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Dear Salwa
The General Medical Device Directive (93/42EEC) became effective within the European Union on 1 January 1995. To verify compliance with the essential requirements of the Directive, each manufacturer (including hospital-based Sterile Service Departments) is/are required to demonstrate that their devices have been produced in accordance with approved technical specifications and in quality- controlled circumstances.
The need for trained and qualified management and technical staff is self-apparent.
Some important requirements for Sterile Processing Technician are:
High School graduation or equivalent with additional course work or training in sterile supply operations (Certification as a Sterile Processing Technician is strongly recommended).
Summary of some important Qualification/Training/Work Experience:
- Experience within an acute care hospital. Experience should include general instrumentation, decontamination, disinfection, set assembly, and sterilization.
- Good relationship and communication skills.
- Understanding of infection control practice as relates to decontamination, sterilization, and sterile storage.
- Must have a cooperative spirit and tact when interacting with employees, direct care staff, and members.
- Must be able to work in a labour/management partnership environment.
- Must be able to speak and write clearly the national language, answer phones and take legible, concise messages.
- Ability to transport heavy equipment. Must be able and willing to work around commonly used potentially hazardous substances, e.g. high-level disinfectants
Profile of a CSSD Manager:
Several years of Professional experience in the areas of sterile goods supply, infection control. an/or operating theatre duties including management experience
Formal training in health, business field or related discipline (minimum two year programme)
CSSD certification
Summary of some CSSD manager's requirements taken from the German Working Group on Quality Assurance in Sterile Supply (Part4. Training, Management, Auditing was published in Central Service 1995, issue no.3: 179- 185):
- For organisational and legal reasons, the CSSD must be assigned a place as an independent operation in the general administration or organisation. The CSSD shall be run from the viewpoint of business management.
- The management of CSSD requires a manager and an established deputy.
- The qualification of the manager shall make it possible to carry out laws, regulations, guidelines, standards, and operational specifications.
- Solid knowledge of the technical and operational parts of CSSD and of the situation in surgical departments, the functional departments, and the wards is necessary.
- The manager of CSSD works closely with users, infection control committee, pharmacy, administration, engineering, and the Central Service Department itself.
- The management of CSSD must be taught regularly by suitable further education measures in all the areas mentioned above. The management of CSSD utilises the staff according to their qualifications and their need for supervision.
- For the introductory training of new employees, a formal introductory training plan must be devised. Audits must be conducted regularly.
Kind regards
Josy Holdener
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