The purpose of this project was to plan the launch of the measuring programme Reprocessing of Medical Devices by producing an action plan and to evaluate this plan by piloting it under five workplace measuring activities.
The aim of the measurement programme Reprocessing of Medical Devices itself is the systematic determination of inhalation exposure through workplace measurements while disinfection is carried out as part of the reprocessing of medical devices, both within health service activities in hospitals and on the premises of specialist doctors who have their own practices. The main focus of the activities under investigation is on automated disinfection in washer-disinfectors. This concerns, in particular, aldehydes (formaldehyde and glutaraldehyde), peroxyacetic acid and hydrogen peroxide. The measuring programme is to investigate work processes and procedures where compliance can be expected with the limit values of the above-mentioned hazardous substances. When selecting workplaces, care must therefore be taken to choose those with better general parameters. The purpose of the measuring programme is not to obtain a representative average of exposure during disinfection activities. Rather, the results of the measuring programme should serve as a basis for "Risk Assessment Recommendations of the German Accident Insurance Institutions" which will then be included in the informative publication DGUV 207-206, "Working with Disinfectants in the Health Service".
The project management infrastructure that is required to initiate this measuring programme is now in place. It has been created in consultation with all participants. This included drawing up a schedule and also appointing individuals to create and review the action plan. The main focus of the activities was on planning the measuring programme and on developing the action plan. The detailed measurement strategy, the accompanying collection of exposure data via the OMEGA software package Hazardous Substances and the evaluation strategy via MEGA (Measurement data on exposure to hazardous substances at the workplace) were described in the format template of the MGU (measurement system for exposure assessment) action plan. Once the action plan was completed and accepted, the measuring programme was officially launched via MGU Info and the first workplace measurements took place in form of a pilot phase.
After the completion of the pilot phase, the measuring programme is being continued, from May 2022 until May 2023, with the involvement of all Measurement Services in the MGU. During this period, at least 36 measurement series (operations) are to be conducted at 12 workplaces with a view to identifying representative shift averages and verifying short-term value conditions.
During the pilot phase, a total of 5 measurements were carried out in different companies by the German Social Accident Insurance Institution for the Health and Welfare Services. The measurement strategy and data collection described in the action plan were reviewed by those involved in the measurement programme. A revision of the action plan was not required. Therefore, the pilot phase can be deemed a success.
This means that measurements using the described measurement strategy can be continued. The measurement results can then be analysed with the purpose of evaluating the initial hypothesis that the work processes and procedures used, which are considered to be "best practice", ensure compliance with the assessment criteria for the hazardous substances formaldehyde, glutaraldehyde, hydrogen peroxide and peracetic acid.
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Keywords for the project: medical devices, medicinal products, MGU measuring programme, exposure, hazardous substances, disinfection, EGU