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The challenge of designing an Endoscopy and Sterile Services facility

Peter Bridge
by Peter Bridge
21 January 2019
3 minutes read

    The demand for endoscopy reprocessing and sterile services has grown tremendously in recent years, with ever-increasing patient throughput leading to the creation of purpose-specific endoscope processing facilities. However, designing a new facility is about much more than simply installing equipment. One of the most important considerations is the infrastructure supporting the unit, particularly the supply of high-quality water to the endoscope washers, which is as important as the equipment itself. Here, we take a look at some of the essential design considerations.

    Regulatory mandates

    Before designing a new endoscope reprocessing unit, it is essential to check the relevant Health Technical Memorandum (HTM) and ISO guidelines, to avoid any issues further down the line. Facilities must comply with the requirements of HTM regulations, which provide guidance on the design and fitting of sterile services facilities and endoscope reprocessing systems. In addition, ISO 15883 specifies the general performance requirements for washer-disinfectors and the quality of water supplied to them. Traceability and accountability are also vital, and so an ISO 13485-compliant medical devices quality management system must be in place.

    Space planningblog-meeting-the-challenge-of-designing-an-endoscopy-and-sterile-services-facility-transformed

    Understanding the current and anticipated future throughput requirements of a new sterile services facility is essential before beginning the design process. This will determine the number of automated endoscope reprocessors, washer-disinfectors, sterilisers, etc. which must be supported, and the quality of water required. Once you have this information, you can establish the total volume of purified water required, and the peak draw on the ring main. This information is essential to guide the development of an appropriate water purification solution, including the choice of pre-treatment systems and size of reverse osmosis unit required.

    One of the most important considerations for water treatment is space. Will the water treatment system and storage facility be housed in the endoscopy unit or elsewhere? What is the size of the plant room? If it is outside the endoscopy unit, how far away is it, and is it on the same floor? What about drainage facilities? And is ventilation required? Much will depend on whether the facility is a new build or an addition to an existing building.

    Movement of people and equipment

    On paper, it may seem as though the design is perfect, but simply finding the space to install everything is just part of the story. There must be a clear walkway in both the plant room and the decontamination unit, with sufficient working space to allow engineers to service and maintain the systems. If the new facility is in an existing building, there may be width and height limitations, or access restrictions, which can affect the movement of both people and equipment.

    Infrastructure for healthcare facilities

    Careful consideration should be given to the infrastructure of the endoscopy facility. Water can come from a variety of sources; mains, ground or well water. This will determine the need for pre-treatments, such as filtration, prior to purification by reverse osmosis. Ultimately, if the water supply to the decontamination unit is not of sufficiently high quality, it will affect the life expectancy of the equipment, and could even impact on patient outcomes. The chosen water treatment solution will also require electrical services, which must support simultaneous operation of all the facility’s equipment and, in many cases a sophisticated HVAC (heating, ventilation and air conditioning) system which uses forced air and vacuum capabilities to achieve a specified number of air changes per hour. Finally, the location and capacity of the drains will, to a degree, dictate where the plant room and other equipment can be situated.

    The above topics are just some of the key aspects of designing an endoscopy suite. Contact us to discuss the specific requirements of your facility. For more information, on the regulatory guidelines and best practices relating to endoscopy reprocessing and sterile services suite management, visit our dedicated Healthcare page.

    Peter Bridge

    Author | Peter Bridge

    Peter has a background in analytical chemistry and has gained a wealth of knowledge and experience working for and supplying to a wide range of pharmaceutical, biotech customers and pharmaceutical companies.

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