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U.S. Department of Health and Human Services

Medical Devices

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Medical Device Use in the Home Environment Guidance Workshop, May 24, 2010 - Breakout Session Notes: Patient Labeling

Facilitator: Pat Paterson Ageless Consulting
Scribe: Lester “Jao” Lacorte

Audience: mostly manufacturers

Facilitator requested public input in writing a guidance document on the migration of medical device technology into the home environment, specifically regarding patient labeling:

  • One size fits all model doesn’t fit
  • Less complex deices are lumped with more complex; the same regulations apply but may not be applicable/relevant
  • Some patients are computer savvy while others are not
  • Design based on therapy-driven input; requires more input from actual patient feedback
  • Homecare standards needed
  • Industry needs more patient input to customize and tailor to specific patient
  • Less-prescriptive and more user-friendly regulations needed to make it easier for industry to comply
  • Precautions, warnings and limitations
  • Labeling described as “pedantic;” labeling should be practical but should describe performance characteristics absolutely needed for manufacturers
  • Engineers and FDA have conflicting guidance in what labeling is needed for consumers
  • Consumer-based company states “unclear guidance received from FDA and engineers”
  • CDRH needs greater guidance for labeling in safety standards
  • Long vs. Short-term memory approach to product labeling and instructions
  • Operator manual different vs. Instructions that may have no table of contents
  • Too much focus relying on clinicians to train on device functions
  • Product warning and labeling
  • FDA should define “meaningful” warning labels––what should a product warning label be?
  • Customer want simple; but due to manufacturers are forced to make labels too complex due to liability issues; complex labeling and wording only discourages patient
  • Manufacturers and clinicians tend to make final decision in industry but uncertain if regulatory (FDA or company’s regulatory affairs department) makes the final decision?
  • Clinical outcomes if product already on the market; but then what data is needed to report?
  • Contradiction since everyone likes a simplified version for patient but for manufacturers, product liability is too cumbersome and complex from a legal standpoint; e.g. “manufacturers have difficulty in giving a simplified 3-page guide when a more extensive version is needed” from a legal viewpoint; IF TOO COMPLEX, PATIENTS WILL NOT READ THE MANUAL
  • Too many warnings for patient will not actually protect patient
  • “Multi-faceted approach needed”: different training instructions for patients, clinicians, Train-the-trainer for the nurses; may need to go beyond User Guide
  • “Products in the home are doing more things” compared to the institution
  • Complication of labeling in institutional vs. Homecare setting may require multi-faceted training approach
  • Same product may be used for the simple as well as complicated condition; this is a conflict in design

Facilitator question to the audience: What is special for home use care to help with adverse events, etc.?

  • Emphasized need for industry and regulators to reach out to patients
  • Devices are diverse, from the simple to the complex
  • “Where is labeling located and how is it written for them?”
  • Clinicians want one location to find labeling? Does manufacturer do this since clinicians want easier access?
    An example: Infusion pump information is needed but need to define the different components designed for each particular therapy, e.g. Intermittent or continuous setting should be defined by clinician, not manufacturer
  • Who to call when device does not work? E.g. Difficulty in engaging with product representative
  • Mary Brooks: “Lock out modes and access codes should be readily available”
  • “Instructions to trouble shoot should be the manufacturer’s issue?” vs. Regulatory
  • Clinicians also have to trouble-shoot; poses different problems
  • The three most important issues––Want a pump that is easy to use, reliable and durable,
  • How is FDA trying to integrate its standards with other agencies? Mary Brooks: “Agency is listening to all viewpoints”
  • Dilemma for industry: simple instructions at 6 grade level vs product liability with rapidly changing industry in a population that may not be tech savvy
  • Demonstration through testing of patients should be general and not specific
  • Measurable outcomes needed to make sure use is simple
  • Testing and validating label used first but human factors development process requested for manufacturers; task analysis needs to be part of development process; focus group okay buy embedded task analysis needed in product labeling
  • “Alzheimer’s patients average 75 years old with no related care givers (with) on oxygen;” difficult for Alzheimer’s patients to describe functioning of device, let alone learn
  • Family caregiver important but homecare providers who come to fix machine often becoming more important; Therefore need education for others, too
  • Instructions need to be “narrative and pictorial” (illustrated)
  • Be mindful of what manufacturers are already doing
  • “There is no simple device,” even for single use devices especially for pediatric age population; Does FDA have product labeling standards for pediatric population since pediatric actually may need to know how to use the device and have to understand instructions
  • Adult instructions different from pediatric instructions in labeling; debate on pediatric and Alzheimer’s patients and should specify how device should not be used in these populations
  • Pediatric group not indicated to get that particular therapy
  • Difficulty in writing label for each particular group involved in care vs label for actual patient
  • Combination products: Clinicians need to decide who is the appropriate user for the device
  • Consistency needed in format for labeling products since difficult to find label in the same place; need for standardization
  • Combination products: Too much information in insert will prevent patients from reading although some patients will read it thoroughly
  • Guidance requested from FDA on FONT size
  • Layman’s term required
  • Older users different from younger users; older users tend not to play and tinker with a complicated device
  • Audio instructions with online e-learning instructions; limited use of audio instructions for patient with voice guidance mode and graphics
  • Some patients may have difficult hearing and seeing
  • On-screen instructions AKA (on-screen?) Support System with a quick start guide––eliminates short/long-term memory of instructions for use
  • How much information is too much to give patients before it is a turn-off to the patient
  • Electronic support system needed
  • What things do you want manufacturers not want FDA to pursue: Give us the minimum requirements, give us objective and not be prescription
  • Electronic labeling of medical devices to download instructions from internet and voice instructions––FDA should provide guidance on this
  • Product development of manuals through acquisition and brand image; manufacturers trying to provide warnings and cautions
  • How to update older product with instructions that are not very clear––Can FDA tell us how to do that?
  • What version software is needed and how to update? Usability as to how website is designed
  • SPL labeling for devices needed, who’s responsible for updating? Is Agency responsible for this when version of instructions
  • How to update labeling without having to re-submit 510k; guidance from FDA required
  • Request FDA to have regulations on electronic labeling for home use

Q: Some patients don’t have a computer or DVD at home to view manual instructions

  • Sequential in labeling and can use hyperlinked
  • Requesting caution to use labeling instructions: not all patients search for manual information the same; NOT intuitive for older people who lose their place on websites
  • Plenty of old websites with old info; request a transitional period from FDA
  • Electronic media can make patients lost
  • Qualifications of users needed for devices; what are criteria for them to use and take device home to use?
  • Some patients may be intimidated
  • Patients given a checklist to sign to say they understand
  • Is there an FDA requirement for a checklist? ANS: NO, it is company by company
  • “Dead man’s Test,” ad dead man can pass that test
  • Pharmacists often get involved in training patients; older vs younger pharmacists e.g. Younger pharmacist didn’t realize patient is hard of hearing
  • Demos needed
  • What do you FDA’s labeling guidance to have?: Manufacturer designs instructions and a 3rd party can validate
  • How do you customize instructions for home infusion nurse vs the patient
  • There are good and poor trainers
  • Multiple sources of training is required
  • New 510k shouldn’t have to be needed
  • Customer support and feedback from supplier; report loop to get feedback on how labeling is produced
  • Is there anything Pat Paterson said that didn’t make sense?
  • Type of device may be a really simple device being lumped in with more complex devices is of concern in guidance document e.g. No electronic interface is needed; suggest 2 different requirements may be necessary