alison stewart programme leader, sterilising technology the open polytechnic of new zealand nzssa...

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