Introduction
On 30th September 2016, I published my blog ‘NSHQS extend AS4187:2014 implementation deadline’ that discussed the NSQHS Advisory No. A16/03 which related to an implementation extension until December 2021.
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 AS4185 in dental practices and office based health care services. The short video addresses that.
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.
