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What is the usefulness of predicting an expiration date from accelerated stability studies unclear?
because there is no validated accelerated testing method and because of the nature of adhesives and conductive gels
What should also include information that demonstrates the role of accelerated stability testing in predicting the expiration date?
accelerated shelf-life testing
What are the two main reasons for using reusable ECG electrodes?
potential for skin reactions and disease transmission
What is the main benefit of disposable ECG electrodes?
they are intended
What must an investigational plan also include in order to be considered?
a description of the device and its important components
What is the name of the non-critical areas of the body that ECG electrodes are used on?
clean, intact skin
What is the regulated under 21 CFR 882.1275?
Electroconductive media
What must the electrode lead wires and patient cables be in compliance with?
test requirements and test methods
What is the name of the document that describes ECG cables and leadwires?
ANSI/AAMI EC53
What must be MRI compliant, X-ray translucent, and MRI compliant before a medical device is introduced into interstate commerce?
21 CFR Part 801
What does 801 Subpart C require for final labeling for an over the counter device?
labeling recommendations
What should the intended use also identify?
the duration and application of use
What should only be used by or in consultation with a health care provider familiar with their proper placement and use?
ECG electrodes
What should be replaced if self-adhesive electrodes no longer stick firmly to the skin?
Self-adhesive electrodes
What is the labeling for devices that contain natural rubber latex?
21 CFR 801.437
What should be included in each planned clinical study?
a detailed description of the initial feasibility study (i.e., study to define clinical metrics or device design)
What specifies the limitations to exemption?
Section 21 CFR 870.9
When was the Draft Guidance on Medical Device Patient Labeling issued?
March 3, 2000
What is the name of the room that is used to submit comments to the agency?
Room 1061
Where can you obtain additional copies of guidance?
the Internet
What are the general types of information that may be included in medical device patient labeling?
types of information that may be included in medical device patient labeling
What is the purpose of Appendix D?
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What is the total time planned for subject follow-up?
time planned for subject follow-up
What does not create or confer any rights for or on any person?
any rights
What is the purpose of this guidance?
to assist manufacturers in their development
What does Device labeling evolve throughout?
the review process
What is the name of the format in which medical device patient labeling is supplied?
pat
What is the purpose of 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
What does patient labeling inform patients or their lay caregivers about?
proper use, risks, and benefits of the device
What is needed to make devices safe and effective?
Adequate directions for operating the devices
What is the term for information that allows the users to become aware of potential problems with the device?
Risk/benefit information
What is the main risk to the patient associated with using a device?
environment
What is the “how to” for a device?
Instructions for Use
What are the primary safety and effectiveness endpoints described as?
specific objective clinical targets
What is the name of the device that is used to physical therapy equipment?
transdermal electrical nerve stimulation (TENS) devices
What type of users are more likely to use the device as you intend?
Knowledgeable
What is a risk/benefit information situation?
instructions for use
What should lay caregivers need to do to explain the operation of the device to others?
explain the operation of the device
What should lay caregivers or others need to understand to use a device?
requirements of care or the alterations of lifestyle associated with care
What are some examples of ways that patients or lay caregivers can cooperate with the prevention, treatment, or diagnosis of an illness?
bone density scan, drugs of abuse test kits
What 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
What is a patient's opportunity to benefit from patient labeling outweighed by the risk of allowing him the opportunity in an emergency?
the risk
What is the patient's right to know, choose, and decide subordinated to?
obligation to give prudent care
What is the minimum time a health professional or supplier must pass along the patient labeling?
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
What are medical image analyzers required to comply with under 21 CFR 892.2070?
special controls
What is the primary safety endpoint?
primary
What can you do to help patients get the most up-to-date information?
place patient labeling there
What is the name of the document that FDA released that detailed the requirements for patient labeling?
Draft Report on Medical Device Labeling: Patients’ and Lay Caregivers
What is grouped together?
similar information
What might not apply to all medical device labeling?
headings related to instructions for use
What is a good place to place a glossary if the medical device labeling is lengthy and complex?
after the table of contents
What is the purpose of the device?
Briefly describe the FDA cleared or approved indications for use
What are conditions under which a device should not be used because the risk of use clearly outweighs any possible benefit?
Contraindications
What are known and reasonably foreseeable hazards?
List known and reasonably foreseeable hazards, not theoretical possibilities
What is the risk of being harmed because of patient characteristics?
substantial risk
What is the goal of risk/benefit information as applied to medical device patient labeling?
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
What should be clearly delineated in the study protocol?
reporting and adjudicating adverse events
What should people's concerns about their personal risk be addressed?
Anticipate and respond to people’s concerns
What can be done to overcome risk?
take the silicone sheet off for a few days, then start again
What can help to ensure more accurate interpretation of risk information?
Combining visuals with brief text that contains the “take-home” message
What should the content of risk messages reflect?
the perspective, technical capacity, and concerns of the target audience
What does “risk” raise?
alarm
What should be limited to when making comparisons?
risks that are similar or closely related
What is the purpose of nalogies?
• may discuss the nature of the risk. • may include alternatives. • may discuss benefits.
What is the attitude toward the risks and benefits?
What is the attitude toward the risks and benefits
What is Embedded in the concept of risk/benefit information?
the type of in Appendix E
What is the specific hazard alert information that a user needs to know before using the device?
general warnings and precautions
What should the benefit-risk framework focus on?
device technology
What do warnings and precautions tell the reader about?
hazards, other than those
What provides information on how to avoid hazards?
Warnings and precautions
What can that approach lead to?
information overload
What is the eighth grade reading level?
ps
What is the name of the step that should be followed for setup?
table top or floor
What is a good example of a checkout procedure?
visual inspection of the device
When should the checkout be done?
at the time of setup and/or before each use
What should the user place immediately before the corresponding task or instruction?
any warnings or safety instructions
What does the section in the medical device patient labeling explain to the user?
the importance of monitoring the activity of the device
What is the name of the device that is used to clean?
device
What is the only subset of the eligible study subject population allowed to accept?
the risks as weighed against the benefits
What should the user briefly outline to help them with maintenance?
proper maintenance actions, who is responsible, and how often the action should be done
What should the user do if extended storage may affect the device?
inform the user
What is the expected failure time and mode and its effect on the patient?
State how long the device will last
What is an example of a device that can be safely disposed of?
mercury containing devices
What is the purpose of the additional device?
impacts the safe and effect
What does troubleshooting help determine when a problem occurs?
if the problem is with the device or with the patient’s condition
What is the name of the section that highlights each group heading?
Highlighting
What should users do if their device displays error messages?
list them and what they mean
What is the name of the section that tells the user how to report undesirable outcomes?
adverse events
What do we refer to the categories of information that not all patients want in medical device labeling?
additional information
What are some patients more risk averse?
some patients
What is the most common way to have additional information available on demand?
most prefer to see it at the end of the document or have it available on demand
What type of information should a patient have to have to be written in?
simple, plain language
What may have adverse event data from other sources?
Other devices may have adverse event data from other sources, e.g., published literature or experience with similar devices
What is the name of the section that contains potentially fatal adverse events?
Contraindications section
What is the name of the device that a patient can use to list their implant?
card or sticker
What is the name of the converter that may need to convert to the proper voltage?
converter
What does the FDA recommend for all other devices?
labeling
What can include a toll-free number or the number for customer assistance?
medical device patient labeling
What is readability defined as?
the style of writing
What is the quantitative factor used to assess readability?
results of readability formulas