Inside CDRH: The Journey of an MDR
Marian Benjamin, Editor, 24×7
The headline of the August 22, 2003 Los Angeles Times read, 2 Patients Die After Alarms Fail. Faulty monitoring systems in an area hospital were suspected to be the cause of the deaths, both of which had occurred since June 30. After investigation, one of the events was found not to be caused by faulty equipment.
The manufacturer has filed two medical device adverse event reports (MDRs) regarding these events with the Center for Devices and Radiological Health (CDRH), the division of the FDA that tracks the performance of medical devices. A spokesperson at CDRH tells me that in 2002, 64,100 individual adverse event reports were filed. These numbers led me to wonder what the process is after an MDR has been filed.
MDRs are filed through the medical products reporting system. Manufacturers and facilities are required to file an MDR any time a device failure has or may have caused or contributed to a death or serious injury. Voluntary reports can also be filed.1
At CDRH, the report is evaluated by one of the analyst-reviewer staff, each of whom has a background in a certain medical field. The analyst-reviewer evaluates the report and determines whether follow-up investigation is warranted.1
To initiate the investigation, the analyst collects additional information from the manufacturer, including patient data, device data, and possibly information on the frequency and severity of other adverse events reported for this or similar devices. If further action is needed, the results of the evaluation are forwarded to the appropriate group within CDRH for action. The adverse-event report remains in the database, enabling future research and evaluation of trends1.
The adverse events report database, Manufacturer and User Facility Device Experience (MAUDE), is updated quarterly and is available through an online search at www.fda.gov/cdrh/maude.html. (Filing an MDR does not necessarily reflect a conclusion by the manufacturer or the FDA that the device caused or contributed to the reportable event, according to Section 21 CFR 803.)2
More than 8,000 new medical devices are marketed in the United States each year. Biomeds can help improve the safety and effectiveness of devices by identifying serious low-frequency events not reported before marketing, by identifying problems associated with staff unfamiliarity with new devices, and by anticipating possible interference between new and existing devices.3 Although we cannot eliminate operator error and equipment failure completely, with diligence, they should be the subject of fewer headlines.
1. Rich S. Nurses play a critical role in adverse event problem identification. Int J Trauma Nurse. 1999;5(3):110112.
2. U.S. Food and Drug Administration. Manufacturer and use facility device experience database(Maude). Available at: www.fda.gov/cdrh/maude.html. Accessed September 3, 2003.
3. Feigal DW, Gardner SN, McClellan M. Ensuring safe and effective medical devices. N Engl J Med. 2003;348(3):191192.