Guidance on Medical Device Patient Labeling

Posted on February 21, 2012. Filed under: Uncategorized |


What is the purpose of this guidance?
This guidance serves a dual purpose:
  1. to assist manufacturers in their development, and
  2. to assist Center reviewers in their review and evaluation
of medical device patient labeling to help make it understandable to and usable by patients (or family members or other lay persons caring for patients).
The writing style we have adopted in this guidance is targeted to manufacturers, since they will be developing the medical device patient labeling.
When translating the professional label into lay language, take care to ensure that it does not alter the intent of the indications, contraindications, warnings and precautions, or other parts of the professional labeling. The lay translation should also provide a balanced presentation of adverse events and the risks and benefits of the device. It should not introduce new claims that are not in the professional label. Device labeling evolves throughout the review process. Therefore, it is your responsibility to ensure that the patient label is consistent with the final professional label.
What is medical device patient labeling?
Medical device patient labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. This labeling may pertain to therapeutic, restorative, diagnostic, or cosmetic devices. Medical device patient labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. This labeling is intended to be supplied, or given to and used by patients or their lay caregivers with or without accompanying professional counseling. Medical device patient labeling may accompany devices intended solely for physicians to operate, devices for both physicians and patients or lay caregivers to operate, and devices operated solely by patients or their lay caregivers.
Why is medical device patient labeling important?
Medical device patient labeling is essential to assure safe and effective use of many, but not all, devices. It informs patients or their lay caregivers about proper use, risks, and benefits of the device in language they can understand.
Medical device patient labeling assists patients or their lay caregivers in understanding the device; its operation, care, and maintenance; the way it interacts with the body to accomplish its purpose; its place and purpose in the patient care regimen; and any safety or disposal issues.
Patient labeling is important for all devices operated by lay users. Adequate directions for operating the devices are needed to make devices safe and effective. For example, as more patients use complex medical devices at home, medical device patient labeling becomes necessary to better communicate to the lay person how to operate the device.
What are the general types of information that may be included in medical device patient labeling?
There are two general categories of information that may be included in medical device patient labeling:
  1. risk/benefit information; and
  2. instructions for use.
Risk/benefit information is information people need to decide to use a device or have it used on them. This information also allows the users to become aware of potential problems with the device. It might include, as appropriate to the device:
  • sufficient descriptive information to tell what the device is and what it is used for,
  • types of people and situations for whom the device would not be a good choice,
  • risks and benefits to the patient or environment associated with the uses of the device,
  • information about maintaining the device or identifying potential problems with the device,
  • alternative therapeutic and diagnostic choices available, and/or
  • other information to enable the person to make an informed decision about the device.
Devices that would have patient labeling consisting primarily or completely of risk/benefit information might be: implants that have no external patient interface once they are implanted, or prescription diagnostic or therapeutic devices that the patient is actively involved in choosing (e.g., laser eye surgery, lithotripsy, intraocular lenses).
Instructions for Use are the procedural steps to follow in setting up, using, cleaning, troubleshooting, and storing a device. This information constitutes the “how to” for the device.
Devices that might have patient labeling that would include instructions for use would be those the patient or lay caregiver has to set up, operate, clean, etc. They might include such devices as suction equipment, intravenous infusion pumps, physical therapy equipment, or transdermal electrical nerve stimulation (TENS) devices.
There are many types of medical devices for which the medical device patient labeling would have both risk/benefit and instructions for use information.
When should you use medical device patient labeling?
Medical device patient labeling should be supplied whenever it can benefit patients or lay caregivers. Patients or lay caregivers benefit from this labeling by increasing their knowledge about the device. Knowledgeable users are more likely to use the device as you intend.
You should know the informational needs of your target audience in order to determine if patient labeling is necessary. Does your audience need or want specific information? Is there something unique about the device (e.g., diagnostic test) that needs to be explained to the patient? Does your audience already know the information?
The following examples illustrate situations where you should consider developing patient labeling. The situations are grouped into risk/benefit information and instructions for use.
You should consider developing risk/benefit information when patients or lay caregivers need to:
  • give personal health information to aid their health care practitioner in deciding to use or not use devices in prevention, treatment, or diagnosis of an illness (e.g., magnetic resonance imaging (MRI));
  • select among similar devices or device procedures;
  • be involved in deciding whether to have a procedure involving the device; and/or
  • understand the effect or influence of the device on the patient or others (e.g., orthopedic rods, screws, and fixation devices; genetic screening).
You should consider developing instructions for use when patients or lay caregivers need to:
  • maintain the device;
  • monitor and report on the operation or output of the device (e.g., pacemakers, glucose monitors);
  • explain the operation of the device to others, such as a practitioner caring for another condition of the patient;
  • explain the patient’s medical situation to others, such as when lay caregivers or others need to understand the requirements of care or the alterations of lifestyle associated with care in the use of the device;
  • know how to alter their lifestyles or care regimens to properly integrate the use of the device; and/or
  • know how to safely dispose of the device.
You should consider developing both risk/benefit information and instructions for use when patients or lay caregivers need to:
  • operate, interpret, and manipulate the device (e.g., programmable implants, home pregnancy test kits, ostomy supplies);
  • know how to be careful in using the device, such as understanding the basis for warnings, precautions, and contraindications; and/or
  • cooperate with the prevention, treatment, or diagnosis of an illness (e.g., preparation for bone density scan, drugs of abuse test kits).
When is medical device patient labeling not usually necessary?
Medical device patient labeling is not usually necessary when:
  • a patient will have no opportunity to benefit from the labeling. The following are typical situations.
  • The device is a tool of the health care practitioner and the patient is not involved in the choice of the device.
  • The device is a tool of the health care practitioner and the patient has no control over or access to the device.
  • The patient can contribute no useful information, such as sensitivities or aversions to materials or abilities to cope with sequelae of device use, that would help the health care practitioner choose or use the device.

Examples of these types of devices include blood pumps, scalpels, or other surgical instruments.

  • a patient’s opportunity to benefit from patient labeling is outweighed by the risk of allowing him the opportunity in an emergency. The following is a typical situation.
  • Time is of the essence so that involving the patient, family member, or lay caregiver to help decide on whether to use the device or select among several devices or procedures using devices would be more risky to the patient’s health than not involving him. In this case, the health care practitioner subordinates the patient’s right to know, choose, and decide to his obligation to give prudent care.

Examples include devices and device procedures whose need arises unexpectedly and intraoperatively. The patient has no opportunity to read patient labeling before the procedure, such as in the case of some catheters or drains.

What should you consider when identifying a method to distribute the medical device patient labeling?
To increase the likelihood that the patient labeling will reach the patient and be read by the patient or caregiver, consider:
  • When should the patient labeling be provided?
  • Must an intermediary, such as a health professional or a supplier, pass along the patient labeling or can it be provided directly to the patient?
  • If an intermediary is involved, will there by any logistical difficulties in passing the patient labeling along and can these be overcome?
  • What are the obstacles to the patient labeling reaching the patient, and what are the solutions to these obstacles?
If you have a Web site, consider placing patient labeling there to help patients get the most up-to-date information.
During pretesting with your target audience, you can ask what method of distribution the audience would prefer and assess experience they have had in the past with the distribution of patient labeling. (See Appendix FPretesting.)

 Suggested Content of Medical Device
Patient Labeling:

 Determining Sequence and Content:
We are suggesting the sequence and content of the following headings for patient labeling. We have drawn much of this information from FDA’s Draft Report on Medical Device Labeling: Patients’ and Lay Caregivers” Medical Device Information and Labeling Needs, Results of Qualitative Research.” (See References – Sequence.)
Medical device patient labeling should flow logically in brief, simple, clear language with highlighting to guide the user to the desired information to meet the need at the moment. The content should be sequenced in a way that is logical for the intended user, with the most important information presented first. Notice that similar information in this suggested sequence is grouped (chunked) together, an organizational technique that participants in FDA’s medical device patient labeling focus groups said they liked. (See References – Sequence.)
A “one size fits all” approach does not work with patient labeling, so the content, and in some cases the sequence, may vary depending on the target audience and the purpose of the medical device patient labeling. Not all of the following headings apply to all medical device labeling. For example, medical device patient labeling presenting only risk/benefit information might not contain headings related to instructions for use.
Through pretesting, such as focus groups, you can systematically gather target audience reactions to your specific medical device patient labeling’s content, sequence, and format. Also, you may find in your pretesting that different wording for the suggested headings is appropriate. (See Appendix F Pretesting.)
 Table of Contents:
Include a table of contents if the medical device patient labeling is lengthy and/or complex. This helps readers quickly and easily find the information they need.
If a glossary is used, place it after the table of contents to alert readers that it is there to help them. Whether or not a glossary is used, definitions should appear in the text.
 Descriptive Information:
Purpose of the device (indications for use):
Briefly describe the FDA cleared or approved indications for use.
Description of the device:
Give a brief physical description of the device, its parts and accessories. A graphic may be the simplest and clearest way to describe a device. All parts of the device shown in the graphic, such as switches, dials, and meters, should be labeled with numbers, letters, or words. The function or purpose of each labeled item should be briefly described in the text of this section. Also, list materials in the device so patients with hypersensitivities can easily identify their risks.
When the device should not be used (contraindications):
Tell when a device should not be used (contraindications). Contraindications are conditions under which the device should not be used because the risk of use clearly outweighs any possible benefit. There may be persons in whom the device should not be used because of their health status. For example, the device may be contraindicated for pregnant women.
List known and reasonably foreseeable hazards, not theoretical possibilities. For example, if hypersensitivity to a material in the device has not been demonstrated, it should not be a contraindication. However, if hypersensitivity to a material has not been sufficiently studied and/or is not scientifically documented, clearly state that information.
Contraindications to the use of a device could include:
  • demonstrated hypersensitivity to a material where there is patient contact with the device,
  • substantial risk of being harmed because of patient characteristics (e.g., age, gender, accompanying therapy, disease state, health status), or
  • continued use in the face of an unacceptably hazardous adverse event.
Risks and benefits:
To make an informed choice about a medical device, a patient must have a thorough understanding of the effects and expectations associated with that device. We characterize this as “risk/benefit” information because the decision making process typically involves the weighing of the positive and negative effects and expectations. It is a global concept that may include a number of specific types of information, depending on the device and the target audience.
The goal of risk/benefit information as applied to medical device patient labeling is to provide the patient with information about the risks and benefits associated with a device or procedure in a manner that is meaningful to the user. Risks and benefits conveyed in an effective and meaningful way to the user should aid the user in deciding whether to use a device, or undergo a procedure that uses a device, and to motivate the user to use the device as labeled.
General guidance for developing risk/benefit information:
  • Anticipate and respond to people’s concerns about their personal risk, or any risks to the environment or society from the use or disposal of the device.
  • Carefully word messages that may arouse fear and anxiety.
  • Tell patients what they can do specifically to avoid risks.
  • Describe risks and benefits clearly and specifically.
  • State both benefit and risk information in the same way (e.g., qualitative or quantitative), if possible.
  • Be positive in the risk messages. For example, state what the patient can do to overcome risk.

(E.g., “In rare cases a sweat rash can develop in the contact area. If a sweat rash develops, take the silicone sheet off for a few days, then start again….”)

  • Balance risk and benefit information. Present factual risk and benefit information without any attempt to influence the patient.
  • Pretest risk messages to indicate how effective they are. (See Appendix F Pretesting.)
  • Use graphs and other visual materials to communicate risk information. Visuals should be colorful enough to attract attention and simple enough to be understandable at a glance. Combining visuals with brief text that contains the “take-home” message can help to ensure more accurate interpretation of risk information.
  • Inform and educate people about risks by using risk comparisons that compare risks that are similar or closely related.
The content of risk messages:
Risk messages should closely reflect the perspective, technical capacity, and concerns of the target audience. The message should:
  • include specific actions that people can take, even if it is only to tell them where to go to get further information or assistance.
  • avoid using vague or unfamiliar terms to characterize the risk (e.g., “some women,” “fourfold,” “lifetime risk”). Word choice greatly influences how people attend to risk information (e.g., “risk” raises alarm, “chance” minimizes alarm).
  • respect the audience by addressing people’s values, preferences, and concerns (e.g., Tell patients about a change in their appearance, such as scarring.),
  • seek strictly to inform, not influence.
  • assume the audience has little technical knowledge when in doubt about the audience.
  • show empathy – with statements that illustrate caring.
  • provide facts – two to three bits of supporting data.
  • use vivid, concrete images, examples, and anecdotes that communicate on a personal level and make technical risk data come alive.
  • limit the comparisons to risks that are similar or closely related when making comparisons.
  • caution against unwarranted conclusions.
  • provide information on consequences of decisions in a balanced manner.
Risk messages:
  • should provide a source for more information.
  • should acknowledge uncertainties, including lack of currently available scientific knowledge.
  • should include analogies.
  • may discuss the nature of the risk.
  • may include alternatives.
  • may discuss benefits.
The content of benefit messages:
  • Present balanced benefit information.
    • Identify outcomes.
    • Estimate the magnitude of outcomes in a way that is meaningful for readers to understand.
    • Evaluate the benefit for individuals.
Evaluation of the effectiveness of the risk/benefit information:
It is important to evaluate the effectiveness of the risk/benefit information by testing it. (See Appendix F Pretesting.)
  • Is there adequate awareness of the risks and benefits, and their potential consequences?
  • Is there knowledge of the risks and benefits, and what steps can be taken to lessen the risks?
  • What are the attitudes toward the risks and benefits?
  • What is the behavior toward the risks and benefits?
Expectations of the device and the procedure associated with the device:
Tell the patient what to expect before, during, and after a surgical procedure and/or the use of the device. If appropriate, give instructions on post-operative or post-procedural care. If the device is one that the patient operates, and the medical device patient labeling has an “Operating Information” section, the information on what to expect could be included in that section.
General warnings and precautions:
Note: Please read the detailed discussion in Appendix E of definitions, purpose, content, format, placement, and other issues related to warnings and precautions.
Embedded in the concept of risk/benefit information is the type of information known as “general warnings and precautions.” This is the specific hazard alert information that a user needs to know before using the device. Provide this information early in the labeling. Present it according to the clinical significance of the item to assist the reader in understanding the relative importance of the information. By the time readers get to the information on warnings and precautions in the labeling, they have probably already made the decision to use the device. At this point, the users know the global risks and benefits, but need specific information to avoid or reduce a particular hazard associated with the use or disposal of the device. It may be appropriate to include general warnings and precautions in a presentation of risk/benefit information for a device where that information might have bearing on the decision to use the device as well as on the actual safe use, operation, or disposal of the device.
Warnings and precautions tell the reader about hazards, other than those that are contraindications to device use. Warnings and precautions provide information on how to avoid these hazards, i.e., sources of harm in the use of the device.
Importance of the need to adhere to a care regimen:
State why it is important to follow the care regimen explained in the medical device patient labeling. This will help to motivate the user to follow the instructions.
 Operating Information:
The user needs to know what to do, how to do it, and when to do it. The operating instructions should:
  • focus on how to operate the device. It is usually not necessary to provide a detailed explanation for lay users of the mechanism of action of the device or why it does what it does. That approach can lead to information overload.
  • assume that the user does not have device or medical knowledge or ability.
  • provide logically ordered steps for the task and make the user aware of the importance of doing the steps in order.
  • state the purpose and the expected outcome of each task.
  • tell the user what steps are essential and which ones are optional.
  • be written at an eighth-grade reading level or below to reach most of the population.
  • be clear the first time they are read. Many people do not reread something they do not understand.
Setup instructions:
Give clear setup instructions. If a user is not responsible for the setup of the device, tell the user this and omit the setup instructions.
Include in setup instructions for the lay user:
  • a parts list, if appropriate.
  • list of materials and tools needed for setup.
  • unpacking instructions, if appropriate.
  • instructions on proper disposal of packing materials or how to return packaging to you for reuse.
  • directions for where the device should be placed, such as a table top or floor. Also state if the device should remain in one place after setup.
  • any warnings or safety instructions specifically related to setup, placed right before the corresponding task or instruction.
  • results of incorrect setup.
  • numbered setup instruction steps in logical order.
  • any special preparation required before first use of the device, such as cleaning or disinfecting.
  • space to write in user-specific instructions.
  • who to call if there is a problem. You may refer users to the assistance section in the medical device patient labeling.
Checkout procedures:
If the device requires any type of checkout procedure for safety and effectiveness, clearly and completely explain this process. This task may be as simple as a visual inspection of the device. Other examples of checkout procedures are calibration and quality control checks.
  • when the checkout should be done, such as at the time of setup and/or before each use.
  • step-by-step procedures for checking proper function of necessary parts of the device.
  • what to do if the checkout shows that the device is not working properly.
  • who to call if there is a problem. You may refer users to the assistance section in the medical device patient labeling.
A clock or calendar graphic may be useful to show the user correct times or days to check the device.
Operating instructions:
Give clear and easy-to-follow operating instructions. These instructions should include:
  • special preparation the user needs before operation, such as handwashing or device warm-up procedures.
  • any warnings or safety instructions specifically related to operation, placed immediately before the corresponding task or instruction.
  • results of incorrect operation.
  • operating steps in logical order, with the expected results.
  • space for user-specific instructions.
  • who to call if there is a problem. You may refer users to the assistance section in the medical device patient labeling.
Importance of the need to monitor the activity of the device:
State the importance of monitoring the activity of the device. This section explains that the user needs to make sure the device is acting the way it should. Give examples of what to check to make sure the device still works properly. For example, check to see that leads are connected, wires are not damaged, and the power is supplied to the device.
Cleaning instructions:
Give clear and complete cleaning instructions.
  • List the supplies needed.
  • Give step-by-step procedures.
  • State how often to clean the device.
  • Tell the user what cleaning accomplishes.
  • Tell the user what the results of failure to clean will be.
  • Include appropriate warnings and precautions for cleaning agents.
  • Describe the results of using improper cleaning solutions or methods.
  • Include suggestions for the proper disposal of the suggested cleaning agents, if appropriate.
Description of maintenance and who should do it:
  • Clearly describe what maintenance actions are the responsibility of the user.
  • If a particular kind of user, such as the lay user at home, is not responsible for maintenance, briefly outline proper maintenance actions, who is responsible, and how often the action should be done. The lay user will then know what to expect and can take action if proper maintenance is not provided.
  • If the device has some maintenance procedures to be done by the user and some done by others, such as the biomedical engineer, you may wish to write this section in two parts. The two parts will help make clear to users what they should and should not be doing to maintain the device.
Storage instructions:
Clearly describe proper preparation for storage and storage conditions. State the results of improper storage conditions. If extended storage may affect the device, inform the user. It may be necessary to include information that addresses extended storage in the sections on setup, checkout, operation, and maintenance.
Expected failure time and mode and its effect on the patient:
State how long the device will last. State what to expect when the device fails. Let the user know if it fails safely or dangerously and the effect on the patient. Include this type of information in the Risks and Benefits section of the medical device patient labeling if appropriate.
Instructions on how to safely dispose of the device:
When appropriate, explain how to safely dispose of the device (e.g., mercury containing devices, sharps). Include your take-back information, recycling options, and refurbishment options.
Instructions on accessories:
If the device comes with or is used with accessories, discuss all appropriate content areas for each accessory. You could have a separate accessories section or include information on the accessories in the content areas that apply.
You may need to include a general warning at the beginning of the medical device patient labeling advising users of problems that may occur if they use accessories other than those you recommend.
Instructions on related, additional devices:
If the patient will receive an additional device after an operation or procedure, include information about the additional device in the medical device patient labeling. Describe why this additional device would be needed, what symptoms might be expected post-treatment, and any other information about the additional device that impacts the safe and effective use of the primary device. A typical situation is when a patient who has had a home infusion pump with a peripheral line also receives a central line.
 Troubleshooting Information:
Provide an easy-to-find troubleshooting section. When a problem occurs, troubleshooting helps determine if the problem is with the device or with the patient’s condition. Anticipate any problems the user may have with setup, operation, or maintenance. Provide solutions for these problems in the troubleshooting section. Group similar problems, such as problems with alarms, and highlight each group heading. Highlighting makes it easy to find each group of problems and the specific problems in it. Put the most life-threatening problems first in each section.
Format this section so that the user can locate specific problems quickly. The troubleshooting section could be a table with a column for signs of trouble and a column for actions.
Clearly describe the symptom of each problem in as few words as possible so that the user can easily match the description to the problem observed. If your device displays error messages, list them and what they mean. Explain the steps necessary to correct the problem. Do not confuse the reader with technical reasons for problems unless the reasons are important to the corrective action.
If there are problems that users cannot or should not try to solve themselves, include warnings or precautions and tell them how to get help.
Instruct users to call their health care professionals for emergency assistance if troubleshooting reveals a patient health problem rather than a device problem.

Note: Putting assistance information in this section does not eliminate the need for a separate assistance section. (User assistance information is discussed in a later section.)

Tell the user how to report undesirable outcomes (adverse events). For example, the user would report malfunctioning of the device, mistakes in using the device, or injury from the use of the device.
 Additional Information:
There are certain categories of information that not all patients want in medical device patient labeling. We refer to these categories as “additional information.” Additional information includes such categories as clinical studies and adverse events. Whether or not to include a particular category depends on the needs of the target audience of the particular medical device. You may want to include additional information in appendices in the medical device patient labeling, or advise the reader that it is available on demand. For example, tell the reader to call the user assistance toll-free telephone number, contact the physician, or go to an Internet site.
FDA’s medical device patient labeling focus testing has shown that some patients like all the additional information, but most prefer to see it at the end of the document or have it available on demand so they can choose to read it or not. (See References – Additional Information.)
Clinical studies:
When developing clinical study information for patients, whether as part of the patient labeling to accompany the device, or as an “on demand” piece, make sure it is written in simple, plain language.
Disease and self-care information:
Members of some target audiences may benefit from disease and self-care information. For example, a patient undergoing bone densitometry benefits from information about osteoporosis.
Adverse events:
When appropriate, provide information about any adverse events. Devices whose applications are supported by clinical trials will have data about adverse events that occurred during these trials and that may be of value to the device user. Other devices may have adverse event data from other sources, e.g., published literature or experience with similar devices. The detail in and the need to include an Adverse Events section depend on the benefit of these data to the device user. For a device cleared under Premarket Notification, which was not supported by clinical studies, the Adverse Events section might include only potential adverse events and a statement of the source of the information.
Include potentially fatal adverse events in the Warnings and Precautions section, or the Contraindications section.
If appropriate, follow the listing of adverse events with statements directing the reader to other sections of the labeling for additional information regarding these adverse events and any steps to take to avoid them.
When appropriate, provide any warranty information. Also, for devices intended to be implanted in the human body for more than one year, consider providing a card or sticker listing the manufacturer of the implant, date implanted, model number, lot number, size, type, or any other appropriate descriptive information. Patients can keep this as part of their personal medical records.
Travel or international use:
If a patient could travel with the device, provide appropriate travel instructions. For example, tell the patient if the medical device is not compatible with foreign power systems. The patient will need an adapter, and may need a converter to convert to the proper voltage. Also, tell the patient to check with the carrier to confirm that the device can be carried and/or used on the airplane.
Provide an index if the medical device patient labeling is lengthy and/or, complex. This helps readers quickly and easily find the information they need.
 Date of Printing:
Put the date that the medical device patient labeling is issued or revised where it can be easily found (e.g., cover or last page). FDA requires dated labeling for prescription devices (21CFR801.109(e)) and recommends it for all other devices.
 User Assistance Information:
Design a clearly marked section that advises users on how to get help for problems with the device. FDA’s medical device patient labeling focus groups indicated that users look at the end of the medical device patient labeling for the user assistance information, although it can be included in other places in addition to the end. (See References – User Assistance Information.) This section should be very easy for the user to find. It may be as simple as putting the customer assistance number near the company name, device name, and model number. The medical device patient labeling can include a toll-free number or the number for customer assistance, as well as an Internet address.
Provide space near the user assistance information, with appropriate identifying terms, for phone numbers of the medical equipment supplier, the home health care agency, the doctor, the referral for disposal of the device, and/or any other appropriate points of contact for the typical user.

Note: Ideally, your toll-free number should be on the device.

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