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Reprocessing Reusable Medical Devices

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Presentation on theme: "Reprocessing Reusable Medical Devices"— Presentation transcript:

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

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