alison stewart programme leader, sterilising technology the open polytechnic of new zealand nzssa...
TRANSCRIPT
Reprocessing ReusableMedical Devices
Alison StewartProgramme Leader, Sterilising TechnologyThe Open Polytechnic of New ZealandNZSSA Representative for Standard Review
Todays objectivesO AS/NZS 4187
O AS/NZS 4815
O Applying the standards
O Where to from here
Cleaning
Inspection
Packaging
sterilization
Transport
Storage
Use
Transport
All processes must be
documented and
validated
StandardsO AS/NZS
4187:2014Reprocessing reusable medical devices in health service organisations
O AS/NZS 4815:2006Office-based health care facilities – Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment
AS/NZS 4187
Scope:O Specifies the requirements and
practices for effective and safe reprocessing, storage, handling and transportation of RMDs
O Application of the principles recognises and acknowledges there are differences and similarities between different types of HSOs
O Applies to wherever RMDs are processed in a HSO
AS/NZS 4815Scope:O Sets out procedures and process
development which can be validated for reprocessing RMD
O In office-based health care facilities not involved in complex patient procedures and processes
O Suitable for medical, dental and allied health facilities and skin penetration establishments
Which standard?O AS/NZS 4187 can be applied to any
HSO environment
O AS/NZS 4815 is written for office based practices only doing non complex procedures
Which standard?O AS/NZS 4187
O ISOO ENO AS
O Where an appropriate ISO standard is in print the AS document is to be retired
O AS/NZS 4815O AS O ISOO ENO NZS
O Many of the AS standards have been or are to be retired
O References AS/NZS 4187
AS/NZS 4187O ISO structure
O Body of the document - Normative section
O Appendix A – Guidance for normative section
O Appendix B - Bibliography
Normative – Body of Standard
O Mandatory statementsO Contains the information required to
establish, maintain and demonstrate continuous quality improvement (CQI) for reprocessing of reusable medical devices (RMD)
O SHALL means the statement must be carried out
O There is no guidance in this section
Appendix A - Guidance
O Guidance to body (Normative section) of standard
O Links to normative by using same clause number preceded by an ‘A’ O ie: normative section - clause 2.4.2.1,
guidance – clause A2.4.2.1
What’s newO Terminology is aligned to ISO
O Quality management focus
O Accountability defined
O It is not a prescriptive document
Policy
Procedure
Work instructions
Reference documents
Risk Management
Risk Identification
Qualitative Risk Analysis
Quantitative Risk Analysis
Risk ResponsePlanning
Risk Monitoring &
Control
Where to from hereNew Zealand Sterile Services Association (NZSSA)O NZSSA audit toolO NZSSA Library: suite of standardsO NZSSA represented on HE-023 committee
O AS/NZS 4815:2006 – will it be revised?O 2 representatives needed to make it a joint
standardO Users need to support the revision
O Supporting the users of the standards
