A.I.M. CONSULTING Ltd

Eucomed AIDC Member Survey

Background

Eucomed is the Voice of the Medical Technology Industry in Europe… representing 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Eucomed members include national trade and pan-European product associations and internationally active manufacturers of all types of medical technology. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.
 
 Business Issue

Eucomed has a number of active working groups focused on particular business areas, processes or issues. In 2006 one of these working groups, the eBusiness Task Force (ETF), identified a gap in its knowledge about the position of its members and member associations with regards to the standards used for automatic product identification. The Health Industry Bar Code (HIBC) standard is specific to Medical Technology, but how does its use compare to the multi-industry GS1 Standard? 
 
 As raising “awareness and understanding of e-Business, including Automatic Identification and Data Capture (AIDC)…” is a key responsibility outlined in its Mission, this was a critical knowledge gap.
 
 Selection

At that time, Q3 2006, Janice Kite was a member and Vice-Chair of the ETF and based on her knowledge and experience she was asked to undertake this piece of research on behalf of the working group.

 Detail


A survey was conducted to “better understand the position of its members and member associations with regard to the standards used for automatic product identification developments”.

The survey was created and approved by ETF and made available to all Eucomed’s contacts in five languages (French, German, Spanish, Italian and English) by email and on the Eucomed member’s intranet, it was open for 6 weeks (October/November 2006). The survey was repeated, unchanged, in Jan/Feb 2008.
The 2006 results came from at least 19 countries with the dominant participating organisations (82%) from medical device manufacturers. The percentage of participants using particular standards were 39% GS1, 19% HIBC with 20% using both GS1 and HIBC, but 55% indicated they would change to GS1 over the next 36 months, whilst 9% would move towards using both standards.
The results of the survey and discussions in the ETF resulted in the Eucomed Guidance on Bar Coding for Medical Devices published in September 2007 that concluded:
 “Eucomed recommends introducing the use of GS1 standards at any opportunity deemed appropriate or from a cost-efficiency and quality point of view. Eucomed believes that companies implementing these standards will be best positioned to meet customer expectations now and in the future and to satisfy the increasing requirement for electronic information exchange. This will improve patient safety and will create the opportunity for business growth.” 
The 2008 results came from a similar number of countries with the same dominant participation (82%) from medical device manufacturers. Of the participants using HIBC or GS1 standards the figures had changed (2006 figures in brackets): GS1 48% (up from 39%), HIBC 19% (unchanged) and 33% (up from 20%) using both. The percentage indicating a change to GS1 was 58% (up from 55%) but so too was the percentage indicating a change to use BOTH standards – 25% (up from 9%). The same period of 36 months was cited for the change.

Benefits

The comparable results from the two surveys indicates a transition phase across the industry in regards to the Auto-Id standards used and the Eucomed Guidance on Bar Coding for Medical Devices therefore remains contemporary in its recommendations and conclusions and provides valued guidance to its members.
 
Update 2010

In June 2009 Eucomed published “Risk-based implementation of Unique Device Identification (UDI), Improving patient safety through product identification and traceability” which states “…Eucomed believes a risk-based approach is needed with regard to the implementation of medical device traceability with unit pack serialisation, evaluating the actual risk to patient safety and risk associated with counterfeiting and reimbursement fraud. Therefore, implementation of serialisation and medical device traceability should focus on the highest risk devices first and exempt those device categories where less risk exists…” 

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