Found sometime ago a great article: Product Liability Insurers Raise The Bar On Risk Management. It´s from The Grey Sheet, a journal/website from Elsevier directed at medical evices regulatory community.

I think there´s one phrase in the article that summarizes it´s intention, and it´s a phrase i totally believe and try to spread:

“Companies get lulled into believing that if they get that FDA stamp of approval, everything’s going to be fine”

This is true in relation to every regulatory requirement from every regulatory agency. The fact is that manufacturer sometimes forgets or try to get away from the fact that THEY are responsable for their devices, not any goverment or regulation.

Canada is one of the first countries to officialy establish a transition period to the third edition of IEC 60601. In truth, they have already adopted the new versions of IEC 60601-1 and IEC 60601-1-2, removing the previous editions from the Health Canada List of Recognized Standards. This meant that only the new versions could be used. But this position was reviewed due to the difficult in the implementaion of the new standard (the main problem is the requirement for a risk management process based on ISO 14971), so they reinserted the older editions in the list. This means that, until December 15, 2008, the old or the new version can be used for regulatory purposes. After that, only the new edition. It´s a short period, but will surely help manufacturers in the adaptation process.

More information on the original link: Inclusion of Second and Third Editions of IEC 60601-1 and IEC 60601-2 on TDP List of Recognized Standards

Thanks for Dmitry from the Elsmar Cove Forum for the tip.

Howdy, folks,it´s been a long time…

No updates here for some.. hum… six months? Wow, only time can tell.

Anyway, it´s been a busy end-of-one-year-beginning-of-another. I´ve been mostly warming things for my consulting practice - i´m planning to put it rock`n`rollling this year - and working on some projects, one of which is the implementation of tests based on IEC 60601-1:2005 at the Technological Research Institute in Brazil. We will be the first lab in the country to be able to execute the tests. Sweet.

But right now i´m more focused on risk management and management in general. And thanks to some discussion groups (mainly Elsmar Cove; i´ve returned, after some time, to the EBME forum, these are two that i really like) and A LOT of reading and studying, i think that now i have a deeper understanding of the ways things happen in the medical device regulatory affairs sector worldwide and the impact of risk management on all that (two must-read documents are Medical device regulations : global overview and guiding principles from the World Health Organization and Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety by G.R Higson - this last one made a high impact on my views of the medical device regulatory sector. Oh, and it can be read on Crcnetbase, but only those who subscribe.

We´ll, in the time i was away, some things happened in the medical device standards arena. A lot of things are related to the new edition of IEC 60601 and the work of TC 62 from IEC on the harmonization of all the standards in the series with the general one. The general standard itself changed a bit, with the release of another corrigendum and a soon to be released Interpretation Sheet (more info in a future post!).

Well, i´ll try to update the site regularly again, but won´t promise anything.

As always, if you have news or topics that you want to see posted on the blog, contact me using the contact form or leave a response on a post.

Oh, and happy new 2008! Better late than never…

The International Organization for Standardization (ISO) published last month the new verison of the risk management standard for medical devices, ISO 14971:2007 - Medical devices - Application of risk management to medical devices. From the site:

ISO 14971:2006 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2006 are applicable to all stages of the life-cycle of a medical device.

The development of this second edition used the experience gained from the application of the previous edition. One of the main problems identified, for example, was that users of the standard failed to understando the principles of risk management applied to the safety of medical devices. This has been dealt with in an extensive annex. Another annex provide real-life examples of hazard and hazardous situations.

This standard is the most important one in the field of medical device safety, simply because the majority of the certification and conformity assessment systems in the world are based on risk management. Even safety standards (for example, the new IEC 60601-1:2005) are being developed inside a risk management framework.