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Medical Device Act and Reporting

Medical Device Act and Reporting

MDR Overview

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the post market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers, and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

 

Mandatory Medical Device Reporting Requirements:

The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

 

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

 

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

 

Device User Facilities: A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

 

A user facility is not required to report a device malfunction but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under FDA’s Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution’s procedures for reporting adverse events to the FDA.

 

Voluntary Medical Device Reporting:

The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program or through the MedWatcher mobile app.

Medical Device/Safety Hazard Reporting

  1. Definitions:
    1. Health hazard means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees.
    2. Safety Data Sheet (SDS) means written or printed material concerning a hazardous chemical (OSHA 500:1131 CH 510 ATT 4 subpart Z).  SDS is an OSHA approved method to make readily available to employees, current information and protective measures for chemical health hazards present in the workplace.
    3. “MDR reportable events” are the adverse events or problems that the medical device regulation requires to be reported.  For facilities, MDR reportable events include patient deaths and serious injuries that medical devices have or may have caused or contributed to, i.e., the devices may have directly caused the events or played a role in the events.
    4. Serious Injury*-There are three (3) possible types of serious injuries, and they are not mutually exclusive:
  1. Life-threatening injuries.
  2. Injuries that result in permanent damage or impairment; and
  • Injuries that require medical intervention to preclude permanent damage or impairment is defined as irreversible damage or impairment that is not trivial.
    1. Adverse events include:
  1. Death.
  2. Life-threatening events.
  • Hospitalization-initial or prolonged.
  1. Disability.
  2. Congenital Anomaly.
  3. Required intervention to prevent permanent impairment/damage.
    1. Malfunction is the failure of a device to meet its performance specifications or to perform as intended.  A malfunction is reportable when it is likely to cause or contribute to a death or serious injury if it were to recur.  The regulation assumes that a malfunction will recur.
  1. The Agency chooses to rely upon the evaluation of hazards provided by the chemical manufacturer or importer.
  2. Procedures are implemented to document the reporting of medical device safety hazards and the subsequent corrective action taken, or to prevent the reoccurrence of an unsafe act.
  3. The Agency understands the importance of communication of hazards for the protection of patients and staff.
  4. The reporting of medical device and safety hazards is the specific responsibility of all employees of the Agency. The Administrator has the responsibility for ensuring compliance with reporting requirements.
  5. A report is required when the agency has information that reason-ably suggest that a device has or “may have” caused or contributed to a death or serious injury of a patient.  If the chance that a device may have caused or contributed to an event is very remote or very unlikely, the event should not be reported.
  6. A report is required when a reporting entity receives information that “reasonably suggest” that a device may have caused or contributed to an MDR reportable event.  This includes any information such as professional, scientific, or medical facts and observations or opinions that would reasonably suggest a device has caused or may have caused or contributed to a MDR reportable event.
  7. All medical devices and safety hazards related to patients, personnel and visitors shall be reported immediately to assure that corrective action is taken.
  8. An employee report of medical device /safety hazard occurrence should be submitted by an employee as soon as possible, listing the exact location and nature of the hazard. Upon completion, the report should be forwarded to the Administrator.
  9. Upon receipt of the employee report of medical device/safety hazard, the Administrator shall conduct an investigation of the reported condition/act and document any action taken or suggested to eliminate the hazard. The manufacturer, if known, will be notified.
  10. The Administrator will then forward the report to the Chairman of the QAPI Committee for further review and analysis. Summaries of all such reported hazards shall be documented in the minutes of the committee meeting.
  11. All records will be retained for audit and reporting purposes. They will be retained for a minimum of five years.
  12. The FDA will be notified by the Administrator when incidents result in serious injury, illness or death or manufacturer unknown. The manufacturer will be notified, if known.  Reports must be submitted on FDA Form 3500A (mandatory MedWatch form) within 10 days from the time that any employee or person affiliated with the agency becomes aware that the device may have caused or contributed to a death or injury.

 

  1. The report is to include the following:
    1. Information about the patient.
    2. Type of adverse event.
    3. Description of the event.
    4. Relevant laboratory/test data and patient history.
    5. Manufacturer and identification of the suspect device and certain other information about the device.
    6. Initial reporter of the event.
    7. User facility/distributor name, address, and contact.
    8. Event problem codes for the device and patient.
    9. Where and when the report was sent.
  2. The following are guidelines for reporting:
    1. Deaths to FDA and Manufacturer within 10 workdays.
    2. Serious Injuries* to the Manufacturer, and the FDA only if the manufacturer is unknown, within 10 workdays.
    3. Annual report of deaths and serious injuries to the FDA every January 1.
  3. A mandatory in-service on Medical Device/Safety Hazard Reporting is provided on an annual basis with documentation of the date and time of the in-service, a list of attendees and an outline of the training content.
  4. Employees will be provided with information and training on hazardous chemicals in the work area during initial orientation and yearly thereafter. The employee orientation will include:
    1. Hazard communication requirements of OSHA.
    2. The presence of hazardous chemicals in the work area.
    3. How to read and interpret labels and SDS.
    4. How to cope with emergency procedures (recognition, reporting, and evacuation).

What to Report to FDA MedWatch:

  • Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures for:
  • Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
  • Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps))
  • Medical devices (including in vitro diagnostic products)
  • Combination products
  • Special nutritional products (dietary supplements, infant formulas, and medical foods)
  • Cosmetics
  • Foods/beverages (including reports of serious allergic reactions