On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to NB-MED for commenting on the document.  NB-MED is also known as TEAM NB.  This organization is the European Association of Notified Bodies for Medical Devices which covers the MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC).  This group publishes guidances that are agreed on by the Medical Device Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Notified Bodies. Once all the responses are agreed to it is anticipated that the document will be released as an NB-MED guidance document.

The History of this DRAFT document is restated below.  Note that any “click here” links are not live in the below text but are live in the actual DRAFT document.

History

During spring 2011, it was realized that the use of EN 60601-1 and its many family members in demonstrating compliance with the relevant and applicable requirements of the European medical device regulatory framework was not too trivial. While relevant guidance on the matter had been published at the CENELEC website as a Q&A document (click here), some Notified Bodies were giving advice that was felt to be not in line with that guidance. On other occasions, questions were raised that were not covered in the guidance.

So, it was concluded that the situation for electrical equipment in medical practice was not totally clear and that additional guidance would be useful. Further contact with the chair of the NB-MED confirmed this desirability, and a small group of experts was established. This group developed an enquiry asking for “practical issues in the implementation”, that was sent to many stakeholders in June 2011(see Annex 1). Also at the international level of IEC the request was distributed (62A/769/INF).

The response to the request was beyond expectation and the small team of experts, initially consisting of three, was expanded with Dr. Klaus Neuder of DKE (Frankfurt, Germany).

End of July 2011, the work on digesting the issues submitted until then started and it took until end of September 2011 until all material had been thoroughly discussed and answers formulated to the questions that were raised. In some cases, the questions were slightly amended to make them a little more general, and a few additional “connecting” questions were developed by the team.

It is believed that the answers, developed in close team cooperation, present a fair response to the issues brought forward and that they can be used as a reference for all stakeholders.

Now it is time for the NB-MED to scrutinize the proposed responses and see if they are also acceptable to all members of NB-MED. The NB-MED comments are kindly awaited by the end of October 2011, at the same e-mail address that was used for the initial submission of the issues: 60601Ed3.NBMED.issues@gmail.com, using the form supplied together with this document.

Happy reading!

The 60601-1 Issues Team:

Dr. Wolfgang Leetz, Dr. Peter Linders Dr. Klaus Neuder Mr. Martin Schneeberg

In the Federal Register Notice the background information (the first few paragraphs of Section 3 [Overview] of the Guidance document) is interesting as follows:

“To understand use-related hazards, it is necessary to have an accurate and complete understanding of how a device will be used.  Understanding and optimizing how people interact with technology is the subject of human factors engineering (HFE) and usability engineering (UE). HFE/UE considerations that are important to the development of medical devices include three major components of the device-user system: (1) Device users, (2) device use environments, and (3) device user interfaces. This interaction and its possible results are depicted graphically in Figure 1.

Fig 1 From FDA Guidance Document - Interactions among HFE/UE considerations result in either safe & effective use or unsafe or ineffective use

For safety-critical technologies such as medical devices, the process of eliminating or reducing design-related use problems that contribute to or cause unsafe or ineffective medical treatment is part of a process for controlling overall risk. For devices where harm could result from “use errors,” the dynamics of user interaction are safety-related and should be components of risk analysis and risk management. By incorporating these considerations into the device development process, manufacturers can reduce the overall risk level posed by their devices, thus decreasing adverse events associated with the device, and avoid potential device recalls.

…”

To submit comments follow these instructions: Submit written requests for single copies of the draft guidance document entitled “Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

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

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

Abstract: This technical specification provides information useful for the performance of effective software risk management, as part of the overall risk management process for medical devices containing software. It does this in the context of ISO 14971:2007, Medical devices – Application of risk management to medical devices and in the context of ISO/IEC 62304:2006, Medical device software – Software life cycle processes. Elements not to be covered include areas already covered by existing or planned standards, e.g., alarms, human factors engineering, networking, etc. (80002-1).  Identical to IEC/TR 80002-1

On October 27, 2009, Leo Eisner, of Eisner Safety Consultants and the Chair of the Medical Track for this Symposium, will be presenting a regulatory update on IEC 60601-1, 3rd edition at the 2009 IEEE Symposium on Product Safety Engineering Society. This presentation will be part of a whole day medical track which will include speakers from the FDA, IEC TC 210 Convener (ISO 14971), experts on the IEC 60601-1, human factors, etc. and will have two panel discussions as well.

UL webpage with regard to ISO 14971 – Risk Management.  Go to the bottom of this UL webpage & log-in to get a case study evaluating why a company may want ISO 14971 certification to support IEC 60601-1:2005 (3rd ed), which has heavy emphasis on ISO 14971.