FDA Advancing Health Medical Devices Instruction Manual

: June 13, 2024
: FDA

Table of Contents

Introduction
Increasing patient access to home use medical technologies
Communicating about devices to diverse audiences
In Summary
References
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EXECUTIVE SUMMARY FOR THE PATIENT
ENGAGEMENT ADVISORY COMMITTEE MEETING
Advancing Health Equity in Medical Devices

Disclaimer: This Executive Summary is for discussion purposes only and does not represent draft or final guidance. It is not intended to propose or implement policy changes about advancing health equity for medical devices. In addition, the references cited herein are for informational purposes only and should not be construed as endorsements.

Introduction

Regardless of race, ethnicity, age, sex, gender, sexual orientation, income, community, or other physical or social characteristics, consumers can benefit from medical devices and health technologies that enable them to reach their full potential for health and well-being. But health and healthcare disparities exist across many dimensions. The FDA’s Center for Devices and Radiological Health (CDRH) is committed to addressing these disparities by working toward assuring that all patients have access to safe, effective, and high-quality medical devices and safe radiation-emitting products. This commitment includes ensuring that devices are designed to be safe and effective, that evaluations of devices take into account the diverse populations for which they are intended, and that patients and consumers have the information they need to make decisions about their healthcare.

Strategic priorities
The FDA seeks to advance health equity by supporting the development of safe and effective technologies to meet the needs of all patients and consumers. No person should be excluded from healthcare and no patient left behind. As part of CDRH’s 2022 to 2025 Strategic Priority to Advance Health Equity, 1 CDRH has set the following objectives:

Facilitating availability of and access to medical technologies for all populations;
Empowering people to make informed decisions regarding their healthcare;
Supporting innovation of novel and existing technologies that address health inequities; and
Reducing barriers to increase participation by diverse populations in evidence generation.

Figure 1. Diagram of CDRH’s Strategic Priority to Advance Health Equity.

FDA Advancing Health Medical Devices - Figure 1

Themes for discussion
CDRH has identified three broad themes to obtain expert advice from the Patient Engagement Advisory Committee (PEAC) that are relevant to medical devices and health equity:
Increasing patient access to home use medical technologies. Medical technologies 2, including digital health technologies, may help bridge the gaps by bringing healthcare directly to patients – at home, at work, at school, and in their communities, in urban, suburban, and rural settings.
Principles for when device evaluation in diverse populations may be needed. The benefits and risks of a medical device can vary across patient populations, which may need to be considered during clinical studies. As part of our strategic priority, CDRH is considering several key principles to guide consideration of when a device should be evaluated in diverse populations to support marketing authorization. CDRH’s goal is to promote inclusivity in clinical research and high-quality evidence generation, and to advance equity in study participation, health outcomes, and timely access to safe and effective medical devices.

Communicating about devices to diverse audiences. To empower consumers to make informed decisions about their healthcare, it is important to provide clear, pertinent, accessible information about their medical technology options.
The recommendations provided by the committee will be used to address considerations for the FDA and industry on these topics.

Increasing patient access to home use medical technologies

Advances in healthcare technology and changes in how people access healthcare have helped to move the use of some medical devices from the clinical environment to the various places people spend much of their daily lives. Generally, a “home use” device is a medical device intended for use in any type of location outside of a professional healthcare facility, including but not limited to, a person’s home, outdoors, workplaces, schools, vehicles, emergency shelters, and independent living retirement homes. 3 Home use technologies may make many forms of healthcare more available and accessible, potentially providing significant benefits in both quality of life and cost of care.
Home healthcare may offer more comfort and convenience to care recipients than hospital-based care and enable recipients to remain independent.
For these reasons, home use devices present an opportunity to advance health equity for underserved people, particularly those who face barriers in accessing care at healthcare facilities.
Home use devices can help diagnose, treat, and monitor many chronic and acute conditions, as well as support recuperative and long-term care. In addition, features of some home use devices can be tailored to the needs of diverse patients through intentional design. In particular, home use devices may be able to be designed with underserved communities in mind, such as diagnostic tests with features enabling use by visually-impaired individuals 4 , digital stethoscopes for monitoring lung and heart disease 5 , wrist-worn blood- pressure monitors 6 for hypertension monitoring, and wearable brain- oxygenation monitors 7 that can provide data important to several conditions.

The rapid, ongoing innovation in digital health technologies is amplifying the potential benefits of home use devices, including their ability to advance health equity. Smartphones and internet connected technologies are already advancing the boundaries of what can be done outside of healthcare facilities. As new electronic devices and software continually provide more capabilities at lower cost, the opportunities for remote healthcare-related services grow, including monitoring patients in their daily lives for signs of problems, alerting caregivers and providers to the need for intervention, recording patient data in their healthcare records for better clinician analysis, communicating directly with clinicians, and informing patient decision-making.

At the same time, home use devices present unique challenges and potential safety risks 8 , including the difficulties some may face in properly operating them, differences in performance of some devices compared to traditional care, and higher out-of-pocket costs for some devices. If not appropriately addressed and managed, these potential problems could limit the extent to which home use devices contribute to healthcare equity.

Design of Devices for Home Use
Home use medical devices have the potential to broaden and facilitate patients’ access to healthcare. However, as their use becomes widespread, it will be important to also think about the design of devices for use outside the clinical environment. With varying environments, it’s helpful to use a human-centered design approach: this method puts people at the center of the process and considers behaviors, ways of thinking, and peoples’ needs and aspirations.
Intuitive Interfaces
The reach and impact of a home use device may be limited if users of the device are highly reliant on instructions, manuals and training to use the device safely and effectively. Many users will prefer, and are more likely to safely and effectively use, products that do not require extensive training or lengthy reviews of written materials. That may be especially true for populations associated with lower levels of digital or health literacy, as well as for people with disabilities for whom documentation and training materials may present special challenges. Intuitive design is a way to reduce a reliance on training, instructions or manuals for safe, effective operation. 10 Training and user manuals may still be necessary to communicate important information, but intuitive design may enable making them simpler, and more focused on applications and benefits of the devices rather than on explaining technological details.
A user interface that is intuitive is one in which users recognize the device’s controls, inputs and outputs as working in a familiar or obvious way. 11 Intuitive interfaces allow users to easily navigate the device’s operations, so that they can focus on the task at hand rather than on figuring out how to operate the device. For example, many people in the U.S. are familiar with the image in Figure 2 representing “play” for audio or video files. The cultural familiarity associated with this symbol makes its use on other devices, platforms or contexts intuitive. Designing devices that are intuitive may increase user as well as clinician acceptance.

Figure 2. Example of Play button
Intuitive interfaces typically have the following characteristics 12:

It is easy to find and understand the different functions that a device performs, and the different types of information it provides.
It is easy to determine how to perform a given function or access a given type of information.
The results of performing a function are expected, and are immediately and clearly conveyed to the user.
There is a minimum of unnecessary or repetitive user interactions.
The device does not malfunction or behave unexpectedly when a user makes a mistake, and allows the user to easily resume appropriate operation.

These design features can be incorporated through an iterative design process that involves direct interactions with or observations of the intended users, along with formative evaluations such as cognitive walk-throughs and simulated use testing. The process typically also involves the consideration of human factors principles in medical device design, which takes into account the physical, sensory, emotional, and intellectual capabilities of humans. The benefits of designs that are intuitive and that take human factors into account include making it easier for users to comply with recommended usage of the technology; making it easier for users to understand device output and functionality; reducing the demand for customer support; and quicker mastery of device operations and procedures.
Mitigating Risks for Safe Use
The safety of end users is always of the utmost importance. Through the application of human factors principles, safety risks related to the home use of a medical device can often be determined and appropriately mitigated. Determining risks to safety involves identifying potential use errors. But predicting the types of errors that individuals will commit may require an in- depth and systematic analysis of ways a user might interact with a device, as well as errors a user might commit during each individual interaction.
Once these probable errors are identified, steps can be taken to modify the design to minimize the chances of users making these errors, and to ensure the device handles any errors in ways that reduce safety risks, and that allow the user to continue to operate the device correctly.
Special considerations for people with physical or cognitive disabilities
People with disabilities represent an enormous set of populations that are in many ways underserved by healthcare. Disabilities such as visual impairment, auditory impairments, reduced dexterity, motor and strength impairment, and cognitive impairments are extremely common in the U.S., as they are throughout the world. Devices that are intuitive and easy to use by others may be much more difficult to use for those with disabilities, if special attention is not considered for their needs. For example, basic but critical features of a device such as blinking lights, warning tones, and keypads may require alternatives for those with visual, auditory or dexterity challenges.

Automation Bias
Automation bias is the tendency for users to exhibit more trust than may be warranted in a device’s actions or in the information it provides, simply because the device is equipped with technology. That potentially excessive trust can result in inappropriate decision-making based on the device’s output, 15 or acceptance of a device’s inappropriate actions.
There are two types of automation bias errors 16 : automation bias omission and automation bias commission errors. Automation bias omission error occurs when users rely on the device to inform them of or correct a problem, but the device fails to do so. Automation bias commission error occurs when users make choices based on incorrect suggestions or information provided by the device, or allow the device to perform an inappropriate action.
It is important to understand how to detect automation bias in medical device users, and how to enlist best practices for mitigating the risks related to such bias. Equipping the device with protective measures such as warning statements and alerts, and providing clear instructions for recognizing and avoiding safety risks, can help mitigate automation-bias-related risks. But the best way to mitigate use-related risk in medical devices is through safety by design—that is, designs that minimize the chances of a device performing an inappropriate action or providing inappropriate information in the first place.
Home use Medical Device Examples
The FDA is committed to facilitating access to medical devices designed to be safe and effective when used outside of clinical settings, while reducing and mitigating problems that can occur in the home environment. Following are some important applications, along with a few examples for each. 15
D. Lyell, E. Coiera. Automation bias and verification complexity: a systematic review. J Am Med Informatics Assoc 2016;24:423-31.
https://www2.deloitte.com/uk/en/pages/deloitte-analytics/articles/automation- bias.html
ISO 14971 Medical devices – Applications of risk management to medical devices
Except where otherwise explicitly stated, comments in this Executive Summary are not intended to be product-specific, nor to be used for product-specific regulatory decision-making. Also, please note that studies and other research cited in this Summary and not explicitly attributed to the FDA, are included strictly for reference purposes.

Devices for pediatric seizures
Among children at high risk for seizures, monitoring for seizure onset can be critical to protecting the children from significant harm, and to better understanding and treating their conditions. Seizure monitoring is typically done through electroencephalography (EEG), which involves measuring electrical activity in the brain, usually through devices with electrodes that contact the scalp. There are numerous home use EEG devices, and some of these can connect by smartphone or other online device to alert caregivers or clinicians in case of abnormal brain electrical activity, and can track seizure activity over time to provide a clearer picture of the condition.
Additionally, some other types of wearable devices measure motion, heart rate, or muscle activity to monitor for seizures at home.
Maternal health
Maternal health is subject to some of the most acute disparities in U.S. health, with studies showing that the risk of death from pregnancy-related causes is two to three times higher for American Indian/Alaskan Native and Black women, respectively, than for White women. 20 Many
of these deaths may be preventable. Disparities also carry over into the much higher number ofserious pregnancy-related complications, including clotting and bleeding disorders,
hysterectomy, acute kidney failure, severe infection, stroke, cardiovascular events including arrest and heart failure, and adult respiratory distress syndrome. 21 Many of these deaths and complications may be preventable through home use devices, which can monitor and provide early warnings of compromised vital signs or other indications of medical distress. One major example is home monitoring of blood pressure, 22 which can be accomplished through a variety of devices, many of them easy to use, inexpensive, and capable of recording and even transmitting data. Importantly, clinicians are monitoring blood pressure and other health indicators during the postpartum period, which is when most maternal deaths occur, and which has historically been a time when women are less likely to be seen by clinicians.
individuals with different lived experiences respond similarly or differently to the intervention.
This not only expands medical knowledge but provides the opportunity to be aware of where unmet needs may exist to further drive innovation and reduce inequities. Furthermore, with greater knowledge of how a medical device intervention affects different populations, consumers can be better empowered to make decisions regarding their health and wellbeing,
leading to improved health outcomes.

Figure 4. Illustration of the key principles, and how they support advancing health equity by increasing the exposure of beneficial devices to individuals that need them.

Challenges to Implementing Diverse, Inclusive Clinical Studies
Diversity, equity, and inclusion should be considered for any medical device clinical study. The FDA can and does provide guidance, support, and encouragement to industry to promote diversity and inclusion in clinical studies, but does not always require sponsors to take specific actions to enroll diverse populations. Medical devices must follow least burdensome principles 61 to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the requirements for authorization. In some cases, requiring a medical device study sponsor to enroll more diverse cohorts of patients may result in larger, longer studies, which could delay access to a new medical device.
For example, requiring that enough participants are enrolled to perform subgroup analysis as evidence of the safety and effectiveness of the device in those subgroups when it is not necessary to determine the safety and effectiveness for marketing a device would not follow least burdensome principles and may add additional time and cost to device development and lead to delay in a device coming to market.
Although FDA can encourage sponsors of IDEs to consider the principles of inclusivity, data generalizability, and timely access as part of clinical study design, there are limitations on disapproving an investigational device exemption (IDE) application if, among other reasons, “‘[t]here is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge gained.’ In many cases, the Agency believes that effective risk management, including the application of risk controls, which includes risk mitigation measures, can result in a favorable IDE benefit-risk determination.” 62
However, FDA can ensure that appropriate information is provided when considering a marketing application, such as intentional design, human factors and usability engineering design, and testing of the medical device. The important information to consider is to show that the medical device addresses the needs of the diverse populations for whom the device is intended.
For example, whether a software diagnostic device was developed using information from a diverse population or only a narrow subgroup.
The greatest opportunity for the FDA to engage with clinical study sponsors is through Presubmissions and IDE applications. 64,65, 66 Pre-submissions offer companies an opportunity to receive input and recommendations from the FDA’s review teams prior to a premarket submission, while IDEs allow an investigational device to be used in a clinical study to collect safety and effectiveness data. CDRH intends to maximize these engagement opportunities to broadly encourage inclusive trial cohorts.

Communicating about devices to diverse audiences

It is important that patients, caregivers, and consumers, including those in diverse populations, be well-informed when they make healthcare choices. CDRH recognizes that transparency and effective communication about medical devices can help overcome barriers to health equity.
Instead of requiring diverse populations to proactively engage the healthcare ecosystem, CDRH is striving to meet patients and caregivers where they are, and to cultivate communication products that can support positive health impacts. Part of that effort involves working to provide clear, accessible information in plain language that better informs people’s decisions about their healthcare, quality of life, and wellness. CDRH is committed to getting input from diverse groups of patients to inform the development of culturally tailored communication materials.
As part of its strategic priorities for advancing health equity, CDRH has set a goal of demonstrating year after year improvement in measures of consumer understanding of our patient/caregiver communications across diverse demographic groups. These improvements will be measured from a 2023 baseline through December 31, 2025. 67
To achieve that goal
CDRH is developing a plan that includes tactics and approaches to increase the transparency, clarity, inclusivity, accessibility, and reach of CDRH communications.
Communicating benefits and risks
One of the most important roles of effective communications about medical technologies is to enable consumers to understand the d benefits and risks to them of a particular medical technology, so they are empowered to make decisions in collaboration with healthcare providers about whether or not a device is appropriate for them.
The first step for CDRH in improving communications about device benefits and risks is to develop a better understanding of patient information needs and barriers to accessing information, and in particular how those needs and barriers may vary across diverse populations. CDRH has, for example, worked with consumers, patient organizations, and healthcare professional societies to understand and address common questions and concerns related to device recalls, 68.
In addition, CDRH is collaborating with organizations with existing trust relationships with diverse communities to increase understanding of the best ways to message and reach diverse audiences. The goal, in part, is to gain insights and increase the body of knowledge and partnership needed to develop culturally responsive, accessible communication materials that effectively reach diverse populations.
In 2022, CDRH undertook an effort to integrate social science methods into its communications, with a focus on consumer message testing to improve the effectiveness of these messages, as appropriate. One of the efforts currently underway is a risk communication study in response to the PEAC’s 2021 recommendation that the FDA consider changes to the communication approach used for medical device recalls.
The study, which includes patient and caregiver
focus groups and interviews, seeks to identify best practices and evidence- based approaches for communicating product recalls and optimal strategies for communicating recalls across different types of medical devices. Study participants are diverse in terms of their demographics and educational attainment, to ensure the study recommendations consider how to effectively communicate with all consumers. Additionally, CDRH has engaged consumer, caregiver, and
healthcare professional panels to recruit and obtain feedback on communications from small samples of target audience members. CDRH has made message testing a more routine part of its communication processes, helping to ensure the information it provides is understandable and useful to the public.
This sort of message testing can highlight the ways in which individuals in different populations may respond differently to information about device benefits and risks and enable more effective communications about potential outcome differences among participants, so that patients and caregivers can be informed when making device-related medical decisions.
In many cases it may be difficult to meet patient needs across diverse populations with the same information about benefits and risks. For example, health literacy—the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions—may vary widely among consumers. In those cases, separate content targeted to specific populations might be more useful such as generation-sensitive messaging.
Applying health literacy principles advances health equity by making information clear, accessible, and more inclusive. 70
For example, in addition to developing culturally tailored
messaging and testing materials with intended audiences, CDRH aims to consistently use humanizing person-first 71 and meaningful language, ensure digital content is accessible to people who use assistive technology, and ensure consumer and patient content is increasingly available in the languages and channels used by intended audiences.
The need for increasingly targeted information will likely grow as medical devices themselves become increasingly tailored to address the differing health needs and characteristics of consumers. In addition, healthcare is advancing toward an era of personalized medicine that may do much for patients and caregivers in underserved and underrepresented populations. But even as benefit and risk information becomes correspondingly more targeted, it will remain important to find a balance between that targeting and maintaining the information’s inclusivity.

Other types of communication
How devices are studied. It is critical that patients, caregivers and healthcare providers trust the information used to develop and evaluate medical devices. Consumers are more likely to have that trust if they know that a device has been studied in groups that are especially relevant to them. As discussed above, CDRH is placing increasing emphasis on ensuring that devices are studied across diverse populations. But it can also be important to communicate information about the extent to which a device has or has not been studied in different populations in ways that are understandable and useful to patients and caregivers.
To that end, CDRH is evaluating ways to provide consumers with concise information about who participated in key clinical trials of devices they may use. This information could describe how benefits and risks of the device varied among different demographic groups. Labeling and instructions. Device labeling 72 often includes warnings, precautions, and contraindications whose complexity and technical language may confuse readers. This information is often important for scientific accuracy and clinical guidance. But the increasing availability and promise of medical devices aimed at home use will amplify the need for clear and simple labeling information. Labeling could provide information on usages and warnings that might prove critical to whether and how a patient safely uses a device.
The need to make labeling information clear to patients and caregivers across diverse populations adds to the challenge. Different groups may find different uses and warnings on labels more relevant and helpful, presenting a challenge in how to meet those differing needs without providing an overwhelming amount of information on the label.
The same is true for device usage instructions and education. Use of a device outside of a healthcare setting may require additional training or instructions for a patient or caregiver. 73
Without clear instructions and educational materials written for a lay audience and useful across diverse populations, patients and lay caregivers may not be able to use the device safely and effectively. The FDA has already been actively engaged in outreach and education related to home use, and the agency will continue to expand this work. 74
Safety concerns. Concerns about a home use device’s safety may arise after the device has been placed into use. Providing home-care patients and caregivers with prompt, clear, understandable and highly accessible information about potential safety concerns with a device they are using, and steps to address those concerns, is critical. This information, too, must be appropriately tailored to diverse populations.
Language
In each of these cases, the language used to communicate information is critical to making the information understandable and useful to patients and caregivers. To help ensure that no person is excluded from healthcare, CDRH is committed to providing clear, accessible information in plain language that better informs people’s decisions about healthcare, quality of life, and wellness.
As part of that commitment, CDRH is engaged in an ongoing effort to make content available in languages other than English. In 2022, CDRH audited its website to ensure consistent use of inclusive images and to identify additional high demand content for translation. CDRH began consistently posting both English and Spanish medical device safety communications and promoting other CDRH and agency content available in Spanish and plans to continue this practice.
More is not always better when it comes to communicating clearly and effectively to a lay audience. An important element of providing patients and caregivers with the information they need to make important decisions about health and healthcare is to avoid overwhelming them with more information than they can comfortably and usefully digest. Offering too much information can obscure that subset of the information that is critical and relevant, and may discourage some individuals from taking on the task of reading through it, and perhaps from even using the device.
The form of media is another important consideration. In particular, people with disabilities may require the availability of various types of communications in specific types of media, such as braille, large print, or audio.
The need to provide information that is tailored to different populations may require longer, or multiple versions of, documents that address these populations’ different concerns. In those cases it would be helpful to ensure that patients and caregivers are able to easily determine which sections or documents best apply to them, so they can omit other material without missing out on essential information.

Disseminating information
Improving the public availability of relevant and helpful information is one of the CDRH’s overarching priorities. CDRH’s efforts to employ communications in ways that advance health equity include disseminating information through the technologies and information sources people already use. Examples of such efforts include posting FAQs to FDA.gov, use of a dedicated and easily joined email distribution list targeting patients and caregivers, and the extensive use of social media.
Despite the overall widespread use of digital communications, the access to or use of online resources varies considerably among different audiences. Ensuring that diverse and especially underserved populations are reached requires taking into account the fact that many people lack digital literacy or internet access. The agency uses available metrics to determine the reach of many of its FDA.gov communications pages, as well as email and social media reach, but the metrics do not currently provide demographic data on users.
In the meantime, CDRH is exploring ways to bring needed, appropriately tailored information to patients and caregivers who may lack online access or digital literacy, or who otherwise are not engaging with CDRH online.

In Summary

The FDA’s CDRH is committed to pursuing the elimination of health and healthcare disparities that currently exist across many dimensions. Those efforts must be active on multiple fronts, including supporting the development of devices that can improve healthcare access, ensuring devices are evaluated for safety and effectiveness in the diverse populations that will use them, and providing patients and consumers with the information they need to make decisions about their healthcare.
Home use devices present one important opportunity to advance health equity for underserved people who face difficulties in accessing healthcare-facility- based care. These devices are already helping many patients better monitor and manage both acute and chronic conditions, including diabetes and complications during and after pregnancy, outside of healthcare facilities. What’s more, digital health technologies are broadening the reach of healthcare and wellness, for example through smartphone applications or other digital therapy platforms that help people monitor or improve a general state of mental health. The promise of home use devices needs to be balanced with awareness of the difficulties many people may have in operating them, their potential differences in performance compared to facility-based care, and potential disparities in the accessibility and affordability of these medical devices.
It is also critical to address a lack of diversity, equity, and inclusion in clinical research relating to medical devices. CDRH is developing a framework to guide researchers and manufacturers in determining when a device should be evaluated in diverse populations, with the goals of improving the generalizability of study data and ensuring that patients have timely access to beneficial medical devices and health technology. Although FDA can encourage sponsors of IDEs to consider the principles of inclusivity, data generalizability, and timely access as part of clinical study design, there are statutory limitations on disapproving an investigational device exemption (IDE) application. The growing availability of home use devices and monitoring tools may help enable more diverse trials, by making it easier and more convenient for patients to participate in trials.
Finally, CDRH is working to ensure that patients have access to clear, concise and accessible information in plain language to support their healthcare decisions, such as, whether a device is right for them, and their ability to effectively and safely use a device. To that end, the Center is committed to incorporating diverse patient input in support of developing culturally tailored and linguistically appropriate communication materials and improving the ability of consumers to find and access materials, online and elsewhere, about medical devices, taking into account disparities in both health and digital literacy.
These efforts to advance health equity present challenges and require ongoing research, investment, and collaboration among CDRH, industry, payors, providers, and patients.
CDRH is committed to the efforts, so that all people in the United States can access the medical devices they need to protect and improve their health and well-being.

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