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.

I really love Google services!

I´ve added a widget on the blog sidebar to experiment Google Talk Chatback. What is it? Well, it´s a service in which blog visitors can talk to me if i´m online on Gtalk (and i´m almost always online as i work with Gmail open in a browser and Gtalk enabled in Gmail) and the best thing is that the user do not have to have Gtalk, because the widget opens a web-based gtalk interface for the conversation! The only problem that i´ve noticed so far is taht users always appeaar as “Guest”, even if they are logged in Gtalk…but, anyway, this is a wonderful feature for improving communication! Give it a try sometime!

Hello all, this is just to tell that i made some modifications on the blog theme. The color scheme changed to align with the scheme of my consulting practice (which is now linked as the blog sponsor in the sidebar). I also rearranged the subscrition link and put a form for the subscription by email, to make it easier to subscribe. Also in the sidebar, a link to my profile in Linkedin can be found. Feel free to add me as a connection!

I removed the options in the navigation bar (equipment, standards, etc). My initial project for this blog (and it´s brazilian portuguese original) was to give static content information on medical equipment, standards and related subjects in a descriptive and linked way. But the truth is that i do not have the time need to put so much information online alone right now, and i think i won´t for the near and distant future. So the objective of the blog will be to provide only news about these topics, and no static content anymore. Hope i can keep a update schedule this way (i also changed my posting habits a bit - now when i make a post i make it in portuguese and english at the same time for the two blogs - so not to procrastinate the translation process :-)).

Hope you enjoy!

As always, the Medical Device Link (whose owner Canon Communications LLC is the publisher of great magazines such as Medical Device & Diagnostic Industry and IVD Technology )has some interesting articles in recent issues of their magazines.

The february issue of MDDI has an article on designing medical devices for home care use which cites some points to take into consideration in the design process, such as ease of use and mobility. In fact, this is another trend int the medical device sector which is tied, for example, to the usability trend in medical device design (which is a cosntante feature of MDDI - this same issue has an article with tips for integrating usabiliy, also know as human factors, in the design development process). Oh, and as all trends, there´s a standard on the horizon about the subject, collateral standard IEC 60601-1-11, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment.

One interesting note in this issue is about the struggle of the FDA against the makers of some bogus devices. I mean, electrophysiological feedback to treat cancer and AIDS? Come on!

The notes also have some points on the recently finished case Riegel vs Medtronic in which the US Supreme Court ruled that consumers cannot sue FDA approved medical devices companies under state law because this would impose requirements different from the federal law (the FDA approves the safety and effectiveness of devices under the federal law). This case has been making a buzz for some time and the decision will continue this trend, as can be seen by the some comments from politicians

Also in this issue, an article comments on the changes on the new version of the medical devices directive - MDD, which took place on september 2007 and will go into effect in march 2010.

The january / february issue of European Medical Device Manufacturer has a paper on the recently published IEC 60601-1-9 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design. The standard requires that manufactuers take into account envinronmental aspects, such as use of environmetal friendly materials, on the design of medical equipment. What i found interesting about the article is the link to www.medical-ecodesign.com, a web-based service which helps manufacturers design equipment in conformance with the standard. As a admirer of web-based solutions, i found this one really interesting and a possible starting point for more general ones.

Finally, the january/february issue of Medical Device Technology has two articles that i liked, one on recent developments of funcional electrical stimulation systems, and another discusses the scope of the european medical devices directives, focusing on the legal implications of products that are excluded from the scope of the directives.

Tttthat´s all, folks!

Testing posting from twitter using twitter tools and twhirl!

Hey ho, let´s go! The new, 2008, 6th edition of the ISO/IEC Directives are here.

The directives are a two-part document (1 general and one specific to ISO and another to IEC) which details the procedures to be followed by standards developers when desigining a new ISO or IEC standards. Best of all, they´re free of charge for anyone interested in understanding how a standard is developed.

This is the link for ISO/IEC Directives, Part 1 - Procedures for the technical work. This part is the same for both organizations.

The IEC-specific supplement is ISO/IEC Directives Supplement — Procedures specific to IEC

I haven´t found the new ISO supplement, but this this ISO Livelink link has a lot of info and documents, for example the old ISO/IEC
Directives, Part 2 - Rules for the structure and drafting of International Standards (i´m not totally sure this Parte 2 won´t be published again..i´ll have to take a look and i´ll update this post if any of the above info is incorrect).

Finally, to understand the need and impact of these documents, ISO published some time ago a brochure entitled How ISO/IEC Guides add value to international standards which is a must-read for those not wanting to delve in the technicalities of the original documents.

Now if only i could find some good samaritan to translate these documents for portuguese (the Brazilian version are still third edition, if i remember correctly :-()

- IEC 62366 Ed. 1.0 - Medical devices - Application of usability engineering to medical devices

This standard is the best example of the regulatory trend to require the use of usability engineering (also know as human factors engineering) to demonstrante conformance to the Essential Principles of Safety and Performance of Medical Devices (to understand what i´m saying about the regulatory trend, take a look at the FDA Human Factors Program at the CDRH website, where you can download human factors guidance documents such as Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices used in Home Health Care. Also take a look at Do It By Design - An Introduction to Human Factors in Medical Devices).

Standard IEC 60601-1-6, on medical electrical equipment usability was the basis for this new standard, which expands the scope to all medical devices.

This standard specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use.

The standard is totally based on risk management and, therefore, is best used integrated in a risk management process and system based on ISO 14971.

More information on the IEC Webstore.

- IEC 60601-2-39 Ed. 2.0 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

The new version of the standard for peritoneal dialysis equipment is already aligned with the third edition of IEC 60601-1 . The technical change made was the addition of a list of essential performance requirements contained in the standard - this list will be a feature of all the new particular standards; this was added to facilitate the understanding of the concept of essential performance of medical electrical equipment.

More info on the IEC Webstore.

- IEC 60601-1-3 Ed. 2.0 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

The new version of colateral standard IEC 60601-1-3 is also aligned with the new edition of the general standard, and also has some technical modifications (which i won´t detail here because x-ray equipment are not my business….yet :-))

More info about the standard on the link da IEC Webstore.

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…