The Principles of Medical Device Decontamination

Manufacturer’s instructions

Continual reference will be made to the need to follow manufacturer’s instructions. There are regulations placed on any equipment designed, manufactured and placed on the market to ensure that they meet health and safety standards. More information on these regulations can be found on the Government’s Health and Safety Executive website. Regulations include providing information on how they should be operated, maintained and repaired. This regulatory framework makes the manufacturer legally responsible for any failure in the equipment where this results in injury, illness or death. However, the manufacturers legal responsibility extends only to the extent that their instructions for use are followed. Any diversion from the instructions for use transfers legal liability to the user, including those decontaminating the device and the organisation in which they work.

High Risk

Endoscopes that enter sterile body tissues: Manual Cleaning, automated cleaning and disinfection: rinse-water with limited bacterial contamination, followed by sterilisation. (Guidance on these endoscopes is not included in the HTM.) Endoscopes that enter sterile body cavities via contaminated body cavities: Manual cleaning, automated cleaning and disinfection; rinse water with very low bacterial contamination.

Figure 3 taken from HTM 01-06, Part A Policy and Management 1 providing a reference to the required level of decontamination for the variety of endoscopes that are in use in healthcare.

Endoscopes that enter contaminated body cavities: Manual cleaning, automated cleaning and disinfection; rinse water with limited bacterial contamination.

Endoscopes without lumens: Manual cleaning and manual disinfection as EQR and use of manual cleaning followed by an endoscope washer- disinfector (EWD) as Best Practice.

Low Risk

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