On 12 December 2012, the FDA issued a new draft guidance for industry and FDA staff on design considerations (for design and development) for devices intended for home use.

Back in April 2010, the FDA launched the Medical Device Home Use Initiative [1], as there were concerns about 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 [2] was the case of a 9-year-old girl using an 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 on if there is a direct connection between her death and the fact that the infusion pump didn’t alarm, but you can see that the improper use of an infusion pump and an infusion pump set caused some major issues at a minimum.

This initiative [1] through the FDA’s efforts has provided additional information and resources for manufacturers, healthcare professionals, home care recipients, consumers and caregivers, and the 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 The key areas of this Initiative are: 1) the issuance of a draft guidance document for manufacturers, recommending actions they should take to receive FDA approval or clearance of devices intended to be used in the home, 2) developing a labeling repository for medical devices that have been approved or cleared for home use (they are still working through this issue to see if this will be a feasible solution), 3) increasing public awareness of the 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To ensure that the FDA considers your comments on this draft guidance before the FDA begins work on the final version, submit electronic or written comments by March 13, 2013.

The draft guidance document [3] is a big step in the right direction as the home use environment is a very different environment than the hospital or clinic setting where medical devices used in those settings are controlled and operated primarily by doctors, nurses or other clinicians. Outside of those controlled environments, medical devices are often operated by a lay person, which can present considerable risks that need to be considered. The draft guidance document considers both OTC (over-the-counter) and prescription devices, the use environment (locations where the device is being used), and 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 it also provides recommendations regarding post market considerations. The guidance does differ a bit from IEC 60601-1-11 (medical electrical devices for use in the home environment) 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.

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.

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.

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  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, doctor’s offices, free standing surgi-centers, dentist offices, and free standing birthing centers.  However, it does not 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, 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 through the Design Control process and the IEC 62304 (medical device software – software lifecycle processes).This means that you, the manufacturer, per the FDA guidance document, will need to  “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. Generally speaking, Design Controls needs to follow the FDA Recognized Consensus Standards (ISO 14971, IEC 62366, IEC 62304, & AAMI HE75) 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 that would raise safety and effectiveness concerns. However, it states that you should 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 are the following:

  • Location – Such as urban, suburban, rural, school, office, retail, trains, planes, cars. How does the applicable environment to your device impact 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 crowded location such as a small apartment with lots of stuff around that the patient may bump the medical device 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 its 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. What 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 are a lot of mineral deposits that end up on the water chamber if distilled water is not used, 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 vents can be an issue in this case if your device relies on air-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 non-intentional.
  • Travel & International Use – Local, regional, international. This means changes in power source voltage, current and frequency are all possible, which could have an impact on the functioning of the device. There could be a 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. In 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 100 volts (differs from the typical 120 VAC in the U.S.). Interpower Corp has a great resource if you need to know the voltage and frequency for each country and also the power plug type. This chart by Interpower [4] is something I refer to on occasion, and I have also seen many of my clients using this document.
    Also, consider the traveler (the user of the device) passing through 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) on the device itself. Or if the user must undergo a “pat-down.” The guidance points the user to the TSA website for information to consider adding to the user’s manual [5].
  • 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, doctor’s office, or 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 to use and you need to consider and use some if not all of the documents that FDA recommends in this section. These documents include: FDA guidance on Human Factors [6] (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 simple (or the KISS concept – Keep it Simple Stupid) to understand, operate, and maintain safely and effectively.  The 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 and 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 (e.g., 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 the device to an outlet that is connected to a switch?); Power outages (back-up power considerations, emergency contact info, how long or how many cycles can the device operate without mains power?); Battery life (how long can the device 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 (its impact on other things and devices).
  • Wireless Technology – Manufacturer will need to meet applicable technology standards (none mentioned in the document), FCC requirements. Safety and effectiveness concerns of the wireless technology will be an important point to highlight and prove to the FDA.
  • Alarm Systems – The FDA recommends following 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 6 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 7 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 [7] (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” [8]; a reference to the Department of Homeland Security for “Prepare for Emergencies Now” [9];  the FDA webpage titled FDA Offers Tips about Medical Devices and Hurricane Disasters” [10]; a reference to the EPA (Environmental Protection Agency) website in how to properly dispose of medical waste focused on state programs and regulations [11];  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 out 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.


 

 

 

About the author:

 

 

Leonard (Leo) Eisner is the head of Eisner Safety Consultants, a firm that specializes in helping clients through the product safety and international regulatory processes (FDA 510(k), CE Mark, Canadian Medical Device Regulations (CMDR), etc.).  The firm specializes in Medical devices. Assistance to clients is provided with a team of experts in the interface with the Safety Agencies and Regulatory Bodies and the creation and implementation of quality systems.

 

Leo is a leading figure in the electro-medical product safety world revolving around IEC 60601-1 and its series of standards. Leo is involved in the standards development process as a member of the US TAG for TC 62, SC 62A and SC 62D, and has been involved in the development of several of the IEC 60601-1 standards including IEC/ISO 80601-2-58 & IEC/ISO 60601-1-12. He is an author of multiple articles on IEC 60601-1 (http://www.eisnersafety.com/safety_articles/) from well-respected trade publications and a speaker on many topics focused on this series of standards.  In the last several years Leo has spoken on IEC 60601-1, 3rd edition & national implementation of IEC 60601-1, 3rd ed. in the countries that have adopted this standard.

 

Leo has over 27 years experience in the Product Safety arena. UL for 9 years – various product categories, TÜV Product Service for 2 years in electrical medical products, 2 1/4 years at Karl Storz Imaging and more than 14 years as a medical device product safety and regulatory consultant. Leo has been a Notified Body Auditor for electro-medical devices and was authorized by NSAI & TÜV Product Service to audit to the EU MDD, CMDR, and ISO 13485.  Leo is a registered Professional Engineer in the Safety Engineering discipline.

 

To contact Leo send an e-mail to Leo@EisnerSafety.com or call 503-244-6151.  http://www.EisnerSafety.com