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About Us

The Sterile Services Department (SSD) is located in the West Corridor, at the Royal United Hospital, Combe Park, Bath.

The Sterile Services Department provides a decontamination service to all Royal United Hospital NHS Trust premises and other external contracted customer including PCT Hospitals, Health Centres, Clinics, Community Nursing areas, General Practitioners' Surgeries and Private Hospitals requiring their re-usable medical devices to be disinfected, re-packaged and sterilised.

A disinfection service for re-usable heat sensitive equipment is also available and a service providing High Level Disinfection for Flexible Endoscopes is managed adjacent to treatment areas in the Gastroenterology Dept and the Cystoscopy Unit.

Re-usable medical devices are cleaned and thermally disinfected in automated washer/disinfectors in accordance with the Health and Technical Memorandum (HTM) 2030 and then repackaged and sterilized in steam autoclaves in accordance with HTM 2010 guidelines.

Flexible Endoscopes are also re-processed in dedicated disinfection units in accordance with the BSG Guidelines for Gastrointestinal Endoscopy and HTM2030.

To operate, the SSD must comply with certain parts of the Medical Device Directive (MDD). The Medical Device Directives are safety regulations made under the Consumer Protection Act 1987 (CPA) and the European Communities Act 1972 which relate to the safe use and manufacture of medical devices.

The Medical Device Directive 93/42/EEC Revision 2007/47/EC covers the placing on the market and putting into service of Medical Devices. In relation to the MDD, the SSD is considered to "re-manufacture" procedure packs, supplementary instruments and theatre sets containing re-usable medical devices, and thus must continually prove conformity to Annex 5, section 3.2 and Article 12 of the directive and provide a "Declaration of Conformity" and use a Quality Management System.

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