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Reprocessing unit for medical devices

Requirements and structure of a decontamination room

The reprocessing unit for medical devices plays a crucial role in the smooth running of a practice, as it ensures the supply of instruments. According to international guidelines, potentially infectious instruments should be reprocessed in a special decontamination room to prevent recontamination.

The basic structure of the processing room

The reprocessing room is a dedicated room in practices and clinics for the preparation, cleaning, disinfection, packaging, sterilization, documentation and approval of contaminated instruments.

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Structure of the reprocessing room for safe instrument reprocessing

A well-structured decontamination room forms the basis for the best possible protection against infection and enables an optimized reprocessing process that saves time and reduces costs. When planning the space for the reprocessing unit for medical devices, the focus should be on the workflow of the reprocessing process, whereby short distances are particularly important. It is therefore also advisable to position the AEMP as close as possible to the treatment rooms.

When setting up a new dental or medical practice, or in the case of conversions or extensions, it is essential to design a separate reprocessing room. If reprocessing takes place in another area of the practice (e.g. in the treatment room), strict measures must be taken to separate patient treatment and instrument reprocessing in terms of time and hygiene and must be documented in writing.

Successful room planning always starts with an analysis of requirements. The expected quantity of instruments to be reprocessed influences the choice of equipment and can even lead to pass-through solutions. Three room concepts are available for the decontamination room:

  1. Single-room solution with zone separation:
    Separation between unclean and clean work areas.

  2. Two-room solution with spatial separation:
    Subdivision into unclean and clean room.

  3. Three-room solution with additional storage space:
    Additional storage room next to unclean and clean area.

The choice of room concept depends on various factors, including the volume of reprocessing and the risk level of the medical devices to be processed (e.g., risk group critical C). In medical and dental practices, single-room solutions with zone separation are predominantly found - due to the relevance, the focus of this blog article is primarily on this room concept.

Room structure and color code

The decontamination room should be large enough to allow hygiene staff to work without any health and safety restrictions. A sensible division of the room comprises two main areas: the "unclean" and "clean" zones. In order to visually emphasize the process steps of instrument reprocessing, a spatial separation into areas is preferred: the unclean area and the clean area. This division can be emphasized by using a traffic light colour code, as shown in the schematic diagram below: Red for unclean, yellow for clean, green for sterile (although in many practices only a division into red for unclean and green for clean has become established).

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Dirty Zone

The dirty zone comprises the delivery area, the washer-disinfector and a workstation for the manual preparation or decontamination.

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Clean Zone

A control area for the unloading of the washer-disinfector, the performing of functional checks and sorting the instruments is located in the clean zone. The sealing device, steam sterilizer and documentation medium are located in the clean zone as well.

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Planning and implementation of the reprocessing unit for medical devices

The successful planning and implementation of a reprocessing unit for medical devices (AEMP) requires careful consideration and coordination, particularly with regard to local laws and standards. Before you start your construction project, it is advisable to talk to a planning specialist in advance to ensure that the economic operation of the AEMP is possible in the intended spatial conditions.

A feasibility analysis is essential to check the realization of your construction project. This involves analysing the spatial conditions, space and area requirements as well as the workflow optimization of the AEMP, taking other structural and technical factors into account. This includes aspects such as room/air technology, water supply technology, required equipment technology as well as storage and logistics concepts.

The following issues should also be considered when designing the treatment room:

  1. Designated space for storage, sorting and disposal:
    Is a dedicated area required for the storage, sorting and disposal of sharps, infectious materials and disposable instruments and sharps?

  2. Window furnishings with fly screens:
    Is it necessary to fit windows with suitable fly screens?

  3. Air system to prevent recontamination:
    Is an air conditioning or air purification system required with airflow from clean to unclean areas to prevent recontamination?

  4. Adequate space for clinical waste disposal:
    Does the design of the reprocessing room provide adequate space for clinical waste disposal?

  5. Accessibility of water shut-off valves:
    Are the appropriate shut-off valves for water supply to equipment easily accessible to staff:inside?

  6. Accessibility of equipment for maintenance work:
    Are the devices used for instrument reprocessing sufficiently accessible for occasional maintenance work?

  7. Protection against recontamination of sterilized instruments:
    Are sterilized instruments adequately protected to prevent recontamination during storage while being easily accessible for reuse? Attention: In msome countries, the storage of sterile medical devices in the reprocessing room is not permitted.

  8. Secure electronic devices with circuit breakers:
    Are circuit breakers and water stops installed to ensure safe operation of the devices (autoclave and washer-disinfector / washer-disinfector)?

Answering these questions not only ensures compliance with legal requirements, but also helps to ensure the efficient and safe operation of the infection control process.

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