ScanCARE Blog

Introduction

If your clinic or healthcare facility is still using AS/NZS 4815:2006, you're working under an outdated framework. The newly introduced AS 5369:2023 is a modernised, risk-based standard designed to enhance infection control and sterilisation practices in Australia. Below, we compare the top 10 differences between AS/NZS 4815 and AS 5369, with a focus on documentation compliance, staff training, and reprocessing protocols.

Read on to discover the Top 10 differences between the standards.

Introduction

In the modern healthcare environment, where safety, traceability, and compliance are paramount, Australia’s regulatory framework for reusable surgical instruments presents a perplexing disconnect. On one hand, the recently published AS 5369:2023 sets a clear expectation for tracking surgical instruments from sterilization through to patient use. On the other, the Therapeutic Goods Administration (TGA) — Australia's national regulator — does not currently require direct part marking or Unique Device Identification (UDI) for Class I reusable surgical instruments, which make up the bulk of surgical tools used in clinical practice.

This divergence between clinical best practice and regulatory requirements is more than just an academic discrepancy — it has real-world implications for patient safety, operational efficiency, and the traceability of critical medical assets. In this article, we explore the current landscape, compare global standards, and ask whether the TGA is overdue for an update.

The shift from AS/NZS 4187:2014 to AS 5369:2023 introduces notable changes in the implementation of Product Families, especially with the detailed guidance presented in section A.5.2 of Appendix A.

In contrast to AS/NZS 4187:2014, AS 5369:2023 offers comprehensive guidance along with a supporting flowchart.

This blog aims to explore the guidance provided and highlight the differences in managing product family classifications between these two standards, making it easier to understand the adjustments required.

Transitioning to an Electronic Tracking system often involves importing your existing CSSD Check Sheets and Surgical Devices data, currently maintained in MS Word or Excel. A common challenge is the varied naming of the same type of surgical instruments. 

For instance, Mayo Forceps for example, might be named in several ways:

• 15cm Curved Mayo Forceps
• Mayo Forceps 15cm Curved
• Curved 15cm Mayo Forceps
• Forceps Mayo  Curved 15cm
•  6" Mayo Curved Forcep

Let's explore five tips on establishing a consistent naming convention for surgical instruments to simplify this process.

What are the benefits and drawbacks of tracking surgical instruments at the tray level and at the instrument level. Which method is more suitable to your facility.

ScanCARE QuickShots offer a condensed version of our in-depth blog posts, summarising the key takeaways and presenting them in a quick, easy-to-read format. Each QuickShots blog will cover essential information on surgical instrument tracking, sterilization, and management, helping you stay up to date on industry best practices and innovations.

In my last blog, we looked at the complex and confusing nature of Product Families and looked at a way to simplify the categorisation process for assigning instruments and instrument sets to product families.

In it we provided a free Product Families Toolkit containing a matrix and a six-part video series, demonstrating how to use it.

Introduction

We are proud to announce the Scancare Academy and our very first course, Understanding & Implementing Product Families, is available now and its completely free to enroll.

In July 2018 I published a blog about being ready for unique surgical instrument identification (UDI) and its implications for Australia and New Zealand.

Since then, the therapeutic goods administration (TGA) in Australia has released a consultation paper relating to the implementation of UDI.

The purpose of this blog is to look at the document and provide an update on what’s happening with the implementation of UDI in Australia.

When people ask me about instrument tracking, there are are number of things I need to find out from them so that I get an idea of what they want to track. So I begin by asking them what they would like to track:

Electronic Medical Record systems have now been widely adopted in Australia and around the world. Possibly the most publicised roll out has been in the United States with the government providing significant fiscal incentives under the Meaningful Use program.

In this blog I use the terms EHR and EMR interchangeably.

In the US for example it's common to use EHR (Electronic Health Record) as the term for a patient’s medical record, whereas in Australia, the personal health record system, MyHealth Record is commonly referred to as an EHR. In Australia, the patient record is generally referred to as an EMR (Electronic Medical Record)

By far the most perplexing issue for customers and delegates I talk to at conferences is Product Families.

This topic is the most read on my blog and our free guide to product family categorisation is by far the most downloaded resource on our web site.

The purpose of this post is to challenge the methodology used in the ISO/TS 17665-3 (ISO) standard by asking ‘Why does it need to be that way?’

 

I recently wrote about new regulations being implemented in Eurpope and the US that require manufacturers to uniquely mark surgical devices at the time manufacture.

Effectively, all reusable surgical devices that are destined for the EU and US markets will need to be marked with a GS1 Data matrix barcode .

In September 2013 the US Food & Drug Administration (FDA) implemented regulations establishing a system to identify surgical devices through distribution and use. Under this rule, each medical device must be labelled with a Unique Device Identifier (UDI).

The UDI needs to be directly marked on the device itself if the device is intended to be used more than once and to be reprocessed before each use.

In August 2015 we wrote about the implications of the new AS/NZS4187 standard on office based healthcare facilities. It is the second best read article on our blog and we have now created snapshot video that covers the main points. See below. 

In August 2015 we wrote about the confusion about the new standard AS4187 versus the previous standard AS4815 in dental practices and office based health care services.  

In June 2015, standards Australia made a statement clarifying which standard relates to Dental Clinics.

The short video looks at the standards and guidelines and the Standards Australia statement works through what that means for dental clinics.

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The best read post on our blog is the one we published way back in August 2015 on the topic of AS4187 product families. It remains very popular so we've created this very short video for you that you may like to share with your friends and colleagues. 

I recently attended the 37th Annual Dental Congress in Melbourne and it was fantastic to catch up with the dental community and talk about the infection control issues that affect them. We had many visitors to our booth and had several enriching discussions with progressive thinking delegates who were passionate about infection control.

One discussion in particular caught my interest, as the delegate had very interesting views regarding the Spaulding Classification and how it was applied in dentistry. Our discussion centred around whether the classification and AS4815 were still relevant and whether AS4187 should be the "go to" standard for office based dental practices instead.

Blog posts and downloads related to product families blogs are by far the most accessed content on our website. By a long way.

And it’s with good reason. The concept of product families can be extremely complicated and confusing.

Last month our Company attended the WHFSS conference in Brisbane as an exhibitor. While I was there, I had a number of interesting conversations with delegates who were using paper based tracking systems and were feeling that the new requirements of AS4187:2014 were going to substantially increase the amount of paper work that they would need to complete.

Some delegates were quite anxious that their paper based system just wouldn’t cut it anymore. Hence their discussions with us.

Just yesterday, I received an email informing me that the AS 4187 compliance deadline of December this year had been extended.

The news surprised me. Our subscription to SAI Global Standards watch would normally have alerted us if there had been an amendment in the standard. So I searched high and low on the SAI Global site and then Standards Australia and then the old trusty Google.

However I was unable to find anything. So I mentioned it to our Office Manager who then went off and tried her luck with Google.

We've all had the experience of sitting in waiting room for what seems and absolute eternity waiting to see a medical professional. Flicking through outdated, dog eared magazines, keeping an eye on the queue, feeling nervous and hoping that it’s your turn next.

It’s crazy really, because not only does it create discomfort and dissatisfaction with patients, it also costs the practice significantly in terms of customer satisfaction and higher operating costs.

But why does this happen and, more to the point, how can it be improved?

Traditional EHR systems do not meet ophthalmologists' functional requirements. This is what an August 2011 report published by the American Academy of Ophthalmology (AAO) says.

The paper which is titled ‘Special Requirements for Electronic Health Record Systems in Ophthalmology’ argues that the field of ophthalmology has a number of ‘specialty specific’ requirements that are not taken into consideration by traditional EHR systems. Its abstract reads:

The advances in surgical procedures and surgical instrumentation, over the past 10-20 years has been astounding. Once upon a time, just about every surgical procedure was open surgery and involved simple pivot based stainless steel instruments. These days, surgical instruments are highly complex hybrid material devices.

This has led to a quiet revolution in sterilizing departments around the world. Instruments were once simple and tray assembly straightforward.

In my blog post titled "What you need to know about Surgical Instrument Direct Part Marking (DPM)" I wrote about the laser etching process. The post discusses what  equipment is required for etching your instruments and the logistic aspects of  the process as well as some of its positives and shortcomings. Today I will revisit some of those concepts but with a wider context as to why you need to etch your instruments.

Generally CSSD managers understand the benefits of laser etching, so today we will see why it’s not already done for you when you buy an instrument.

The new version of AS/NZS 4187 released on the 15^th December last year brought some very significant changes to the previous standard. One of the most significant ones being the standards reference to Product Families.

Staff privileges and system security are two common features of surgical instrument tracking systems that we are often asked about.

Hourly rates or process costing information, for example, is usually considered confidential and for this reason CSSD and theatre managers need to be able to regulate who can and who cannot access this level of detail.

Network IT adminstrators too, have an interest in this topic as they need to ascertain the level of security provided by the tracking application.

My experience is that the needs of clinical managers and those of network IT administrators don’t always align. Individual stakeholder requirements warrant careful consideration to achieve successful and sustainable outcomes for all concerned.

This post discusses how to navigate the area of staff privileges and security to meet and satisfy all stakeholders' needs. 

Short on time? Why not download our handy 1 page User Roles Chart?

 

With the deadline for implementation of AS4187 2014 coming up fast, I thought that it may be worthwhile to take another look at product families.

There seems to be a lot of interest in AS4187 and product families and my blog of August 2015 is by far our most read page on our website. The helpful categorisation guide gets downloaded several times each week.

In January 2013, the National Safety and Quality Health Service (NSQHS) came into effect requiring mandatory compliance for all public and private hospital and day surgeries and the majority of public dental practices.

Re-usable Medical Devices must, in accordance with AS4187 2014, be labelled prior to sterilisation. The label must identify the contents and provide information for batch control. 

But while the standard's requirements are critical, there are also a number of other requirements such as OH&S that may affect the way you label your RMD’s.

Body art and personal appearances services are a fast growing industry and we are experiencing increased downloads of our eBook on surgical instrument tracking by owners and managers of body piercing clinics and body art studios. So I want to bring these types of businesses and services into the discussion on infection control and sterilizing standards. Particularly the use of re-usable devices used for skin penetration.

The price of a surgical instrument tracking system is an important consideration if you are considering moving to an automated solution. In order to put together a business case, you will, besides the cost, also need to know the difference between the various offerings and what you can expect to be included in each system.

Complying with Australian standards AS4187 or AS4815 can be a difficult task for any health care facility, but for office based health care facilities, physical space limitations can make it even more difficult. Finding space to wash, wrap and sterilize surgical instruments can be tricky for the smaller facilities and bench space is typically limited so finding space to put things can be a challenge.

AS2828.1 is a standard that specifies the requirements for the physical aspects of health records. It covers size, quality, layout, and colour. The objective of the standard is to improve the quality of health care by facilitating communication between healthcare professionals. Standardisation of medical record across health care facilities can help achieve this.

 Many healthcare operators today view integration of sterilizer and washer machine as essential or so it seems given how frequently Medical Practice Managers and CSSD Managers ask me questions on this topic. But is the really the "must have" that many of us think it is?

The latest version of AS/NZS 4187 released on the 15^th December 2014  brought some very significant changes to the previous standard. One of the most significant changes is the standards reference to Product Families.

In my blog "Here's how to make sense of the AS4187 categorisation of instrument product families", I provided an overview of ISO/TS 17665-3:2013 - Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization.

In today's post I will get into the specifics of how to apply the standard to a dental assessment tray.

Medical Forms and AS28281.1

A whole new world of benefits will open up to you when you move from a paper based medical records system to digital.

For example you can create custom lists of things like medications or health funds and link them to text pickers and select lists. This way, instead of having to use the keyboard, users users can select an item from a (dropdown) list. So accuracy is greatly improved because the risk of typing errors is minimised.

You also have the option of adding check boxes to select “yes/no” type checks and transfer data automatically from one text field to another, so you only have to type it once!

These are just a few example but digital medical records offer you so many options.  So let’s take a look at an example medical record and apply some digital magic to it.

Doctors, nurses and care givers having been doing medical rounds since time began.

Segen’s Medical dictionary defines rounds as:

‘Bedside visits by a physician—or other health professional—to evaluate treatment, assess current course and document the patient’s progress or recuperation’

(from: Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.)

I don’t know how many tender documents I have filled out that contain questions about integration. Can it integrate with this, can it integrate with that?

It may seem a good idea to cover all bases and request technology vendors to integrate with your existing solutions. However in my experience integration can be complex to setup and maintain and it doesn’t always give you a lot of benefit. The risk in integrating systems from individual technology vendors is that your business continuity is now in the hands of two vendors who frequently have no partnership or existing or previous collaboration.

AS2828.1 specifies the requirements for the physical aspects of health records' size, quality, layout, colour, order of filing and record cover.

Although it appears to apply exclusively to paper based health records, AS2828.1 needs to be taken into account for health records that have been digitised from paper as well as Electronic health records.

Infection control and laser etching medical instruments.

In my blog What you need to know about Surgical Instrument Direct Part Marking (DPM), I wrote about the benefits of surgical instrument marking.  I also touched on some lesser known but important aspects that need to be considered.

The ability to quickly retrieve and return of instruments is one of the important benefits that a surgical insrument tracking solution can provide.

If you are considering an instrument tracking solution, then the tips in this blog will hopefully make your life easier down the track.

Introduction

Just about everyone these days wants their surgical instruments etched with 2D data matrix barcodes. There are plenty of benefits to be gained from doing so.

It speeds up the instrument assembly process and reduces the need for your people to memorise instrument names. The assembly process becomes very simple. Team members scan a barcode on an instrument and the computer tells them if it’s the right one or not and when the tray is complete.

 

Surgical Instrument Product Families for Ophthalmologists

The new version of AS/NZS 4187 released on the 15^th December last year brought some very significant changes to the previous standard. One of the most significant changes is the standards reference to Product Families.

In a previous blog, I provided an overview of ISO/TS 17665-3:2013 - Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization.

Today I will get into the specifics of how to apply the standard to a Cataract Tray. Let's take a look at how to do that.

If you’re a member of the Dental Health community you’re probably aware that a lot has happened in the last 12 months. I am referring to infection control breaches that have happened
in New South Wales. Around the same time two documents were released that have the express purpose of preventing such issues.

 

They are:

• AS4187 2014
• The Australian Dental Association Guidelines for Infection Control Third Edition 2015.

Infection Control has become a hot topic and the Australian Dental Board's release of an open letter  dated 16^th July 2015 reminding Dental Practitioners of their Infection control obligations under the National Law is testament to that.

With this blog, I will try to provide some guidance through the maze of standards and guidelines and provide dental practitioners with a list of relevant documentation for further reading.

Healthcare associated infection can be one of the biggest challenges faced by a health care facility. 

If you are considering a digital patient records system, it may well be worth looking to see that the system is AS2828 compliant.

Why, you ask? After all AS2828 is about paper medical records right?

Well...not exactly.

EMR, EHR, PCEHR, eHealth – what’s it all mean?

When it comes to naming computerised medical record solutions, the common approach, is to give them an acronym, or at the very least get the letter ‘e’ in there somewhere. The result is confusion.

I am frequently in conversations with people who randomly interchange EMR with EHR, eHealth with PCEHR and Paperless Medical Records with Digital Documents. And who can blame them?  It’s ambiguous and a conversation like that generally results in a headache.

In this post I hope to shed more light on what the terms all mean and bring it back to plain language.

Thinking about going paperless in your medical practice? One of the first big decisions you will be confronted with is whether to choose a web-based solution or a desktop application installed locally on your desktop computer.

On the 15^th December last year, a new version of AS/NZS 4187 was released. The standard is complex and there is so much to understand. There are many requirements. So what can you do to ensure your ophthalmic centre is compliant?

Previously I wrote about the new version  of AS/NZS 4187 (what it means for day surgeries and a reference table to AS4187 terminology for CDS Managers) which was released on the 15^th December last year. It has brought some very significant changes to the previous standard. In this blog post I discuss the standard's application to the reprocessing of flexible endoscopes.

The new version of AS/NZS4187 released on the 15^th December last year, contains a number of differences in terminology to the previous version. The new standard also uses abbreviations.

This blog contains a list of the abbreviations and their meanings and looks at some of the important differences in terminology.

The new version of AS4187 (AS/NZS 4187) released on the 15^th December last year brought some very significant changes to the previous standard. One of the most significant changes is the standards reference to Product Families.

On the 15^th December last year, a new version of AS/NZS 4187 was released. The standard is complex and there is so much to understand. So how do you know if your Day Surgery Clinic is compliant or not?

When it comes down to it, probably the only way to know for sure is have and keep the required documentation.

For an auditor, documentation of process and proof of process is everything. Say what you do and have proof that you're doing it. But in the case of AS4187, it's do what it says and have proof you’re doing it.

Somewhere in a health care clinic in the inner suburbs of a large Australian capital city – Tuesday 8am

Hey Betty...Have you seen the chart for Mr Smith...? I got it out yesterday afternoon with a bunch of others as we have a really busy day today.

Theatre optimisation rates are important for both Private and Public health care facilities. It’s about better patient outcomes and quality of care. Moreover, an optimised theatre asset will allow more patients to be treated in a shorter amount of time. In the instance of private healthcare facilities operating theatres are also a main income producing asset.

A new version of AS/NZS 4187 was released on the 15th December last year and, given that there is a 2 year adoption period specified, office based healthcare facilities in particular need to familiairise themselves with this updated standard.

Transitional planning is crucial when making the move from your current paper based medical records system to a paperless one. For example, when to stop using one system and start using the other? What do you do with your current paper medical records? Should you scan them all into the new system? Scanning all your records could be a significant and costly task. Perhaps you can make the transition over a period of time, taking a staged approach. Are there other options?

Patient Experience or Performance?

Are both possible? Pressure to improve performance and client retention is experienced by private and public hospitals around Australia. The patient experience and utilisation of medical assets are both key factors in realising these goals. But in a system that is frequently overburdened, where do you start and where can the biggest impact be made in the shortest amount of time?

AS2828 is a standard containing 2 parts. Part 1 relates to the format of paper based patient health records and part 2 relates to digitised or scanned health records.

At first glance AS2828.1 appears to relate only to paper records, however the standard has implications for those who are considering moving to a digital medical records system.

A quicker and easier way for CSSD Managers and Perioperative Nurses to pass AS/NZS 4187 compliance audits

You know the feeling, accreditation is getting closer and your stress and anxiety levels are becoming elevated. Tomorrow is the day and you’re wondering, hoping, praying that you’ve crossed the "T's" and dotted the "I's". You’re not going to sleep well tonight, you will replay that same old movie in your mind over and over again.

I know from personal experience that accreditation is one of the most stressful periods in the life of a manager. Scancare is accredited to AS NZS ISO 9001-2008 and we are about to undergo external accreditation again. For managers of CSSD’s and theatres who run manual tracking systems, it is an incredible amount of work making sure that their documentation is update and accurate.

The good news is that when it comes to AS/NZS4187 compliance, for those who use an electronic tracking system based on the principles of quality management, most of the leg work is already done.

Optimising the Lifespan of Surgical Instruments

Laser etching of surgical instruments with 2D Data Matrix barcodes is increasingly being considered by healthcare facilities.  These laser markings facilitate individual level instrument tracking, quick identification and assembly of instruments sets. However studies have shown that marking of stainless steel alters the surface composition and degrades the natural passive layer resulting in a mark that is  susceptible to corrosion. When this happens, both infection control and the lifespan of your surgical instruments are compromised. Indeed stories frequently circulate through medical instrument circles about instruments rusting and needing to be destroyed. 

Paperless or digital medical records management systems, are the buzz term these days. It seems like just about every medical practice manager at private and public hospitals is seriously considering adopting digital patient charts and going paperless. There are multitudes of systems out there that, from a distance, all look similar. So which one is right for your medical organisation and what are the most important things you should consider when making the change? 

Read on if you want to discover 4 aspects that you need to consider when making the change from a paper system to a digital medical records system.

In a competitive marketplace where shareholders have high expectations, it is incumbent on any medical practice management team to ensure that they are getting the most efficient use from their theatre asset. But how do you know if you are maximising the return on your medical assets and, if not, what can you do about it?