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Medical Device Reprocessing as Reflected 17 Years after Introduction of the Medical Devices Act

Evaluation of the DGSV congress workshop devoted to this topic

F. Bakker, M. Schreiner, F. Böhlke

It is not just the coming into force of the Medical Devices Act (MPG), based on European Directive 93/42/EEC of 14 June 1993, that has been the chief driver of the ongoing improvements seen in the quality of medical device reprocessing and in the tightening of the requirements addressed to the users. In addition to a plethora of recommendations, guidelines and legal acts, new technologies, modern materials, devices and processes accentuate the
need for commensurately skilled users and for conductance of reprocessing in line with the state of the art in science and technology. Workshop 3 held at the German Society of Sterile Supply (DGSV) conference 2010 in Fulda, ”Medical device reprocessing as reflected 17 years after introduction of the Medical Devices Act“, focused on various stages of the instrument
circuit, with delegates expressing their views through an anonymous polling system. Simultaneous presentation and evaluation of the responses granted delegates insights into the extent to which MPG has been implemented 17 years after its introduction, while highlighting
also where there is still need for action and for further discussion. The workshop was directed in particular towards those responsible for, or working in the field of, medical device reprocessing, e. g. Central Sterile Supply Department (CSSD) or endoscopy department. This paper presents the findings of the workshop.

Within the framework of four workshops held during the DGSV annual conference from 7 to 9 October 2010 in Fulda a total of 80 participants were surveyed for their views on medical device reprocessing and on implementation of the Medical Devices Act (MPG) within their establishment. The survey was conducted using a TED system, thus permitting anonymous evaluation of the responses. The main aim was to ascertain to what extent MPG has been implemented 17 years after its introduction. As illustrated in Figure 1, respondents consisted of a large variety of representatives of larger and smaller CSSDs.

The question regarding the highest qualification in the respondent’s own CSSD showed that almost two-thirds of respondents stated that at least one person in the CSSD had successfully completed Specialist Training Course III (a training course designed for CSSD personnel). One out of every seven respondents even stated that their CSSD employed a staff member with a qualification higher than that of Specialist Training Course III. Only one respondent said that the CSSD had no qualified person.
The question as to whether a quality management system was in place in the
respondent’s own CSSD was answered with ”Yes“ by over 90 % of those surveyed. However, only in around one-third of CSSDs was the QM system certified. Although more than 90 % of respondents admitted to working in a CSSD with a quality management system, in around one out of every six CSSDs medical devices were not at all classified as per the