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  There are 2 MD&DI articles on the Home Use Draft Guidance and one of the articles deals with an IV pump that probably shouldn’t have been in the home use environment with really sad results.

If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval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

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The FDA draft guidance says that the Home Use environment doesn’t include the use of a medical device in a “professional healthcare facility” (a defined term in the draft guidance) setting as noted in the definition for a “home use device”.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healthcare facility” setting per the FDA’s interpretation) that the FDA won’t consider it to fall under the FDA’s draft guidance document and therefore under IEC 60601-1-11:2010 (1st ed.) which is the standard the FDA draft guidance document mentions exclusively, in terms of medical electrical equipment home use device standard.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

The Federal Register notice (FR Notice) continues with details about the workshop.  The public workshop is free with registration (please register early) and will be held on April 29 – 30, 2013 at the FDA White Oak Campus at 10903 New Hampshire Ave, Bldg 31 Conference Center, the Great Room (room 1503A), Silver Springs, MD 20993. To register for the workshop visit the FDA’s Medical Devices News & Events – Workshop & Conferences calendar.  There is also an option for a Webcast to view the workshop from off-site web facilities.  To sign-up in this way use the same registration link as above but make sure to note that you want to attend via a webcast vs in person.  The contact person for this workshop is Mary Brady, Mary.Brady@fda.hhs.gov who is also involved with the Home Use Medical Device Initiative so this is a good tie-in with that subject as labeling is critical to get consistent for ease of use or Usability (or Human Factors some call it).  Refer to the blog post on the Home Use Medical Device Draft Guidance document that was issued on 12 December 2012 for details about the Home Use Draft Guidance document and also about the Home Use Initiative.

In the background section of the FR Notice for this Workshop FDA indicates “Currently, there are no regulations that explicitly define and describe a standard content and format for medical device labeling. FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error. Also, there is no single available source of medical device labeling for people to view, search, and download for devices that are used in clinical and non-clinical environments. FDA is aware of and concerned with the risk of medical errors that result from lost or inaccessible labeling.”

FDA also conducted a 2-phase research study with Research triangle Institute (RTI) of healthcare professionals in regard to their experiences with medical device labeling, and what they would like to see in a standardized version of device labeling. Key findings from the study helped create an outline for standard content and format for medical device labeling id’ing the most relevant sections.  Also, survey participants asked for a “quick reference guide”  for proper device operation & use.  They indicated that would be more convenient and effective with the option of referring to a more comprehensive form of labeling.

Additionally FDA also conducted a survey of the National Family Caregivers Association (NFCA) on medical device labeling to elicit home caregivers’ experiences with medical device labeling for devices used in the home environment.  Here again is another tie-in with the Home Use Medical Device Draft Guidance document and blog post on this subject.  It is clear this initiative is tied-in with the Home Use Initiative and will help support each of the initiatives.  FDA continues to say in the FR Notice “As more medical devices migrate out of clinical care environments and into patients’ homes, the assurance that devices are being used properly and safely no longer resides with a healthcare professional; rather, the responsibility is with the patient, spouse, sibling, or even children. When medical devices are sent home with patients or are moved from one location to another, the labeling often becomes misplaced, lost, damaged, or discarded, which may result in adverse events or other complications due to misinterpretations and absence of proper labeling.”

Per the FDA FR Notice the workshop will focus on the following topics for discussion

A. Summary of FDA Work on Labeling

1. RTI two-phase research study of healthcare professionals regarding device labeling.
2. NFCA survey of consumers on medical device labeling.
3. Cooperative Research and Development Agreement with Kwikpoint for the development of visual language for device labeling.
4. The Center for Drug Evaluation and Research measures of success with standard labeling and the use of a drug repository.

B. Standard Content and Format of Device Labeling

1. Review the outline for a draft standard content and format of medical device labeling.
2. Current thinking on a standard content and format of medical device labeling.
3. Use of symbols in medical device labeling.
4. Discuss a shortened version of standard medical device labeling.

C. Repository of Medical Device Labeling for Home Use Devices

1. Online access to device labeling.
2. Panel discussions on using an online device labeling site.
3. Discuss the types of devices whose labeling should be on the site.

For additional information on the topic also refer to the RAPS News article on 4 Jan 2013.

In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”

The draft guidance document states in section IV: “This guidance explains FDA intentions to apply its regulatory requirements to a subset of mobile apps. This subset, which we are calling mobile medical apps as defined in section III (definitions), includes only those that meet the statutory definition of a device; and either:

• are used as an accessory to a regulated medical device;
• or transform a mobile platform into a regulated medical device.

This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s).”

Also, the draft guidance details a long list of app’s that don’t fall under this draft guidance document.

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

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

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

…”

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

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