1. Reprocessing Reusable Medical Devices
Alison Stewart
Programme Leader, Sterilising Technology
The Open Polytechnic of New Zealand
NZSSA Representative for Standard Review

2. Todays objectives AS/NZS 4187 AS/NZS 4815 Applying the standards
Where to from here

3. All processes must be documented and validated
Cleaning
Inspection
Packaging
sterilization
Transport
Storage
Use
All processes must be documented and validated

4. Standards AS/NZS 4187:2014 AS/NZS 4815:2006
Reprocessing reusable medical devices in health service organisations
AS/NZS 4815:2006
Office-based health care facilities – Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment

5. AS/NZS 4187
Scope:
Specifies the requirements and practices for effective and safe reprocessing, storage, handling and transportation of RMDs
Application of the principles recognises and acknowledges there are differences and similarities between different types of HSOs
Applies to wherever RMDs are processed in a HSO

6. AS/NZS 4815
Scope:
Sets out procedures and process development which can be validated for reprocessing RMD
In office-based health care facilities not involved in complex patient procedures and processes
Suitable for medical, dental and allied health facilities and skin penetration establishments

7. Which standard? AS/NZS 4187 can be applied to any HSO environment
AS/NZS 4815 is written for office based practices only doing non complex procedures

8. Which standard? AS/NZS 4187 AS/NZS 4815
ISO EN AS
Where an appropriate ISO standard is in print the AS document is to be retired
AS/NZS 4815 AS
ISO EN
NZS
Many of the AS standards have been or are to be retired
References AS/NZS 4187

9. AS/NZS 4187 ISO structure Body of the document - Normative section
Appendix A – Guidance for normative section
Appendix B - Bibliography

10. Normative – Body of Standard
Mandatory statements
Contains the information required to establish, maintain and demonstrate continuous quality improvement (CQI) for reprocessing of reusable medical devices (RMD)
SHALL means the statement must be carried out
There is no guidance in this section

11. Appendix A - Guidance Guidance to body (Normative section) of standard
Links to normative by using same clause number preceded by an ‘A’
ie: normative section - clause , guidance – clause A

12. What’s new Terminology is aligned to ISO Quality management focus
Accountability defined
It is not a prescriptive document

13. Policy
Procedure
Work instructions
Reference documents

14. Risk Management Risk Identification Risk Monitoring & Control
Qualitative Risk Analysis
Quantitative Risk Analysis
Risk Response
Planning
Risk Monitoring & Control

15. Where to from here New Zealand Sterile Services Association (NZSSA)
NZSSA audit tool
NZSSA Library: suite of standards
NZSSA represented on HE-023 committee
AS/NZS 4815:2006 – will it be revised?
2 representatives needed to make it a joint standard
Users need to support the revision
Supporting the users of the standards