres:
Detection of Formaldehyde Residues in Plastic Material Sterilised in Low Temperature Steam and Formaldehyde
(Zentr Steril 2003; 11 (6): 393-400.)

Abstract
Object: To determine the presence and persistence of formaldehyde residues in different plastic materials sterilised by low temperature steam and formaldehyde (LTSF) and the cumulative effect of several sterilisations, using an optimised extraction and quantification method.

Material and methods: Different plastic materials (4 samples/type of plastic) (silicone, polyurethane, polysulphone, chloroprene and latex) were sterilised by LTSF (50ºC and 60ºC) and the formaldehyde residues quantified. The residues were determined using an optimised extraction method (solid phase microextraction) and gas chromatography and mass spectrometry quantification with a 6 ng detection limit. The persistence of the residues 48 hours and one week after sterilisation and the cumulative effect of three successive sterilisations on two pieces of silicone were also evaluated.

Results: The levels of formaldehyde residues (ng/cm2) detected following sterilisation by the 50 and 60ºC cycles respectively were: silicone, 2.4 and 1.7; polyurethane, 23 and 21; polysulphone, 11.9 and 16.6; chloroprene, 112 and 236; and latex, 39.3 and 10.9. One week after sterilisation 0.8 ng/cm2 were detected in the silicone and 2.6 ng/cm2 following three consecutive sterilisations.

Conclusions: The levels of formaldehyde detected in the different plastics following sterilisation by LTSF (50 ºC and 60 ºC cycles) were below the limit proposed by the European Committee for Standardisation for high risk equipment. Although extremely low concentrations of formaldehyde were still detected a week after sterilisation, no cumulative effect was found as a result of successive sterilisations.

Amenability to Cleaning Project Group (PGR):
Investigations to Demonstrate Amenability to Cleaning of Surgical Instruments
(Zentr Steril 2003; 11 (6): 401-408.)

Abstract
Evaluation of standard instruments has revealed that the gap in jointed instruments is a critical zone when it comes to cleaning. This paper investigates to what extent needle holders are amenable to cleaning after having been put to use. By way of comparison, a description is given of tests conducted with a sheep blood soil and of the relationship to gap width and size of closure surface. The instruments were successfully cleaned in both series of tests.

R. Seavey*, An Nuyttens:
The Facts: Wet Packs and Plastic Accessory Cases
(Zentr Steril 2003; 11 (6): 409-413.)

Abstract
Three types of accessory cases were studied: plastic, metal, and hybrid (combination metal and plastic) cases. All packs were prepared, loaded and sterilized in accordance to The Association for the Advancement of Medical Instrumentation (AAMI) and the European Committee for Standardization (CEN) standards. The studies were performed at independent institutes in the USA and Europe and focused on steam sterilization. In the sterile processing community, there is a perception that plastic accessory (instrument) cases have a greater tendency to experience wet pack problems. This paper addresses wrapped accessory (instrument) cases and is a result of independent studies. Several parameters were evaluated including the loading, weight, mass and different case designs. All three types of packs performed well and no wet pack problems were observed.

LETTERS

Bowie & Dick Test

STERILIZATION BASICS

P. Hooper:
Labelling Requirements

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

Updating the Decision Tree on Risk Assessment and Classification of Medical Devices