In Germany, there are up to 1 million (!) healthcare-associated infections per year - of which around 30,000 cases are fatal.
Especially to avoid serious cross-contamination, reprocess-able medical devices should be made available and used with the same safety for every patient application.
For reprocess-able medical devices, the efficacy of the reprocessing procedure proposed by the manufacturer must be reproducibly demonstrated (validation of the reprocessing procedure).
On the one hand, this is necessary to ensure safe reprocessing while maintaining the required performance of the medical device. On the other hand, a risk to the patient, by using non-validated reprocessing methods, can be excluded.
The tests include the validation of the cleaning bar and disinfection bar in manual and mechanical processes.
Furthermore, the sterilizability of resterilizable products must be tested using different methods (steam sterilization, hot air sterilization, low-temperature process (FO, EO, H2O2/plasma)).
The European standards define that type tests are the basis of any quality assurance for medical devices. These are the responsibility of the manufacturer. Secure validations are the responsibility of the operator.
HygCen validates the processing of various types of medical devices according to the applicable european, international and american standards (eg EN ISO 17664, EN ISO 15883, EN ISO 17665, ANSI / AAMI ST79: 2010).
HygCen Austria GmbH
Accredited Testing Laboratory and Inspection Body for Hygiene and Medical Devices