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Central Service - Issue 3/2008

Central Service - Issue 3/2008

Central Service - Issue 3/2008

FROM THE FIELD

Y. Uetera*, Y. Saito, K. Ide, H. Yasuhara, N. Kumada, R. Saito, O. Takahashi:
Reduced Water Supply to the Water Ring Vacuum Pump

Abstract
The vacuum pump plays an important role in the prevacuum autoclave. The present report is concerned with how the prevacuum autoclave is affected by reduced water supply to its water ring vacuum pump.
Our prevacuum autoclave is equipped with a water ring vacuum pump. The sterilizer manufacturer recommends that water should be supplied to the vacuum pump at 5 litre/min. It is also recommended that end pressures of vacuum pulses should be lower than 80 mbar absolute.
Since vacuum pulses failed to attain the recommended level, our prevacuum autoclave underwent mechanical repair. It was revealed that water was supplied to the vacuum pump at 3.5 litre/min. The flow valve in the water supply system was then replaced with a new one. The impaired flow valve showed rusty corrosions in the lumen.
After replacement of the flow valve, flow rate improved from 3.5 to 4.5 litre/min. Maximum vacuum level also improved from 95.2 to 54.5 mbar absolute in the unloaded chamber. EN 285: 2006 recommends that the vacuum level should be lower than 70 mbar absolute.
Moreover, in the vacuum leak tests, vacuum level improved from 96.3 to 58.0 mbar absolute after the repair. Vacuum leak rates were 0.08 and 0.11 mbar/min before and after the repair, respectively. According to Health Technical Memorandum 2010, the vacuum level should be lower than 70 mbar absolute, and the vacuum leak rate lower than 1.3 mbar/min.
In the present case, chamber integrity was considered satisfactory, and the vacuum pump function improved remarkably after the repair. Therefore, it is suggested that the reduced water supply to the water ring vacuum pump could be a cause of insufficient vacuum pump function in the prevacuum autoclave. Moreover, the end pressures of vacuum pulses should be monitored in every batch cycle

RECOMMENDATIONS

AFS Working Group*:
Architecture and Sterilisation Premises

Abstract
This document is the fruit of a joint collaboration between members of the French Sterilisation Association (AFS) whose goal was to find answers to questions about architectural organisation which anyone in charge of, or employed in, the Central Sterile Supply Department (CSSD) could ask themselves. It is a proposal for rational organisation of sterilisation in the light of regulatory constraints.
This study aims to enhance the sterilisation environment, while making provision for "forward movement" and for tracking of the medical devices (MDs) to be sterilised. Our study is confined to steam sterilisation.
This document is not a review of sterilisation procedures but rather is intended as a guide to organising the CSSD in respect of the different architectural constraints that can be encountered. Nor is it a list of suppliers or manufacturers

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

Performance Requalification on Changing the Process Chemicals

LEGAL ISSUES

M. Kraft:
Framework Conditions and Requirements to Ensure the Technical Functional Safety of Reprocessed Medical Devices

EDUCATION

Ursel Oelrich*, Wolfgang Fuchs, Armin Meßmer:
Visual Inspection, Maintenance and Functional Testing of Standard

Abstract
This paper describes the minimum requirements for proper conductance of visual inspection, maintenance and functional testing of standard dismantlable bone punches from a manufacturer’s perspective. Based on past experiences the most common mistakes made and problems encountered are outlined as well as the measures taken to eliminate them and find effective long-term solutions to problems.
By complying with the specifications and recommendations one can be sure that, as far as the hygiene and technical requirements are concerned, only impeccable dismantlable bone punches will be used or that, alternatively, any inadequate dismantlable bone punches will undergo appropriate treatment. As such, risks to either patients or users are largely ruled out, and expensive repairs or new purchases are kept to a minimum.
While carrying out maintenance and repair tasks for non-dismantlable bone punches a major problem with residues was found in 20% of these devices following automated decontamination (in particular in the gap between the slider and main handle part). Bearing in mind the problems relating to cleaning, Aesculap has been supplying a comparable range of dismantlable Kerrison bone bunches for more than 10 years now. These are available in different designs.
This paper describes by way of example visual inspection, maintenance and functional testing of dismantlable bone punches so as to highlight how an instrument of a complex, optimised design can be cleaned.


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Free Access to Central Service E-Paper
Since 2008 Central Service has also been available as electronic E-Paper version. Subscriptions are possible to the print issue only, the online E-Paper issue only, or as a combined subscription to both. A free E-Paper version of back issues of Central Service is now available for subscribers to the print issue (starting from Volume 16, 2008). Please contact to order your free E-Paper access code.

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