Hospital department cleans up
The department responsible for washing and sterilizing up to 26,000 surgical instruments a day at the Norfolk and Norwich University Hospital has been awarded top European certification for its high quality standards.
The state-of-the-art Sterile Services Department (SSD) at NNUH operates 24 hours a day to provide a complete decontamination and sterilisation service to a total of 28 operating theatres. The SSD team not only serve the needs of the NNUH but also Cromer Hospital, local Primary Care Trusts as well as many GP practices and health centres.
The decontamination and sterilisation process is performed by a team of over 80 highly experienced sterile services professionals. The department is designed and built to comply with all the current environmental controls. Decontamination and sterilisation equipment is tested, maintained and validated to the highest national and international standards. The department is now fully accredited to ISO 9001:2000; ISO 13485:2003 and the Medical Device Directive 93/42/EEC.
Sterile Services manager David Scotton said: “This type of accreditation is difficult to achieve and the staff have worked extremely hard towards these standards. European certification means that we can place the CE mark on sets of sterilized instruments if we wish to market them.”
The department operates six wash-disinfectors and seven steam sterilizers (autoclaves), which are supported by advanced tracking and monitoring software to ensure instruments are tracked all the way through the sterilisation process and back to the operating theatres.
Notes to editors:
ISO 9001:2000 – is a quality management system designed to facilitate continuous improvement. A quality management system is a network of processes, and a process is made up of people, work, activities, tasks, records, documents, forms, resources, rules, regulations, reports, materials, supplies, tools, equipment, and so on – all the things that are needed to transform inputs into outputs. In general, a quality system includes all the things that are used to regulate, control, and improve the quality of products and services.
ISO 13485:2003 – this international Standard specifies requirements for a quality management system when an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Medical Devices Directive 93/42/EEC – this European Directive details the essential requirements and assessment procedures for Medical Devices. The essential objective of the assessment procedures is to enable authorities to ensure that products placed on the market conform to the requirements of the directives, in particular with regard to the health and safety of users and consumers. This Directive establishes the rules which enable an organisation to CE mark their products.