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If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo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>

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for your organization to keep up with all the different data sources we have the solution for you at a reasonable price. A Standards Reconnaissance Subscription Service to help medical electrical device manufacturers keep up to date on all the changes that occur for these documents so you are prepared for future changes well ahead of the norm and you are able to stay up to date on your list of standards. The focus of this service will be on the documents for medical electrical equipment & systems (MEE&S = IEC TC 62, SC 62A – 62D) and home use medical electrical equipment & systems (Home Use MEE&S = IEC Active Assisted Living System Committee (IEC AAL SyC) and any other Home Use medical electrical equipment documents from the IEC TC 62, SC 62A – 62D including IEC 60601-1-11 Home Use Environment).

We plan to go live with the db by the end of Sept 2015.

Please reserve your spot by September 28, 2015 for this db subscription service.

Some of the features will include [For Paid Subscribers unless noted otherwise]:

• Notification e-mails when changes occur (i.e. Change in transition information from FDA for a standard) and new records are entered into the db.
• Receive either 2 or 4 reports per year (depending on Subscription level) summarizing:
  • key issues of that report cycle for MEE&S or home Use MEE&S,
  • estimated timeline for the publication of draft standards & other relevant documents of significance, and
  • full listing of all the documents in your part of the db with status information.
• Access to our searchable db (depending on Subscription level access to the either the MEE&S or Home Use MEE&S part of the db or the whole db) on our dedicated db website if you are a paid subscriber. [Limited access for free level of service with 10 – 15 standards (pre-defined)]
• Print out db search results the way you want them
• Export db search results for your use (limited by the terms & conditions of the db)

There are several parts of this db [For Paid Subscribers unless noted otherwise]:

• Standards db – including information on the standards, technical reports, technical specifications, and publicly available specifications that are active or current, in draft or development which would include voting level documents such as New Work Proposals, Committee Drafts, etc., and withdrawn documents (The previous version of the active standard).
• List of standards publishers & associated country (this will cover 50+ countries) [includes free service level],
• List of Medical Device Regulators with their websites, if available, for a selection of countries including all the of EU & EFTA countries.  We plan to expand this to include all countries in the world by the end of Stage 2 (below),
• Guidance Documents – Guidance documents that the regulatory bodies use for their national regulatory systems. Like for the US, Canada, & Europe. They will be added sometime after going live by end of stage 2 or 3 (see below).

Once the db goes live you can check out how the db works by accessing the free level of service to view a few examples of current standards (about 10 to 15). With the free service level you will be able to use most of the db features set other than obtaining reports, the update notification service, but you will not have access to List of Medical Device Regulators db of Guidance documents db.

Pricing starts at only:

• $4,500/year for Base Entry Subscription (2 reports per year and select either MEE&S or Home Use MEE&S part of db),
• $6,500/year for Mid-Level Subscription (4 reports per year and full access to db), or
• $9,000/year & up for Premium Subscription (2 personalized reports for your company’s needs based on conversations with Leo Eisner, 2 reports per year from the Premium Subscription level, and full access to db)
  All payments to be paid in US$ only.

We plan to go live with the db by the end of Sept 2015. Since we will be releasing the db in stages the early adopters will get a discount (20%) for the first annual subscription cycle and additionally we will throw in extra months to your subscription commensurate with how early you subscribe.  The earlier you subscribe the more free months will be added to your first yearly subscription for no additional charge.

Please reserve your spot by September 28, 2015 for this db subscription service and to guarantee a discounted first year price and to obtain extra months added for free. To reserve your spot for the Base entry or the Mid-Level Subscriptions please arrange a $750.00 (US$) deposit and for the Premium Subscriptions please arrange a $1,500.00 (US$) deposit. Contact us to arrange for deposit.

There will be a couple stages for the release of information for the db.  We plan on continual updates over time to provide a really valuable resource and continually make it better. The first stage will be complete prior to the official release of the db which will include all the updated information for the IEC based MEE&S & Home Use MEE&S documents including updates on the small number of joint IEC/ISO documents.  Stage 2 will be initiated just before the release of the db, which will include updates for the US, EU, and Canadian versions of the IEC & IEC/ISO MEE&S and Home Use MEE&S documents and IEC/ISO joint documents. We plan to have stage 2 completed around Jan 2016.  Stage 3 will include updated information adding in the supporting medical device (non-medical-electrical) documents you need for your regulatory submissions such as ISO 10993 series of standards, ISO 15223-1, etc.  This stage will initiate with the non-medical-electrical standards for IEC and ISO and in the future we will add other Standards Developers.  We expect to start on stage 3 around Jan 2016 and have not yet scheduled it’s completion.

Please contact Leo Eisner to find out more details about this db. He can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

On Aug 14, 2015 FDA updated the Final Guidance Document titled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”.  It was originally issued as a Final Guidance on July 1, 2015.  The main change for this current revision was to add 8 product codes that were overlooked due to an administrative error where the FDA missed some comments from a public consultation.  Additionally, they added a couple important clarifications to the Guidance.

This Guidance describes the FDA’s intent to exempt the product codes mentioned in this Guidance of the unclassified medical devices, and Class II & I medical devices that are subject to section 510(l) of the FD&C Act, from premarket notification requirements.  The FDA believes devices identified in this Guidance document (Section IV) are well understood & don’t require premarket notification (510(k)) to assure their safety & effectiveness.  So, the FDA intends to propose exempting these devices from premarket notification requirements of section 510(l) & (m) of the FD&C Act, subject to limitations on exemption criteria in a slew of 21 CFR sections in the 868.9 to 890.9 range (refer to Guidance for details).  When FDA publishes such a proposal it will be published in the Federal Register but until the publication of a final rule or order exempting these devices from 510(k), the FDA doesn’t intend to enforce compliance with 510(k) requirements for these identified devices.  Therefore, the FDA doesn’t expect manufacturers to submit 510(k)s for these devices during this time period.

The 2 clarifications are: 1) It is not FDA’s intent to exempt any combination products that fall under the list of product codes that are subjected to this Guidance Document.  2) The product codes mentioned in the Guidance that contain an antimicrobial agent are not within the scope of this Guidance.

The product codes added to the latest version of the Guidance include:

• DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass – (classified under 21 CFR 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting)
• OCY – Endoscopic Guidewire, Gastroenterology-urology – (classified under 21 CFR 876.1500 Endoscope and accessories)
• KOE – Dilator, Urethral – (classified under 21 CFR 876.5520 Urethral dilator)
• FTA – Light, Surgical, Accessories – (classified under 21 CFR 878.4580 Surgical lamp)
•  GZM – Analyzer, Rigidity – (classified under 21 CFR 882.1020 Rigidity analyzer)
• GZO – Device, Galvanic Skin Response Measurement – (classified under 21 CFR 882.1540 Galvanic skin response measurement device)
• HCJ – Device, Skin Potential Measurement – (classified under 21 CFR 882.1560 Skin potential measurement device)
• HLJ – Ophthalmoscope, Battery-powered – (classified under 21 CFR 886.1570 Ophthalmoscope)

The product codes that were updated include:

•  MRQ – Analyzer, Nitrogen Dioxide – (classified under 21 CFR 868.2385 Nitrogen dioxide analyzer).  The change was to add the following text: “This intention only applies to stand-alone devices and not those that are components of nitric oxide delivery systems used to monitor nitrogen dioxide levels during inhaled nitric oxide therapy.”
• KKX – Drape, Surgical – (classified under 21 CFR 878.4370 Surgical drape and drape accessories).  The change was to add the following text: “This intention does not apply to devices including an antimicrobial agent.”

If you need help in determining if your products needs a 510(k) premarket notification or a Premarket Approval (PMA) or to help prepare your documentation for FDA approval, 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).

We also set-up pages to do the same for checking on the status of the IEC 80601 series of current & draft standards, which are standards that are jointly developed between IEC & ISO, and TRFs of the current 806012 series standards.  These later standards are called either IEC 80601-X-Y standards or ISO 80601-X-Y standards.  The lead organization gets their organization initials in the standards identifier.

This is a great resource to be able to stay up to date on the standards that are being developed, the updates to current standards and to ensure your standards library is up to date as required under ISO 13485 and also under most medical device regulatory national schemes.  If your organization needs help keeping track of current &/or developing standards our organization can help you develop a system or we can do this work for your organization’s standards and external documents library.  Please feel free to contact us about this at Leo@EisnerSafety.com or 503-244-6151.

Last summer Amendment 1 (A1) came out and if you haven’t yet you should start learning about those changes as they will be impacting you sooner rather than later (sign-up for an FX Conferences recording of my recent presentation on A1 of IEC 60601-1 and its’ impact on users, follow the instructions to get a $50.00 discount, and sign up for the presentation titled “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users”) and also A1 can help you as it will reduce the amount of Risk Management File work you need to do for a product safety certification or approval. There are about 25 less Risk Management File requirements when using A1 vs using 3^rd ed.  To understand the differences and changes of A1 it is highly recommended that you get the IEC 60601-1 edition 3.1 (consolidated) edition as that shows you where all the changes are to the text vs 3^rd ed.  Note, when you submit for testing thru a test lab you will either want to use either edition 3.1 or 3^rd ed. but you can’t mix and match as that would not work well and any CB scheme certified lab, among most other labs, will not mix and match requirements as it gets messy quickly.

So, what are the current changes to the standards related to alignment with 3^rd ed. & the new Interpretation Sheet?  Let’s start with the standards.

The updates are actually withdrawal of two standards that have been embedded into 3^rd ed. when it was released (i.e. IEC 60601-1-1, 2^nd edition – Medical Electrical Systems & IEC 60601-1-4 Programmable Electrical Medical Systems) and so the 2^nd ed. aligned standards needed to be withdrawn as 2^nd edition of IEC 60601-1 has been withdrawn since the publication of 3^rd edition back at the end of 2005.  The withdrawal report to IEC for IEC 60601-1-1, Edition 2.0 (now in IEC 60601-1, 3rd ed. in clause 16) covered the following 3 points, and it is the same circumstances for IEC 60601-1-4, edition 1.1 (1^st ed. + A1) (now in IEC 60601-1, 3rd ed. in clause 14):

• IEC 60601-1 Ed. 2.2 (IEC 60601-1:1988+A1:1991+A2:1995) was withdrawn in 2005, yet those who want to use it have been able to do so for the past seven years.
• IEC 60601-1 Ed. 2.2 makes normative reference to a number of supporting standards that have been revised or superseded, yet users have been able to find the versions they need to implement Edition 2.2.
• With the changes made in Amendment 1 to IEC 60601-1:2005, there are substantive technical differences between this collateral standard and its respective clause in IEC 60601-1 Ed. 3.1. Therefore, this document can no longer be considered to represent the generally accepted state of the art.

Let’s move onto the Interpretation Sheet 3 (or IS3) for IEC 60601-1 3^rd edition and also for edition 3.1 or 3^rd edition + A1.  It is the 3^rd interpretation sheet issued since IEC 60601-1, 3^rd edition has been issued.  IS3 is a clarification of the requirement for sub-clause 13.1.2, 4^th dashed line which the sub-clause is titled “Emissions, deformation of ENCLOSURE or exceeding maximum Temperature”.  The requirement of concern is:

“The following HAZARDOUS SITUATIONS shall not occur;”

“- ….”
“-     temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be touched, exceeding the allowable values in Table 23 when measured and adjusted as described in 11.1.3;”  (This is the fourth dashed line of 13.1.2)

So, this requirement is saying that this situation should not occur (following HAZARDOUS SITUATIONS) if there is a part that isn’t an APPLIED PART (An APPLIED PART is a part of the device that in NORMAL USE necessarily comes into physical contact with the PATIENT for the device to perform its function.  So, a part other than an APPLIED PART) that is likely to be touched that exceeds the temperature limits of Table 23 (Allowable max temperatures for ME EQUIPMENT parts that are likely to be touched) in the temperature test method described in sub-clause 11.3.

The IS3 gives an alternative route to meeting the above requirement by stating the following:

“This is clarified by the following:

The above requirement is regarded as fulfilled in accordance with Subclause 4.5 for temperatures at the surfaces of the enclosure, if the following conditions are fulfilled:

− The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT CONDITION is 105 °C; and

− the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS, the temperature of: (indicate the surface of concern) could get hot and there is a possible RISK of a burn if touched, and

− if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the ENCLOSURE; and

− the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT CONDITION is acceptable, and

− the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL RISK resulting from applying the requirement of the standard.

NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1.

NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is shown below.”

To access this IS3 for free please go to the IEC website link.

If you need assistance with this or other issues, please contact us at Leo@EisnerSafety.com.

What’s it about:  The FDA published its draft guidance on Design Considerations for Devices Intended for Home Use in December of 2012, as part of an initiative started back in April 2010 “to support the safe use of medical devices in the home.” The guidance document is a significant step forward helping manufacturers understand the design criteria, user environments to consider, environmental considerations, and labeling issues. It also looks at other standards and FDA guidance manufacturers should consider, as well as post-market considerations, and other vital aspects of designing and developing devices that are intended to make the devices safer and easier to use.

Join us for this timely and informative audio conference presentation as our speaker takes attendees on a guided tour of the draft guidance. The presentation reviews the key points of the document as it relates to the IEC 60601-1-11 standard (Home Use Medical Electrical Equipment), human factors and usability (user environment), environmental considerations, labeling, and design controls (including risk management).

This audio conference will cover:

• Variations in the definition of home-use device under FDA and IEC 60601-1-11
• How the draft guidance relates to FDA’s Medical Device Home Use Initiative
• Environmental considerations discussed in the draft guidance
• User environments to be considered
• Key elements to keep in mind when designing home-use devices
• Labeling considerations
• Post-market considerations
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.

In Addition to this article I have blogged on the topic a couple other times so if you want to see more material (original post) on the topic please continue to read on more of the details and experiences that impact many different people in many different ways (some good and some not so good) on the use of Medical Devices in the Home Use environment and how that impacts the users and their families that use these old and new technologies in the home.  Sometime these devices really are only designed for the hospital setting like some IV pumps, patients may have trouble with them to the point that patients pass away, which is a real tragedy no matter how you look at it.  There are 2 MD&DI articles on the Home Use Draft Guidance and one of the articles deals with an IV pump that probably shouldn’t have been in the home use environment with really sad results.

If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

The end of the transition period for 2^nd ed. of IEC 60601-1 is June 30, 2013.  By July 1, 2013 I hope you will be using the 3^rd ed. based standard for your FDA premarket submissions declarations of conformity.  Are you ready for this transition period and where is the transition information located?

The answer is that the IEC version of 60601-1 isn’t a Recognized Consensus standard after the end of the transition period for 2^nd ed. of IEC 60601-1.  FDA will allow the 2nd ed. of IEC 60601-1:1988 + A1: 1991 + A2:95 (Recognition Number 5-4, Recognition List #013) up til the end of the transition period of June 30, 2013 but the transition period isn’t noted in this entry of the Recognized Consensus Standards list.  So, where do you suppose it is located?  One could search for a very long time and not come up with the answer, as the FDA database for Recognized Consensus Standards is not flexible when it comes to search terms.  You need to know to search for the US national version of the standard, which is the AAMI ES version.  Also, the entries for the 3^rd ed based US national version of IEC 60601-1 vs. the 3^rd ed. + A1 national version of IEC 60601-1 aren’t in the database the same way.  One is in the database as ‘ES60601-1’ and the other is ‘ES 60601-1’.

So, as of now you can start to use the ANSI/AAMI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012, including the A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment – Part 1: General requirements for basic safety and essential performance [Recognition Number 5-71, Recognition List #029] OR ANSI/AAMI ES 60601-1:2005/A1:2012 [Recognition Number 5-74, Recognition List #030] Recognition list #030 was issued on 15 Jan ’13.  Up to and thru June 30, 2013 you can also use the 2^nd ed. of IEC 60601-1 [Recognition Number 5-4, Recognition List #013].  In the Extent of Recognition section of both ES 60601-1 standards you will find a sub-section titled “Transition:” which states:

“FDA recognition of Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 is hereby superseded by recognition of ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment – Part 1: General requirements
for basic safety and essential performance. FDA will accept declarations of conformity, in support of premarket submissions, to Edition 2:1988 (A1:1991+A2:1995) of IEC 60601-1 until June 30, 2013. After this transitional period, declarations of conformity to Edition 2:1988(A1:1991+A2:1995) of the standard will not be accepted.”
Note, the text of the transition for both of the ES 60601-1 standards is the same.

If you company needs support dealing with the IEC 60601 series of standards, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

Buyer Beware – Nursing Home Use Issue:

The FDA draft guidance says that the Home Use environment doesn’t include the use of a medical device in a “professional healthcare facility” (a defined term in the draft guidance) setting as noted in the definition for a “home use device”.  So, that means if you have a device that is designed only for use in a nursing home environment (a “professional healthcare facility” setting per the FDA’s interpretation) that the FDA won’t consider it to fall under the FDA’s draft guidance document and therefore under IEC 60601-1-11:2010 (1st ed.) which is the standard the FDA draft guidance document mentions exclusively, in terms of medical electrical equipment home use device standard.

I noted that the AAMI version of IEC 60601-1-11 standard which is titled “ANSI/AAMI HA60601-1-11:2011 (IEC 60601-1-11:2010, MOD)” has some US national deviations.  The National Deviation of import is that note 2 of the definition for “Home Healthcare Environment” (sub-clause 3.2) has been changed from saying that a nursing home is considered to be the “Home Healthcare Environment” to be a “professional healthcare facility”.   This spurred me to check the FDA’s List of Recognized Consensus Standards and the standard the FDA has Recognized for this issue is the IEC 60601-1-11:2010 version of the standard and not the AAMI version.  In the FDA’s Recognition it states “While this standard (IEC 60601-1-11:2010) recognizes long term care facilities as home use environment, FDA does not consider long term care facilities to be home use environment.”  This surprised me, somewhat, as the AAMI standard has the exception specifically stated right in the US National Deviations and the FDA’s lead for the Home Healthcare Initiative Mary Brady is one of the two co-chairs for the AAMI version of the standard.  Meaning it is clear to me that the FDA was well aware of the national deviation that ended up in the US National standard ANSI/AAMI HA60601-1-11 whereas it is not in the IEC version of the standard and never could be as it is an international standard and therefore national deviations are not allowed. This implies to me that the FDA made a mistake (dare I say such a thing) and should have referenced the AAMI HA60601-1-11:2011 standard instead of the IEC 60601-1-11:2010 standard in the FDA draft guidance and as the US National Recognized Consensus Standard.

So the current bottom line is this (remember it is a draft guidance so it may change):  If you have a device intended only for the nursing home environment and you go to a Safety Agency (i.e. UL, CSA, Intertek, TÜV SÜD, etc.) for a Safety Certification Mark you may be forced into the Home Use standard under IEC 60601-1-11:2010 unless you point out to the Safety Test House that there is a US deviation under the AAMI version (AAMI HA60601-1-11:2011) which says that Nursing Home Equipment is a professional use device which means the standard wouldn’t apply.  That is only if you are going for the US market only.  If you also want the EU or Canada or another country it is likely you may end up needing to get a Safety Agency Mark to IEC 60601-1-11:2010.  If you do get the Nursing Home Use device Safety Agency certified to IEC 60601-1-11:2010 and you go to the FDA for a pre-market submission (i.e. 510(k)) with this as part of your market clearance test data and you use the FDA draft guidance for home use, as well, you may run into some trouble because now the FDA may say this isn’t a Home Use Device per the draft guidance and so they may ask a lot of questions or they could ask you to rethink your approach and resubmit when you get things straight.

MD&DI Articles:

The two articles are “FDA’s Home Use Draft Guidance: Good But Not Gospel” and the really heat breaking story “How a Bad IV Pump Got into Nancy Stark’s Home”.  I hope these articles give you some perspective on the draft guidance document and I know I will be sending in a comment to the FDA in regard to the Home Use Draft Guidance based on the above “Buyer Beware – Nursing Home Use Issue” so hopefully the FDA can clarify this and make it clearer to the user of the Guidance document and that it links better to the applicable standard.

Related Articles:

FDA on Quest to Standardize Mandatory MedDvc Labeling

FDA Issues Draft Guidance on MedDvcs Intended for Home Use

Back in April 2010 the FDA launched the Medical Device Home Use Initiative as there were concerns of the growing number of safety issues with medical devices intended for professional settings like a hospital being misused in the home setting.  An example is the misuse of infusion pumps intended for the hospital or other professional healthcare environment and not the home use environment. One of the many case studies that the FDA is publishing on a monthly basis was the case of a 9 year old girl using a insulin infusion pump set that was discarded from the hospital with an infusion pump.  Soon after using the infusion pump set she had nausea and vomiting and ended up in the emergency room.  When the medical professional removed the cannula it became apparent that it was bent and sadly the infusion pump didn’t alarm or notice the change.  The next day she died due to heart failure.  The case study on the FDA website is not clear if there is a direct connection to her death and the fact that the infusion pump didn’t alarm but you can see that the use of an infusion pump and the infusion pump set being improperly handled and maybe even the infusion pump wasn’t set-up properly caused some major issues at a minimum.

This initiative through FDA’s efforts have provided additional information and resources for manufacturers, health care professionals, home care recipients, consumers, and caregivers and FDA is continuing to develop and encourage the safe use of home use medical devices.  The key areas of this Initiative are 1) the issuance of a draft guidance document (just released and that is what this post is all about) for manufacturers recommending actions they should take to receive FDA approval or clearance of devices intended to be used in the home, 2) develop a labeling repository for medical devices that have been approved or cleared for home use (they are still working thru this issue and seeing if this will be a feasible solution), 3) Increasing Public awareness of the situation of use of medical devices outside the clinical setting.

To ensure that the FDA considers your comments on this draft guidance before the FDA begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by March 13, 2013.

The draft guidance document is a big step in the right direction as the home use environment is a very different environment than is the hospital or clinic setting where the medical devices used in those settings are controlled and operated primarily by the Dr’s, nurses or other clinicians. Whereas, outside those controlled environments (i.e. hospitals & clinics) medical devices many times are operated by a lay person (user with no professional training or experience) and so there are considerable risks that need to be considered which this FDA draft guidance document attempts to consider. The guidance document considers both OTC (over-the-counter) and prescription devices, the use environment (locations being used such as at home, in the shower, at the tennis court, out shopping, on a train or bus, on an airplane, at the beach, out for a run, etc.), and the discusses different unique risks. “The draft guidance provides recommendations for minimizing the risks associated with home use devices by considering the user, the use environment, the device or system, human factors, and labeling.” The guidance says that the recommendations apply to design and development of the device but also provides recommendations regarding postmarket considerations and lastly that the design & development recommendations should be considered even if the device that is likely to used in the home even if the device isn’t intended solely for home use.

The guidance does differ from IEC 60601-1-11 (medical electrical devices for use in the home use environment) a bit in the definitions as the guidance says that:

A home use device is a medical device intended for users in any environment outside of a professional healthcare facility or clinical laboratory. The term includes devices intended for use in both professional healthcare facilities and homes.

A professional healthcare facility is an environment where operators with medical training are continually available to use devices when patients are present. This includes but is not limited to hospitals, long-term care facilities, nursing homes, emergency medical services, clinics, and outpatient treatment facilities.

A qualified healthcare professional is a licensed or non-licensed healthcare professional with sufficient skills and experience with the use of a device to aid or train someone to use and maintain the device.

A home is any environment other than a professional healthcare facility or clinical laboratory where a device may be used.

Whereas, in the IEC 60601-1-11:2010 standard the following definitions mean that the Nursing Homes are considered to be a Home Healthcare Environment which is in conflict of the FDA draft guidance document which doesn’t include it in their definition as a “Home Use” Environment.

Home Healthcare Environment (clause 3.2) is a dwelling place in which a Patient lives or other places where Patients are present, excluding professional healthcare facility environments where Operators with medical training are continually available when Patients are present

Within this same definition (clause 3.2 of IEC 60601-1-11) there are a couple notes that clearly state what a Professional Healthcare Facility is including environments such as a hospital, clinic, Dr’s offices, free standing surgi-centers, dentist offices, free standing birthing centers BUT doesn’t include Nursing Homes as a Professional Healthcare Facility.  This is where the FDA guidance document and IEC 60601-1-11 differ and this is surprising to me as the FDA guidance document does refer directly to IEC 60601-1-11 in seven cases in the guidance document so they are relying on it for some of the basis of the guidance document.

Design controls are called out in several ways in the guidance document including use of Design Controls per 21CFR820.30 which if you have an FDA QS (Quality System) per the QSR (Quality System Regulation) this should be included in your QS if you design products.  Also, it discusses as part of the Design Controls the use of the Risk Management Process per ISO 14971 with some additional inputs to the risk management process including from Human Factors / Usability Engineering Analysis per AAMI HE74 (Human Factors Design Process for Medical Devices), AAMI HE 75 (Human Factors Engineering – Design of Medical Devices), and IEC 62366 (Application of usability engineering to medical devices).  Lastly, this section of the guidance also discusses that software should be controlled thru the Design Control process and that IEC 62304 (medical device software – Software lifecycle processes) as well a couple FDA Guidance documents on Software are important to consider, as applicable to your home use device.  This means that you, the manufacturer, will need to per the FDA guidance document “broaden your existing concept development and preliminary testing processes to account for the needs of home users and requirements for straightforward device operation, obvious interface layouts, and appropriate alarm methods.”  As you can see Design Controls will be important to follow the FDA Recognized Consensus Standards (ISO 14971, IEC 62366, IEC 62304, & AAMI HE75 but HE74 isn’t an FDA Recognized Consensus Standard) and the applicable FDA Guidance documents, as well.

Now, let’s look at Environmental Considerations a bit more – As I mentioned earlier in this post there are many locations to consider.  The guidance document in section 3, “Environmental Considerations”, refers the reader directly to IEC 60601-1-11:2010 (1st edition), it also indicates that you should label the device to include warnings against using the device in environmental conditions which would raise safety & effectiveness concerns but never label to mitigate risks (very similar tone as from the EU Commission in regard to all 3 Medical Device Directives). The main environmental considerations this section of the document covers the following environmental considerations:

•  Location – Such as urban, suburban, rural, school, office, retail, trains, planes, cars.   How does the applicable environments to your device impacts the patient, the device,  and the environment around the device?  What’s the impact on the device from Electromagnetic Interference (EMI)?
• Physical Location – Consider the structure of the location(s) the device will be used in. What about a crowed location such as a small apartment with lots of stuff around that the patient may bump into on a regular basis?  Are there any hazards because of the crowded environment, such as tripping hazards, device cables getting tangled, device getting bumped, etc.
• Contaminants – Consider the environment a non-sterile location.  Consider the risks that your device or the location of it’s use could be contaminated with such things as smoke, pet hair, household chemicals, etc. Design the product to prevent ingress of liquids and particulates.  Refer to IEC 60601-1-11 as these are some of the considerations within the standard.
• Water supply, if applicable to the device – type of water – distilled vs well or tap water – An example would be the impact if a CPAP machine used tap water vs distilled water there is a lot of mineral deposits that end up on the water chamber which means some of that could be breathed in by the patient.  So, is this a hazard?  Something for the manufacturers to figure out.
• Temperature – There could be a variation in temperature within a home that doesn’t have air conditioning, what if the device is portable and left in the car on a really hot day or on a snowy day?
• Dampness & humidity – Similar considerations to Temperature.
• Atmospheric pressure changes –  Elevation and plane travel have impact on this issue.
• Air-flow – Blocked air vent can be an issue in this case if your device relies on ait-flow.
• Child-proofing – Since the device will be in the home and many homes have children or children visitors the devices should be child-proofed (avoid small parts being accessible, minimize number of detachable parts, etc.).
• Tamper-proof – Intentional and no-intentional.
• Travel & International Use – Local, regional, international.  This means change in power source voltage, current & frequency are all possible which could have impact on the functioning of the device.  There could be need for a battery back-up and labeling to deal with identifying what power adaptor would be sufficient to work for what country of use.  Some countries such as Japan depending on what part of the country you are located in you have either 50 or 60 Hz, but only 100Volts (differs from the typical 120 VAC in the US).  Interpower Corp has a great resource if you are looking to know what is the voltage and frequency for each country and also the power plug type.  This chart by Interpower is something I refer to on occasion but I can see many of my clients using this document.
  Also, consider traveller passing thru security checkpoints and how that impacts the patient of body-worn devices and the impact of the x-ray or other screening technologies (now and in the future) impact on the device itself. Or if the user must under go a “pat-down” The guidance points the user of this guidance to the TSA website for information to consider being added to the user’s manual.
• Fluid Exposure – Fluid spills and submersion of fluids.  This is also considered in IEC 60601-1-11.

The guidance goes on to “User Considerations” for section 4 of the document.  The user in this case is not the same as the Health Care professional that uses devices in the hospital, clinic, dr’s office, out-patient surgi-center, nursing home, and other professional health care facility.  Home users can have a wide range of disabilities that the device maker will need to consider in the design of the device including physical, sensory/perceptual, cognitive, emotional capabilities and disabilities.  So, you need to make the device as easy as possible as can be used and you need to consider and use some if not all of the documents that FDA recommends in this section which includes: FDA guidance on Human Factors (issued july 2000 – dated compared to the next few standards noted here), IEC 62366:2007, AAMI HE75:2009, IEC 60601-1-11:2010.

Section 5 goes into “Device Considerations” which the FDA means to keep it simple (or the KISS concept – Keep It Simple Stupid) to understand, operate, and maintain safely & effectively.  FDA provides some device – specific considerations that the device maker should consider in their design and development of the device(s) at hand such as:

• Lock-out mechanisms – to avoid access to certain functions that the health care provider may need to set.
• Calibration – avoid calibration if possible and if not minimal calibration by the user (make sure to have very clear step by step instructions & clear feedback while doing any calibration steps).
• Mechanical Strength – Refer to IEC 60601-1-11 for mechanical tests of both transit operable and non-transit operable devices.
• Electrical Issues – Supply mains (power source tests per IEC 60601-1 – interruption, voltage limitations); Internal electrical power source (i.e. batteries – charging issues, IFU details, replaceable batteries); Permanently installed devices (grounding issues); Outlets and Adaptors (can the device share power with another device?, can you connect device to an outlet that is connected to a switch?, etc.); Power outages (back-up power considerations, emergency contact info, how long or how many cycles can the device operate without mains power?, etc.); Battery life (how long operate on a fully charged battery?)
• EMC (Electro-magnetic compatibility) – Refer to the FDA Recognized Consensus Standard IEC 60601-1-2:2007 Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.  This standard considers tests for immunity of the device to the outside world and emissions from the device to the outside (it’s impact on other things and devices).
• Wireless Technology – Manufacturer will need to meet applicable technology standards (none mentioned in the document), FCC requirements.  Safety & effectiveness concerns of the wireless technology will be an important point to highlight and prove to the FDA.
• Alarm Systems – FDA recommends to follow IEC 60601-1-8:2006 (2nd edition) – Medical electrical equipment; Part 1-8: General requirements for basic safety and essential performance; Collateral Standard: General requirements, tests and guidance for alarm systems in medial electrical equipment and medical electrical systems.

Section six discusses “Human Factors” including User Training, Certification and the FDA guidance documents and standards such as ISO 14971:2007 (Risk Management for Medical Devices), IEC 62366:2007 (mentioned earlier in this post) and AAMI HE75:2009 (mentioned earlier in the post).

Section seven discusses “Labeling” at length including the FDA requirements under 21CFR Part 801 (Labeling) & 809.10 (Labeling for in vitro diagnostic products); FDA guidance document on Patient Labeling (Issued April 2001); 6 other FDA guidance documents; IEC 60601-1-11:2010, section 7.5.2; ISO 15197 First edition 2003-05-01, In vitro diagnostic test systems – Requirements for blood-glucose monitoring system for self-testing in managing diabetes mellitus, Clause 5; a booklet that FDA put together for the Home User of the Device – titled “How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity”; a reference to the Department of Homeland Security for “Prepare for Emergencies Now”;  the FDA webpage titled “FDA Offers Tips about Medical Devices and Hurricane Disasters”; a reference to the EPA (Environmental Protection Agency) website in how to properly dispose of medical waste focused on state programs and regulations;  and references to IEC 60601-1-2:2007.  I am disappointed the guidance doesn’t refer to other sections of IEC 60601-1-11:2010 as there are other important areas to consider for marking & labeling from both IEC 60601-1:2005 (or AAMI ES 60601-1:2005) in clause 7 and also in IEC 60601-1-11:2010 in clause 7.

Section 8 goes into “Postmarket Considerations” including Customer Service, Medical Device Reporting and Selling or Purchasing Used Prescription Devices.

Section 9 is the conclusion section of the document pointing at that if you follow this document in the design and development of your device you have a higher likelihood of a safe and effective device.

Section 10 is a listing of additional resources to consider while you are on this journey of designing a safe and effective home use device.