Convergence of favourable factors
It has become evident that the use of devices designed for a clinical setting in the home environment can expose both patients and users to serious hazards. A prime example is infusion pumps. Originally designed for clinical usage in environments such as hospitals, frequently these are now 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 leading to death as a result of drug over or under dosing.
The last five years have seen a clear and growing market interest in medical devices and wellness products. Because of this growth there is a need for developing some of the applicable standards and helping medical and wellness devices manufacturers through the maze of an ever increasing volume of standards and regulations.
Maze of regulations, guidance, standards
Regulations governing medical devices may be decided by national and regional bodies.
In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA), an independent governmental administrative organization, is tasked, among other things, with drug and medical device testing. It has four offices for medical devices.
In Europe, many entities at national and regional levels play a role in assessing, evaluating, issuing guidance documents and modifying regulations for medical devices. Among these, the Medical Device Expert Group (MDEG), established by the EU Commission, is composed of delegates from member states' competent authorities and other EU well-known organizations. The MDEG, which has a Working Group on New & Emerging Medical Device (MEDDEV) Technologies, issues so-called MEDDEV Guidance Documents. Some non-EU countries also adopt these Guidance Documents.
The same models apply in many other regions/countries of the world. Other bodies, such as Britain’s BSI group and Germany’s TÜV organizations, also play an active role in the medical device industry nationally and worldwide. Other organizations, like the Association for the Advancement of Medical Instrumentation (AAMI), a non-profit organization, are active in the development, management and use of safe and effective healthcare technology.
International Standards for electrical equipment, electrical systems and software used in healthcare developed by IEC Technical Committee (TC) 62: Electrical equipment in medical practice, and its Subcommittees (SCs), are adopted at a regional or international level by these bodies.
The AAMI Home Care and EMS Environments Committee has adopted IEC 60601-1-11:2015, the IEC International Standard for medical electrical equipment and systems (MES) used in the home healthcare environment, as ANSI/AAMI HA 60601-1-11, a US national standard.
Defining a "home use" medical device
What is a home use medical device? Is it a medical device operating in a house, apartment, or apartment block environment, or is the scope broader than that? The home use environment makes up a fairly significant part of our world compared to the clinical part (hospital, clinics, surgeries and the like), and there is considerable variance in the definitions of “home use” found in IEC 60601-1-11, in ANSI/AAMI HA 60601-1-11 and in the FDA’s Guidance on Design Considerations for Devices Intended for Home Use.
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 both 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 labelled 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”.
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 as an extension of the home use environment, not as a professional healthcare facility.
In addition to IEC 60601-1-11, there are a dozen or so IEC and ISO International Standards, published or in development, that relate to the medical device home use environment, some of which reference IEC 60601-1-11.
Home care - a special environment
The home care environment poses different challenges to those applicable in a controlled clinical environment such as a hospital or clinic. The challenges may include factors such as environmental controls that are not always available or reliable, dust and pet hair that can impact the performance of the device, power source issues and no backup generator (unlike in a hospital), unreliable protective earth or none at all. Many home use devices rely on the lay user for the device operation [impacts the usability (human factors) of the device] rather than on a professional healthcare provider, so markings and labelling should be written accordingly. For instance, they should take into account the ability to process information and literacy from a cognitive perspective, as opposed to an educational level. The guidance considers that users of the device may have some type of cognitive impairment and the design and labelling of the device (including the user manual) should adjust for that consideration.
In addition to healthcare, there is a growing emphasis on helping the elderly and people with disabilities live a healthier, more active and independent life, known as Active Assisted Living (AAL). The use of information and communication technology (ICT), audio, video and multimedia systems and equipment provides an ever wider range of opportunities to enhance the quality of life for these growing sectors of the population.
IEC work supporting AAL across sectorial issues
The IEC has for many years actively facilitated the development of AAL solutions. In October 2011 the Standardization Management Board (SMB) established Strategic Group (SG) 5: Ambient Assisted Living. In 2014 SG 5 was transformed into a SEG (Systems Evaluation Group) and eventually into a Systems Committee, SyC AAL, which held its first committee meeting in March 2015.
IEC SyC AAL has the role of promoting safety, security, privacy and cross-vendor interoperability in the use of AAL systems and services, and of fostering standardization which enables their usability and accessibility (see articles on SyC AAL in e-tech December 2014 and December 2015).
The IEC SyC concept is fairly new and has only been introduced in the past few years. Instead of the typical TC structure that focuses exclusively on one technology, the SyC AAL brings together a multitude of technology experts (i.e. medical devices, consumer electronics, Internet of Things, computer systems and networks) from several IEC TCs (IEC TC 59: Performance of household and similar electrical appliances; IEC TC 61: Safety of household and similar electrical appliances; IEC TC 62: Electrical equipment in medical practice; IEC TC 79: Alarm and electronic security systems; IEC TC 100: Audio, video and multimedia systems and equipment), and Subcommittees of the Joint Technical Committee set up by the IEC and the International Organization for Standardization (ISO), ISO/IEC JTC 1: Information technology).
To address transverse standardization and broader system-wide issues, SyC AAL has also established formal liaisons with other ISO TCs, the International Telecommunication Union (ITU), industry consortia like Continua as well as with other organizations such as AALiance 2.
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. 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 gap not covered by other standards.
The IEC is also investigating Standards development requirements applicable to interconnected medical and healthcare technologies, and non-medical interconnected devices used in a home environment. These technologies include interconnected medical and healthcare devices, well-being devices and wearable sensors, robotics and assistive devices, as well as supporting services. These interconnected technologies and services need to be able to operate together safely, and were a major reason for the creation of the IEC SyC AAL.
IEC SyC AAL will play central role in developing and supporting solutions
The world of home use medical devices and systems continues to grow in terms of the number of devices, standards and regulations being developed. These devices are increasingly popular for a number of reasons:
- they can be used in the home and other environments with less need for reliance on clinicians
- they can communicate relevant data to medical staff via advanced communications technologies
- they can help keep patients out of hospitals and reduce re-admissions
- they can help manage healthcare costs by reducing the amount of time that patients need to spend with clinicians.
Significant efforts are currently underway to provide clear and consistent standards for home use medical and non-medical devices and systems. As always, manufacturers need to stay informed about the changing regulatory landscape, as well as about standards and regulations under development. Work by IEC SyC AAL will help achieve this.
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 international regulations and on product safety, risk management, quality systems and regulatory submissions. Eisner is a member of various IEC TC 62 Subcommittees and several IEC SyC AAL Working Groups, as well as of a number of US National Committees for medical electrical equipment and home use medical devices.
* edited version of article first published in "In Compliance" magazine