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.

A proposal has been circulated, on 21-JAN-2011, for a vote to form a Joint Working Group between ISO/TC 184/SC 2, Robots and robotic devices (non-medical robots) and IEC/TC 62 and its subcommittees to establish a new Joint Working Group on Safety for medical devices using robotic technology.  The following info is only part of the complete proposal.  If you have further interest please contact Leo Eisner at Leo@EisnerSafety.com.

Some Background:

Currently published international standards only cover robots in industrial environments. However, the situation is changing and new types of service robots are emerging. In light of these developments, ISO/TC 184/SC2 established a new work group (WG 7) on personal care robots. That group has been focused on formulating safety requirement for non-medical personal care robots. That group is working on a new standard, ISO 13482, Robots and robotic devices – Safety requirements – Non-medical personal care robot. This document will be advancing to the Enquiry Stage (ISO DIS) in early 2011 and publication is expected in 2012.

While initially focused on non-medical applications, WG 7 recognized early that work was likely to be needed on medical devices utilizing robotic technology. In June 2008, a liaison with IEC/SC 62A was established. Prof. John Hedley-Whyte volunteered to serve as the liaison officer. In September 2009, ISO/TC 184/SC 2 established a WG 7 study group on medical care robots. The study group is comprised of experts from Canada, France, Germany, Japan, Korea, Romania, Switzerland, UK and USA. The Secretary of SC 62A has attended two of the study group’s meetings. Members of the study group also participated in a workshop on Medical Care Robots sponsored by the US Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and held at FDA’s offices outside Washington D.C. in February 2010.

The WG 7 study group has concluded that the time is appropriate to initiate formal work on safety standard(s) for medical devices using robotic technology. The study group made a series of proposals to ISO/TC 184/SC 2 that resulted in the resolution in Annex A (please contact Leo Eisner if you would like a copy of this Annex). The potential for a joint project between IEC/TC 62 and its subcommittees and ISO/TC 184/SC 2 was also discussed at the IEC/TC 62 Chairman Advisory Group meeting in October 2010 in Seattle.

The Proposal:

ISO/TC 184/SC 2 is proposing the formation of a JWG with IEC/SC 62A under IEC administrative lead to develop a new work item proposal for a Collateral Standard in the IEC 60601 family. The scope of this work would be:

Establish basic safety and essential performance requirements for medical electrical equipment and systems employing robotic technology (i.e., medical robots). The work would encompass medical applications (including aids for the disabled) covering invasive and non- invasive procedures such as surgery, rehabilitation therapy, imaging and other robots for medical diagnosis and treatment.

The current working definition of a robot is an “actuated mechanism programmable in more than one axis with a degree of autonomy, moving within its environment, to perform intended tasks”. Autonomy is currently defined as the “ability to control movement and communication to perform intended tasks without human intervention”. Before a meaningful new work item proposal can be circulated, the proposed JWG will need to refine these definitions so as to establish the appropriate boundaries for this work.

While the initial work would be with SC 62A dealing with the general aspects of medical robots, close liaison will be maintained with other TC 62 subcommittees, particularly SC 62D, looking forward to the potential for work on standards for particular medical robot applications.

If approved, it is expected that the experts currently serving on the study group would be transferred to the JWG and a New Call for Experts issued in IEC/SC 62A and ISO/TC 184/SC2.

National Committees are requested to provide their responses using the IEC electronic voting system by: 2011-04-22

So, if you would like to have some input to your National Committee you will need to contact them soon as national votes tend to be called for at least 1 month prior to the official deadline for the National Committees.

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

The scope states, noting that all ALL CAPITAL words are defined either in this standard or other referenced standards:

“Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEM SECURITY (the KEY PROPERTIES). This international standard does not specify acceptable RISK levels.

NOTE 1 The RISK MANAGEMENT activities described in this standard are derived from those in ISO 14971 [4]. The relationship between ISO 14971 and this standard is described in Annex A.

This standard applies after a MEDICAL DEVICE has been acquired by a RESPONSIBLE ORGANIZATION and is a candidate for incorporation into an IT-NETWORK.

NOTE 2 This standard does not cover pre-market RISK MANAGEMENT. This standard applies throughout the life cycle of IT-NETWORKS incorporating MEDICAL DEVICES.

NOTE3 The life cycle management activities described in this standard are very similar to those of ISO/IEC 20000-2 [10]. The relationship between ISO/IEC 20000-2 and this standard is described in Annex D.

This standard applies where there is no single MEDICAL DEVICE manufacturer assuming responsibility for addressing the KEY

PROPERTIES of the IT-NETWORK incorporating a MEDICAL DEVICE.

NOTE 4 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, the installation or assembly of the MEDICAL DEVICE according to the manufacturer’s ACCOMPANYING DOCUMENTS is not subject to the provisions of this standard regardless of who installs or assembles the MEDICAL DEVICE.

NOTE 5 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, additions to that MEDICAL DEVICE or modification of the configuration of that MEDICAL DEVICE, other than as specified by the manufacturer, is subject to the provisions of this standard.

This standard applies to RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and providers of other information technology for the purpose of RISK MANAGEMENT of an IT- NETWORK incorporating MEDICAL DEVICES as specified by the RESPONSIBLE ORGANIZATION.

This standard does not apply to personal use applications where the patient, OPERATOR and RESPONSIBLE ORGANIZATION are one and the same person.

NOTE 6 In cases where a MEDICAL DEVICE is used at home under the supervision or instruction of the provider, that provider is deemed to be the RESPONSIBLE ORGANIZATION. Personal use where the patient acquires and uses a MEDICAL DEVICE without the supervision or instruction of a provider is out of scope of this standard.

This standard does not address regulatory or legal requirements.“

The information on this page is based from IEC webstore for IEC 80001-1, 1st ed.

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)

Download all our newsletters at http://www.EisnerSafety.com/esc-news/

Summary:
This issue is packed full of important updates and useful information. First, we are going to focus on additional updates with regard to IEC/EN 60601-1:2005/2006 as there is significant news since the last issue of our newsletter.

Next we delve into the MDD Amendment 2007/47/EC specifically on the updated Classification MEDDEV and the new Clinical Data requirements. We also would like to remind you when your EU MDD Notified Body is up to reviewing your technical file or design dossier you need to make sure you have addressed the Usability and Clinical Data requirements as they apply to all medical devices under the MDD Amendments. If you need help with these new requirements to the MDD we have a toolkit that will be helpful to you.

Lastly, our Associate Christine Ruther writes about an FCC publication in regard to medical devices that use inductive coupling to recharge batteries.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

How to Subscribe:

If you would like to subscribe to our newsletters please go to the upper left hand corner of any our web pages on the website and enter your e-mail address in the subscribe box.  You will receive an e-mail from newsletter@EisnerSafety.com.  Please click the confirm link to opt-in to the newsletter. If newsletter@EisnerSafety.com goes to your junk mail folder please white list our e-mail address so you can enjoy our newsletters.

There is additional information, including how collateral and particular standards will be treated and how US National infrastructure requirements enacted as statue (e.g. NFPA 99) will be implemented with this Standard, and how Risk Management will be used with this standard, on the FDA Consensus Standard web page for ANSI/AAMI Es 60601-1:2005 http://ht.ly/22kSQ

Previously you had to order Replaced or Withdrawn IEC publications thru the IEC Central Office Customer Service Center.  This changes should make the purchase of these documents quicker and easier.