Bill Overview
Title: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.
Description: This bill establishes certain requirements relating to the Food and Drug Administration's (FDA's) public notices on the potential new risks of approved medical devices (i.e., emerging signals), including with respect to the standards of evidence needed for such notices. The FDA must update its current guidance on emerging signals to align with the bill's requirements.
Sponsors: Sen. Marshall, Roger [R-KS]
Target Audience
Population: Individuals globally affected by medical devices
Estimated Size: 250000000
- The bill addresses the FDA's communication about risks associated with medical devices.
- There are approximately 34,000 different types of medical devices that are used globally, affecting patients who use them.
- The total number of active medical devices globally can be estimated in the billions, considering both medical facilities and personal medical devices.
- Individuals likely to use medical devices include those in healthcare facilities, personal users (diabetes patients using glucose monitors, heart patients with pacemakers, etc.), and people undergoing medical treatments.
- The global adult population is over 6 billion, and a significant portion either directly uses medical devices or is in environments where they're used.
Reasoning
- The policy targets improving communication about medical device risks, potentially affecting healthcare providers and patients using medical devices.
- Given the budget limitations, focusing on improving communication can be cost-effective and have a broad impact on patients using medical devices.
- Many people in the U.S. rely on medical devices due to chronic conditions, creating a need for clear risk communication from the FDA.
- Individuals not directly impacted by improved communication may still benefit indirectly through healthcare facilities.
- Estimating the affected population involves considering both direct users of medical devices and healthcare professionals.
Simulated Interviews
retired (Florida)
Age: 65 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- I'm always worried about new devices.
- Better communication would help me understand risks and feel safer.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
software engineer (California)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- I think it's important to stay informed about potential risks to my family.
- I support policies that increase transparency about health risks.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
nurse (Ohio)
Age: 55 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 10/20
Statement of Opinion:
- In my line of work, having up-to-date information on device risks is invaluable.
- Better guidance helps me ensure patient safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 10 | 8 |
heart patient (Texas)
Age: 38 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- I didn't know about risks until it was too late last time.
- Clearer FDA notices would ease my anxiety about my device.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 9 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 10 | 5 |
marketing professional (New York)
Age: 29 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 18/20
Statement of Opinion:
- I don't use medical devices, but information transparency is essential.
- Improving FDA communication helps everyone in the long run.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
diabetes patient (Illinois)
Age: 60 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 14/20
Statement of Opinion:
- It's crucial to know potential risks as soon as possible.
- Improved FDA guidance will increase my trust in devices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
caregiver (Michigan)
Age: 50 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 13/20
Statement of Opinion:
- Having the latest risk information helps in making safe choices for my parents.
- The policy seems beneficial for ensuring device safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
health tech consultant (Colorado)
Age: 47 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Increased communication streamlines advisement on risk management strategies.
- This policy might improve the guidance framework we build upon.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
retired (Arizona)
Age: 71 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 9/20
Statement of Opinion:
- There's always a nagging worry about device issues.
- Seeing commitment from FDA could ease some of my concerns.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
hospital administrator (Georgia)
Age: 55 | Gender: female
Wellbeing Before Policy: 9
Duration of Impact: 5.0 years
Commonness: 11/20
Statement of Opinion:
- It's good to have more clarity on device risks.
- Better communication from FDA will help with procurement decisions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 9 |
| Year 3 | 9 | 9 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Cost Estimates
Year 1: $10000000 (Low: $8000000, High: $12000000)
Year 2: $10000000 (Low: $8000000, High: $12000000)
Year 3: $9500000 (Low: $7500000, High: $11500000)
Year 5: $9000000 (Low: $7000000, High: $11000000)
Year 10: $8000000 (Low: $6000000, High: $10000000)
Year 100: $5000000 (Low: $3000000, High: $7000000)
Key Considerations
- Updating FDA guidance and maintaining adherence to new standards will require consistent budgets over the implementation timeframe.
- Potential challenges in swiftly communicating new risks could increase immediate administrative costs.
- The policy may catalyze improvements in both public health and the industry's response to emerging device signals.
- The broader public trust in medical devices may improve, augmenting consumer confidence and possibly indirect economic benefits.