Medical Electrical Equipment Information Blog - IEC 60601-1, ISO 13485, ISO 14971, medical devices, biomedical engineering and the like

Inspection priority - FDA guidance on the use of ISO 13485 audit reports

Marcelo — Sat, 09 Aug 2008 01:10:48 +0000

FDA will publish shortly a guidance document on how the agency will use ISO 13485 audit reports voluntarily submitted by device manufacturers. The idea is that these manufacturers can be classified as a “low priority inspection” need because they will have shown the FDA that they have already been audited. This way FDA can focus on manufacturers which do not have a ISO audited system.

Original nrews from the website site FDANews.com - FDA Plans to Release ISO Audit Guidance Shortly.

I was warned at the Elsmar Cove Forum - thanks Dustyn!

New white paper: IEC 60601-1: Changes from 2nd to 3rd Edition

Marcelo — Sun, 27 Jul 2008 00:02:32 +0000

Some time ago, Intertek offered some webinars on the changes of the new edition of IEC 60601-1. Now they published a “white paper” resuming the subject, which can be obtained in the following link resumido sobre o assunto que pode ser baixado a seguir: IEC 60601-1: Changes from 2nd to 3rd Edition.

It´s a good start for people not aware of the changes.

Objective overview of the GHTF

Marcelo — Thu, 12 Jun 2008 14:10:40 +0000

Just a quickie. This link “of the IEC-TECH nesletter” gives a very good one-page overview of what is the GHTF - Global Harmonization Task Force.

Regulatory Affairs Professionals Society (RAPS) Horizons Conference online presentations

Marcelo — Fri, 06 Jun 2008 13:46:51 +0000

I´m really hapy that biomedical blogs (and medical device blogs) are spreading in the world. In some time i´ll make a compilation of those for you.

Anyway, i found sometime ago in the Medical Devie Blog a link for the presentations of the Regulatory Affairs Professionals Society (RAPS) Horizons Conference.

Some of the presentations (in mp3 and pdf) are:

- Business Strategic Role of the Regulatory Professional
- Navigating the Product Development Process
- Developing Regulatory Strategy
- Risk Management With New Technologies

You can find the link at the Medical Device Blog

I´m trying to become a member of RAPS. I really like their aproach to “making better healthcare products possible”, and, i´m fully entering the medical device regulatory affairs consultancy business, i think this is the right place to go.

Great article on product liability and risk management

Marcelo — Fri, 06 Jun 2008 13:16:44 +0000

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.

Web-Based Biomed Courses and Mit Opencourseware

Marcelo — Thu, 05 Jun 2008 14:01:05 +0000

Just a quickie. Found at The Biomed news about two online courses beyong offered by the University of Vermont. It seems that´s just for their students, but at least this is a great initiative….

In this same subject I don´t remember if put it here before, but there are some related biomedical courses in the Mit Opencourseware - Health Scienes and Technology Division

Device Marketers and The Blogosphere

Marcelo — Thu, 05 Jun 2008 13:38:17 +0000

This blog thing might be a legal pain for device manufacturers. In another article from The Grey Sheet (via the Medical Devices Today Blog), “Legal Issues Abound For Device Marketers In The Blogosphere”, some light is shed about the fact that device manufacturers might have a very good time and tool using blogs, but also a bad time related to marketing and regulations.

The best part relates to easy acess and feedback from costumers and other stakeholders. Thare´s no denying the power of the instant, easy comment system of blogs. But as cited in the article:

“From a legal, regulatory standpoint, it can be kind of a minefield.”

Device makers have to take into account possible false device claims, misinterpretations and other marketing liability issues.

This seems to me more troublesome in the US due to the restrict legal reuirements from the FDA and FDC. I´m not sure if other countries have this strict kind of regulatory control (Brazil certainly has not). Can anyone share some info on this?

Links from readers

Marcelo — Thu, 05 Jun 2008 13:16:42 +0000

Hello all, long ntime no posting.

Some of our readers send tips for links that i think might interest some of you.

Sally gave the tip for the article The Top 100 Open Source Software Tools for Medical Professionals. As a lover and user of open source software (Wordpress, which powers this blog, is one of those softwares) i really liked the list, which has a lot of software specific to the medical domain which i dind´t know yet. Thanks, Sally!

Noticing some posts about electrotherapy on this blog, Bil mentioned a white paper named “Multi-Modality Electrotherapy, A Safe and Cost-Effective Adjunctive Treatment for Managing Pain” on the VQ OrthoCare´s company website. This paper has and interesting comparison between tradicional pain management treatmens (for example, medication) versus what they call “pain treatment with multi-modality electrotherapy”. Thanks Bill!

Finally, Fiona wrote about the article “25 Tips to Help Protect Yourself from Medical
Errors” They´re general and sometimes obvious tips, but i´m sure people tend to forget these a lot, so it´s really a must read and keep in mind article. Thanks Fiona!

Mega guide to ultrasonic power measurement

Marcelo — Mon, 31 Mar 2008 16:44:33 +0000

The NPL (National Physical Laboratory) from England put online a guida to power measurement of medical ultrasonic equipment (based on IEC 61161) . It´s very detailed and will surely help people making these kind of measurements.

Link: http://www.npl.co.uk/server.php?show=ConWebDoc.2282

The navigation is a littleweird (each one of : Introduction | Radiation Force Balances | Measurement | Additional Information | Further Reading has various pages)

Revised edition of the external cardiac pacemakers standard

Marcelo — Fri, 28 Mar 2008 00:59:39 +0000

The second edition of “IEC 60601-2-31 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source” has been recently published by the IEC> The main chage was the alignment with the new editio of the new standard IEC 60601-1:2005. Some technical comments were maed during the drafting but they were postponed for a future amendment if needed.