gms | German Medical Science

GMS Hygiene and Infection Control

Deutsche Gesellschaft für Krankenhaushygiene (DGKH)

ISSN 2196-5226

The safe processing of medical devices in the interests of patient protection

Die sichere Aufbereitung von Medizinprodukten im Interesse des Patientenschutzes


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  • corresponding author Axel Kramer - Institute for Hygiene and Environmental Medicine, Ernst-Moritz-Arndt-University, Greifswald, Germany
  • Ojan Assadian - Department of Hygiene and Medical Microbiology, Medical University, Vienna, Austria
  • Christian Jäkel - Law firm Sozietät Dr. Rehborn, Office Berlin, Berlin, Germany
  • author Marc Kraft - Technische Universität Berlin, Department of Medical Technology, Berlin, Germany

GMS Krankenhaushyg Interdiszip 2008;3(3):Doc27

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter:

Veröffentlicht: 3. September 2008

© 2008 Kramer et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen ( Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.



The correct processing of medical devices serves the prevention of infection and, within the multi-barrier system of hygiene measures, is indispensable in the prevention of infection in the interests of patient protection. In order to achieve the ends of preventative health protection, the hygiene, safety-technology and legal conditions must be clearly defined, and the user must be made familiar with these conditions through a program of public education. Research work to further develop processing procedures, including quality assurance, is also essential. The issue here is the safe processing of both re-usable medical devices and medical devices declared as single-use.

In 2006, the International Expert Group for Safety in Medical Device Reprocessing (smdr) was set up in order to analyze the various issues involved, and to define the necessary framework conditions for proper processing. The smdr is composed of hygienists, experts from various clinical fields, medical device specialists, and specialist lawyers, under the auspices of the German Society for Hospital Hygiene (Deutsche Gesellschaft für Krankenhaushygiene, DGKH) and the German Society for Sterile Supply (Deutsche Gesellschaft für Sterilgutversorgung, DGSV). On the German board, the area of hygiene is represented by Prof. A. Kramer (who is also the spokesperson for the group), Prof. H. Martiny and Dr. K.-D. Zastrow; the legal area is represented by Dr. C. Jäkel and Prof. V. Großkopf; the area of technical-functional safety is represented by Prof. M. Kraft; Dr. U. Müller represents the area of biocompatibility; economic aspects are dealt with by Prof. W. von Eiff, and issues affecting the users of medical devices are handled by Dr. M. Antz, Prof. U. Hesse, Dr. D. Gärtner, Dr. C. M. Krüger and Dr. R. Lippert. The International Board is composed of Prof. O. Assadian (Wien), Prof. D. Hu (Shanghai), Prof. J. Fereres (Madrid), Prof. G. French (London), Prof. H. Kobayashi (Tokyo), Prof. Li Han (Peking), Dr. H. Walfridsson (Linköping) and Dr. A. Widmer (Basel).

The smdr is currently addressing the following issues:

  • What is required in the interests of patient safety?
  • Analysis of the current situation with regard to the safety of the processing of medical devices for repeat and declared single-use in the areas of GP and dental practices, in central supply as well as medical device processing under industrial conditions. The analysis includes highlighting shortcomings in the provision of detailed processing guidelines by manufacturers of medical devices that can be processed.
  • Developing ethical, hygiene and legal framework conditions for the processing of medical devices for processors and authorities.
  • Conditions and requirements to ensure the technical-functional safety and biocompatibility of processed medical devices.
  • Holding events and providing further training on the subject of processing.

While in the past the media have often pointed out (in one-sided reports) the risks of reprocessing medical devices declared for single use, an analysis of dental practices [1] showed that the greatest shortcomings lie in the out-patient sector. Although the Robert Koch Institute (RKI) also demands quality management with regard to processing in individual practices, the implementation thereof leaves much to be desired. Analogously, this applies to the correct processing of gastrointestinal endoscopes. Experts assume that around one infection occurs per 1.8 million gastroscopy procedures. Today, endoscopes can be satisfactorily processed, so it is unacceptable for Heliobacter pylori, Hepatitis B- and Hepatitis C-Virus or C. difficile [2], [3], [4] to be found during checks of the results of processing. With regard to the latter virus, a sporicidal disinfection stage should be required in the processing procedure. On the other hand, new developments in the field of endoscope technology, featuring more extensive diagnostic and intervention options, also present new challenges for processing.

Another important smdr initiative was the preparation of an opinion in reply to the BMG’s request for a progress report on the processing of medical devices in Germany (published in 2008) [5]. Following an evaluation of the submissions, the BMG has drawn the following conclusions:

  • The importance of correct processing in the interests of increasing patient protection must be emphasized even more strongly to all those involved.
  • The legal framework for the processing of medical devices is sufficient. To clarify what is required, however, some adjustments should be made in future legislation.
  • A fundamental revision of the provisions in connection with the processing of so-called single-use products, leading to a complete prohibition, is not appropriate, nor is it necessary on other grounds. Instead, the basic principle applies: the same standard of safety for all medical devices, regardless of whether these are declared by the manufacturer as re-usable or single-use products.
  • Specific requirements regarding the processing procedure for critical medical devices should be defined in more detail.
  • There are significant differences between the out-patient and in-patient sectors with regard to knowledge of the RKI/BfArM recommendation.
  • The monitoring of the processing procedure in healthcare facilities and processing by external service providers is of paramount importance.
  • The personnel resources available to the supervisory authorities are insufficient in places.
  • In the meantime, the subject of safe medical device processing has been taken up at the EU level. The BMG progress report points out that in accordance with Art. 12a Directive 2007/47/EC, the European Commission is required to submit a report on the reprocessing of medical devices by 2010.

The present issue of ‘GMS Krankenhaushygiene Interdisziplinär’ is another activity in which the smdr is involved.

In an overview preceding the smdr articles, the possible socio-economic and socio-cultural factors, as well as regional differences with regard to the occurrence of resistant bacteria and the related resistant genes, are discussed with the objective of reducing the problem of antimicrobial resistance in both developed and developing countries.

The articles that follow deal with the ethical, legal, hygiene and material-technical requirements for safe processing. At the same time, the user is provided with guidance for decision-making, such as a description of quality management for processing medical devices, including the requirements with regard to certificates for processors of medical devices, because many users do not know who is entitled to carry out proper processing of these products. Of course, these requirements also apply to medical devices declared for single-use. The results of a prospective randomized study on processing confirm, from the operator’s point of view, the equivalence in the standard of re-sterilized ultrasonic scissors and new devices.

Finally, in order to temper what at times is perceived by the authors as the overkill of the current requirements, an attempt is made to define the limits of sterilization safety within parameters that are both feasible and practical.


Kramer A, Meyer G, Ertzinger S, Kietz K, Schrader O, Martiny H. Multi-centre study on the implementation of selected hygiene measures in 331 dental surgeries. Hyg Med. 2008;33(3):64-73.
Andrieu J, Barny S, Colardelle P, Maisonneuve P, Giraud V, Robin E, Breart G, Coste T. Prevalence and risk factors of hepatitis C virus infection in a hospitalized population in a gastroenterology unit. Role of endoscopic biopsies Gastroenterol. Clin Biol. 1995;19(4):340-5.
Roth K, Heeg P, Reichl R, Cogdill P, Bond W. Quality assurance on reprocessing accessories for flexible endoscopes - just how clean are cleaned instruments really. Zentr Steril. 1999;7(2):84-96.
Bader L, Blumenstock G, Birkner B, Leiß O, Heesemann J, Riemann JF , Selbmann HK. HYGEA (Hygiene in Gastroenterology - Endoscope Reprocessing): Study on Quality of Reprocessing Flexible Endoscopes in Hospitals and in the Practice Setting. Z Gastroenterol. 2002;40:157-70. DOI: 10.1055/s-2002-22326. Externer Link
Bundesministerium für Gesundheit (Federal Ministry of Health). Erfahrungsbericht zur Aufbereitung von Medizinprodukten in Deutschland (Field report on the processing of medical devices in Germany). 2008. Available from: Externer Link