Medical Device Reporting

Although medical device reporting is a bit out of the domain that many of us in the pharmaceutical world work in, situations sometimes arise where we need to know something about device reporting.  This is true for those of us who have combo drug/device products.  So now would be the time for a quick review of device reporting that touch the pharma world – especially since FDA just put forth a new draft guidance on Medical Device Reporting:https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm359130.htm

This document is aimed at “manufacturers”, including ex-US companies whose devices are cleared for marketing in the US.  It is a Q&A type document but it covers the major points needed for device reporting and references the appropriate US federal regulations.

Here are the major points.  I’ve combined various answers for simplicity.  This is not a complete summary but touches on those areas that drug/pharmaceutical specialists might likely see.  The obligations and requirements for manufacturers are addressed:

• Definition: Manufacturer. See 21CFR803.3 for the full and complex definition of “manufacturer”.   For pharma companies, this definition is important because any entity that changes the container, wrapper or labeling is considered a manufacturer.  So if a pharma company repackages or includes another company’s device to be marketed with their drug product, the drug company becomes a “manufacturer” for reporting purposes.

• SOPs: You must have written SOPs to determine if all adverse medical device events are Medical Device Reports (MDRs) and you must keep complete files.
• Submit reportable MDRs. MDRs are defined as “events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur”.  See 21CFR803.3
• “Serious injury” is defined as “an injury or illness that is life threatening, results in permanent impairment of a body function or permanent damage to a 
body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. “ Note that this is different from the definition of a pharmaceutical SAE.
• “Malfunction” is defined as the “failure of a device to meet its performance specifications or otherwise perform as intended.”

  This is actually a tricky term since reportability is further defined by FDA to include:

  • “The chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote;
  • The consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury;
  • The malfunction results in the failure of the device to perform its essential function and compromises the device’s therapeutic, monitoring or diagnostic effectiveness, which could cause or contribute to a death or serious injury or other significant adverse device experiences required by regulation. The essential function of a device refers not only to the device’s labeled use, but also to any use widely prescribed within the practice of medicine.” (Italics inserted by the author).

    There is some lack of clarity as to whether this applies to long-term implants and devices that are life-supporting or life-sustaining.  FDA further states that “malfunctions that are not likely to cause or contribute to a death or serious injury if they recur do not have to be reported”.  But then FDA states: “We consider a malfunction that is or can be corrected during routine service or device maintenance to be an MDR reportable event if the recurrence of the malfunction is likely to cause or contribute to a death or serious injury.  So this is a bit ambiguous.

  • 30-Day Reports. Manufacturers must submit to FDA reportable deaths, serious injury or device malfunction within 30 calendar days of become aware of the event using a MedWatch form or an electronic submission.  Reports must be in English.
    • The initial report must contain patient information, information about the AE or device problem, device information, initial reporter, manufacturer information, report sources and more.  See 21CFR803.52(a) to (f) for details.
    • 5-Day Reports. The reporting time frame is 5 working days if the MDR reportable event “necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health or FDA requests it be submitted in 5 days.  Reports must be in English and on a MedWatch form or electronically.
      • “Remedial action” is any action, other than routine maintenance or servicing of a device, necessary to prevent recurrence of an MDR reportable event … FDA does not consider an action taken to correct only a single device involved in an MDR reportable event to be a remedial action. “

•  Supplemental Reports. These are follow-up reports and should be submitted within 30 calendar days of the receipt of the new information. Use a MedWatch form or submit electronically.

• Causality: In the above definition “caused or contributed” to a death or serious injury means that the problem “was or may have been attributed to a medical device or that a medical device was or may have been a factor in a death or serious injury” due to device “failure, malfunction, improper or inadequate design, manufacture, labeling or user error.”  This is quite different from the causality/relatedness definitions used in the drug world.
• “Reasonably known”. FDA expects the manufacturer to obtain information on the safety problem that is “known or reasonably known”.  Information should be gotten by contacting a user facility, importer or reporter and information that can be obtained by analysis, testing or other evaluation of the device.
• Follow-up. The manufacturer should investigate any “written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution” from any source.

  FDA states: “You must investigate all complaints of AEs”.  Refer to the guidance for further information on due diligence, assisting user facilities in reporting MDRs and other nuances about reporting and follow up.

  “MDR follow-up investigations should involve a “good faith effort” to obtain information and should not focus only on the number of attempts to obtain such information.” But then FDA gives a number! 
”A “good faith effort” to obtain additional information should include at least one written request for information.”

• Training. “… manufacturers have a responsibility to inform all employees, including marketing, sales, engineering, manufacturing, regulatory, legal, installation, and service personnel, to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports.” The regulatory clock starts when “whenever any employee becomes aware of an adverse event…Employees should be trained…”.   Very similar to the drug world.
• Non-reportable MDRs.
  • A medical judgment is made by a physician, nurse, risk manager, biomedical engineer or other qualified person that “your device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur.”
  • You did not manufacture the device.

• Electronic reporting.  FDA refers the reader to their website for information on HL7 ICSR electronic reporting: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceReporting/default.htm
• Literature reports. “…if the information in the literature source is made known to you or to any of your employees, and the information reasonably suggests that a reportable event or events may have occurred, then you must comply with the requirements of the MDR regulation and make a reasonable attempt to investigate each event.”  It is not clear that there is an obligation, as there is for drug reporting, to do formal and periodic literature searches.

Comments: Device reporting is different from drug reporting even though the same MedWatch form is used.  There are significant nuanced (and not so nuanced) differences in definitions, timing (calendar days vs working days) and requirements.  The attempt here is to sensitize those folks who work in the drug world who also happen to have devices (usually in combo products) that they also have device reporting obligations.  Examples include: drug manufacturers who include an injection pen or needles/syringes with their product or spacers with an inhaler.

If you fall into this category, you must take the time to carefully go through the regulations and guidances (there are others) that cover device reporting to FDA.  Note also that worldwide device reporting is not as harmonized as drug reporting and that each region or country has different requirements that the company must be sure to obey.