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:
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.
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.
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.
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?
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.
