Bill Overview
Title: Clarifying Remanufacturing to Protect Patient Safety Act of 2022
Description: This bill specifies that entities that remanufacture medical devices in a manner that could change the performance or safety specifications or the intended use of the device must register with the Food and Drug Administration as producers of medical devices and comply with related requirements.
Sponsors: Rep. Peters, Scott H. [D-CA-52]
Target Audience
Population: People who utilize healthcare systems that use remanufactured medical devices
Estimated Size: 331000000
- The bill pertains to entities involved in the remanufacturing of medical devices, which are a significant component of the healthcare industry.
- Hospitals, clinics, and any healthcare settings that use remanufactured medical devices will be affected as they may face changes in device costs or availability.
- Healthcare professionals may experience changes to device documentation or training due to the new registration and compliance requirements.
- Patients who rely on medical devices will be impacted by changes in the safety, availability, and potentially cost of these devices.
Reasoning
- The healthcare industry is broad, with the remanufacturing sector being a subset primarily concentrated in urban areas where large hospitals and specialized clinics are prevalent.
- The policy cost suggests significant compliance monitoring and possible effects on device costs which might be transferred to medical service costs.
- Stakeholders range from manufacturers to end-users and thus need to cover a range of socioeconomic backgrounds for comprehensive insight.
- Due to the scale of the US healthcare system, even minor policies might ripple significantly through patient experiences especially in devices reliant sectors like cardiology or neurology.
- The commonness of various entities affected by the policy will differ, from less common device remanufacturers to highly common healthcare professionals and patients depending on these tools.
- Estimates take into account both direct (manufacturer, provider) and indirect (patient) stakeholders who would notice changes in everyday operations and costs.
Simulated Interviews
Hospital Administrator (Boston, MA)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- While patient safety is paramount, the increased administration could lead to higher costs for hospital materials.
- We might have to reassess our contracts with certain suppliers if their costs increase due to compliance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Medical Device Engineer (Palo Alto, CA)
Age: 56 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Our company will need to invest significantly in compliance to meet new requirements, which may slow down innovation.
- However, it could standardize quality, which is good for long-term safety perceptions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 8 |
| Year 2 | 7 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Nurse (Chicago, IL)
Age: 30 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 1.0 years
Commonness: 8/20
Statement of Opinion:
- This policy could lead to more clear guidelines and training regarding device use, which is positive.
- Potential temporary shortages during transition could make patient care slightly challenging.
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 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
None, Retired (Miami, FL)
Age: 67 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 10/20
Statement of Opinion:
- Safety and reliability of devices is very important to me.
- I am worried that costs might increase and lead to higher out-of-pocket expenses.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
Biomedical Technician (Houston, TX)
Age: 27 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Compliance might increase job stability but could also lead to layoffs if costs are too high for the company.
- Quality enhancements could also improve my confidence in the work we do.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Clinic Owner (New York, NY)
Age: 39 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- I worry about tightening budgets as compliance increases costs on remanufactured items we rely on.
- The policy will likely require us to increase prices, potentially impacting service accessibility.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Health Insurance Analyst (Dallas, TX)
Age: 49 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 7/20
Statement of Opinion:
- More stringent policies could impact premiums if costs of remanufactured devices increase for providers.
- Yet, improved device safety data can reduce long-term patient care costs.
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 |
Healthcare Consultant (Seattle, WA)
Age: 34 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This policy will necessitate clients to strictly adhere to new compliance standards, testing our advisory strategies.
- Could lead to hospitals seeking more cost-effective alternatives to remanufactured options.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Patient Advocate (Atlanta, GA)
Age: 70 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 8/20
Statement of Opinion:
- My role is to ensure that this policy does not negatively impact patients' access to affordable device options.
- Safety improvements are wonderful but affordability is also crucial.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Legal Advisor (Nashville, TN)
Age: 42 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This law will increase demand for my consulting services as businesses seek to navigate new regulations.
- Although compliance is good, it could lead to a market consolidation if small players can't keep up.
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 |
Cost Estimates
Year 1: $50000000 (Low: $30000000, High: $70000000)
Year 2: $40000000 (Low: $25000000, High: $55000000)
Year 3: $40000000 (Low: $25000000, High: $55000000)
Year 5: $40000000 (Low: $25000000, High: $55000000)
Year 10: $40000000 (Low: $25000000, High: $55000000)
Year 100: $40000000 (Low: $25000000, High: $55000000)
Key Considerations
- The necessity for clear definitions and guidelines to avoid ambiguity for remanufacturers.
- Ensuring that the FDA is sufficiently funded to handle the increased regulatory responsibilities.
- Balancing regulatory costs with potential benefits from improved safety and performance of remanufactured devices.