Safe Medical Device Act

1.

Hospital beds are NOT considered a medical device

A.

True
B.

False

Correct Answer
B. False

Explanation
Hospital beds are considered a medical device. These beds are specifically designed to provide support and comfort to patients in healthcare facilities. They often come with adjustable features and specialized functions to cater to the needs of patients, making them an essential medical device in hospitals and other healthcare settings.

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2.

A report of an injury from a defective medical device must be submitted within 10 days of the incident

A.

True
B.

False

Correct Answer
A. True

Explanation
According to the given statement, it is required to submit a report of an injury from a defective medical device within 10 days of the incident. This implies that the statement is true.

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3.

The FDA created the Medical Device Reporting Act

A.

True
B.

False

Correct Answer
A. True

Explanation
The FDA, which stands for the Food and Drug Administration, is responsible for regulating and overseeing various aspects of healthcare products in the United States. One of their important roles is to ensure the safety and effectiveness of medical devices. The Medical Device Reporting Act (MDR) is a legislation that was indeed created by the FDA. This act requires manufacturers, importers, and device user facilities to report any adverse events or product problems associated with medical devices. By implementing this act, the FDA aims to collect and analyze data to identify potential risks and take necessary actions to protect public health. Therefore, the statement is true.

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4.

You do not need to fill out an incident report if your client is injured by a defective medical device

A.

True
B.

False

Correct Answer
B. False

Explanation
Filling out an incident report is necessary if a client is injured by a defective medical device. This report helps document the incident, gather important information, and initiate any necessary investigations or actions to prevent future occurrences. Failing to report such incidents can lead to legal and regulatory consequences, and may also hinder efforts to improve patient safety.

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5.

You do need to notify a supervisor immediately after a client is injured by a medical device

A.

True
B.

False

Correct Answer
A. True

Explanation
It is important to notify a supervisor immediately after a client is injured by a medical device because supervisors need to be informed about any incidents or accidents that occur in order to take appropriate action. By notifying a supervisor, they can assess the situation, provide necessary medical assistance, and initiate any necessary investigations or reports. This helps ensure that the client receives proper care and that steps are taken to prevent similar incidents in the future.

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6.

The Medical Device Reporting Act helps to protect the clients & the public from injury

A.

True
B.

False

Correct Answer
A. True

Explanation
The Medical Device Reporting Act is a regulation that requires manufacturers, importers, and device user facilities to report any adverse events or product problems related to medical devices. By enforcing this act, it ensures that any potential risks or issues with medical devices are promptly identified and addressed, ultimately protecting the clients and the public from potential injury or harm. Therefore, the statement "The Medical Device Reporting Act helps to protect the clients & the public from injury" is true.

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7.

A hoyer lift or a mechanical lift is a medical device

A.

True
B.

False

Correct Answer
A. True

Explanation
A hoyer lift or a mechanical lift is indeed a medical device. These lifts are used in healthcare settings to safely transfer and move patients who have limited mobility or are unable to bear weight on their own. They are designed to provide support and assistance to caregivers in lifting and transferring patients, reducing the risk of injury to both the patient and the caregiver. These lifts typically consist of a metal frame with a hydraulic or electric system that allows for easy lifting and lowering of patients. Overall, hoyer lifts or mechanical lifts play a crucial role in patient care and safety.

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8.

You are required to report any malfunctions that may occur with a medical device

A.

True
B.

False

Correct Answer
A. True

Explanation
It is important to report any malfunctions that may occur with a medical device because it can potentially affect the health and safety of patients. By reporting malfunctions, appropriate actions can be taken to address the issue and prevent any further harm. Therefore, it is necessary to report any malfunctions that may occur with a medical device.

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9.

Do not clean the device if it malfunctions & an incident occurs

A.

True
B.

False

Correct Answer
A. True

Explanation
The correct answer is true because if a device malfunctions and an incident occurs, it is important not to clean the device. Cleaning the device may tamper with the evidence or cause further damage. It is recommended to leave the device as it is and seek professional assistance to properly handle the situation.

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10.

Do not attempt to fix or repair a medical device yourself

A.

True
B.

False

Correct Answer
A. True

Explanation
It is important not to attempt to fix or repair a medical device yourself because medical devices are complex and delicate instruments that require specialized knowledge and expertise to handle. Attempting to repair a medical device without proper training can lead to further damage or malfunction, which can have serious consequences for patient safety. It is always best to leave the repair and maintenance of medical devices to trained professionals who have the necessary skills and knowledge to handle them safely and effectively.

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