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The article focuses on the use of standard operating procedure (SOPs) help to demonstrate compliance with all the hygienic and technical requirements legally specified for medical device reprocessing. Topics include SOPs describe the correct implementation of all relevant work steps in the respective workplace; and SOPs being compiled to complement a procedure for all relevant steps of the reprocessing process.

The article highlights the recommendations of Germany's Quality Task Force for maintaining hygiene standards when dealing with external persons in the Reprocessing Unit for Medical Devices (RUMED). Topics discussed include health risks facing external persons in the RUMED, hazard assessment as per the Biological Agents Regulation, and mandatory protective measures for external persons.

The article examines the implications of the Medical Device Regulation (MDR) for operators of medical devices in healthcare institutions in the European Union (EU). Topics discussed include important changes introduced by the MDR for medical device operators and manufacturers, implications of changes to the classification system, and the Medical Device Law Implementing Act in Germany.

The article presents the transport and storage not adversely affecting the medical device characteristics. Topics include sterilized medical devices (MDs) being protected against contamination when transported between the reprocessing department and the site of use; using MDs harbor potentially infectious contaminants against which the must be protected; and sterilized MDs must be transported separately from non-sterilized MDs in ruling out contamination.

Currently, heat-sensitive flexible endoscopes are reprocessed in central RUMEDs, a RUMED situated within the endoscopy department as well as in decentral RUMEDs. Before deciding where reprocessing is to be carried out, structural and technical prerequisites, manpower as well as organizational and logistical structures must be considered. Regardless of the choice of reprocessing site, reprocessing must meet the same quality requirements. Following manual precleaning and cleaning, flexible endoscopes should preferably undergo automated reprocessing in an automated endoscope reprocessor (AER) using validated processes (EN ISO 15883-4 [5]). Depending on the type of endoscope used, validated reprocessing processes must meet various requirements and include manual precleaning , automated cleaning and disinfection in an AER, drying, and possibly sterilization and storage. That calls for personnel with commensurate specialist knowledge and qualifications. The structural and technical facilities are the key to consistent separation between unclean and clean work steps, reprocessing safety and infection prevention. If sterilization is indicated for medical and hygiene reasons for heat-sensitive components, a suitable low-temperature process should be chosen in accordance with the manufacturer's instructions. [ABSTRACT FROM AUTHOR]

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The development of instruments for minimal invasive surgery (MIS) is moving in the direction of the miniaturization of mechanical components, a combination of multiple functions in a single instrument, and the introduction of new techniques, in particular those reducing bleeding and thermal damage when cutting blood vessels. These tendencies have consequences for the reprocessability of the instruments, usually making reprocessing more difficult. In particular cleaning--the removal of contaminations from tiny lumina, joints, etc., is highly demanding. In addition, proof of successful cleaning is difficult, and no standardised method of doing this in practice is currently available. An overview of the problems associated with the reprocessing of instruments for minimal invasive surgery is given, and a numbers of possible solutions are discussed.

Wear, tear, and possible contamination after 100 clinical cycles of three test trays were investigated on laparoscopic "tracer" instruments in a prospective clinical study. Failure was below 4 per 100 laparoscopies, and remaining contamination was detected after passing 100 cycles in 20%, which happened to control instruments from open surgery as well. Further clinical data of contamination levels for apparently clean instruments must be collected to evaluate and correlate to microbiological testing.