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U.S. Department of Health and Human Services

MedSun: Newsletter #14, May 2007

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Newsletter #14, May 2007


Top-Ten Reported In Vitro Diagnostic Devices

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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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Hospitals "Going Green"

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“Going green” is making its mark on the health care industry as increasing numbers of hospitals and other health care facilities take on green initiatives as their contributions to protecting the environment along with safeguarding their patients. The vast majority of hospitals planning new construction are doing so under the guidance of green building criteria, and already-existing facilities are retrofitting systems to increase energy efficiency and confront environmental issues. Others concerns being addressed include food safety, recycling and waste reduction, and indoor air quality.

Premier, Inc., the largest health care alliance in the United States dedicated to improving patient outcomes while safely reducing the cost of care, has through its Safety Institute chronicled the progress of the green movement in the Nation’s hospitals and other healing facilities. Instead of its regular monthly publication of Premier Safety Share, in April 2007, Premier distributed Premier Green Link, an e-mail newsletter highlighting many of the green health care initiatives that intersect with patient safety.

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DS-X Device Safety Exchange, a MedSun Program

DS-X Lessons Learned

Question of the Month with Comment

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Does your hospital have a policy or process to track faulty devices that are returned to manufacturers for evaluation and analysis? What problems or challenges do you find with the process? Is the process different for single-use products, devices or instruments, or other special cases? (This excludes devices that are sequestered for legal purposes.)

For clinical equipment, we have the vendor/manufacturer sign a release form, which we send to the Biomedical Engineering Department. Staff temporarily remove this device from their inventory and then set up a tickler list to contact the manufacturer monthly about its progress in evaluating the problem. For single-use disposable items, a similar process is followed by the Risk Management Department. All potential legal cases are sequestered with both our facility and/or third-party evaluations. Our greatest challenge is that manufacturers often find that the equipment or disposable item "does not have any defect affecting the performance of the device" or that "the device is operating within normal design parameters." Another common response we receive is, "the device was operated in a manner for which it was not designed," but, of course, it obviously failed or we wouldn't be sending it back for evaluation.

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Discussions with Healthcare Providers

Executive Summary: Home Health Specialists Discussion

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A focus group with home health specialists was conducted by conference call on May 21, 2007, in preparation for development of the HomeNet subnetwork in the Food and Drug Administration’s (FDA) Medical Product Safety Network (MedSun) Project. The individuals who participated were associated with MedSun health care facilities. Attendees from the home health community included a quality improvement specialist, a durable medical equipment (DME) company representative, risk management/infection control staff, a rural home care provider, a registered nurse who works in quality improvement, a hospital-based biomedical engineer, and a hospice case manager for a home health/hospice agency.

The group discussed problems observed with medical devices and their use in the home environment. The participants also discussed the types of medical devices used in their home health programs, as well as differences in the age and quality of devices between those that may be brought to the home environment and those used in other health care settings. Their responses indicated that some providers are vigilant about device distribution, training of patients and caregivers, and responsibility for maintenance. Although some agencies work with DME companies to use the same equipment that is available in hospitals, others do not. In these cases, patients may not be able to bring a medical device they used at home into the hospital environment because of issues related to the device’s age, maintenance, and the staff’s unfamiliarity with it. The participants also noted that patients may be sent home with devices, such as a holter monitor or a particular infusion pump, that are not routinely managed in the home.

The group also discussed issues with labeling and use instruction. Among the barriers to device use the participants identified were the age of the population; inability of the patient or caregiver to speak or read English; the unmet need for instructing individuals who are illiterate or have low literacy; and family members, neighbors, and staff (both professional and nonprofessional) who are not familiar with the devices. The participants seemed to agree that there was generally a great lack of adequate labeling and instructions for devices. They noted concerns about the small font size on the labeling and inadequate instruction on how to turn a device on or off, recognize problems with alarms, respond to alarms, and troubleshoot to quickly rectify problems. In addition, they identified the need to train emergency responders on the use home equipment.

Reporting problems with medical devices was generally managed by the completion of an occurrence report that would be forwarded to Safety and Risk Management for processing. It was also learned that the Joint Commission will be evaluating competency training of patients in operation of devices and that DME companies must be accredited in 2008 in order to participate in competitive bidding. Further, individual States may mandate proof that instructions were understood, including device operation (by return demonstration) and environmental safety issues (e.g., exit strategy in the event of fire). Also mentioned was a bill under consideration by Congress that would confer ownership of a device to the patient after 36 months of use. This would sever any relationship with a home care agency or DME, which could have a significant impact on reporting problems with the device or maintenance programs.

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Updated May 1, 2007

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