Podcast
Questions and Answers
What types of reporters are mandated to submit MDRs to the FDA?
What types of reporters are mandated to submit MDRs to the FDA?
- Manufacturers, importers and device user facilities (correct)
- Manufacturers and importers only
- Health care professionals only
- Patients and consumers only
What is a limitation of the MAUDE database?
What is a limitation of the MAUDE database?
- It provides data on the frequency of device use
- It only accepts reports from healthcare professionals
- It provides accurate and verified data on device use
- It may contain incomplete or biased data (correct)
Which of the following is not a resource mentioned for reporting medical device information?
Which of the following is not a resource mentioned for reporting medical device information?
- Electronic Hospital Reporting System (correct)
- MedWatch
- MDR Database Search
- Device Advice
Why can the incidence of an event not be determined from the MAUDE database alone?
Why can the incidence of an event not be determined from the MAUDE database alone?
What is the purpose of submitting a FOIA request in relation to Medical Device Reports?
What is the purpose of submitting a FOIA request in relation to Medical Device Reports?
Who is encouraged to submit reports of significant adverse events or product problems with medical products?
Who is encouraged to submit reports of significant adverse events or product problems with medical products?
Which document is specifically designed for mandatory reporting by manufacturers and other regulated entities?
Which document is specifically designed for mandatory reporting by manufacturers and other regulated entities?
Which group does not fall under mandatory reporting requirements?
Which group does not fall under mandatory reporting requirements?
What is the purpose of MedWatch?
What is the purpose of MedWatch?
Which communication method is provided for questions about medical device reporting?
Which communication method is provided for questions about medical device reporting?
What is the time frame for submitting mandatory reports after becoming aware of a reportable event?
What is the time frame for submitting mandatory reports after becoming aware of a reportable event?
To whom must reports of death be submitted?
To whom must reports of death be submitted?
Which reportable events require submission to the manufacturer or FDA?
Which reportable events require submission to the manufacturer or FDA?
What is required of mandatory reporter agencies regarding MDR programs?
What is required of mandatory reporter agencies regarding MDR programs?
What types of penalties can result from failure to comply with FDA MDR requirements?
What types of penalties can result from failure to comply with FDA MDR requirements?
What is defined as a medical device?
What is defined as a medical device?
What does the term 'caused or contributed' refer to in relation to medical devices?
What does the term 'caused or contributed' refer to in relation to medical devices?
What types of medical devices are included in the definition?
What types of medical devices are included in the definition?
Which of the following outcomes can be attributed to an adverse event? (Select all that apply)
Which of the following outcomes can be attributed to an adverse event? (Select all that apply)
What information is necessary to report regarding the medical device involved in an adverse event?
What information is necessary to report regarding the medical device involved in an adverse event?
Who could be the operator of the medical device at the time of its malfunction?
Who could be the operator of the medical device at the time of its malfunction?
What is a critical first step after identifying an adverse event with a medical device?
What is a critical first step after identifying an adverse event with a medical device?
Which piece of information is NOT typically required in the report of an adverse event?
Which piece of information is NOT typically required in the report of an adverse event?
If a single-use device was involved in an adverse event, what information regarding its use should be reported?
If a single-use device was involved in an adverse event, what information regarding its use should be reported?
What should be done if multiple units of the same model are similarly affected by an adverse event?
What should be done if multiple units of the same model are similarly affected by an adverse event?
Which of the following is NOT considered an adverse event outcome?
Which of the following is NOT considered an adverse event outcome?
What is the primary purpose of the Medical Device/Ambulance MALFUNCTION/FAILURE Report?
What is the primary purpose of the Medical Device/Ambulance MALFUNCTION/FAILURE Report?
Who should be contacted immediately in the event of serious patient or crew harm or death?
Who should be contacted immediately in the event of serious patient or crew harm or death?
What does the status of the patient post-event indicate if marked as 'Unstable'?
What does the status of the patient post-event indicate if marked as 'Unstable'?
In the context of the form, which of the following describes an 'Adverse event'?
In the context of the form, which of the following describes an 'Adverse event'?
What information is NOT required in the patient information section of the report?
What information is NOT required in the patient information section of the report?
What is indicated if the medical device malfunction did NOT affect patient care?
What is indicated if the medical device malfunction did NOT affect patient care?
Which of the following options represents a possible status of the patient prior to the event?
Which of the following options represents a possible status of the patient prior to the event?
Which of the following best describes an incident marked as affecting patient care and contributing to harm?
Which of the following best describes an incident marked as affecting patient care and contributing to harm?
Study Notes
Mandatory Reporting Guidelines
- Mandatory reports must be submitted as soon as practicable, but no later than 10 workdays after knowledge of a reportable event.
- Death reports must be sent directly to the FDA, with a copy sent to the manufacturer if known.
- Reports of serious illness or injury should be submitted to the manufacturer or the FDA if the manufacturer is unknown.
- User facilities are required to provide an annual summary of mandatory device-related event reports to the FDA.
MDR Program Requirements
- All mandatory reporter agencies must develop and implement a written Medical Device Reporting (MDR) program.
- The MDR program should specify reporting responsibilities, assigned tasks, documentation requirements, and information flow.
Penalties for Non-Compliance
- Non-compliance with FDA MDR requirements can lead to substantial penalties, including civil money penalties of 15,000perviolation,uptoamaximumof15,000 per violation, up to a maximum of 15,000perviolation,uptoamaximumof1 million per proceeding.
- Possible consequences include civil injunctions and criminal prosecutions.
Definitions
- Caused or Contributed: A death or serious injury attributed to a medical device.
- Medical Device: Any instrument or apparatus used for preventing, diagnosing, mitigating, or treating diseases, including both disposable (e.g., catheters) and non-disposable products (e.g., syringes).
Voluntary Medical Device Reporting
- Healthcare professionals, patients, caregivers, and consumers can submit voluntary reports of significant adverse events to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program, or through the MedWatcher app.
Reporting Procedures
- Medical device reports can be submitted by mandatory reporters (manufacturers, importers, user facilities) and voluntary reporters (healthcare professionals, patients, caregivers, consumers).
- Mandatory reporting for manufacturers and user facilities utilizes Form FDA 3500A.
MAUDE Database
- The Manufacturer and User Facility Device Experience (MAUDE) database houses MDRs submitted to the FDA.
- Limitations of the MAUDE database include potential incomplete data, under-reporting of events, and inability to determine the incidence or prevalence of reported events.
Additional Resources
- Individuals can request information related to Medical Device Reports via the Freedom of Information Act (FOIA).
- General inquiries regarding MDR policies can be directed to the Division of Industry and Consumer Education (DICE).
Contact Information
- For serious patient or crew harm, contact EMS MD immediately; all other inquiries can be emailed.
- The submission of reports does not imply an admission of fault by medical personnel or facilities involved.
Studying That Suits You
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Description
Test your knowledge on the mandatory reporting requirements for reportable events in user facilities. Understand the protocols for submitting reports of death, serious illness, and serious injury to the FDA and manufacturers. This quiz will help reinforce your understanding of regulatory compliance.
