Our homepage in german language:

http://www.sterilgutverpackung-bewerten.de

University Medical Center Goettingen

Prof. Dr. med. H. Dunkelberg (M.D.)

Dr. med. U. Schmelz (M.D.)

Georg - August - University

Department of General Hygiene and Environmental Health

Humboldtallee 34A

D-37073 Goettingen, Germany

Phone:

0049-551-50078861

0049-551-394973

Fax:

0049-551-50078864

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Attainment of the highest level of microbiological quality for packing, transport and storage of sterile medical devices

 

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This home page inaugurates a new chapter in data-supported quality assurance with regard to terminally sterilized medical devices that implements the International Standards applying to sterilization in transport and storage. The various microbial challenges in transport and storage of sterile material can be evaluated and checked at in terms of the sterility assurance level of 1 : 1,000,000 with the method described here.
 
Quality assurance procedures of this kind are required because the conventional commercial packaging for sterilized medical devices has a limited barrier efficiency to the passage of airborne microorganisms. The procedure described here can be used to demonstrate and verify compliance with the specifications of the European Medical Device Directive 93/42/EEC of 1993. According to this directive sterilized medical devices should remain sterile under the conditions of storage and transport envisaged.
 
An important step consists in establishing the relevant ambient conditions. On the basis of concrete input data, the computer program presented calculates the microbiological challenge to the packaging of sterilized medical devices resulting from transport and storage. The packaging must show the appropriate effectiveness of the barrier if the sterile state is to be maintained at the high safety level. Vice versa, it can be tested and confirmed, whether specified limit values of the microbial challenge are not exceeded in transport and storage so that performance characteristics of the packaging are not overtaxed and sterility is not endangered (EN ISO 11607-1:2006;5.5.2). This method offers the possibility to calculate the date of expiry of sterile-packed and stored sterilized medical devices on the basis of concrete data. A high quality level and cost effectiveness are the basis of this performance appraisal. It also fulfills the highest requirements and expectations of the patient with regard to the supply of sterilized medical devices.

We are offering this program to physicians and specialised staff at hospitals and outpatient departments, the manufacturers of medical products and those responsible for health services.