Service Notice - GMDN Administration Office closed on Monday 27th May 2013
Dear Customers, the GMDN Administration Office will be closed on Monday 27th May 2013, due to a UK public holiday. This will not affect your access to the GMDN Database. We apologise for any inconvenience.
23/05/2013 15:03:19
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FDA announce proposed Rule on UDI
The US Food and Drug Administration have published their long awaited proposed rule on Unique Device Identification (UDI). The Rule proposes that all medical devices distributed in the USA carry a unique device identifier and this and other data elements are available on a centralised database. Following the guidance published by the GHTF, the GMDN will be included in this data set. The GMDN Agency is working closely with the FDA to implement the database. More information about the rule can be found at www.fda.gov/udi.
18/07/2012 12:42:58
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GMDN and IHTSDO sign Cooperation Agreement
Oxford, UK and Copenhagen, Denmark: 27 April, 2012
The Global Medical Device Nomenclature Agency (GMDNA) responsible for the international naming system for medical devices (GMDN) and the International Health Terminology Standards Development Organization (IHTSDO), the leading provider of standardized clinical terminology (SNOMED CT), are pleased to announce that they have signed a Cooperation Agreement.
The Cooperation Agreement shall result in the use of the GMDN as the basis for the medical device component of SNOMED CT and the opportunity for GMDN to be populated with any SNOMED CT medical device component content that is not pre-existing. The Agreement is consistent with the aims of both organizations to minimize duplication and to support harmonization and is the culmination of discussions over the last year relating to how the two organizations can work together for the mutual benefit of their stakeholders, including:
• A more comprehensive and harmonized clinical terminology
• Greater utility and access to both terminologies
• Opportunities to improve organizational efficiencies
The initial duration of the Agreement is for a period of five years and the parties intend to identify further opportunities to work closer together for the benefit of their stakeholders.
The Agreement will benefit patients across the world and all users of SNOMED CT and the GMDN in promoting comprehensive terminology based medical records, covering the needs of regulators, the medical device industry and healthcare professionals. The arrangement will help to link the medical device supply chain to the application of care to individual patients for medical device, patient risk and safety use cases.
The arrangement will provide patient safety benefits in terms of recall of defective devices, when model and serial number or later UDI are stored in patient records, public health analysis on morbidity and mortality in correlation with medical devices and will also ensure the quality of the supply chain.
Andy Wiesenthal, acting Chair of the IHTSDO Management Board, said of the agreement, “I’m delighted with this cooperation arrangement. It will make it possible to incorporate the extensive medical device content of GMDN into SNOMED CT for the benefit of all SNOMED CT users”.
Janet Trunzo, Chair of the GMDNA Committee, added “the agreement will make GMDN content more widely available for the ultimate benefit of patients and global health. Both parties have also committed to identify if there are ways of working more closely together to deliver further benefits”.
About IHTSDO
The IHTSDO (International Health Terminology Standards Development Organisation) and its current 19 Members seek to improve the health of humankind by fostering the development and use of suitable standardized clinical terminologies, notably SNOMED CT, in order to support the safe, accurate, and effective exchange of health information. IHTSDO’s governance structure allows Members to control and guide the development of SNOMED CT, to ensure it meets both their joint needs and the specific needs of their individual countries. SNOMED Clinical Terms™ (SNOMED CT™) is a standardized terminology that can be used as the foundation for electronic health records and other applications. SNOMED CT contains more than 310,000 unique concepts and more than 1.3 million links or relationships between them that ensure that this information is captured consistently, accurately, and reliably across health systems. The terminology is in use in more than fifty countries around the world. SNOMED CT was originally created by the College of American Pathologists by combining SNOMED RT and a computer-based nomenclature and classification known as Clinical Terms Version 3, formerly known as Read Codes Version 3. For more information please visit: www.ihtsdo.org
27/04/2012 11:01:46
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GMDN and IHTSDO Announce Agreement
Oxford, UK and Copenhagen, Denmark: December 1, 2011 Senior representatives of the Global Medical Device Nomenclature (GMDN) Agency. responsible for the international naming system for medical devices and the International Health Terminology Standards Development Organisation (IHTSDO), the leading provider of standardised clinical terminology (SNOMED CT), are pleased to announce that they have recently finalised the business principles that will form the basis of a long term cooperation.
The Cooperation Agreement shall result in the use of the GMDN as the medical device component of SNOMED CT. This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation.
The finalisation of the business principles followed a series of discussions throughout the summer and fall, where the following objectives were agreed:
- A more comprehensive and harmonised clinical terminology
- Greater utility and access to both terminologies
- Opportunities to improve organisational efficiencies
The Agreement will benefit patients across the world and all users of SNOMED CT and the GMDN in promoting comprehensive terminology based medical records, covering the needs of regulators, the medical device industry and healthcare professionals. The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases.
About IHTSDO
The IHTSDO (International Health Terminology Standards Development Organisation) and its Members seek to improve the health of humankind by fostering the development and use of suitable standardized clinical terminologies, notably SNOMED CT, in order to support the safe, accurate, and effective exchange of health information. IHTSDO’s governance structure allows Members to control and guide the development of SNOMED CT, to ensure it meets both their joint needs and the specific needs of their individual countries. SNOMED Clinical Terms™ (SNOMED CT™) is a standardized terminology that can be used as the foundation for electronic health records and other applications. SNOMED CT contains more than 310,000 unique concepts and more than 1.3 million links or relationships between them that ensure that this information is captured consistently, accurately, and reliably across health systems. The terminology is in use in more than fifty countries around the world. SNOMED CT was originally created by the College of American Pathologists by combining SNOMED RT and a computer-based nomenclature and classification known as Clinical Terms Version 3, formerly known as Read Codes Version 3.
For more information please visit: www.ihtsdo.org
02/12/2011 15:29:59
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GMDN 20th Birthday!
The GMDN Agency celebrates 20 years since Medical Device Regulators first met at the 1st international workship on 14-15 November 1991, to discuss the harmonisation of medical device nomenclature. The participants were EU, EFTA, Canada and the USA.
15/11/2011 12:31:13
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Big increase in New Term Requests
The adoption of the GMDN for regulatory purposes by so many countries in recent months has certainly boosted the number of our members. This has also had the effect of increasing the number of new term requests we have received. We would like to ask Companies to send us their applications for new terms for their innovative products earlier in the product development process, rather than leaving it until they introduce their new products to the market. In this way we hope to better meet customer deadlines. Members can be assured that their sensitive product information is kept confidential throughout the new term development process.
10/11/2011 09:27:45
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Staff changes at GMDN
After many years at the head of the organisation responsible for publishing the GMDN, Maurice Freeman has decided to retire as CEO of the GMDN Agency and has become Founder and Senior Advisor. The new CEO is Mark Wasmuth, who has been Secretary General for the last 18 months. Maurice commented "The recent growth in Membership of the Agency puts it on a sound economic standing and I look forward to its continued good health".
This summer we also welcome Dr Barry Daniels as our new Nomenclature Developer. Barry has vast experience both as a medical practitioner and IT systems developer and joins our expanding team of experts responsible for new term development. Barry said "this is an ideal job for me and I look forward to meeting and discussing the need for new GMDN terms with our clients".
10/11/2011 09:26:50
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GMDN and IHTSDO Start Collaborative Efforts
UK and Copenhagen, Denmark: September 12, 2011
Senior representatives of the Global Medical Device Nomenclature (GMDN) Agency responsible for the international naming system for medical devices and the International Health Terminology Standards Development Organisation (IHTSDO) the leading provider of standardized clinical terminology (SNOMED CT), have recently met to explore ways of collaborating in a long term relationship. The 3 day meeting in Singapore followed a series of discussions throughout the summer, and identified the following benefits:
- A more comprehensive and harmonised clinical terminology
- Greater utility and access to both terminologies
- Opportunities to improve organisational efficiencies
Each group will propose to their respective Management Boards:
- To conclude an agreement on the incorporation of the GMDN terminology into SNOMED CT for clinical evaluation purposes by the end of the year
- That the two not–for-profit organisations continue to seek an even closer alliance and opportunities to reduce costs further
About IHTSDO
The IHTSDO (International Health Terminology Standards Development Organisation) and its Members seek to improve the health of humankind by fostering the development and use of suitable standardized clinical terminologies, notably SNOMED CT, in order to support the safe, accurate, and effective exchange of health information. IHTSDO’s governance structure allows Members to control and guide the development of SNOMED CT, to ensure it meets both their joint needs and the specific needs of their individual countries. SNOMED Clinical Terms™ (SNOMED CT™) is a standardized terminology that can be used as the foundation for electronic health records and other applications. SNOMED CT contains more than 310,000 unique concepts and more than 1.3 million links or relationships between them that ensure that this information is captured consistently, accurately, and reliably across health systems. The terminology is in use in more than fifty countries around the world. SNOMED CT was originally created by the College of American Pathologists by combining SNOMED RT and a computer-based nomenclature and classification known as Clinical Terms Version 3, formerly known as Read Codes Version 3.
For more information please visit: www.ihtsdo.org
For a full copy of this information, please contact the GMDN Agency.
12/09/2011 16:31:36
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GMDN Membership grows to meet the demands of Regulators
The number of GMDN members has increased by over 100% in the past year. This dramatic increase is due to the recent implementation of the GMDN Codes by many Medical Device Regulators into their national requirements. Many of our members who are larger manufacturers are also moving to global multi-site licenses, to help coordinate the use of GMDN throughout their organisations. With the growth in membership, the cost of membership renewal will remain unchanged for the year ahead. Maurice Freeman our CEO stated “The increase in membership has helped us to reduce the individual costs in real terms to our members, in the difficult trading conditions we have at this time.”
05/09/2011 12:45:52
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New GMDN Terms for Diagnostics and Therapeutic Radiation Devices
Innovation in hi-tech equipment for medical examination, monitoring and treatment continues to increase the number of GMDN terms for this category of products. Alan Fields, GMDN Core Expert said, “Manufacturers are developing new equipment for both hospital and home-care monitoring of patients health and we are very pleased to have a new product specialist in our Expert team to help with this category.”
05/09/2011 12:45:43
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Turkey Authority requests manufacturers to use GMDN
The Turkey Social Security Institute, who is responsible for repayment of medical device expenditure by Turkish hospitals, has requested all suppliers check that they are using the current version of GMDN codes when applying for product registration. Suppliers have until May 2011 to supply the necessary information to the nation medical device databank (TITUBB). Suppliers can get Turkish language support from our Promotional Representative website - www.gmdn.com.tr
If any GMDN Members are having difficulty in meeting the requirements of the TITUBB system, please can they contact us by email for assistance.
28/04/2011 16:31:43
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European Regulators are using GMDN
A number of European medical device regulators are now requesting the use of GMDN Codes when registering products. The following countries, Italy, Poland, Czech Republic, Greece and Estonia have implemented the use of GMDN ahead of future EU-wide requirements to use the GMDN Codes for EUDAMED data-exchange on medical device incidents between Member States.
28/03/2011 14:51:26
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European Regulators are using GMDN
Following the commitment of the European Commission to translation all GMDN terms and definitions into EU Member State languages, many national Medical Device Regulators are now requesting GMDN Codes when registering devices, in preparation for the EUDAMED post market vigilance system, due to be implemented from May 2011.
16/12/2010 09:35:04
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New GMDN Terms for Complementary Therapy
A number of new GMDN terms for Complementary Therapy Devices have been created for those regulators who now recognize and regulate such products as medical devices, this being especially the case in the Far East and Australia. These devices may be used alone or to complement allopathic medicine. Commonly their use is related to the body's innate energy system. Examples of devices in this Category include acupuncture needles/devices, bio-energy mapping systems/software, magnets, moxibustion devices, suction cups, etc. Alan Fields, GMDN Core Expert said, “As a global nomenclature we need to develop and include GMDN terms to cover all requirements of the Healthcare Sector, even though such products may not be identified as medical devices in all countries”.
16/12/2010 09:34:34
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US FDA outlines recommendations for UDI
At the FDA UDI conference in Baltimore in this month, the FDA has provided detailed recommendations on its Unique Device Identification (UDI) requirements. Delegates at the conference were told by FDA Senior Advisor for Patient Safety, Jay Crowley, that the new system for post-market regulation “will establish a single device identification system that is consistent, unambiguous, standardized and globally harmonized” and uses the GMDN as part of the “minimum data set”. The US policy supports the draft guidance on UDI published by the GHTF.
16/12/2010 09:34:02
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GHTF endorses GMDN for global use
The Global Harmonisation Task Force (GHTF), the body responsible for international harmonization in the regulation of medical devices, has officially endorsed the GMDN as the preferred “single nomenclature system that is readily available globally for regulatory purposes”. In a recent press release it added that “The use of a single system would enable consistency in classification and identification, the consistent capture of product information across manufacturers, sponsors, distributors and in the clinical setting, for example, in hospitals.”
16/12/2010 09:33:28
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FDA recommends GMDN for UDI
The US Food and Drug Administration has identified the GMDN Codes as being part of the ‘minimum data set’ for their planned Unique Device Identifier (UDI) database for medical device pre and post market control. The plan was revealed in a presentation given by the FDA at the recent IDN Summit medical device conference in the US.
16/09/2010 09:04:14
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New Terms for Dental Devices
The past 3 months has seen an increase in the number of Dental terms that have been added to the GMDN database. This follows recent guidance published to EU dental practices concerning improvements in equipment sterilisation procedures. Alan Fields, Co-chair of the Expert Group said “We were surprised by the large number of new term requests in this category”.
14/09/2010 11:11:41
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New GMDN Categories
There are 2 new categories of GMDN which manufacturers are now using, 'Healthcare Facilities' used for building-related products and furnishings for the function and utilization of healthcare facilities, or for home healthcare, which are not involved in patient diagnosis or disease-related treatment and 'Lab Equipment Devices' used to contain, handle, process, measure, examine and identify clinical specimens or other substances typically in the evaluation of physiological and pathological conditions.
14/09/2010 11:11:15
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GMDN Language Support for EUDAMED
The European Commission is investing 2.5 M EUR to translate the GMDN terms and definitions into 20 European Languages. As the translations are completed they are being added to the database, which now supports language selection. The EC plans to support the translation process for the foreseeable future to ensure EU Member States can enforce the Eudamed post-market vigilance system, due to become obligatory from May 2011.
14/09/2010 11:09:41
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Reduced membership cost for smaller manufacturers
GMDN Agency is pleased to introduce a reduced level of Annual Contribution for smaller manufacturers with only few generic products, and with low annual sales (now below 500 thousand Euros). This reduces the base annual cost to 100 Euros, allowing full internet access to all terms (up to 20,000), and the versatile search mechanism, plus identification of a number of codes for selected generic terms (see details for Schedule ‘B’ Members).
20/08/2010 08:39:14
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GMDN invests in the long term
The GMDN Trustees met recently to discuss the work being undertaken by the European Commission to translate the GMDN into 20 official languages of the EU. The Eudamed post-market vigilance system is due to be up and running in the near future. To ensure we meet the expected future demand for GMDN as a result, the Trustees have agree to invest 350 000 EUR in additional IT hardware and software. The planned modification to the GMDN website will eventually allow members to select their language preference, from those included, when using the system. Until alternative funding can be secured, we have had to make a small increase to subscriptions. These have remained unchanged for the past 4 years.
29/04/2010 13:07:22
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Eucomed recommends GMDN
Eucomed, the European Medical Technology Industry association, welcomes the Decision adopted by the European Commission to make the use of the Eudamed database obligatory by EU Member States from 1 May 2011. To ensure consistency of data, Eucomed recommends using the GMDN nomenclature as the ‘internationally recognised nomenclature’ called out in the new EU legislative text.
29/04/2010 13:06:17
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Orthopaedic Implant Terms!
GMDN terms for orthopaedic implants have undergone a major review to ensure the terms cover the wide range of devices available in the market today. Work done by GMDN experts has produced a new structure for orthopaedic device terms within the Collective Terms - Device Applications. This change will speed up the search for orthopaedic devices using the advanced GMDN search tool, the Navigator.
29/04/2010 13:05:50
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ISO 9999 Collaboration continues
The number of new terms for devices for persons with disability has increased recently, following close collaborations with the ISO technical committee (TC 173/SC2) responsible for ISO 9999:2007 Assistive products for persons with disability. The ISO TC has been supporting the GMDN ever since its inception in the 1990’s and now the concepts contained in the latest version of the standard are being fully integrated into the GMDN.
29/04/2010 13:05:25
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Seeing more clearly with GMDN
The review of device terms covering contact lenses has been completed by our GMDN Experts in Japan. This has updated a number of existing terms and introduced new ones to meet the needs of the industry following development in ophthalmic technology. Alan Fields, Co-chair of the Expert Group said “We have been looking into this subject for some time and the way forward looks clear”.
29/04/2010 13:04:55
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GMDN Web Access
To obtain access to GMDN for any purpose you should only use one of the official GMDN web links. These safe sites are www.gmdnagency.com and www.gmdnagency.org . Other links that can be used are www.gmdn.co.uk , www.gmdn.eu , www.gmdnagency.co.uk , www.gmdnagency.eu and www.gmdnagency.net .
07/04/2010 14:24:08
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Bogus GMDN warning
We have received complaints concerning transmission of viruses and malware through other websites offering GMDN codes or access. Please contact us if you have any doubt about the authenticity of the GMDN website you are using.
07/04/2010 14:23:32
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Translations support EUDAMED
The European Commission has undertaken the translation of all current P Terms into 20 official languages of the EU. This will remove the last barrier for the implementation of the EU post-market vigilance system (EUDAMED). The GMDN website is currently being updated to allow members to access the new language versions of the GMDN. Further information on EUDAMED can be found at http://ec.europa.eu/enterprise/sectors/medical-devices .
03/02/2010 16:04:07
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Don’t lose touch
With so many new terms and changes made on a daily basis to the GMDN, you need to make sure your subscription remains current. Terms selected by Members and listed in the ‘My Terms’ area will be monitored by the website software and Members will receive an automatic notification by email of any changes to their terms. A subscription renewal reminder is automatically sent to Members a month before it is due.
03/02/2010 16:03:42
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New Terms process improved
The GMDN Agency gets about 30 requests per month from manufacturers for new terms. To make sure Member requests are dealt with in a timely manner, information on the new device is lodged using the electronic form at www.gmdnagency.org/request and immediately transmitted to the Expert Group.
Alan Fields, Co-chair of the Expert Group said “The team have been working very hard over recent months to generate new terms following the high demand from our members”. Manufacturers are requested to provide as much information as possible to assist the Experts Group.
The group will decide if a new term is appropriate or not, or whether an existing term needs revising to include the new variant. Either way the decision is made in full consultation with the manufacturer.
03/02/2010 16:02:09
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More GMDN Terms!
Last month saw the number of Preferred Terms published by the GMDN Agency increase by over 4000 new terms.
The most current new terms being for In Vitro Diagnostic medical devices (IDVs) developed in conjunction with EDMA, FDA and TGA. In the near future these are being expanded to include approximately 12,000 new and revised terms to meet the need of the industry. Once these new IVD terms have been checked, they will be uploaded to the GMDN database.
03/02/2010 16:01:10
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Trustees support commitment to pursue future free access
It has, for many years, been the preferred wish of GMDN Agency to be able to provide access to GMDN, free at the point of use (e.g. free to manufacturers, hospitals, etc). It is thus necessary to obtain a guarantee of annual funding, to cover the continuing costs of developing and managing the large data file.
The enlarged Board of Trustees at its first meeting confirmed its commitment to achieve this goal of 'Free Access', by means of appropriate world-wide funding, ( e.g. - by means of shared annual costs between Global Regulatory Bodies).
Footnote:- GMDN is working in cooperation with the Global Harmonisation Task Force (GHTF), The Asian Harmonisation Working Party and others, to enhance the governance structure of GMDN, and to provide appropriate input from its many stakeholders.
Whilst searching for sources of funding to eventually achieve the possibility of free access, it should be noted that there are considerable costs being incurred when including translated versions (25+ languages) within the data file (more than 20,000 Generic Terms plus definitions for each language).
15/08/2009 16:05:04
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