Questions and Answers
What is the primary purpose of the Safe Medical Device Act?
To ensure compliance with FDA reporting requirements
Which action can mitigate safety risks in medical devices?
Regular safety inspections and reporting
If you identify an unsafe medical device, who should you notify first?
The primary care physician
A hospital bed with non-functioning wheel brakes should be reported to:
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What does the FDA stand for?
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How often should a medical device be inspected for safety?
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What indicates that a medical device is safe?
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What should you do if a medical device has an outdated safety inspection sticker?
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Why is it important to check the safety inspection sticker on a medical device?
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What does a medical device with a safety inspection sticker dated within 24 months of the current date indicate?
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Study Notes
Safe Medical Device Act
- The purpose of the Safe Medical Device Act is to protect residents and caregivers, and to comply with the reporting requirements of the FDA.
Safety Risks and Reporting
- Early identification, detection, and reporting of unsafe medical devices mitigate safety risks.
- Reporting of unsafe medical devices is crucial to ensure safety.
Notification of Primary Care Physician
- It is necessary to notify the primary care physician if an unsafe medical device is identified.
Examples of Unsafe Medical Devices
- A hospital bed with one of the four wheel brakes not working is an example of a potentially unsafe medical device that should be reported to the supervisor or nearest healthcare provider.
FDA
- The FDA stands for Food and Drug Administration, not Further Device Access.
Safety Inspection
- A medical device with a safety inspection sticker dated within 24 months of the current date is recognized as safe.
Safe Medical Device Act
- The purpose of the Safe Medical Device Act is to protect residents and caregivers, as well as to comply with the FDA's reporting requirements.
Importance of Identification and Reporting
- Early identification, detection, and reporting of medical device issues mitigate safety risks.
- Healthcare providers must report any unsafe medical devices to their supervisor or nearest healthcare provider.
Identifying Unsafe Medical Devices
- A hospital bed with one of its four wheel brakes not working is considered an unsafe medical device and should be reported.
- Any medical device with potential safety risks should be identified and reported.
FDA and Medical Device Safety
- The FDA does not stand for Further Device Access.
- The FDA plays a role in regulating and ensuring the safety of medical devices.
Medical Device Safety Inspections
- A medical device with a safety inspection sticker dated within 24 months of the current date is recognized as safe.
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