Home Use Medical and Wellness Devices

Originally published in the August 2016 issue, with some slight updates in January 2017. For the latest updates, please contact Leo at Leo@EisnerSafety.com.

Diverse Markets Converging for Health and Wellness Devices Used in the Home Environment

Why are home use medical and wellness devices drawing so much attention and growing at an explosive rate? I would say the nexus of the Internet of Things (IoT), the “super-aging” of societies around the world¹ (which is directly tied to patients wanting to be comfortable in their home environments instead of in sterile impersonal clinical environments), the portability of devices, the growth of wearable technologies, the increasing costs of health care, and the huge regulatory burden/costs to obtain approval by national regulators. Also, there has been significant growth in the number of applicable standards and regulations that apply to medical devices, especially around software, health informatics, privacy and security issues.

Additionally, it has become evident that the use of devices designed for the clinical environment in the home environment can expose both patients and users to serious hazards. A prime example is Infusion pumps² that were meant for clinical usage, such as in hospitals, that are placed in the home by care providers or healthcare organizations. Infusion pumps, if not redesigned thoughtfully for the home care market and patient use, can be too complex or confusing to use, potentially causing serious harm or death from over or under dosing issues.

The Increase in the Markets for Home Care and Wellness Products

In the last five years I have seen a marked increase in the interest in the medical device home use and the wellness market. Because of this growth in the industry I saw a need to get more involved in the development of some of the applicable standards and I have become a member of a variety of home use medical device and wellness standards development committees to help medical device and wellness manufacturers through the maze of ever increasing standards and regulations. I first got involved on the regulatory side of medical home care by providing the U.S. Food and Drug Administration (FDA) with feedback both formally and informally on its draft Guidance on home use medical devices.³ A couple years later I joined the Association for the Advancement of Medical Instrumentation (AAMI) Home Care Committee, which adopted IEC 60601-1-11,⁴ the standard for medical electrical equipment and systems (MES) used in the home healthcare environment, as a U.S. National Standard (AAMI HA 60601-1-11⁵). In 2015, I became a member of the very new IEC System Committee for Active Assisted Living (SyC AAL), which covers both medical and non-medical devices in a system network.

In this article, I will talk more about each one of these areas to provide readers with some insight into this growing market. If the markets weren’t growing like they are we wouldn’t have the published standards or the developing standards as there wouldn’t be the interest to accelerate the development of these documents.

The home care environment poses challenges that are different from those applicable in a controlled clinical environment like a hospital or clinic. The challenges may include items such as environmental controls not always available or reliable, dust and pet hair that can impact the performance of the device, power source issues and no backup generator (like in a hospital), unreliable protective earth or none at all,⁶ many home use devices rely on the lay user for the device operation [impacts the usability (human factors) of the device] or sometimes by a family member vs. by a professional healthcare provider, education level of lay users may be lower than a professional health care worker and so the markings and labeling should be written for an eighth grade level per both the IEC and AAMI HA 60601-1-11 standards. The FDA’s Guidance on home use medical devices looks at the literacy from cognitive perspective versus an education level. The Guidance considers that users of the device may have some type of cognitive impairment and to adjust for that consideration in the design and labeling of the device (including the user manual).

Definition of a “Home Use” Medical Device

What is a home use medical device? Is it a medical device operating in a house, apartment, or condominium environment or is the scope broader than that? It is so much more than just for use in the home. The home use environment is a pretty big portion of our world compared to the clinical portion (hospital, clinics, physician’s offices and the like), and there is considerable variance in the definitions of “home use” found in the FDA’s Guidance, IEC 60601-1-11 and AAMI HA 60601-1-11, 2^nd Ed.

Let’s break down the definition, its differences and similarities between these three source documents. All three documents agree that a home use device is not intended by the manufacturer to be used only in the clinical setting. If the device is intended to be used in the home environment and in a clinical setting, it is still considered a home use device because it can be used in the home environment. If a device is intended for use exclusively in a clinical setting, then by definition the device is not a home use medical device.

The FDA Guidance definition of a home use device “is a medical device labeled for use in any environment outside a professional healthcare facility.” This includes but is not limited to outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes. If the device is intended to be used in professional healthcare facilities and also outside those facilities, it meets this definition.”

The FDA Guidance goes on to define what a professional healthcare facility is which is “either…

any environment where personnel with medical training continually available to oversee or administer the use of medical devices. This includes, but is not limited to, hospitals, long-term care facilities, nursing homes, emergency medical services, clinics, physicians’ offices, and outpatient treatment facilities; or a clinical laboratory.”

FDA’s home use Guidance definition of a professional healthcare facility includes nursing homes, whereas in IEC 60601-1-11 a nursing home is considered in the home use environment, so is not considered a professional healthcare facility. IEC 60601-1-11 applies to nursing homes, as well as all the other home use environments like using a home use medical device at the office, while driving your car, while traveling on a plane or a train, at the swimming pool, while you are at school and so many more environments. The definition of “home use” in AAMI HA 60601-1-11 (Clause 3.1 in Note 2) follows what the FDA Guidance indicates that a nursing home is considered a professional healthcare facility, and so it is not part of the home healthcare environment for this U.S. standard.

Other Standards Affecting Home Use Medical Devices

In addition to IEC 60601-1-11, there are an increasing number of IEC and ISO standards related to the medical device home use environment, some of which reference IEC 60601-1-11. A partial list of additional home use medical device standards, either published or in development, is shown in Table 1.

Table 1

The IEC is also investigating standards development requirements applicable to interconnected medical, healthcare technologies, and non-medical interconnected devices used in a home environment. These technologies include interconnected medical and healthcare devices, robotics, well-being devices and wearable sensors, assistive devices, as well as supporting services. These interconnected technologies and services need to be able to operate together safely. So the IEC has formed a new committee called the System Committee for Active Assisted Living (SyC AAL).

The IEC’s System Committee for Active Assisted Living⁷

The “system committee” (SyC) concept is a fairly new, and was just introduced in the past few years. Instead of the typical technical committee (TC) structure that focuses exclusively on one area of expertise i.e. Electrical equipment in medical practice (TC 62) or Audio/video, information technology and communication technology (TC 108), or household and similar electrical appliances (TC 61), a system committee brings together a multitude of technology experts (i.e. medical device, consumer electronics, the Internet of Things, computer systems and networks) from a large number of IEC TCs, and Subcommittees of the Joint Technical Committee set up by the IEC and the International Organization for Standardization (ISO), to other external standard development organizations (SDOs) and industry consortia like Continua⁸ and other organizations like AALiance2⁹ to address transverse standardization and broader, system-wide issues. The SyC AAL is interested in working with other AAL research projects seeking to standardize their R&D results.
The standards development work conducted by a (SyC) begins at the system level rather than at the level of individual products, thereby supporting the investigation of more complex issues related to devices, services, systems, infrastructure, and interoperability. And just like a TC, a SyC can publish international standards and other IEC deliverables such as Technical Reports and Technical Specifications but only to fill any gaps that may exist with other standards.

The SyC AAL is currently structured with four Working Groups (WGs), a Project Team (PT), and two Chairman’s Advisory Groups (CAGs). A fifth WG is in the proposal process tentatively will be on “connected home environment.” The SyC AAL has also established formal liaisons with other IEC TCs as well as external SDOs. Table 2 on page 196 is just a partial list of current TCs and SDOs with which the SyC AAL is engaging in its standards development efforts.

Table 2

The goal of this coordinated effort is to support the development of standards for home use medical systems and non-medical devices that: 1) enable usability and accessibility of AAL systems and services; 2) enable cross-vendor interoperability of AAL systems, services, products, and components; 3) address systems level aspects such as safety, security and privacy; and 4) enhance the quality of life and foster independent living.

Focus of SyC AAL’s Current Activity

As previously noted, the SyC AAL currently consists of four separate WGs, with a 5th WG on it’s way, currently in the proposal process. each with their own specific focus. WG1 is focused on defining the template for use cases and developing a pilot set of about 36 use cases. The pilot use cases are intended to help identify standardization gaps, define user requirements, define the scope of the AAL, define a template for use cases, to prioritize and categorize use cases, and to develop a framework for future use cases. These use cases are building the basis for the development of an AAL architecture model and reference architecture. From the initial set of pilot use case already developed, WG1 has identified the following use case “clusters”: Prevention and Management of Chronic Conditions; Social Interaction; Mobility, (Self-) Management of Daily Life Activities at Home; Occupation in Life; Case for the Future; Living Well with Dymentia; Living Actively and Independently at Home; and Wellness. The New Work Proposal was issued as SyCAAL/60/NP and national committee members of the Syc AAL and liaison committees TC59, TC 61, TC 62, TC 79, TC 100, and SyC Smart Cities have been advised of this document to be able to comment on it by the closing date of March 17, 2017.

WG2 is focused on architecture and interoperability issues. The main purpose of WG 2 is to develop AAL specific requirements based on the use cases. Specific WG2 efforts include:

1. Define reference terminology and harmonization with other IEC TCs and SDOs
2. Address interoperability between domains that impact AAL functionality
3. Define systems and their topology based on the AAL use cases and stakeholders
4. Define interoperability framework for systems, services, devices and components of AAL system using existing standards
5. Study feasibility of existing AAL reference architectures
6. Describe general technical requirements for AAL
7. Describe different architectural layers and how they interact with each other
8. Describe interaction of devices and systems with services in the “cloud”.
9. Address security and privacy issues for AAL devices and services in the to be defined architecture
10. Liaise with open platform providers and enable interoperability in the AAL environment

The Quality and Conformity Assessment Working Group (WG3) covers all quality, conformance and interoperability related issues of AAL, extending into products, systems, components and services. The objectives of WG3:

• To develop quality and conformity criteria based on the use cases and requirements and integration profiles developed by SyC AAL WGs 1 and 2
• To ensure quality, conformity, privacy and security for both sides of the AAL architecture, the device and the services
• Work with a Conformity Assessment Body (CAB) to develop relevant schemes
• Organize interoperability testing events (called Plugfests)

WG3 will also examine avenues to ensure that products, services, components and systems can ultimately be tested or, where required, certified to meet the necessary levels of safety, reliability and performance in compliance with the relevant standards, including the IEC Standards.

Finally, WG4 is focused on issues related to regulatory affairs. That’s because AAL practices are regional in nature and reflect differences in health care policy and laws/regulations, the manner in which health care is administered and provided, cultural and societal differences, and other factors. Specific objectives of WG4 include:

• To develop an overview of AAL initiatives on national and regional levels with details on R&D projects and trials
• To develop an overview of regulatory requirements on national and regional level with details on AAL policies including social codes, laws on privacy, data protection and security
• To develop an overview of the relevant AAL organizations on national and regional level such as elderly and disability organizations

WG4 is currently surveying various regions around the world with the goal of developing a Technical Report that includes specific recommendations for areas of standardization, especially with respect to privacy, data protection and security.

Separate from WG activity, one of the SyC AAL CAGs is in the process of defining different assistance levels depending on the needs and requirements for the user, as follows:

• Supported comfort, well-being and security
• Self-managed healthcare assistance
• Social care and social interaction assistance
• Medical assistance
• Remote assistance

The objective of this effort is to keep older people and people with special needs as long as possible autonomous and independent in their home environment.

In addition, the SyC AAL’s Project Team (PT) is drafting a terminology document, currently identified as IEC 60050-871, Active Assisted Living (AAL) –Terms and definitions. When completed, IEC 60050-871 is expected to objectively communicate what the AAL environment is, and to help ensure the consistent use of terms across all standards that address systems and devices that operate in the AAL environment.

Conclusion

The world of home use medical devices and systems continues to grow in terms of the number of devices, standards and regulations that are being developed. These devices are increasing in popularity because they are able to be used in the home and other home environments with less reliance on clinicians; because they are able to communicate relevant data to the clinician via advanced communications technologies; because they can help keep patients out of the hospital and reduce re-admissions; and because they can help manage healthcare costs by reducing the amount of time that patients and clinicians need to be in the same place.

As this article has illustrated, significant efforts are currently underway to provide clear and consistent standards for home use medical and non-medical devices and systems and for the SyC AAL. As always, manufacturers need to stay up to date on the changing regulatory landscape, as well as standards and regulations under development.

Endnotes

1. IEEE Pulse (EMBS) – “The Super Aged Society – Japan’s Kaiteki Institute Studies How to Keep The Elderly Healthy And Active,” March 13, 2014. http://pulse.embs.org/march-2014/super-aged-society
2. “Infusing Patients Safely, Priority Issues from the., AAMI/FDA Infusion Device Summit,” AAMI, (not sure if published in Oct or Nov best guesses) 2010. http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/Summits/AAMI_FDA_Summit_Report.pdf
3. “Design Considerations for Devices Intended for Home Use, Guidance for Industry and Food and Drug Administration Staff,” U.S. Food and Drug Administration, November 24, 2014. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm331681.pdf
4. IEC 60601-1-11, 2^nd edition, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
5. ANSI/AAMI HA60601-1-11:2015 (2^nd edition) MEDICAL ELECTRICAL EQUIPMENT — Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
6. The IEC 60601-1-11 and ANSI/AAMI HA 60601-1-11 standards both assume there is no reliable earth ground (protective earth) as there are many houses around the world that are not set-up with reliable grounds. There are exceptions to this rule by using an electrician to install a reliable ground for a specific medical device used in the home care environment, which is called out in a separate standard like home ventilators.
7. http://tinyurl.com/SyC-AAL
8. http://www.continuaalliance.org
9. http://www.aaliance2.eu

Leonard (Leo) Eisner is principal consultant at Eisner Safety Consultants, a network of consultants headquartered in Portland, Oregon (US) that provides support to medical device companies on US, Canadian, European and other international regulations and provides support for product safety, risk management, quality systems, and regulatory submissions. He is heavily involved in the development of IEC standards, he is the US Co-Chair for IEC TC 62 / SC 62D and is a member of many US National Committees for Medical Electrical Equipment, Home Use Medical Devices, and System Committee for Active Assisted Living. He can be reached at Leo@EisnerSafety.com.