What’s on the menu?

Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents

Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants will be your guide

What to do in the meantime?
Select applicable and normative standards for testing; and
How to set up a solid future-proof test plan

Ian Sealey of Vertexian will explain it

When, Where, How:

7 October 2024

Clayton Hotel Chiswick
Arrive 5:00 PM
Starts 5:30 PM
Ends 8:45 PM

Networking and meet for drinks afterwards

Register by either using our Contact form or send Leo a LinkedIn message via his profile.

If you would like to meet with Leo during the week of 7 Oct in London please contact him to schedule this rare opportunity.

Presenters Background:

Leo is the founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry (from SME’s to Fortune 500’s) with product safety compliance & regulatory support focused on:

• design for compliance to IEC 60601 series of standards;
• design reviews against applicable requirements;
• identification of applicable standards, laws, regulations, directives and guidances;
• labeling reviews;
• support with test labs;
• training

Leo’s leadership and commitment in the standards development process runs deep and over many years including his involvement in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years. 
His IEC 60601-1, 4^th edition involvement:

• Co-Convener of IEC/TC 62/SC 62A/WG39 – User interface aspects
• Advisory group member of IEC/TC 62/SC 62A/AG 50 – IEC 60601-1 Ed. 4.0 editing & leadership team
• Committee member IEC/SC 62A/WG37 – General requirements

To see a more detailed list go to Leo’s LinkedIn Profile.

Ian Sealey is the founder of Vertexian and is a medical device regulatory and quality consultant, with over 25 years’ experience. Vertexian provides the medtech industry with support in the following areas:

• electromedical devices;
• risk management;
• pre-compliance testing;
• training;
• UKCA marking; and
• manufacture of IEC test equipment

He was Assistant Secretary to the Board of the Department of Health (DH), a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA), and a principal Medical Engineer in the National Health Service (NHS). He is a director of a health-related charity and a visiting university lecturer.

Need help with 60601 series standards including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. He team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments of 2022 (MDUFA V). The ASCA program’s goals are to:

• streamline the conformity assessment in medical device submissions,
• enhance the FDA’s confidence in test methods and results,
• decrease the need for additional information related to conformance with a standard,
• promote consistency, predictability, and efficiency in medical device review,
• serve as a least burdensome approach to conformity assessment

The ASCA program’s final guidance documents, issued in 2020, set the current framework for the program:

• Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Final Guidance (Program Guidance)
• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the ASCA Pilot Program – Final Guidance (Standards Specific Guidance)
• Biocompatibility Testing of Medical Devices – Standards Specific Information for the ASCA Pilot Program – Final Guidance (Standards Specific Guidance)

The FDA grants ASCA accreditation to test labs that meet the requirements of the program. The ASCA test labs are authorized to conduct testing and the output from the lab is a summary report that the manufacturer submits to the FDA (more to come). Once the FDA approves an ASCA test lab the FDA identifies the scope of recognized consensus standards that the lab is able to test too (they are able to expand that list over time & the FDA may suspend any and all of the scope of the lab, if appropriate), the name & address of the lab and the ASCA contact on the ASCA test lab list. If the lab is suspended there seems to be a note in the current scope, there is no separate search feature on the db for active and suspended labs. I just sent in a request to the standards and conformity assessment (S-CAP) group that is in charge of this db to ask if they can make this more user friendly.

FDA has added standards to the list of approved standards beyond what is noted in both Standards Specific Final Guidance documents and plans to continue to add recognized consensus standards to the list/db. You can search the list of recognized consensus standards db but make sure you click the check box next to “Included in ASCA?” to view the list of standards that are included in the ASCA program. When you get to the link for a specific standard make sure you review the standard and see if any limitations on the standard if a partial or full recognition and also if there are any limits from the ASCA program perspective so you know what to expect. Then you need to make sure the test lab you are planning to use has the applicable standards in scope, that apply to the product that you want to test for your submission to the FDA.

You’ve chosen a test lab and gotten a test quote including the ASCA costs. Now you need to get the testing done but please make sure before you submit to the FDA you don’t have any comments on the summary report from the ASCA lab that aren’t positive towards the approval. If there are any issues you want to resolve them before a final report is issued from the test lab to the manufacturer. The manufacturer provides the summary report as part of the premarket submission, not the test lab. You want a clean summary report going to the FDA, as the FDA relies on the ASCA’s test lab summary report instead of the full test report that has been submitted in the past.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA, the ASCA program or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List # 060. A reminder that Recognized Consensus standards are considered voluntary by the FDA for premarket submissions but they are what the majority of manufacturers use to facilitate & streamline the premarket process.

Relevant FDA Guidance and/or Supportive Publications*

US national differences:

1. (Recognition Number: 19-46) ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]

2. Attachment Form No.: US_ND_IEC60601_1U ATTACHMENT TO TEST REPORT IEC 60601-1: US NATIONAL DIFFERENCES – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
(https://documents.iecee.org/ords/f?p=702:558:::::P558_DOCUMENT_FILE_ID:2955038)

Note from Leo: This is a US National Difference Test Report Form issued by the CB Scheme for CB scheme reports.

You have 3 options
1 expires after December 17, 2023
The first 2 are acceptable now & going forward.

1) Use IEC 60601-1 Edition 3.2 (Recognition # 19-49) from now onward making sure to use References #1 AND #2.
Note: This first option is the best of the three. Test to the IEC standard as that way you can prepare your product for the US domestic and international markets at the same time. If you pass the testing you’ll meet most if not all requirements and then you can deal with the few US National Differences by applying the US National Differences which are also in item 2) of this list anyway. This is less restrictive for your product than if you test your product to the US version of the standard (ANSI AAMI – Item 2 of this list) and then try to go to the international market which most countries will require IEC testing anyway.

2) Use ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Recognition Number: 19-46) from now onward.
Note: This SIS is an older Recognized Consensus Standard but by inference, one would be wise to make sure that you also get the US National Difference Test Report mentioned above for the IEC 60601-1, ed. 3.2 which is based on the ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Recognition Number: 19-46)

3) During the transition period FDA will accept a declaration of conformity in support of premarket submissions to the older ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (Recognition Number: 19-4) but it will be superseded by recognition of ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) [Including Amendment 2 (2021)] (Recognition Number: 19-46) after December 17, 2023.
Note: The SIS says that Recognition Number: 19-4 (ANSI/AAMI ES60601-1, edition 3.1) by Recognition Number: 19-46 (ANSI/AAMI ES60601-1, edition 3.2) but if you are smart I would switch to Recognition Number 19-49 (IEC 60601-1, edition 3.2). FDA should accept this Recognized Consensus standard for your premarket submission as long as your submission includes the US national differences References #1 & #2.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

The FDA on May 30, 2022, same day as when the recent AAMI 60601 Amendments were Recognized, added the Interpretation Sheet 1 (ISH1) – Amendment 1 – on Essential Performance (Clause 4.3) and Single Fault Condition (Clause 4.7) based on IEC 60601-1:2005+A1:2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance to:
FDA Recognition # 19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] and
FDA Recognition # 19-4 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).

ISH1 was added to both FDA Recognitions # 19-46 & 19-4 as a “Relevant FDA Guidance and/or Supportive Publications” not as an independent Recognized Consensus Standard.
The ISH1 was Issued 2021-03 by IEC. One reason why FDA probably didn’t include the ISH1 as a Recognized Consensus Standard is because it isn’t an ANSI and AAMI approved standard. A blog post on the ISH1 when it was issued can be viewed here.

The FDA has been reviewing Essential Performance (EP) during submission for many years, since the publication of the 3rd edition of IEC 60601-1:2005 and their Recognition of ANSI AAMI ES60601-1:2005. It was even discussed during the expert panel, May 2018, at the ASCA Workshop, which I was the expert on EP on the panel. So, expect that FDA will review your submission for EP both for the safety and the EMC side of your testing.

Questions you need to consider early in the product development:
* have you identified the clinical functions of your device that are EP,
* have you started your EP analysis,
* has the EP analysis been fully connected with your Risk Management File,
* have you written your EP so it is capable of being tested for the safety and EMC which will be tested differently,
* and so much more…

One of the next steps out of the generation of the ISH1, as noted in the blog post on ISH1, was the formation of the Project Team PT 62A-1 with a goal to generate a technical report IEC TR 60601-4-6 as a guidance document on Essential Performance. PT 62A-1 has been meeting since February of 2022 and been trying to work on figuring out how we want to provide guidance to manufacturers, test houses and regulators on Essential Performance and Faults related to EP. The main reason for this is that we have seen there is so much confusion on this subject by some manufacturers, test houses and regulators and we want to provide a document that will provide a consistent guidance on the concept of Essential Performance and Fault Safety related to EP.

Need help with Essential Performance, 60601 series standards (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

So are you ready for all the changes of Amendment 2 of IEC 60601-1 and all the Amendments?

Join us for a live free webinar on an Insider’s look at IEC60601 Amendments: detailed guidance from a committee member responsible for changes – Aug 27, 10 AM PT/ 1 PM ET

With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC60601 series is massive, creating a swell of confusion around understanding the updates & how to transition for compliance.

Greenlight Guru has teamed up with Leonard Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendments Project.

This in-depth webinar will cover clarifying details around the massive changes of the Amendments Project, provide guidance on updated standards already published, insider knowledge into updated standards not yet published & what to expect, & how to prepare accordingly for the impact it will have on your firm and product lines.

SOME OF THE CHANGES WE WILL COVER INCLUDE: 

• Updates to IEC 60601-1 (Medical Electrical Equipment)
• Updates to IEC 60601-1-2 (EMC)
• Updates to IEC 60601-1-8 (Alarms)
• Impacts of standard changes on:
  • Design
  • Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
  • Safety certifications
  • Labeling / markings / packaging
  • Tests/ retesting
  • Essential Performance
  • Risk Management File
  • Usability Engineering File
  • Software Life Cycle Process
• Q&A session

WHO SHOULD ATTEND?

• R&D Engineers and Management
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Medical Device Executives
• Clinical Affairs Professionals and Management

It’s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape.

With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC 60601 series is massive, creating a swell of confusion around understanding the updates and how to transition for compliance.

We’ve teamed up with Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendment Project.

This in-depth webinar will cover clarifying details around the massive changes of the IEC 60601 Amendments, provide guidance on the updated standards already published, insider knowledge into the updated standards not yet published and what to expect, and how to prepare accordingly for the impact it will have on your firm and product lines.

SPECIFICALLY THIS WEBINAR WILL COVER:

• Updates to IEC 60601-1 (Medical Electrical Equipment)
• Updates to IEC 60601-1-2 (EMC)
• Updates to IEC 60601-1-8 (Alarms)
• Impact of standard changes on:
  • Design
  • Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
  • Safety certifications
  • Labeling / markings / packaging
  • Tests/ retesting
  • Essential Performance
  • Risk Management File
  • Usability Engineering File
  • Software Life Cycle Process
• Q&A session

Who Should Attend?

• R&D Engineers and Management
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Medical Device Executives
• Clinical Affairs Professionals and Management

ABOUT GREENLIGHT GURU

Greenlight Guru is the only medical device quality management system (MDQMS) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

ABOUT EISNER SAFETY CONSULTANTS

Eisner Safety Consultants supports your regulatory, quality systems, product safety, EMC, and engineering needs. Our experts speed your way to on-time product approvals via safety and regulatory agencies. We provide assistance with U.S., Canadian, European, & other international regulations. You can see a full list of the service offerings from Eisner Safety Consultants by visiting their website to learn more.

Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two:

• Medical Device Regulation (EU) 2017/745 and
• In Vitro Diagnostic Regulation (EU) 2017/746

Bassil Akra of TÜV SÜD some of the costs of this transition in his post on LinkedIn. It ain’t going to be cheap!

Back to our regularly scheduled post:

This Friday 5 May 2017 should be marked in your calendar or journal as a momentous date when the EU Official Journal will publish the Medical Device and In-Vitro Diagnostic Regulations and the transition periods for both start (3 years for the MDR & 5 years for the IVDR)!!  This is the start of a turning point for many medical device and IVD manufacturers as the clock starts ticking away til the end of the transition periods of these new Regulations.  If you haven’t started your transition planning strategies for your products & product families the pressure should be mounting quickly as there is so much to deal with for this transition time. Check out these resources for learning more about the MDR & IVDR. See below for some more details about the challenges you need to consider and START PLANNING for NOW (don’t wait)!

There is no grandfathering once the transition period ends for the applicable Regulation.  So, in 3 years and a day or so if you don’t meet the MDR or 5 years & a day or so if you don’t meet the IVDR you won’t be able to CE Mark your device and sell or distribute your medical or IVD device in the EU (& hopefully the UK which is in the middle of Brexit implications as UK will not be part of the EU by end of transition period).

We have talked about some of the challenges in the implementation of the MDR but here are more details to consider for your strategic planning:

• New definitions to deal with including nanomaterial, Unique Device Identifier, interoperability, economic operator, among other new & modified definitions.
• Person Responsible for Regulatory Compliance: Identify personnel that is  responsible for regulatory compliance with the Regulation and have a minimum work experience in the applicable device field and a minimum of academic qualifications.
• Enormous Single EU Database (not ready yet): Impacts all Economic Operators (which includes manufacturers) – Will register all devices, manufacturers, Economic Operators, CE Certificates, new clinical investigations, & incident reporting.  Will manage all Unique Device Identifications and Single Registration Numbers (SRN).
• Regulations are much more explicit now for the Quality Management System (QMS) & Risk Management System (RMS) requirements.  Beyond just what is in EN 13485 (ISO 1385:2016) & EN 14971
• Economic Operators (new to MDR): Impacts the activities of EU Representatives, Importers, Distributors & Manufacturers – Different Responsibilities depending on type of Economic Operators.
• Traceability of Devices Between Economic Operators: Between all Economic Operators (wow that in itself can be huge!) and all the way down to the healthcare institutions & in some cases down to the patients devices used on.
• Annex I now called Safety & Performance Requirements (not Essential Requirements): Much more prescriptive, addition of UDI & SRN to labelling requirements, all manufacturers will need to update all their Annex I checklists, new Clinical Evaluation & Clinical Performance Evaluations requirements
• Clinical Data: Much more prescriptive especially for higher risk class devices (class III & implantable devices) – Clinical Investigations needed in many cases now & restrictions of the type of clinical data allowed for class III devices (much more restrictive using equivalency data), post market clinical follow-up requirements for high risk class devices (i.e. annual summary reports for Class III & implantable devices).
• Notified Bodies: Much more prescriptive in competency requirements, conflict of interest, designation process, etc.  The end result is fewer Notified Bodies & Notified Bodies with narrower scopes after the designation process.  Also, with the nexus of  the EU regulations, Canada’s MDSAP requirements, and medical device manufacturers transitioning to ISO 13485:2016 the Notified Bodies resources are being strained which means less resources available to the medical device manufacturers. The limited resources means it may be a challenge to complete these processes without hitting the edge or past the transition period so start now or you may not be able to keep all your CE medical devices on the EU market in about 3 years from now when the clock runs out.

If you need help with your EU MDR or IVDR transition planning please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC SC 62A Maintenance Team (MT 28 & MT 30) and Working Group (WG14) meetings from March 22 – March 31, 2017 in Oslo, Norway and London, United Kingdom to start the work of reviewing the items agreed on (in Frankfurt Oct 2016) for IEC 60601-1, 3rd ed. + Amendment 2 (or ed. 3.2) for development and comment.

A2 of IEC 60601-1 & its’ related collateral standards are anticipated to be published by the end of 2019.  In only 2+ short years from now!!!!  Will you be ready?  We are offering a web special til the end of March May 2017 on our Annual Standards Trends Reports.  See more below.

A2 changes & collaterals changes may include any of the following:

• safety gaps needing corrections,
• known problems for regulatory bodies,
•  inconsistencies within the standard,
• technical errors, and
• updates of standard references.

The above was the criteria for the ‘Short List’ vote on which items were agreed to in Frankfurt (Oct ’16) for A2 for IEC 60601-1 and it’s collateral standards.

Also, you need to be aware that the items that didn’t make it to the ‘short list’ are slated to be worked on for the 4th edition of IEC 60601-1 (the ‘long list’) which is scheduled to be published in 2024.  This will be a much more significant set of changes including potentially restructuring the standard and maybe even making the whole series a database standard.

Are you ready for changes coming for 60601-1, 3rd edition + Amendment 2 and 4th edition of IEC 60601-1?

We can help you stay up to date and ahead of the curve so you are prepared for these changes that are coming.  Check out our Annual Standards Trends Report as a fantastic resource that can save your company significant time and money (upwards of $100,000+).

To provide you an opportunity to receive the Eisner Safety Consultants Annual Standards Trends Reports for a significant discount of this year’s copy of these reports (publication between Late May to June 2017) we are offering a web special til the end of March May 2017 to give you the opportunity to learn from Leo about the Amendment 2 meetings in Oslo, Norway and London, U.K. The reports will include more details where these Amendment 2 changes are at and what these changes are.  If you want to stay ahead of your competitors, and save on the cost of standards committee membership fees, save on travel expenses, save time instead of sitting in these meetings, and getting the benefit of staying up to date on medical electrical equipment & systems (MEE&S) standards and home use MEE&S standard consider this amazing deal:

Eisner Safety Consultants

Annual Standards Trends Reports on MEE&S &

Home Use MEE&S Options

Get This Year’s Report(s): May/June 2017 Annual Standards Trends Report (ASTR) Options:

Normally priced at $1,997.00 Web Special $1,597.00 for the:

May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTR OR

May/June 2017 Home Use MEE&S ASTR

Normally priced at $2,997.00 Web Special $2,497.00 for the:

Bundle pricing of both the May/June 2017 MEES & Home Use MEE&S ASTRs

Get This & Last Year’s Report(s): March 2016* & May/June 2017 ASTRs Options:

Normally priced at $2,397.00 Web Special $1,997.00 for the:

March 2016* & May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTRs OR

March 2016* & May/June 2017 Home Use MEE&S ASTRs

Normally priced at $3,697.00 Web Special $2,997.00 for the:

Bundle pricing for all 4 Reports – March 2016* & May/June 2017 of both MEE&S & Home Use MEE&S ASTRs

* = MAR ‘16 ASTRs issued as of MAR ‘16 with no updates for these ridiculously low rates.

If you need help with IEC 60601-1 please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants and considered the ‘IEC 60601 Guy’ by many of his clients and associates.

Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & stay in the hospital for 2 days in Early June 2016.  I was out of work for about a month and so I got a close birds eye view of why the medical device and wellness device markets are exploding.  This explosion of interest comes from several factors including the “Super aging” of societies around the globe, Internet of Things (IoT), the portability of devices, the growth of wearable technologies and other factors discussed in the article.

There is a huge need to support those at home that are sick, injured, has an acute issue or chronic illness that want a comfortable life and would rather stay at home then be in a sterile hospital or other clinical setting any longer than they have too.  I know I was ready to get home after 2 days in the hospital, even though I had to rest at home, I was much more comfortable at home than in the hospital setting.  So, now I can appreciate how important it is to have these medical and wellness devices evaluated for the proper environment and proper standard(s) and to meet national regulations.   One of the issues that is important to this conversation is the blurry line between home use medical devices and wellness devices.  FDA has written guidances for both Home Use Medical Devices and Wellness Devices to clarify from their perspective.  There, also is a newer IEC System Committee called Active Assistive Living (SyC AAL) that is looking at the gaps in standards and other IEC technical documents for home use medical devices and non-medical devices (Some being wellness devices).  The article goes into detail on this SyC AAL and also looks at the medical electrical device standards focused around Home Use Medical Electrical Devices.

Enjoy the article and if you have interest in or need help with the IEC 60601-1 series, home use medical electrical devices or the SyC AAL please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants.

A reminder that FDA Guidances and Recognized Consensus Standards are voluntary.  But I remind my clients’ that if you don’t use these voluntary documents for premarket submissions you make your life and the reviewer’s life a lot harder, typically.  So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run.  In the short run, you may need to do more testing but if you don’t you risk the chance of your product not being accepted by the FDA.

The Guidance goes on to say that “the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.”  The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-2²) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 14708³ for active implantable medical devices.

The Guidance continues with a listing of details that FDA is expecting manufacturer’s provide in their premarket submissions, so the medical device EMC information is clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission.  The Guidance points to the FDA Recognized Consensus Standards database located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

The rest of the Guidance, Section II “EMC Information”, details the list of items the FDA is expecting of the manufacturer’s for premarket submissions.  And of course the FDA leaves an opening for a broad statement at the end of the section that says: “Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).”

If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

^{Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”}

<sup>1. According to International definitions, “disturbance” is the cause and “interference” is the effect. In the US, “interference” is often used interchangeably for both cause and effect though more often for the cause. 
2. IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests, AAMI/ANSI/IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and AAMI/ANSI/IEC 60601-1-2: 2014 [4th Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests 
3. ISO 14708-3 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators</sup>