Top-Ten Reported In Vitro Diagnostic Devices
MedSun: Newsletter #14, May 2007

Steven Gutman, M.D., M.B.A. Director, Office of In Vitro Diagnostics

As part of its patient safety initiative, the Office of In Vitro Diagnostics (OIVD) has begun to track on a monthly basis all signals from all sources about patient issues as they relate to the use of in vitro diagnostic devices (IVDs). While LabNet provides a unique and informed method of active surveillance, the Food and Drug Administration (FDA) continues to receive input on product performance from a wide variety of sources. These include voluntary company product recalls; medical device reports of adverse events; trade and consumer complaints; information obtained from the Internet, especially from listservs; and the literature and the formal and informal communications from Government partners working in laboratory-related activities at the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare & Medicaid Services.

Our first collation of these signals and the review of death-and-injury IVD-related medical device reports for the last 5 years have resulted in an IVD-specific, top-ten list of products that generated the highest volume of patient death-and-injury reports:
•Glucose meters and test strips
•Instruments and assays that measure coagulation factors
•Troponin-measuring devices
•Devices used to collect patient specimens, such as blood collection tubes, vials, serum separators, blood collection trays, and vacuum sample tubes
•Automated blood culture instruments
•Automated differential cell counter (instruments, reagents, and control materials)
•Devices that measure blood gases and electrolytes
•Therapeutic drug monitoring devices
•Devices that measure CKMB (Creatine Kinase Isoenzyme MB)
•Automated slide stainers

Many of these products are not surprises. They represent product problems that have already been identified and are being addressed by FDA. Glucose meters top the list because of the extraordinary volume of their use, their use under environmentally diverse conditions, and the risks associated with inaccurate test results. Now a standard of modern diabetic care, these meters are critical medical products. We remain vigilant, and we closely monitor reports on all these devices. Further, we work with companies when problems are identified so that we can inform both professional and home users promptly of any required actions. Problems observed over the years have been diverse and have included issues with reagents, software, device labeling, and design. While many problems have been easily corrected, identification of the root cause of some problems has been challenging.

Point-of-care coagulation tests, particularly those intended for home use, are a more recent addition to the list of IVDs that FDA must monitor postmarket. Again, we believe this reflects the broad scale of use and the significant impact that test results can have on medical decision making. Problems have been diverse and have included issues with design, manufacturing, and reagents.

Finally, because of its common use in critical care settings (identification of heart attacks and heart disease), troponin has been an analyte of special interest to OIVD’s patient safety team. In the past, FDA has worked collaboratively with industry and academia to disseminate educational messages on the analytical and biological limitations of these tests.

We have been impressed with the responsive and responsible manner in which companies have identified problems and risen to the challenge of communicating problems and solutions to users of high-volume products, often used in diverse settings. We believe our interactions with companies improve the quality of their communications and the strength of their outreach programs. Our interactions also ensure parity and consistency in the way companies handle important diagnostic device problems.

The remaining devices on our IVD top-ten list are a diverse assortment of diagnostic products with no common theme. This diversity reflects the complexity involved in the manufacture and use of diagnostic devices. OIVD remains committed to identifying diagnostic device problems and to ensuring that they are addressed in a timely manner consonant with patient safety and public health. Members of the laboratory community can contribute to our mission by referring problems to us in a timely manner, with clear and comprehensive information, to allow our actions or reactions to be well informed and based on good science. LabNet participants are a unique part of our patient safety net, and we are grateful for the opportunity to use the information you provide us to help maintain quality in laboratory medicine.


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