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U.S. Department of Health and Human Services

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OCD FY2003: Assuring Safe Products in the Market

 Postmarket Surveillance: Medical Device Adverse Event Reporting

Adverse Event Reports

During FY 03, FDA received 60,767 individual medical device adverse event reports from manufacturers, user facilities, and importers. Additionally, 3602 voluntary reports were submitted by health care professionals and the public. CDRH staff analyzes the reports to determine if the use of a particular product is resulting in unexpected problems or risks, and to identify trends that can improve risk management and reduce use error. The top problems identified this fiscal year were: aortic connector device failures that led to hemorrhage and death; thrombus and reactions associated with coronary stents; meningitis associated with cochlear implants; aneurysm-related deaths associated with endovascular grafts; hospital bed fires; toxic shock syndrome associated with a particular brand of tampon; off-label use of an adhesion barrier; and saline leakage in the access port of the lap band adjustable gastric band.

Alternative Summary Reporting

CDRH continues to accept more reports into the Alternative Summary Reporting (ASR) program. In this program, manufacturers submit abbreviated reports in a line item aggregated way. This program is for devices with problems that are well-known and well-documented. For example, problems with medical devices that are well-known and well-documented include: shearing of central line catheters, endossoeus implants failing to osseointegrate, and breast implant ruptures. Approximately 40 manufacturers participate in this program for 50 different types of classified devices. Three manufacturers are currently participating in the electronic version of ASR, which is still being piloted. FDA received 61,553 reports in the summary database in FY 03.

International Vigilance Report

Policies and procedures for the exchange of information between regulatory authorities continue to be refined by the Global Harmonization Task Force - Study Group 2 (Medical Device Vigilance and Postmarket Surveillance). During 2003, the FDA and 15 countries participated in the electronic global exchange of more than 140 international vigilance reports between National Competent Authorities (NCAs). Postmarket vigilance reports primarily involve recalled devices with a potential for adverse events in countries where the product is distributed. Member countries participating in the exchange periodically evaluate the usefulness of vigilance reports to their safety programs. Evaluations thus far indicate the program is a very effective tool for the rapid global dissemination of device safety information used to protect public health.

Medical Product Surveillance Network (MedSun)

The FDA Modernization Act of 1997 (FDAMA) directed FDA to change the current MDR regulation pertaining to user facilities from a required universal reporting system to a system comprised of a subset of user facilities. Since February 2002, FDA has been collecting data about problems with the use of medical devices from a sample of hospitals and nursing homes. This data collection, called the Medical Product Surveillance Network (MedSun) is an interactive Internet-based reporting program. During FY 03, FDA continued recruitment of reporting facilities from the east coast and mid-west region of the United States, for a total of 180 facilities (nationwide representation will be achieved in FY 04). FDA has collaborated with these facilities to determine the effectiveness of various incentives and types of feedback on the quantity and quality of reports sent into the system. Throughout FY 03, FDA targeted the MedSun system to obtain specific medical product information. Additionally, in FY 03 a pilot project was begun to more directly target the sending of reports from laboratories (pathology and in vitro diagnostic tests) in the reporting hospitals.

IVD Patient Safety Team

Early in 2003 the IVD Patient Safety Team (PST) was formed as a part of a larger Total Product Life Cycle (TPLC) program. The team’s mission is two-fold: first, to explore new avenues to obtain timely, useful and accurate postmarket information on the devices CDRH regulates in order to feed this information back to the premarket review; and second, to facilitate the merger of premarket and postmarket activities to smooth the transition to the TPLC concept. The team now serves as the “umbrella” team to oversee several project teams summarized below.

  • IVD MedSun/LabSun Pilot Team - During the last year the LabSun Pilot team has been very active. The team designed two report forms: a short form for minor events in the laboratory where patients were not directly impacted and a longer report form for incidents of more significance. Working with CODA, the contractor for the MedSun Project, the team recruited and trained nine sites in the Maryland, Virginia and DC area for a currently ongoing four month pilot of laboratory reporting. CDRH has already had several reports come in, one resulting in a compliance investigation.
  • IVD Listserv Team - This team has been participating in passive listening on several listservs and feeding issues back to the PST, the postmarket staff, and the respective divisions. There have been several incidences where discussion topics which were monitored resulted in compliance actions or in OIVD posting Lab Safety Tips on the OIVD website.
  • IVD Adverse Event Reporting Activity and Transition to OIVD Team - At each PST meeting, the team was updated on newly received adverse event reports that met criteria the PST specified – deaths, hospitalization, and voluntary reports. Two computer-based training sessions on review and analysis of adverse event reports were conducted by CDRH’s OSB analysts. Currently, nine OIVD staff are being trained as analysts. On August 22, OIVD staff began to receive IVD adverse event reports directly and to manage their follow-up. The OIVD analysts’ group meets regularly to discuss problems and issues. Each analyst reports adverse events regularly to the respective OIVD division in order to integrate information from the reports into premarket reviews.

 Postmarket Collaborations

Global Medical Device Nomenclature (GMDN)

Since 2001, the further development and maintenance of the GMDN has been the responsibility of the GMDN Maintenance Agency. CDRH is represented in both the Maintenance Agency Policy Group (MAPG) which administers the nomenclature, and the Expert Team (ET) which is responsible for the technical upkeep of the nomenclature. The terminology now contains over 18,000 terms, 7,000 of which are preferred terms with definitions used for product identification. In addition, the GMDN is now an ISO and CEN (European Standardization Organization) standard, and therefore has been adopted by many nations. CDRH continues to migrate towards the eventual adoption of the GMDN, and to that end is systematically reviewing linked procodes in the GMDN for accuracy, and is working with ECRI to attempt to merge the current version of their Universal Medical Device Naming System (UMDNS) with CDRH procodes and the GMDN into one database.

Hospital Bed Safety

Death and injury adverse events associated with patient entrapment in hospital beds continue to be reported to FDA. The Hospital Bed Safety Workgroup (HBSW), under FDA’s leadership and in partnership with hospital bed manufacturers, national health care organizations, patient advocacy groups, and the Department of Veterans Affairs, has developed the following products this year:

  • Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long-Term Care Facilities and Home Care Setting. These guidelines are the first to provide a uniform set of recommendations for caregivers in hospitals, long-term care facilities, and in the home when assessing their patients’ need for and possible use of bed rails.
  • A video entitled, “Do No Harm” produced by AARP. The 22-minute video for caregivers and health care facilities that provide real-life situations on the use of bed rails in both acute and long-term care environments and offers insights by patients and their families, nurses and other caregivers. FDA’s website for bed safety provides a link to these new clinical guidelines at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ MedicalToolsandSupplies/HospitalBeds/default.htm. In addition, FDA is developing dimensional guidelines and educational materials for manufacturers, caregivers and consumers to identify and reduce risk of entrapment in new and existing hospital beds.

Systematic Technical Assessment of Medical Products (STAMP)

  • Surgical Stapler and Clip Applier STAMP -The CDRH Surgical Stapler and Clip Appliers STAMP Committee convened in September 2001 to address adverse events associated with surgical staplers and clip appliers. The reported events described cutting and device component failures, resulting in pain, bleeding, tissue necrosis, hypovolemic shock, cardiac tamponade, and subsequent deaths and serious injuries. Surgical staplers and clip appliers are used in gastrointestinal, gynecologic, thoracic, and other surgeries to resect or transect tissues and to create anastomoses. These devices have been marketed for years and their use results in shortened surgical procedure times. The STAMP is composed of representatives from CDRH and the American College of Surgeons (ACS). In addition to reviewing adverse event reports, the committee discussed adequacy of training programs for surgical staplers and clip appliers, reuse of single use staplers, and manufacturing/design issues. The ACS believes that reuse of single use staplers is not an issue in the United States, but a common practice in Mexico, South America, Central Europe, and parts of Asia. Additionally, problems with surgical staplers and clip appliers are rarely discussed in professional meetings and manufacturers do not discuss device failures with surgeons. The STAMP believes that some clinicians may not be aware of problems reported with surgical staplers and clip appliers and proposed to present information about these devices through publications, websites, professional meetings, and FDA Advisory Panel meetings. The STAMP also plans to conduct a Rapid Response Survey (RRS) to determine user awareness of device problems.
  • Laparoscopic Trocar Injuries STAMP - CDRH convened a STAMP Committee to address the increasing numbers of reports of deaths and serious injuries related to the use of laparoscopic trocars—devices used to penetrate the abdomen and pelvis for insertion of laparoscopes and surgical instruments. The committee members included FDA staff and health care practitioners with expertise in health care, engineering, laparoscopic procedures and human factors. The committee completed the following activities:
    ­ Reviewed and analyzed FDA adverse event surveillance data, trocar labeling, patient brochures on laparoscopic surgery;
    ­ Reviewed FDA device recall data;
    ­ Reviewed existing published literature; and
    ­ Published an article (ACOG Today, October 2002) to provide information about laparoscopic trocar injuries and FDA’s adverse event reporting program. The committee will publish a summary of findings by the end of 2003.

 Postmarket Epidemiology

CDRH epidemiologists conduct applied epidemiological research using a variety of methods and databases and provide consultative services to ODE and others on issues requiring epidemiological expertise, from systematic reviews of the literature to risk assessments, to the design and conduct of observational studies. Major epidemiological research during the past year that resulted in publications in scientific journals and presentations at national professional meetings include: allergic reactions to platinum in breast implants; serious injuries associated with the use of hemostasis devices; the epidemiology of tampon associated toxic shock syndrome; patient safety terminology; an active surveillance system to detect medical device associated adverse events that are generally undetectable through routine surveillance; postmarket evaluation of the Oxyfirst fetal oxygen saturation monitoring system; breast implant rupture; evaluation of the completeness of studies undertaken by industry as a condition of premarket approval of their products; adverse events associated with the adjustable silicone gastric band; use of the National Electronic Injury Surveillance System (NEISS) to assess the frequency of injuries due to medical devices; gender differences in pulmonary artery rupture; and uses and outcomes associated with transmyocardial revascularization.

ODE/DRAD/EB Pilot Project

As part of CDRH’s effort to formalize Total Product Life Cycle precepts within the premarket review process, ODE’s Division of Reproductive, Abdominal, and Radiological Devices (DRARD) participated in a pilot cooperative project from February 2002 to February 2003 with the Epidemiology Branch (EB) of the Office of Surveillance and Biometrics. The purpose of the project was: to determine when and how the EB could best provide appropriate input/recommendations to DRARD regarding potential postmarket investigations and to initiate, and later evaluate, product-specific postmarket plans. Over the course of the year each epidemiologist participated in the review of a PMA being evaluated by DRARD. Two of the PMAs that were approved during the year had post-approval studies. In both cases the epidemiology reviewer played a large role in the study design. There also were a few “firsts” that took place during the pilot project. This was the first time that the EB was involved with an expedited PMA and the first time well-defined Postmarket Plans were developed prior to device approval. It also was the second time that the EB made a presentation to the panel as part of the FDA presentation of the PMA. Both groups believed that the involvement of the EB in the PMA review enhanced the review process. All participants believed that early involvement was the best approach. Both sides believed that there was not enough experience gained from just one year, but that the collaboration looked very promising. Therefore, the decision was made to continue and refine the pilot project over the next year.

Drug-Eluting Stents

FDA and the American College of Cardiology (ACC) began studying drug-eluting stents within the ACC’s National Cardiovascular Data Registry (ACC-NCDR). The ACC-NCDR is a confidential quality measurement program for cardiovascular specialists, hospitals, and cardiac catheterizations labs for collecting information on practice patterns and outcomes. The registry collects 142 core data elements needed for measuring the clinical management and outcomes of patients undergoing diagnostic cardiac catherizations and percutaneous coronary interventions. The ACC-NCDR consists of over 1.4 million patient records. FDA currently has a contract with ACC to access data with specific patient- and procedure-level information to examine the prevalence of use and experience of patients with drug-eluting stents.

 Medical Errors

Guidance for Industry on Reducing Medical Errors Associated with Patient/Provider Use of New Products
CDRH developed a model of use errors based on real-world experiences of nurses, biomedical engineers, and home users who use a variety of medical equipment and on known examples of use errors from literature and experience within CDRH and Human Factors (HF) and a few from HF in other industries (but which could apply to medical devices). The current model, called UPCARE, consists of four main components: Unmet User Needs, Perception; Cognition, and Actions. These four broad categories represent all cases of use-error that have been collected and each is broken down further within the model into subcategories. The categorizations are based on actual experiences of users and known use problems. UPCARE represents the only known descriptive model of use-errors with medical devices and was presented at the 8th Annual International Conference of Industrial Engineering Theory Applications and Practice in Las Vegas this year. Upon completion of this work, it will provide a source of specific and useful information for manufacturers, adverse event reporters and evaluators, reviewers of new device submissions, and device users. As such it will help guide design refinements in medical equipment and support other strategies for error-reduction.

 Electronic Labeling

Usability Research in Best Rractices for the Presentation of Electronic Labeling
On November 18, 2003 OHIP hosted the “Medical Device Electronic Labeling Conference.” The purpose of the conference was to add to the knowledge base about current best practices for conveying medical device information electronically to health care professionals, patients, and consumers. Five experts from the public and private sector presented information about research-based Web design and usability guidelines, user-centered design issues, and writing style and format for Web-based applications. Attendees included representatives from all the Centers.