Fascinating article here from MD+DI looking at emerging device technology that can ‘revolutionize’ healthcare. Read more here. From orthopaedic devices with embedded technology, self-monitoring stents, alarm technology, sterilization breakthroughs, microbial information systems, replacement body parts, cancer screening, anti-aging technology, to devices that treat as they diagnose. 2012 will certainly be an exciting year for the medical devices industry!
The Medtech worldview
An interesting article published earlier this month on Device Talk. If you’re thinking of expanding your markets or just interested in the latest global industry trends, this is a must read. Peter Fitzgerald, Stamford cardiologist, outlined at the last TCT2011 symposium the opportunities in the life science arena. Click here to read the full article.
The 510(k) Utopia: Consistency
Good news for the international medical device industry. The FDA is implementing a staff training scheme for all new medical device reviewers.
The ultimate aim of this scheme is to ‘improve the consistency of medical device reviews’; this has got to be good news for device manufacturers involved in the 510(k) process. Inconsistency has often been the industry’s experience thus far and any initiatives to tackle this issue will be welcomed by organisations all over the world and the healthcare sector in the States which oozes a cutting edge and innovative ethos.
In order to be belt and braces about a consistent approach to the 510(k) process, perhaps the scheme should be made compulsory for existing staff as well as new. You can read more about it by clicking here.
Are you looking to sell your Medical Device into the US?
If so, there are some important regulations you need to know.
Medilink East Midlands are holding a 1 day training course on FDA regulations for Medical Devices. Run by experts in the field from High Edge Consulting, this free one-day workshop will focus on the key issues required to get your device onto the US market.
For further details and to book a place, click here (takes you to Medilink East Midlands website).
CE Marking & Risk Management training courses – Birmingham, UK
- 13 & 14 September – CE Marking – an Introduction to the Medical Devices Directive
- 28 & 29 September – Risk Management of Medical Devices ISO 14971
Click on course above for more details
Medical Device Sterilization Training
7th July 2011 – Gamma & E-beam (advance) & 13th July 2011. – Ethylene Oxide (advance)
1 day courses at Holiday Inn Birmingham Airport, UK. Sterilization experts from High Edge Consulting, Isotron & Notified Bodies.
Special offer price £875 + VAT for both courses (usually £1050) or £475 + VAT for 1 course (usually £525). Book and pay by calling +44 (0)115 921 6200.
GHTF officially endorses the use of the GMDN nomenclature system
GHTF have issued a position statement on the Single Global Nomenclature System for Medical Devices. In a statement (see below) published on their website, the GHTF acknowledge that the use of a single global nomenclature system is one of the key elements to achieving a globally harmonised approach to medical device regulation.
“The nomenclature of a medical device facilitates its progression through the entire product life cycle. 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. It would streamline medical device recalls, adverse event reporting and postmarket surveillance and monitoring.
The GMDN is a system of internationally recognised coded descriptors used to generically identify medical devices, which is now being utilised by many of the world’s medical device regulators and industry. The GHTF therefore endorses the GMDN coding system as the preferred nomenclature system for regulatory purposes for medical devices and will continue to work to ensure its effective governance and availability.”
If this is the way to go in the future it raises the question as to what happens for those manufacturers and regulators using alternative nomenclature systems such as the UMDN. Read more on this issue at http://www.ghtf.org/about/statement-gmdn.html.
Should the MHRA have greater powers?
In the news this week is the article about the High Street shop Pound World who have been fined £5,000 for selling medical devices that are not CE marked. The MHRA found that Pound World was selling dangerously faulty digital thermometers, bandages, plasters and sterile dressings all of which were not CE marked as required by UK regulations. Pound World continued to sell the thermometers despite warnings to take them off shelves last year by the MHRA. Is profit before public health more important to Pound World?
The question is should the MHRA have more powers than they currenlty have to force shops like Pound World to withdraw non compliant items straight away or have the power to remove the items themeselves. If the MHRA had such powers and could also fine the likes of Pound World perhaps the trade of non compliant goods would be significantly reduced. Judging by the number of fines and costs Pound World pays out (£9,000 costs in this example) the £1 market must be very boyant indeed. Is Pound World a one off or just the tip of the iceberg?
Health Canada seek input from Medical Device manufacturers on the use of GHTF STED format
Health Canada has drafted a guidance document on the use of the GHTF STED format for Class III and IV device submissions and is seeking input from manufacturers. The guidance document integrates the STED within the Canadian medical device licensing framework. The consultation draft document can be found at http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/consult_md_draft_gd_im_ebauche_ld_sted-eng.php . The consultation is open until the 12th December 2010.
GHTF publish additional guidance on auditing of QMS
The Global Harmonization Task Force (GHTF) have published additional guidance as follows:
- SG4/N30 2010 Guidelines for Regulatory Auditing of QMS of Medical Device Manufacturers – Part 2 Regulatory Auditing Strategy
- SG4/83 2010 Guidelines for Regulatory Auditing of QMS of Medical Device Manufacturers – Part 4 Multiple Site Audits
- SG4/84 2010 Guidelines for Regulatory Auditing of QMS of Medical Device Manufacturers – Part 5 Audits of Manufacturer Control of Suppliers
- SG1-N65 2010 Registration of Manufacturers and other parties and of medical devices
Further information can be found at http://www.ghtf.org/sg4/sg4-final.html