This could have a huge impact on the EU market place including the patients, medical device manufacturers (especially the smaller medical device companies), and put jobs at risk, as well.  See the article from Eucamed on a survey they did of medical device companies in Europe to get an idea of the costs involved with these proposed changes.  On 25 Sept 2013 Eucamed said they expressed “…disappointment and strong concern at the outcome of a vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI)….” in their Article titled Rushed deal leaves patient and jobs in second place.

There are several sources I rely on a regular basis to keep up to date on this changing landscape and the next two websites are some of my favorite blogs as they have very reliable information that is on point, sometimes they will even make a predication here or there (with decent odds of being right, but not always) and always helpful for the medical device manufacturer.

The first of the 2 websites I read regularly is Medical Device Academy.  The article provides analysis and interpretation of how the EU took the next step in approving the proposed medical device regulations. This article covers a lot of ground including the EU Commission Press Release about two new documents in relation to Notified Bodies, Eucamed’s Political Positioning, Next Steps in the Proposed Medical Device Regulations Approval Process (important to read), and lastly Why is there a Rush?

The second website I am always checking up on is MedicalDeviceslegal written by a lawyer that works at a boutique life sciences law firm Axon Lawyers located in the Netherlands who is able to keep a really good pulse of the industry and the development of these types of regulations, laws, directives, and such.  He has written many articles on this specific subject and has been following the process closely.  His latest article indicates that the “ENVI vote result worst of all worlds”.   He gives you the bad news straight up.

Other resources I rely on a pretty regular basis that also have articles on this subject are: 

• RAPS Regulatory Focus which has 2 articles for today 26 Sept 2013 on the subject:
• European Parliament Passes Landmark Medical Device, IVD Reform Proposals
• European Commission Strengthens Oversight of CE-Marking Process
• MASS DEVICE article I saw today on the topic but with other related articles from other days:
• EU panel approves FDA-like requirements for medical devices
• Fierce Medical Devices one article I saw today but with other related articles from other times:
• EU committee backs tougher, U.S.-style device approval system

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

Later in the article there are Highlights of Proposed Changes to 510(k)

This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ’09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment 2007/47/EC, our Standards & Regulations Update Service, announcement of the Medical Device Track at the Oct ’09 IEEE Product Safety Engineering Society, and on the launch of Eisner Safety Consultants New Website.

Subscribe to the newsletter to get future newsletters.  Go to any page on the website www.EisnerSafety.com and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

The article discusses when IEC 60601-1:2005 will be mandatory, including the US, EU, & Canadian National versions.  There is a look at the development of the standard and why implementation has taken so long.  As there can be conflicting requirements for the manufacturers the article discusses the steps to consider in developing a company strategy to transition from second to third edition for its product lines. This last item is a special segment in the web version only.

MD&DI May ’09 article on Risk Management by Mike Schmidt