Our Hospital Sterilisation and Disinfection Unit HSDU is a licensed unit registered with the Medicines and Healthcare products Regulatory Agency MHRA and is responsible for the collection/delivery, decontamination, and sterilisation of reusable medical devices, for use in direct patient care.
HSDU holds accreditation for BS EN ISO 13485: 2016 and the UK Medical Devices Regulations 2002 Part II as amended Regulation 14.
Decontamination is the combination of processes including cleaning, disinfection, inspection, packaging, and sterilisation, used to render a re-usable item safe for further use on patients and handling by staff. The effective decontamination of reusable surgical instruments is essential in minimising the risk of transmission of infectious agents.
The reusable surgical instrument cycle highlights each stage of the decontamination process through which surgical instruments and medical devices must pass through before use. Effective decontamination requires the attainment of acceptable standards at all stages of the life cycle.
Medical devices can be classified in a variety of ways, such as purpose for use, materials of construction, and the risk of contamination/infection transmission to a patient.
A re-usable device is designed to be used on a patient, decontaminated and then used again with another patient. The process can be repeated many times with re-usable devices until it is no longer needed, is damaged, unsafe to use or otherwise replaced. The emphasis is therefore placed on ensuring that the device is safely handled and decontaminated between patients.
Devices enter the cycle as either new devices provided by a manufacturer or on loan that need to be prepared for first time use or following actual clinical use.
Failure to effectively process devices in any of these stages will result in inadequate decontamination, rendering the device or instrument non-sterile and non-usable.
