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.
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.
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.