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  The key areas of this Initiative are 1) the issuance of a draft guidance document (just released and that is what this post is all about) for manufacturers recommending actions they should take to receive FDA approval or clearance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To ensure that the FDA considers your comments on this draft guidance before the FDA begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by March 13, 2013.

The draft guidance document is a big step in the right direction as the home use environment is a very different environment than is the hospital or clinic setting where the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.

Currently, HC recognizes both 2nd & 3rd edition of IEC 60601-1.  Based on what has been published, before this notice, after June 1, 2012 HC would only accept IEC 60601-1, 3rd ed. with the related Collateral standards (i.e. IEC 60601-1-XX that are aligned with IEC 60601-1, 3rd ed.) and related Particular standards (i.e. IEC 60601-2-XX that are aligned with IEC 60601-1, 3rd ed.).  This doesn’t work well as there are some Particular standards that aren’t aligned with 3rd ed., as of yet, or that have only recently (in the last year or so) been published by IEC and so many manufacturers haven’t had the time and/or resources to understand the requirements, do any redesign work, update to their labeling, update their Risk Management File to meet IEC 60601-1, 3rd. ed with any related Collateral & Particular standards, prepare the product for testing (including gathering all appropriate information [component info, etc.] to support the testing), test the product that will hopefully show that the manufacturer complies with all the requirements of the IEC 60601-1, 3rd ed. and the applicable Colateral and Particular standards.  That is unless the manufacturer has a lot of resources and are on top of the standards as they are being developed thru IEC and are starting on all this work prior to the applicable standards being published.

So, this HC guidance document sets out the following for the transition rules to be applied as of June 1, 2012:

1. If there is no Particular standard that is directly applicable to the device, it should conform to IEC 60601-1:2005 and its applicable Collateral standards.
2. If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1:2005 was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1:2005 and its applicable Collateral standards in addition to the(se) Particular standard(s).
   NOTE: If there are multiple Particular standards that apply to the device you will want to take the latest Particular standard publication date and if that is still before June 1, 2009 use this item 2.  If it is after June 1, 2009n then use item 3.
3. If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1: 2005 was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply.  During this transition, HC will accept conformity to both editions and related Collateral standards (and both will be listed on HC’s List of Recognized Standards).  
   Refer to NOTE in item 2. 

These transition rules will not be applied retroactively, meaning that if you have a HC Medical Device License for your product and you used IEC 60601-1, 2nd ed. unless there is a significant change to your product that impacts the characteristics of IEC 60601 series of standards you won’t have to retest to IEC 60601, 3rd ed and submit for an Amended License Application.  HC doesn’t require meeting the ‘state of the art’ in the same sense as is stated in the Essential Requirements of Annex I in the EU Medical Device Directive (MDD) or similarly in the Active Implantable Medical Device Directive (AIMDD) so the manufacturer only needs to submit to HC when they have a new medical device that requires a HC license or the manufacturer has to amend their HC medical device license because they have significant change(s) to the product(s) that impact characteristics addressed by the 60601 series of standards.

You still can submit for a HC Medical Device License to 2nd edition of IEC 60601-1 before June 1, 2012 but you will need to make sure it is shipped prior to June 1, 2012.

Standards are voluntary per the CMDR so if you have test data to IEC 60601-1, 2nd ed. and the applicable Particular & Collateral Standards you still could submit this test data to HC after the Transition Rules (items 1 – 3 above) prescribe IEC 60601-1:2005 & applicable standards.  The mfr would have to provide a summary of the differences in the testing compared to IEC 60601-1:2005 and provide a rationale to demonstrate that these differences do not affect the validity of the testing in demonstrating of the device’s safety and effectiveness.

The guidance document does state that HC reserves the right to require additional testing deemed necessary to demonstrate safety and effectiveness of any device. 

A very important note is stated near the end of the document which says:

” A Medical Device Licence issued by Health Canada provides authorization to import or sell a medical device in Canada and is evidence that the device meets the requirements of the Medical Devices Regulations.  Manufacturers are reminded that Provincial or Territorial electrical safety requirements are separate and distinct from the requirements of the Regulations.  For further information regarding these requirements, contact the applicable regulatory authorities.  A listing of some such authorities is available at: http://www.csa.ca/cm/ca/en/community/electrical/regulators.”