Podcast
Questions and Answers
What is one consequence of failing to comply with FDA medical device reporting requirements?
What is one consequence of failing to comply with FDA medical device reporting requirements?
- Reduction in FDA oversight.
- Civil money penalties up to $1 million. (correct)
- Non-public reprimands from FDA.
- Increased product approval speed.
Which of the following is NOT a component that must be included in a written MDR program by mandatory reporter agencies?
Which of the following is NOT a component that must be included in a written MDR program by mandatory reporter agencies?
- Personnel training plans. (correct)
- Tasks to be assigned.
- Documentation requirements.
- Flow of information.
What is meant by 'serious injury' in the context of medical device reporting?
What is meant by 'serious injury' in the context of medical device reporting?
- A minor injury that does not require medical attention.
- An injury that is life-threatening or requires surgical intervention. (correct)
- Any inconvenience to a patient's daily life.
- A temporary illness that resolves within a week.
How does the NWC EMSS promote a culture of safety?
How does the NWC EMSS promote a culture of safety?
Which definition best describes a medical device?
Which definition best describes a medical device?
What is the purpose of the annual summary of mandatory device-related event reports to the FDA?
What is the purpose of the annual summary of mandatory device-related event reports to the FDA?
Which of the following penalties can result from non-compliance with medical device reporting?
Which of the following penalties can result from non-compliance with medical device reporting?
What should the credibility of the MDR program be built upon according to the NWC EMSS?
What should the credibility of the MDR program be built upon according to the NWC EMSS?
What is the purpose of submitting a Medical Device/Ambulance malfunction/failure report?
What is the purpose of submitting a Medical Device/Ambulance malfunction/failure report?
Which statement correctly describes the status of a patient post-event if the report indicates 'Unstable'?
Which statement correctly describes the status of a patient post-event if the report indicates 'Unstable'?
In the context of the report, what does a medical device malfunction indicate if it 'Affected patient care but caused no harm'?
In the context of the report, what does a medical device malfunction indicate if it 'Affected patient care but caused no harm'?
Which of the following options must be included in the patient information section of the report?
Which of the following options must be included in the patient information section of the report?
What should be done immediately in the event of serious patient or crew harm or death?
What should be done immediately in the event of serious patient or crew harm or death?
What is the primary purpose of medical device reporting (MDR)?
What is the primary purpose of medical device reporting (MDR)?
What legislation is the foundation for the final rule on medical device reporting issued by the FDA?
What legislation is the foundation for the final rule on medical device reporting issued by the FDA?
Within how many work days must mandatory reports of serious illnesses or injuries be submitted once a user facility is aware of the event?
Within how many work days must mandatory reports of serious illnesses or injuries be submitted once a user facility is aware of the event?
What should be done if an ambulance is unexpectedly taken out of service during a call?
What should be done if an ambulance is unexpectedly taken out of service during a call?
Which of the following is NOT a category of incidents that must be reported to the FDA?
Which of the following is NOT a category of incidents that must be reported to the FDA?
What action is mandated when a death related to a medical device occurs?
What action is mandated when a death related to a medical device occurs?
What time frame must a second ambulance or licensed EMS non-transport vehicle arrive to begin care, according to Illinois law?
What time frame must a second ambulance or licensed EMS non-transport vehicle arrive to begin care, according to Illinois law?
Who is encouraged to submit voluntary reports about serious adverse events related to medical devices?
Who is encouraged to submit voluntary reports about serious adverse events related to medical devices?
Which bodies are required by the MDR regulation to report device-related adverse events?
Which bodies are required by the MDR regulation to report device-related adverse events?
What does the Safe Medical Devices Act (SMDA) require from mandatory reporters?
What does the Safe Medical Devices Act (SMDA) require from mandatory reporters?
Who can voluntarily report significant adverse events or product problems with medical products to the FDA?
Who can voluntarily report significant adverse events or product problems with medical products to the FDA?
What was one of the objectives of the 1995 final rule issued by the FDA regarding medical device reporting?
What was one of the objectives of the 1995 final rule issued by the FDA regarding medical device reporting?
What action must a provider agency take if a response time exceeds 6 minutes for a 9-1-1 call?
What action must a provider agency take if a response time exceeds 6 minutes for a 9-1-1 call?
What is the primary purpose of reviewing ambulance malfunction incidents?
What is the primary purpose of reviewing ambulance malfunction incidents?
Which of the following statements about Medical Device Reporting is false?
Which of the following statements about Medical Device Reporting is false?
What should be completed after notifying the EMS MD of an ambulance malfunction?
What should be completed after notifying the EMS MD of an ambulance malfunction?
What is the purpose of Form FDA 3500A?
What is the purpose of Form FDA 3500A?
Which of the following is NOT a method to submit voluntary reports through MedWatch?
Which of the following is NOT a method to submit voluntary reports through MedWatch?
Where should written inquiries regarding medical device reporting be sent?
Where should written inquiries regarding medical device reporting be sent?
What is the main audience for Form FDA 3500?
What is the main audience for Form FDA 3500?
Which of the following is true regarding the MedWatcher mobile app?
Which of the following is true regarding the MedWatcher mobile app?
What should individuals do if they need help interpreting MDR policy?
What should individuals do if they need help interpreting MDR policy?
Which option accurately describes the MedWatch program?
Which option accurately describes the MedWatch program?
What is the effective date mentioned for the medical device failure/malfunction policy?
What is the effective date mentioned for the medical device failure/malfunction policy?
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Study Notes
Legislative Mandate
- Medical device reporting (MDR) is crucial for identifying device problems that threaten public health and safety.
- FDA established MDR regulations under the Safe Medical Devices Act of 1990 and finalized on December 11, 1995.
- Mandatory reporting includes adverse events such as deaths, serious injuries, illnesses, and issues that may affect patient safety.
- Healthcare professionals, patients, and consumers are encouraged to submit voluntary reports on significant adverse events using MedWatch.
- Mandatory reports should be filed within 10 working days of awareness of an event; death reports need to be sent to the FDA and manufacturer.
- User facilities must provide annual summaries of mandatory device-related event reports to the FDA.
- Non-compliance with MDR can lead to penalties up to $1 million, civil injunctions, or criminal prosecutions.
Definitions
- "Caused or contributed" implies a medical device may have played a role in a death or serious injury.
- A "medical device" includes instruments used for prevention, diagnosis, or treatment of diseases (e.g., catheters, syringes).
- "Serious injury" entails life-threatening conditions or permanent impairment necessitating medical intervention.
Policy Overview
- NWC EMSS promotes a culture of safety, emphasizing incident reporting without fear of retaliation.
- If an ambulance is taken out of service unexpectedly, notify the EMS Medical Director and complete an Equipment Malfunction form.
- Continuous review of incidents is integral to quality improvement and protected by the Medical Studies Act.
- In cases of ambulance malfunction, a backup vehicle must be called if the primary cannot respond in stipulated timeframes.
Reporting Requirements
- Mandatory reporters (manufacturers, importers, user facilities) must report device-related adverse events to the FDA.
- Voluntary reporting is encouraged for health professionals and consumers who encounter device issues.
- Reports can be submitted via the MedWatcher app or through MedWatch’s online forms and telephone services.
Contact Information
- For serious incidents, directly contact the EMS Medical Director.
- General reporting protocols and queries should be directed to designated FDA offices.
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