Bill Overview
Title: PREVENT Medical Device Shortages Act of 2022
Description: This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues. Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues. The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device. Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.
Sponsors: Sen. Casey, Robert P., Jr. [D-PA]
Target Audience
Population: People dependent on medical devices
Estimated Size: 330000000
- The bill specifically targets manufacturers of medical devices, especially those that are critical during public health emergencies.
- Patients who rely on critical medical devices can be directly affected by supply shortages.
- Health care providers depend on the steady supply of medical devices to deliver effective patient care.
- The entire healthcare system, including hospitals and clinics, would need to adjust to any supply changes.
- Medical device shortages can impact patient outcomes and the effective functioning of healthcare services globally.
Reasoning
- The policy primarily targets manufacturers of critical medical devices by imposing notification requirements and redundancy management plans.
- It directly affects supply chains, especially during public health emergencies, which can help prevent device shortages.
- Patients relying on critical medical devices will benefit through better availability during emergencies.
- Healthcare providers, including doctors and hospitals, will be able to provide continuous care without interruption due to shortages.
- The policy's primary focus is preventive measures to curb issues before shortages manifest, thereby stabilizing the healthcare system.
Simulated Interviews
Healthcare Administrator (San Francisco, CA)
Age: 54 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- The policy ensures that our hospital has the medical devices needed during critical times.
- It simplifies our supply chain planning as manufacturers will need to be more proactive about potential disruptions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
Retired Electrical Engineer (Orlando, FL)
Age: 65 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- I'm relieved knowing there will be measures to prevent runs on crucial medical devices.
- Knowing my pacemaker supply is monitored gives me peace of mind.
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 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Supply Chain Analyst (Austin, TX)
Age: 38 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 12/20
Statement of Opinion:
- The redundancy plans can improve supply resilience, especially in emergencies.
- I expect balanced device availability without sudden downturns.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Medical Device Sales Representative (Chicago, IL)
Age: 29 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- More regulations might increase costs but also improve market stability.
- Our company may benefit from planning and less surprises in supply chain.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
Oncologist (Boston, MA)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- Stable device supply ensures I can provide uninterrupted care to my patients.
- It eases the stress of potential shortages.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 9 | 6 |
| Year 3 | 9 | 6 |
| Year 5 | 9 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 5 |
Diabetes Patient (Nashville, TN)
Age: 50 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 17/20
Statement of Opinion:
- The act reassures me regarding the continuous availability of my insulin pump.
- Knowing actions are taken to prevent delays and shortages is a relief.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 8 | 4 |
Policy Maker (Seattle, WA)
Age: 32 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 8/20
Statement of Opinion:
- This legislation seems well thought out to handle deficiencies before they become crises.
- I anticipate greater health system equilibrium with these proactive measures.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 6 | 6 |
Retired Nurse (Atlanta, GA)
Age: 74 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 14/20
Statement of Opinion:
- It's comforting to know that measures are in place to ensure equipment availability, especially for age-based vulnerabilities.
- Previously, disruption fears were frequently harbored by my demographic.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Biomedical Engineer (New York, NY)
Age: 59 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 6/20
Statement of Opinion:
- This strengthens the field I work in by ensuring better planning and resilience.
- Manufacturers might face increased compliance costs initially, but long-term lives could be saved.
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 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 6 |
Physiotherapist (Phoenix, AZ)
Age: 41 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 13/20
Statement of Opinion:
- This ensures that my patients have unhindered access to their required devices.
- It contributes to continuous care without sudden loss of therapeutic devices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 4 |
| Year 20 | 8 | 4 |
Cost Estimates
Year 1: $100000000 (Low: $80000000, High: $120000000)
Year 2: $85000000 (Low: $68000000, High: $102000000)
Year 3: $90000000 (Low: $72000000, High: $108000000)
Year 5: $75000000 (Low: $60000000, High: $90000000)
Year 10: $60000000 (Low: $48000000, High: $72000000)
Year 100: $50000000 (Low: $40000000, High: $60000000)
Key Considerations
- The bill mandates prompt notification to the FDA of supply disruptions, expanding the existing notification requirements.
- FDA will need to allocate resources towards processing notifications and conducting facility inspections.
- Manufacturers will incur costs related to compliance and may pass some costs to consumers.
- The expected reduction in supply disruptions could offset some costs by reducing emergency response needs and maintaining consistency in healthcare delivery.