THE NEW STANDARD

The new version of AS/NZS 4187:2014 is here.

All health services must demonstrate compliance by December 2021. Accrediting bodies will be assessing health services’ early planning ahead of this deadline.

There are several components of the new standard which will affect each health service in a different way.

All health service organisations in Australia need to consider:

 

  • Space, layout and design
  • Product families
  • Water quality
  • New equipment
  • Instrument identification and traceability

Space, layout and design

This means physically segregating the reprocessing environment and equipment by redesigning your floor plan and allocating more space to your central sterile services department.

Space, layout and design

This means physically segregating the reprocessing environment and equipment by redesigning your floor plan and allocating more space to your central sterile services department.

Product families

This is the most significant change. Reusable medical devices (RMDs) are grouped according to their materials, intended use, design characteristics, physical mass and thermal conductivity.

Grouping devices in to product families addresses some of the challenges posed by the increased range of RMDs available and the variety of design, complexity and reprocessing requirements.

You are required to:

  • understand and document the product family for each individual device used
  • correctly reprocess and sterilise each device according to its product family and the manufacturer’s instructions.

 

Water quality

Water quality is a critical consideration in all stages of the reprocessing of reusable medical devices. The new standard sets out requirements for water supplied to a CSSD and used for reprocessing RMDs including monitoring schedules and reporting.

Softened, filtered, demineralised, reverse osmosis or distilled water needs to be used in accordance with the equipment manufacturer’s specifications. Poor water quality can adversely affect the cleaning process and damage a device.

Information about local water supply should be available from your local water authority.

Regular testing and monitoring of water quality will help to detect contamination which could cause staining or corrosion of a device. It may be necessary to treat water before using it for reprocessing and sterilisation.

The key water quality elements that should be considered are:

  • hardness (ie high mineral content)
  • pH
  • total organic carbon
  • ionic contaminants (e.g. heavy metals, halides, chlorides, phosphates and silicates) and resistivity
  • temperature
  • microbial population
  • bacterial endotoxin.

Want to know what to do to meet the new standard? Download our Transition to AS/NZS 4187:2014 guide.

New equipment

To meet the requirements of the new standard, most CSSDs will need the following new equipment:

  • A pass-through washer disinfector (compliant with ISO 15883)
  • A pass-through steriliser (compliant with EN 285 or EN 13060)
  • A water system capable of providing water of the quality laid out in table 7.2 of AS/NZS 4187:2014.

All new equipment must undergo installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). These tests must be documented and meet the applicable national and international standards.

All CSSD equipment must also be compatible with the detailed specifications provided by RMD manufacturers.

Instrument identification and traceability

The new standard requires that all instruments be traceable. Your CSSD should have a system which can identify the cleaning process applied to each RMD, including an ability to track a device to a patient, and allow a recall if required.

Instrument tracking has several benefits including increased traceability, improved patient safety, enhanced risk management and increased accountability.

All health services must have procedures for identifying and tracking semi-critical and critical reusable medical devices during reprocessing and subsequent use on patients.

In the event that a non-conforming device is used and a recall is necessary, health services must have a traceability system than can identify affected patients.

The standard recommends that health services should be working towards an electronic tracking process and record system.

Locations

Melbourne

10 Biodiversity Boulevard, Epping Vic 3076, PO Box 3216, Broadmeadows, Vic, 3047
Phone: (03) 9494 0964

Sydney

5 Sheridan Close, Milperra NSW 2214, PO Box 474, Parramatta, NSW, 2124
Phone: (02) 8722 0504

Perth

54 Tacoma Circuit, Canning Vale WA 6155, PO Box 966, Subiaco, WA, 6904
Phone: (08) 6154 8901

 

Contact Us: Phone +61 (03) 9494 0964

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