Those codes! Avoiding errors with MDR reports
By Mary Weick-Brady, RN, MSN
Team Leader, Product Evaluation Team
Division of Postmarket Surveillance Center for Devices and Radiological Health
Office of Surveillance and Biometrics
U.S. Food and Drug Administration
Rockville, MD
The final Medical Device Reporting (MDR) regulation became effective July 31, 1996. Since then, U.S. Food and Drug Administration (FDA) staff have observed numerous errors and omissions in the MDR reports submitted by user facilities to report device-related deaths and serious injuries. These errors cause major gaps in FDA’s adverse event reporting database and may delay manufacturers’ failure analyses while the manufacturers contact user facilities for additional information. The FDA plans to send letters to user facilities that have submitted incomplete mandatory forms (MedWatch Form 3500A) to request they file supplemental reports.
The following case study is a composite based on reports filed with the FDA. The names of individuals and facilities are fictitious.
Pat Anser, a staff member at Rolly Regional Hospital, has been assigned responsibility for reporting medical device adverse events to the FDA and to manufactures. Pat is scheduled for MDR training next month. In the meantime, he receives a report of a patient death in the operating room. A 29-year-old patient died during ENT surgery, when an electrocautery unit ignited in the oxygen-rich environment and she sustained fatal burns. Several days have passed, and Pat is being pressured to get out the report as soon as possible, since the hospital has nearly reached the 10-day deadline for reporting.
He checks the coding manual, completes the front page of the mandatory MedWatch Form 3500A, and then receives a phone call to attend a meeting immediately. Pat looks at the back of the form and quickly fills out F.1, 4, 5, and 12. He knows that gathering the rest of the information to properly complete Section F will take some time time he doesn’t have now. He quickly addresses the envelope and mails it. The patient and device codes, along with the rest of Section F, are blank. The manufacturer has to follow up with Pat to retrieve the missing information and is thus delayed in analyzing the incident.
What happened?
Filling in all parts of the mandatory MedWatch Form 3500A is a legal requirement. It communicates critical patient-related information to the FDA clinicians who analyze these reports. They search the database by codes in particular, by device and patient codes. When user facilities provide correct and complete information, it is possible to identify trends that may involve multiple devices, patient types, and manufacturers. The results of the database analysis enable the FDA to provide timely public health notifications, including safety alerts, public health advisories, and medical alerts to user facilities and patient populations.
Correct coding by user facilities enables the FDA to check that the manufacturer has reported the event when required. FDA device recalls rely on proper coding of the MedWatch form; if codes are omitted, the FDA cannot properly analyze the report and may miss a potential public health emergency. Also, correct coding enables the FDA to better respond to information requests from the public under the Freedom of Information Act.
Staff who are assigned responsibility for reviewing adverse events and reporting them to the manufacturer and the FDA must have:
• adequate training;
• sufficient time to accurately complete the mandatory MedWatch Form 3500A within the deadline;
• resources necessary to fill out the form, including a coding manual, copies of incident reports, and access to the device and/or patient involved, if possible.
Filling out forms completely and correctly can:
• save lives and avoid injuries;
• save time and money expended on telephone calls from manufacturers to user facilities;
• preclude FDA letters requesting missing information from manufacturers (and, in the future, from user facilities);
• preclude FDA inspections of manufacturing firms and user facilities to determine the facts of adverse events.
FDA field employees have been trained to train user facility staff across the United States regarding the MDR regulation, with the expectation that these individuals will use this knowledge to train staff at other facilities. In the meantime, you can contribute to the joint effort of user facilities, manufacturers, and the FDA by studying the coding manual, including the instructions and coding for patient-related and device-related terms.
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