Executive Summary

More and more patients are interested in monitoring and maintaining their health by themselves, and they are investing in a wide range of consumer products to enable them to do so. At the same time, healthcare is shifting from the inpatient hospital environment to the home environment, largely due to the escalating costs of health services and hospital stays. This Guidance Article will help facilities assist their patients in selecting and using consumer products safely, appropriately, and with a proper understanding of both the benefits and limitations of these technologies.

Understanding the limitations is particularly important to avoid inappropriate reliance on such products and to recognize the potential implications of their widespread use: Consumer products may not always monitor and display the same parameters as traditional medical devices, fulfill their marketing claims, or meet patient expectations.

Depending on how a consumer-grade medical device is used, it may fall into one or more of the following categories:

1. Identification or notification devices—intended to alert the consumer to changes in their general physiologic status that might be predictive of a harmful or even life-threatening change in their health

2. Disease management devices—intended to treat users suspected of having, or who have been treated for, a specific physiologic condition or a chronic disease

3. Self-care or preventive health devices—intended to facilitate overall wellness of the consumer

Consumers may need advice from physicians when considering these over-the-counter medical products. Because they can be purchased and used without physician oversight, we encourage physicians to ask their patients whether they are using any of these products. Physicians and patients should consider whether the products are safe for use, whether the data generated by the products will be useful to the patient and/or to clinical management, whether the products meet the clinical need of the patient, whether the patient can use the device independently, and whether there are any limitations to the product's use in the patient's home environment. Physicians should encourage their patients to review factors such as instructions for use, operating requirements, accessories needed, notifications generated, device usability, purchasing sources, and the availability of customer support, including the ability to report problems with the product.

Who Should Read This

Table of Contents

Overview

More and more patients are interested in monitoring and maintaining their health by themselves, and they are investing in a wide range of consumer products to enable them to do so. At the same time, healthcare is shifting from the inpatient hospital environment to the home environment, largely due to the escalating costs of health services and hospital stays. Both patients and physicians are increasingly looking to consumer medical products to help provide some level of care in the home when a traditional medical device is inappropriate, too expensive, or inconvenient. There is also recognition that the data from consumer devices can be useful in clinical management. This article will help facilities assist their patients in selecting and using consumer products safely, appropriately, and with a proper understanding of both the benefits and limitations of the technologies. 
 

What Is a Consumer-Grade Product, and Is It a Medical Device?

On the web pages linked below, FDA defines three relevant (and overlapping) groups of devices that are used for healthcare applications:

1. Medical device: "An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals." This group includes a wide range of products from bandages to CT scanners to pacemakers.

2. Home-use medical device: "A device intended for use in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a health care professional in order to be used safely and effectively." This includes devices intended for use in both professional healthcare facilities and homes; a physician prescription is usually required for the use of these devices. Some examples are durable medical equipment like ventilators, nebulizers, wheelchairs, infusion pumps, and apnea monitors.

3. Consumer products: These are "medical devices consumers use on their own to solve health issues and improve quality of life." They are also referred to as direct-to-consumer medical devices, consumer health-based technologies/devices, over-the-counter devices, consumer-based medical devices, and consumer-grade medical devices. Consumer products don't require a health professional for every use and may be purchased directly by consumers without a prescription. In some cases, patients or their physicians can view trended or tabulated data from these products via web portals or electronically generated reports.

The crucial difference between consumer products and the other two types is that the other two, medical devices and home-use medical devices, must be cleared or approved for marketing by FDA. In contrast, consumer products may not always go through the FDA approval or clearance process.[1]  

 

How Useful Is the Data from These Devices?

While consumer products offer the potential to improve or facilitate patient care, it is essential to understand the limitations of these technologies in order to avoid inappropriate reliance on them for diagnostic purposes and to recognize the potential implications of their widespread use.

1. Consumer products may not collect the same signals as traditional medical devices. For example, a medical-grade ECG monitor is used to monitor and display heart rate and cardiac waveforms in a clinical setting via a series of electrodes that collect and interpret electrical signals directly from the heart. In contrast, a consumer fitness tracker that reads and displays heart rate is really collecting the pulse rate using an electronic sensor embedded in a wristband. The fitness tracker may not be FDA cleared to diagnose specific cardiac conditions that the medical-grade ECG monitor is cleared for.

2. Consumer products may not fulfill their marketing claims. While direct-to-consumer marketing often focuses on a consumer product's potential to alert users to critical events, patients must understand the likelihood and risks of both false negatives and false positives. Risks from false negatives include a false sense of security, leading patients to avoid necessary care, whereas false positives can lead patients to seek unnecessary care. There is little evidence on the reliability and accuracy of data obtained from certain unregulated consumer-grade products, which may not function as intended. In addition, the ability of consumer products to fulfill their marketing claims relies at least in part on a user entering and updating their own data—a requirement that leaves the products vulnerable to data entry errors. Missing or incorrect data can confuse users, impede care, and waste the patient's and physicians' time.

3. Consumer products may not always fulfill patient expectations. Suppliers of consumer products are generally reliable about placing warnings on their products, cautioning that they are not medical devices and are not intended for use in preventing or diagnosing medical conditions. Nevertheless, consumers clearly adopt them for the purpose of monitoring or identifying situations that may require medical attention, not realizing their unsuitability for those situations. 
 

Three Categories of Consumer-Grade Medical Devices

Consumer-grade medical devices fall into one or more of the following major categories, based on the way they are used.

Identification or Notification Devices

1. These devices are intended to alert the consumer to changes in their general physiologic status that might be predictive of a harmful or even life-threatening change in their health. The devices usually convey time-sensitive information, and we believe physicians need to be aware that patients are buying these devices and may seek guidance on their use.

2. Examples include baby vital signs monitors and smartphone-enabled ECG monitors.

Disease Management Devices

1. These devices are intended for users suspected of having or who have been treated for a specific physiologic condition or a chronic disease. The consumers may already know what their condition is and need a tool to monitor their health effectively.

2. Examples include blood glucose meters, blood pressure monitors, and electronic stimulators.

Self-Care or Preventive Health Devices

1. These devices are intended to facilitate the overall wellness of the consumer. Users of these devices are usually healthy individuals making a conscious effort to take care of their mental and physical well-being.

2. Examples include fitness trackers, digital scales, and pedometers.


 

Aspects of the Product Physicians Should Consider

Consumers may need advice from physicians when considering over-the-counter medical products, and because these products can be purchased and used without physician oversight, we encourage physicians to ask their patients whether they are using any of these products. Factors for physicians to consider when talking to their patients include the following:

1. Is the device safe for use even if it hasn't been cleared by FDA? Using a product that has not met regulatory requirements isn't necessarily unsafe. But it has the potential to be harmful. Complications may include direct harm (e.g., shocks, burns, bruising, skin irritation, pain) as well as indirect harm from false-positive or false-negative readings and indicators.

2. Will the data generated by this product be useful to the patient and/or for clinical management? To assess the safety, accuracy, and performance of the product, refer to safety guidelines, peer-reviewed literature, and objective comparative reports such as those published by ECRI Institute (for example, our Evaluations of consumer-marketed baby vital signs monitors and smartphone-enabled ECG monitors).

3. Does the product meet the clinical need and the expectations of my patient? Ask your patient what they expect the product to do for them, and critically evaluate available device labeling, vendor claims, and supporting peer-reviewed literature (if available) to help you decide if (1) the product is capable of fulfilling your patient's expectations and (2) your patient's expectations are appropriate given your assessment of their health status. For example, if you have a patient with suspected cardiac rhythm problems interested in using a phone-based ECG monitor, they may need access to a Holter monitor instead for diagnostic purposes, depending on the suspected condition.

4. Will I have access to the data or information from the device? Review the device specifications to learn whether you would have access to the patient's health data and how this access would be available (e.g., directly through the consumer device versus logging into an online portal). Ensuring that the device offers adequate data management that provides actionable information to a busy clinician and to the patient would facilitate prevention of information/data overload.

5. Will my patient be able to use the device independently without requiring clinical support? As applicable, take into account the physical dexterity, flexibility, and sensory coordination abilities of the patient. Review how easily an untrained user can operate the system, as well as device features that help the user communicate with a clinician.

6. What are the limitations of the patient's home environment? Consumers using the devices in a home setting may have certain environmental limitations such as space restrictions, electromagnetic interference, safety hazards, and cleaning and disinfection limitations. Discuss these factors with your patients who are considering consumer products.
 

Aspects of the Product Consumers Should Consider

Although consumer products are generally intended to be easy to use by patients with no formal training or medical experience, some products may be more or less straightforward than others. Patients should be encouraged by their physicians to consider the following:

1. Instructions for use: Review the instructions for use and the vendor's recommendations for cleaning and disinfection. Ensure that you are confident in using the device and have information on the features and intended use of the device.

2. Operating requirements: Review the labeling and the instructions for use to learn if the device requires specific components such as power sources, outlets, telephonic connection, and access to the Internet to ensure that it is operational.

3. Accessories: Review which accessories are needed to obtain optimal functionality from these devices. Accessories include batteries, smartphones if the device needs to be connected to an app, leads, cables, and sensors.

4. Alarm notifications: Review whether the device will provide alarms that notify you of any abnormal change in the monitored or tracked parameters. Ensure that you are familiar with the various alarm messages and have access to information helpful in interpreting them.

5. Device usability: If possible, evaluate the usability of the device you are interested in using.

a) Is the text large enough for you to read?

b) Are the displays readable across a range of lighting conditions?

c) Are the buttons, keypad, or touchscreen display easy to use?

d) Are the instructions for use available in your preferred language?

e) Will you be physically comfortable while using the device (for example, applying sensors, connecting cables to the devices)?

f) Is it easy to reset/reboot the device if needed?

g) Is it easy to identify factors in your home environment that could limit or impede use of the device?

6. Purchasing sources: Ensure you are buying from a reliable source; for example, if you buy a device online, check the customer reviews. Also, check the seller's return policy and customer support statement before you place an order.

7. Problem reporting and customer support: Ensure that the vendor offers responsive customer support for reporting problems with the device and obtaining troubleshooting assistance.
 

Stage of Development of Consumer-Grade Medical Devices

The area of consumer-grade medical devices is constantly evolving in regard to data management, cybersecurity, regulation, and payment models. There has been increased interest in integrating data generated by these devices into the patient's health record. This may give clinicians better access to consumer data for analysis and care management. 
 

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[1] For detailed information on medical device classifications and the difference between FDA approval and clearance, refer to the discussion on FDA's website.

Glossary

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References

Topics and Metadata

Topics

Health Information Technology; Technology Management; Technology Selection; Transitions of Care

Caresetting

Hospital Outpatient; Physician Practice

Clinical Specialty

Bariatrics; Cardiac Electrophysiology; Clinical Nutrition; Diabetology; Emergency Medicine; Maternal and Fetal Medicine; Obstetrics; Pain Management; Primary Care

Roles

Allied Health Personnel; Clinical Practitioner

Information Type

Guidance

Phase of Diffusion

 

Technology Class

 

Clinical Category

 

SourceBase Supplier

Product Catalog

MeSH

ICD9/ICD10

FDA SPN

SNOMED

HCPCS

Disease/Condition

 

Publication History