Caregiving is an inherently difficult role, replete with the emotional strains of watching a loved one deteriorate physically or mentally while trying to balance work and home responsibilities, and finding needed services with little or no guidance. These challenges are compounded by extreme stress, emotional overload, and a sense of isolation. Family caregiving is a lifespan issue, encompassing those with chronic conditions, disabilities, disease or the frailties of old age. Caregiving embraces a wide spectrum, ranging from the families of children with special needs to adult children caring for parents with Alzheimer's disease. Many family caregivers interact with medical devices in home settings.

Advances in medical technology have allowed care recipients to remain ambulatory and independent. Because care recipients expect to be able to stay independent, mobile or active, the term “home use” extends beyond the home to encompass all environments in which a person plans to use his or her medical device to continue or enhance the quality of daily life.1 

The survey provided information on the content of medical device labels that respondents deemed important in devices used in the home, such as cleaning and troubleshooting information.

For medical equipment designed for longterm use in the home, labeling will often not be with the device. In such cases, the home healthcare provider must develop his or her own basic instructions for use, maintenance, and cleaning. Through the MedWatch adverse event reporting system, the Food and Drug Administration (FDA) receives medical device reports of problems that stem from missing, absent or inadequate labeling, or misinterpretations of the information in labeling and instructions for use (IFU).

The FDA also receives anecdotal information from consumers, healthcare practitioners (HCPs), healthcare organizations and device manufacturers suggesting interest in enhancing medical device equipment labeling content and format. Consumers and HCPs are particularly interested in having a searchable website containing medical device labeling and instructions for products intended for home use.

This study was conducted to help the FDA better understand device labeling-related challenges that family caregivers face when care is provided in the home environment. Study respondents are members of the Caregiver Action Network (CAN), formerly the National Family Caregivers Association (NFCA), which educates, supports, empowers, and advocates for the more than 65 million Americans who care for loved ones with a chronic illness or disability or the frailties of old age,2 advocating for the needs of family caregivers, including their desires and need for instruction in the safe and effective use of medical devices in the home. These findings will assist in guiding the FDA's future efforts to characterize information pertinent to medical device labeling and provide online access in order to facilitate safe medical device use at home.

The sensory, cognitive, and physical characteristics of each person will impact their understanding and use of a product.

The sensory, cognitive, and physical characteristics of each person will impact their understanding and use of a product.

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A web-based survey contained multiple choice questions with pre-coded responses offering CAN respondents the opportunity to provide free-text responses and comments. The questionnaires were developed collaboratively by CAN, FDA/CDRH, and contractor to the FDA Social and Scientific Systems (SSS). Questions for both methods were based around the following topics:

  • Medical Conditions and Equipment Used

  • Medical Equipment Training

  • Information Provided in Instructions and Other Sources

  • Instruction Use

  • Instruction Preferences

The survey questionnaire was administered via e-mail to a random sample of CAN members who met selection criteria (n=557; See Appendix 1 in online version of this article). The email provided background information about the FDA and the purpose of the study.

The web-based survey was conducted October 5, 2011 through January 6, 2012. Reminders were sent four times over the course of the study, in October, November, and two in December. After the survey closed, results were collated and de-identified to maintain respondent confidentiality and then analyzed by the authors.


One hundred twenty-seven respondents completed the web-based survey, a 22% response rate. Ninety-five percent of all respondents care for adult family members (over 21 years old). Forty-nine percent and 45% of these respondents care for a family member 65 years or over (n=63) or a family member between the ages 21–64 years (n=58), respectively.

Of these 127 respondents, 77% care for their family member in their own home (n=99) and 59% of all respondents have cared for their family member more than five years (n=76). Forty-four percent of all respondents care for their spouse/partner (n=56).

Medical Conditions and Equipment Used

The majority of respondents indicated that they have been using their medical equipment for two or more years for chronic conditions, including heart disease, lung disease, and diabetes, or conditions related to stroke and cancer. Free text responses also included conditions, such as dementia and Alzheimer's disease.

The survey determined that the home medical equipment respondents most commonly used in the care of family members included wheelchairs, specialty hospital beds, blood glucose monitors, patient lifts, nebulizers, and assistive equipment, such as canes, walkers, and bathroom handrails. Survey questions allowed respondents to share their experiences using the aforementioned medical products, specifically their experiences with the labeling and instructions that accompany the products they use.

The survey determined that the home medical equipment respondents most commonly used in the care of family members included wheelchairs, specialty hospital beds, blood glucose monitors, patient lifts, nebulizers, and assistive equipment, such as canes, walkers, and bathroom handrails.

Medical Equipment Training

Respondents indicated that their medical equipment is most often delivered to their homes from the manufacturer or received from a pharmacy or drug store. From the free-text responses, respondents indicated that their equipment was handed down from friends or family after previous use. Respondents specified that it was ‘somewhat easy to very easy' to learn how to use their medical equipment, and most received training prior to use. Equipment use training was most often provided from the medical supply company representative.

Other responses indicated that no training was received; or that training had been provided by the home health provider, rehabilitation staff, or hospital staff. Other methods besides training that helped respondents learn how to use their medical equipment included trial and error, following written (paper) instructions from the manufacturer, Internet instructions, verbal instruction, or observation and return demonstration.* Respondents noted that the best time to receive written instructions was upon delivery of equipment at home and the worst time was at the hospital.

Information Provided in Instructions And Other Sources

When manufacturer instructions came with their medical equipment, respondents indicated that it was ‘somewhat easy' to follow. Instructions were typically provided in a manual, booklet, or information sheet format. Respondents specify that the table of contents was most helpful in finding the information they need to use their equipment. When seeking information to troubleshoot their product, respondents believed they could ‘quickly and easily' find the information in the manufacturer's instructions.

In free-text responses, respondents indicated that they would make use of the 1-800 helpline, or ask a nurse or company representative when they need information about using their product in general or for information about troubleshooting. Free-text comments indicated that a DVD would be helpful for these purposes.

In addition to manufacturer's instructions, respondents indicated that they obtained information from medical supply companies, home health agencies, and hospitals, in the same format as the manufacturer's instructions. Interestingly, even when manufacturer's instructions are provided, information from additional sources is obtained in order to simplify and clarify the manufacturer's instructions.

Instruction Use

Respondents did not always use the instructions, because they felt the training they received was enough. The survey results indicated that most respondents commonly used their instructions when they were first learning to use their equipment; until they felt comfortable using it; and for information about cleaning.

Respondents did not always use the instructions, because they felt the training they received was enough.

Respondents often referred back to their instructions when there was a problem, to find a phone number, or to refresh their memory and ensure they were using their equipment correctly. When respondents referred back to their instructions, they found what they needed to know. However, respondents specified that the information they needed was not always contained in the manufacturer's instructions. Instead, this information could come from other sources, such as from friends.

Respondents who keep their instructions often file them with other medical information for as long as they own the equipment, which allows for easy access if needed. However, not all respondents have the instructions for their equipment. Whether this is because they never received it, or because they lost it requires further exploration.

Most instructions include pictures and diagrams; however, whether respondents find them helpful is unclear. Interestingly, free-text responses indicated that pictures, diagrams, and other visuals are indeed useful and suggest that these be included in the instructions. Respondents report that the information they need to have to use their medical equipment, in the order of importance, includes the following:

  • Cleaning information

  • What the device is used for

  • General operation and troubleshooting information

  • Where to obtain replacement parts

  • Storage information

  • Emergency contact information

  • Alarm information – what they mean

  • Assembly information

  • Battery information

  • Calibration information

  • Care and maintenance information

Instruction Preferences

Respondents indicate that they most prefer to find information via paper instructions, such as a manual, brochure, or quick-start guide affixed to the equipment itself. In addition, respondents will also seek information online and find it helpful to obtain instructional information by phone with a company representative or home health nurse. To that end, respondents commonly turn to these sources, in addition to seeking advice from friends or others with the same condition or equipment.

Respondents specify that a short version or quick-start guide would be helpful, especially if it includes the following:

  • Basic information, such as set up and troubleshooting

  • How-to instructions

  • Cleaning instructions

  • Do's and Don'ts

  • Step-by-step instructions

  • Short descriptions

  • Diagrams

  • Laminated cards on equipment with basic information

  • An 800-number helpline

  • Checklists

  • Large fonts

Sixty-five percent of all respondents are very comfortable with using computers (n=83), and 70% of respondents indicate they would welcome and make use of an FDA ‘searchable website that contained instructions for medical equipment used in the home' (n=90). Respondents noted that if the FDA created a searchable website, it should include videos to supplement the written instructions, diagrams, and pictures, all of which should be easy to print, and parallel the instruction preferences discussed above.

Individuals likely to use medical products in the home setting may be elderly, chronically ill patients of any age, pregnant women, high-risk infants, and rehabilitation patients. These individuals vary significantly in their ability to operate and maintain devices. Complex instructions with multiple steps could confuse the user's ability to understand or adequately operate the device. To that end, instructions and information written in simple language should accompany any home use device product. Photographs, diagrams or other graphical representations may be used to provide clarity, as evidenced by respondent preferences.

Individuals likely to use medical products in the home setting may be elderly, chronically ill patients of any age, pregnant women, high-risk infants, and rehabilitation patients.

Survey results about medical equipment training portray an interesting situation: More complex devices used in the home environment are designed to be used by trained healthcare professionals in an acute care facility, rather than in a nonclinical setting. Furthermore, care recipients may not be able to choose the devices that they will ultimately use, as the device may be pre-selected by their insurance, for example.

For these reasons, care recipients may not receive devices that are optimal for their comprehension level or that of a family caregiver. Therefore, it is imperative that home care recipients are properly trained on how to use their device as well as provided with instructional information that is readily accessible, easily understood and in a format that meets the users' needs.

While this study generated important feedback on medical device labeling and use instructions, not all respondents (n=127) answered every question. Toward the end of the survey, there was attrition, evidenced by the dwindling number of responses to all remaining questions. This is likely due to the fact that respondents were requested to answer questions related to three pieces of medical equipment, which, in hindsight, is a large time commitment. While the free-text responses presented respondents with an opportunity to elaborate on their responses, many free-text reactions include ‘gripes' about the specific equipment(s) they use. Future studies like this one should consider responses of this nature during survey question development.

Social desirability respondent bias was also present in this study. When comparing responses to questions with pre-coded selections with responses to questions that offered free text, there was a tendency for respondents to select favorable pre-coded responses to downplay the difficulties they experience, especially with regard to learning, following instructions, and using medical equipment.

The pre-coded responses do not always match free-text feedback, which many times express frustration and confusion with regard to following medical device labeling and instructions. Furthermore, many free-text responses indicate that respondents do not recall receiving or did not receive instructions upon receipt of their medical equipment, which may also skew the results.

Many study respondents are comfortable using computers, and often refer to information sources online and using a website that contains instructions for medical equipment used in the home. This finding, however, cannot be generalized to the entire population. Clearly there is selection bias at play: Respondents taking a web-based survey are likely to be more comfortable with computers, which could impact their ability to accurately respond to these questions.

Another limitation to this study is that CAN respondent educational levels were not captured, nor were they included as part of the selection criteria eligibility. Authors suggest that in future studies of this nature, a question to obtain respondents' educational levels be included to determine whether there are relationships between education and labeling comprehension ease.

Food and Drug Administration
Medical Device Home Use Initiative
April 2010
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Caregiver Action Network (CAN), formerly the National Family Caregivers Association (NFCA)
About NFCA
Available at: Accessed Oct. 31, 2012

* An educational technique in which someone demonstrates what he or she has just been taught, or had demonstrated to them.

About the Authors

Janette Collins-Mitchell, MT, MS, RN, is at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). E-mail:

Diana Kaufman-Rivi, MPH is at the FDA/CDRH. E-mail:

Simran Singh, MS, RN, CNL Candidate, is at the FDA/CDRH. E-mail:

Lisa Winstel is chief operating officer at Caregiver Action Network. E-mail:

Mary Weick-Brady, MSN, RN, is senior policy advisor in the Office of the Center Director, CDRH/FDA, and works on labeling and home-use issues. E-mail: