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  There are 2 MD&DI articles on the Home Use Draft Guidance and one of the articles deals with an IV pump that probably shouldn’t have been in the home use environment with really sad results.

If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval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.   

If you are interested in the IEC 60601 Series of Standards for Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES), this is the group that will allow you to share your experiences, ask questions and discuss your opinions. This is a platform for 60601 experts, and those that want to learn more, to discuss topics related to this large set of standards related to MEE & MES including 7 Collateral Standards (and counting) and over 60+ Particular Standards. In addition to these Particular Standards, there are many other standards that apply to MEE & MES. 

This series of standards is very important in the medical device regulatory world as the IEC 60601 series of standards are the “Gold” standard for national regulatory agencies such as the FDA, Health Canada, The EU Medical Device Directives (MDD & AIMDD), the Japanese Ministry of Health, Labour & Welfare (MHLW), and many other national regulators. Most countries adopt these standards into their national standards mostly without modification but on occasion national deviations are needed to meet the national electrical code among many other issues. 

This group is here to discuss a wide range of topics related to the IEC 60601 series of standards, the regulatory impact of these standards (such as the differences in 3rd ed. vs 2nd ed. of IEC 60601-1 & country specific regulatory impacts), the changes continually happening in this field (i.e. 3rd ed. of IEC 60601-1, IEC 60601-1, 3rd ed. + Amendment 1, etc.), what are the regulatory requirements for specific countries as they evolve (like in the Middle East & Asia), and many more topics within the medical device world are also up for play.

The group is run by Leo Eisner of Eisner Safety Consultants, an expert in the IEC 60601 series of standards, and the group is owned by IEC.  Please come and join us in this new adventure and see what you can bring to this new group and/or learn from your group members.

* NOTE:  The IEC is the owner of this LinkedIn sub-group under their main umbrella IEC LinkedIn Group.  Leo Eisner is the manager of the group and if you have any questions with regard to the IEC 60601 series of standards on Medical Electrical Equipment Sub-Group please contact Leo.

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

IEC is planning on also issuing an updated consolidated version of IEC 60601-1:05 which will include Interpretation Sheets 1 & 2  (IS 1 & IS2), Corrigendums 1 & 2 (Corr 1 & Corr 2), and A1.  They hope to have this out next week.  The IS 1 & 2 and the Corr 1 & 2 are available free on the IEC.ch website (refer to weblinks 2 sentences prior).

The US national version (AAMI) of A1 is in the works and AAMI is hoping to get the approvals done soon so they can also publish it as a US based Amendment as soon as possible but it may take awhile before it gets published as they didn’t expect IEC to publish the document quite so soon.  They are also planning to issue a consolidated version of the AAMI standard similar to the IEC version plus of course it would include the US National Deviations.