Medium

Equipment

• Ability to demonstrate that washer disinfectors are fit for purpose, operating effectively, maintained adequately, and tested and validated in line with current guidance

• Compliance with SHTM 2010(sterilizers)
• Compliance with Protocol on the Local Decontamination of Surgical instruments, if neither washer disinfector nor ultrasonic washer are reasonably practical

Interim requirement plus:

• Compliance with SHTM 2030 (washer disinfectors must be part of decontamination process; manual cleaning limited to pre-clean, in accord with manufacturers’ instructions, before washer-disinfector)

• Accreditation to Article 12 or Annex V of the Medical Devices Regulation 1994
• Compliance with SHTM 2031 (clean steam for sterilisation)
• Practice and procedures to follow ISSM Quality Standards and Recommended Practices for Sterile Service Departments

• BS EN 554 Sterilization of medical devices — validation and routine control of sterilization by moist heat

Facilities

• Physical separation of clean and dirty processes

Interim requirement plus:

• Space and design of whole facility to follow SHPN 13 (Guidance on sterile services department)
• Compliance with BS5925 Class L (Environmental cleanliness in enclosed spaces)
• Compliance with SHTM 2025 (Ventilation in healthcare premises)

Staff

• All personnel carrying out decontamination processes have documented training needs assessment and record of training received

Interim requirement plus:

• Compliance with BS EN 46002 (General standard on quality system requirements) and BS EN 724 (Guidance on complying with EN 46002)

• Accreditation to Article 12 or Annex V of the Medical Devices Regulation 1994

Management

• Senior member of staff with documented responsibility for decontamination processes and capable of assessing and treating risks associated with ineffective decontamination processes and documented evidence of appropriate training
• Senior Manager with overview in accord with HDL 2001(10)

• Steps taken to introduce systems which enable the tracing of sets of surgical instruments to the patients on whom they have been used and links this information with records of their decontamination

Interim requirement plus:

• Qualified Manager (e.g. Member of ISSM or equivalent) in charge of CSSD
• Compliance with BS EN 46002 (General standard on quality system requirements)
• SHTM 2010 Sterilization: Overview and management responsibilities
• SHTM 2030 Washer-Disinfectors Overview and management responsibilities
• SHTM 2031 Clean steam for sterilisation
• MDA Device Bulletin DB 9801 Medical Device and Equipment Management for Hospital and Community based Organisations
• Full implementation of systems which enable the tracing of sets of surgical instruments to the patients on whom they have been used and links this information with records of their decontamination.