On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information can be found on our blog post on this topic.

On March 4th  join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group).  Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry.  Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.

Biomedical Division Northern California Discussion Group  andSan Francisco Bay Area Chapter

Topic: ”Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas:

• IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry
• Usability and Human Factors verification, validation, and regulatory requirements
• Clinical evaluation and investigation regulatory requirements

Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Geetha Rao, PhD, VP, risk management and strategy, Triple Ring Technologies, Inc; Ibim Tariah, technical director, BSI Healthcare; Craig J. Coombs, RAC, president, Coombs Medical Device Consulting, Inc.; and Juergen Stetin, president and CEO, PROSYSTEM AG 

When: March 4, 2011 (Friday), presentations start right at 8:30AM check-in 7:45AM with Continental Breakfast

Registration Contact: Wesley Carr or call +1 301-770-2920 ext. 231 Registration form for event, must register by Feb 25, 2011, space is limited

Where: Crown Plaza Mid-Penisula, 1221 Chess Drive Foster City, CA 94404

This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend on March 21, 2010.  There is no transition period for the amendment to the MDD.

First, we are presenting an audio conference titled “Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?” which will be on March 25^th.  Please come and join in the audio conference.  See below for a special discount code that only Eisner Safety Consultants is able to provide to you.  Next we want to remind you about the MDD Amendment deadline and that we can help you out with our MDD Amendment Toolkit, which is only $249.00.  Our third article summarizes the recent important information related to 60601-1, 3^rd ed. and related standards.  This is a must read especially the part with the FDA.  Lastly, we let you know that there are 3 different ways to get up to date notices from Eisner Safety Consultants (ESC Updates) on the medical device industry regulatory, product safety and quality system news.

If you have any questions regarding any of the subjects of this newsletter please feel free to contact us.  We hope you enjoy our fifth newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

From AAMI March 12, 2010 press release

The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.

Carol Herman, director of standards at the FDA’s Center for Devices and Radiological Health (CDRH), made the announcement during the Association for the Advancement of Medical Instrumentation (AAMI)/FDA International Conference on Medical Device Standards and Regulation, which took place in Reston, VA, March 9-10.

“We will not only recognize the third edition of the standard, but we will also recognize all collaterals and all particulars,” Herman told attendees.

The third edition of 60601-1 offers general requirements for basic safety and essential performance of medical electrical equipment. It also contains requirements for reliable operation to ensure safety.

CDRH hopes to publish notice of the recognition in the Federal Register by June, Herman said. Once the notice is published, users will have three years to transition to the third edition and the related collaterals and particulars, Herman added.

The standard already has been recognized and harmonized in Europe for the last several years, said Charles Sidebottom, director of corporate standards for Medtronic and secretary of IEC/Sub Committee 62A, which developed the standard.

Sidebottom, who is chair of AAMI’s Board of Directors, says that the subcommittee has been working with CDRH staff to get the standard recognized since well before it was even published. “For us that is a real big deal that the agency formally announced recognition of the whole collection of standards,” he said.

AAMI had adopted its own version of the standard with national deviations called ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD), which includes original IEC text where U.S. modifications are introduced for easy comparison of requirements, as well as a number of the collateral and particular standards.

Changes on the Horizon

The CDRH recognition comes as a new amendment to 60601-1 is under development, which includes some changes to the original standard.

One of the proposed changes focuses on extending the scope of 60601-1 to include medical software systems. The amendment includes a definition of medical software systems and associated technical requirements.

The amendment also aims to streamline the application of risk management. It clarifies how a manufacturer should apply the standard’s requirements when evaluating residual risk, Sidebottom said during a presentation at the conference. When there are specific requirements with specific acceptance criteria, compliance is “presumed to establish acceptable risk,” Sidebottom added. The amendment also revises how to establish alternative risk controls or test methods.

The amendment clarifies the definition of essential performance to more fully explain the process for identifying essential performance and mitigating the risks associated with its loss or degradation, said Sidebottom. “Essential performance is performance other than that related to basic safety,” he said. “In many cases, differentiating between basic safety and essential performance is not that important because the standard says both have to be maintained. However, in some cases it is important to draw that distinction so the standard needs to be clearer about how the manufacturer should go about identifying the essential performance.”

The amendment is expected to be published in August 2013.