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.

Topic: “Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12” The Medical Electrical Device Collateral Standards in the Home Healthcare Environment and the Proposed Emergency Medical Services Environment, respectively

Presenter: Leo Eisner of Eisner Safety Consultants

When: March 3, 2011 (Thursday), 8:30 – 9:30AM (Pacific), 11:30AM – 12:30PM (Eastern)

Where: At your office or conference room (No travel required)

What’s it about: Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS).  Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.

In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.

Cost & Registration: Fx Conferences registration page for this event. Cost is normally $249.00 but with the Eisner Safety Consultants special discount you pay only $199.00. When checking out use the $50.00 discount code AF2009EIS.

Our Events Listing Page has events we are presenting at and also there is a listing of industry events that may interest you.

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

Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment

Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories

When: Feb 10, 2011 (Thursday)

Where: Anaheim Convention Center while you are at the MD&M West Conference

What’s it about: The market for home healthcare equipment is expected to grow exponentially over the coming years, as the delivery of healthcare services shifts from clinical settings to the home. But manufacturers face a series of unique challenges in supplying home healthcare equipment that is both effective and safe. IEC 60601-1-11 “Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Applications” was recently published to address the safety hazards that exist when medical devices are moved into the home. IEC 60601-1-11 is a collateral standard, meaning that it directly references provisions in IEC 60601-1, and is used in conjunction with IEC 60601-1 for the certification of home healthcare equipment. In addition to the publication of the new standard, FDA has launched the Medical Device Home Use Initiative, which is expected to impact the regulatory approvals of medical devices for use in the home. In this presentation, two leading experts in medical device safety, one who participated in the writing of IEC 60601-1-11 and the other working on a sister standard for the emergency medical services type electrical medical devices, will discuss the major considerations all design engineers must consider when designing a medical device that may be marketed for home use.

Learn more: About DesignMed West 2011

Conference Registration: Webpage

Please feel free to contact us on this matter if you would like some assistance in learning more about this proposed standard as it applies to your products.

Leo@EisnerSafety.com 
503-244-6151 (USA)

From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page:

“This is the list of guidance documents CDRH is considering for development this year (2011). CDRH plans to update this list every year. CDRH invites interested persons to submit comments on any or all of the guidance documents on the list to docket FDA-2007-N-0270. Comments may include draft language on the proposed topics and/or suggestions for new or different guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public.

The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued Level 1 drafts that may be finalized following review of public comments. This list of proposed guidance documents is not binding. CDRH is not required to issue every guidance document on the list and may issue guidance documents not on the list.

Current FDA and CDRH guidance documents can be found on the CDRH Guidance Document page.”

Further along in the description of the process the FDA CDRH says this process is to “provide stakeholders an opportunity to provide comments and/or draft language for those topics as well as suggestions for new or different guidances.”

After talking with the FDA Oct 5 with one of the people that has written some of the draft guidances that will come out later this year he indicated that if the document comes out for public review & comment and there is no feedback that doesn’t make the document as good as it could be.  The FDA is really seeking feedback on the draft guidance documents to make them much better and to be useable by the stakeholders.

The webpage http://ht.ly/2OiXg where the CDRH is considering documents for FY11 has instructions on how to comment on these draft guidance documents.

Also, at the bottom of the webpage http://ht.ly/2OiXg there is a list of “What guidance document is CDRH considering for development during FY 2011?”  The list is over 40 items long and covers areas such as product specific, safety standards, medical device quality systems, guidance on postmarket and compliance issues, among other areas.  Below is a list of some of the draft guidance they hope to publish and get comments on in their FY 11.  Note that not all of these will make it out of FDA by the end of their FY11 (ends Sept 2011):

• Application of IEC 60601-1 Third Edition
• Medical Device ISO 13485
• Radio-Frequency Wireless Technology in Medical Devices
• Medical Device Appeals and Complaints: Guidance on Dispute Resolution
• Medical Devices Containing Materials from Animal Sources (except IVDs)
• Medical Device Home Use
• Medical Device Premarket Clinical Studies: Levels of Evidence
• Manufacturing Site Change Supplements: Content and Inspectional Considerations
• Medical Device Reporting for Manufacturers
• “510k Actions”‐FDA and Industry Actions on Premarket Notification Submissions
• Distinguishing Medical Device Enhancements from Product Recalls and Corrections
• Electronic Medical Device Reporting
• Computed Tomography
• Implantable Cardiovascular Defibrillators
• Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
• Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
• Pediatric Information in Diagnostic Medical Device Premarket Submissions