E-Submissions Coming for Medical Device & Pharmaceutical Manufacturers http://ht.ly/5y1ZQ

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.

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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.

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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