4
Identifying and Understanding Adverse Medical Device Events

“The hardest thing over the time that he was growing up—in the first year, mostly—was establishing my credibility with the doctors as a reporter to them…. [T]hat was the hardest thing, people not believing … that there was something going on and that I wasn’t just a hysterical mother.”

Nancy Harder, parent, 2004

Communication gaps between patients or parents and physicians are a longstanding concern in medicine and can cause considerable distress to parents. Poor communication can contribute to adverse events or other harms when physicians do not give credence to patient or family reports of problems, as recounted in the quote above from the mother of two children who have spina bifida and rely on cerebrospinal fluid shunts and other medical devices. Inadequate communication can also create problems when patients and family caregivers are inadequately prepared to fulfill their responsibilities for using or maintaining complex medical device. As care has shifted out of the hospital into the home, parents are bringing children home with ventilators, feeding tubes, monitors, and other complex or unfamiliar devices. This is stressful enough without the additional stress of poor training and education about the device use and problem identification. Communication gaps may reflect a physician’s lack of awareness of the problems that families and patients face in safely using medical equipment at home.

As emphasized in Chapter 1, the migration of care from hospital to home has brought many benefits, but it also presents risks as parents and families assume responsibilities for device operation, maintenance, and problem recognition once assigned to health care professionals. Surveillance programs, which have other limitations described in this chapter, have yet to adjust to the changed circumstances of much patient care.

The identification, reporting, and analysis of serious adverse device events and device failures and malfunctions are important elements of the



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Safe Medical Devices for Children 4 Identifying and Understanding Adverse Medical Device Events “The hardest thing over the time that he was growing up—in the first year, mostly—was establishing my credibility with the doctors as a reporter to them…. [T]hat was the hardest thing, people not believing … that there was something going on and that I wasn’t just a hysterical mother.” Nancy Harder, parent, 2004 Communication gaps between patients or parents and physicians are a longstanding concern in medicine and can cause considerable distress to parents. Poor communication can contribute to adverse events or other harms when physicians do not give credence to patient or family reports of problems, as recounted in the quote above from the mother of two children who have spina bifida and rely on cerebrospinal fluid shunts and other medical devices. Inadequate communication can also create problems when patients and family caregivers are inadequately prepared to fulfill their responsibilities for using or maintaining complex medical device. As care has shifted out of the hospital into the home, parents are bringing children home with ventilators, feeding tubes, monitors, and other complex or unfamiliar devices. This is stressful enough without the additional stress of poor training and education about the device use and problem identification. Communication gaps may reflect a physician’s lack of awareness of the problems that families and patients face in safely using medical equipment at home. As emphasized in Chapter 1, the migration of care from hospital to home has brought many benefits, but it also presents risks as parents and families assume responsibilities for device operation, maintenance, and problem recognition once assigned to health care professionals. Surveillance programs, which have other limitations described in this chapter, have yet to adjust to the changed circumstances of much patient care. The identification, reporting, and analysis of serious adverse device events and device failures and malfunctions are important elements of the

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Safe Medical Devices for Children U.S. Food and Drug Administration’s (FDA’s) overall program of postmarket surveillance. A primary aim of the agency’s adverse event reporting program is to identify serious problems with a device (or its use) that become evident after a device is marketed when—depending on the device—it is used with many more patients, with different patient populations (e.g., children), in different ways (e.g., involving ad hoc modifications for pediatric use), for different purposes, in new and possibly less well-equipped settings, over longer periods, and, sometimes, by less experienced or skilled clinicians and care teams. Systematic clinical studies are often a superior tool for assessing these dimensions of device use, but such studies are not realistic for the entire array of devices that enter the market each year. Moreover, just as premarket studies may fail to detect rare events, so may postmarket clinical studies. Although FDA is most interested in reports of serious unanticipated events, the adverse event reporting program also collects information that can be useful in understanding certain already recognized risks, for example, patient deaths by entrapment in the rails of hospital beds. In addition, reports of device failures and malfunctions—even when they have not caused harm—can help FDA and manufacturers to detect hazards that arise from aberrations in the manufacturing, distribution, modification, maintenance, storage, or reprocessing of a medical device. Adverse event reports can also lead to improvements in the design of a device. For example, in response to problem reports, manufacturers have redesigned cardiac pacemakers to make them substantially less susceptible to electromagnetic interference from modern necessities such as microwave ovens and cellular telephones (Niehaus and Tebbenjohanns, 2001). For the most part, the public health goals and the limitations of postmarket surveillance policies and programs apply to both adults and children. Systems that support effective postmarket surveillance for patients generally are the foundation on which additions, adaptations, or emphases suited to children’s particular needs are then built. For example, the FDA guidance on assessment of pediatric medical devices cited in Chapter 2 makes sense only within an already existing structure for evaluating the safety and effectiveness of medical devices. The first part of this chapter expands on Chapter 3’s description of the FDA program for adverse event reporting. It includes statistics on reports to FDA of adverse device events that involve children and presents examples of actual reports. This discussion is followed by a number of vignettes that illustrate the range of factors and devices that contribute to adverse medical device events with children and the complexities in identifying and understanding these events. Most of the vignettes depict events that result not from single faults or errors but rather from the interplay between weaknesses in some aspect of the design or manufacture of devices and the

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Safe Medical Devices for Children circumstances of their use with children. Following the vignettes is a review of the sources of adverse events, the limitations of adverse event reporting, and FDA responses to these limitations. The chapter concludes with recommendations for the FDA. ADVERSE DEVICE EVENT REPORTING AND FDA As described in Chapter 3, FDA has authority for two programs of adverse event reporting that involve medical devices. The primary program receives mandatory reports of certain adverse device events from device manufacturers and user facilities and also accepts voluntary reports from health care professionals, consumers, and others. This program is a form of passive surveillance in that it awaits event reports. Active surveillance involves more direct effort by a sponsoring agency to obtain information, for example, through surveys. In addition, based on a sample of user facilities, FDA has created the pilot MedSun program, which includes some elements of active surveillance. FDA provides Form 3500A (online at http://www.fda.gov/medwatch/getforms.htm) for manufacturers, user facilities, and importers to use for mandatory reporting of serious adverse events and problems involving devices, drugs, and biologics. (Vaccines have a separate reporting system.) The first page of the form asks for information about the patient (including age, sex, and weight); event or product problem, including an open-ended description of the problem; product, including identifying information (e.g., for devices, the brand name, model, manufacturer, model and lot numbers) and other details (e.g., whether a device was an implant and if explanted, whether it is available for examination, and what concomitant medical products or therapies in use); outcome (e.g., whether it involved a death or required some kind of intervention); and initial reporter (e.g., contact information, whether a health professional). The second page of the mandatory reporting form requests additional information from user facilities and importers (e.g., where the event occurred, when they became aware of it, who to contact for further information) and manufacturers (e.g., whether they evaluated the device, whether they took any remedial action. For voluntary reports, FDA provides Form 3500, which has a first page that is almost identical to Form 3500A but has no second page. FDA also offers the option of online reporting for voluntary reporters. The voluntary

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Safe Medical Devices for Children reporting form, the online option, and the instructions for reporting clearly require reading skills and knowledge above the levels possessed by many consumers. For example, the form uses terms like “relevant history,” “congenital anomaly,” “concomitant products,” “event abated,” and “labeled strength” (FDA, 2003o). The agency urges consumers who want to report an event to have their physician complete the form. Both mandatory and voluntary reports involving devices are compiled in the Manufacturer and User Facility Device Experience database (MAUDE). After certain information is removed (e.g., patient age, facility name), the reports are made available in a searchable public database. FDA and manufacturers have access to the full reports to support their analyses. Table 4.1 shows the number of adverse event reports received by FDA from late 1984 to 2004 by major category of reporter, requirement for reporting (mandatory or voluntary), and type of event as designated by the person reporting it. The great majority of reports in MAUDE are submitted by manufacturers. One of the most notable trends shown in the table is the shift of adverse event reports to the alternative summary reporting option after its introduction by FDA in 1995. In recent years, such summary reports have accounted for more than half of total reports, for example, nearly 98,000 of the almost 152,000 reports received in 2004. The sizeable increase in adverse event reports (primarily injuries and malfunctions) from 1992 through 1994 has been attributed, in part, to reports of problems with silicone breast implants, which account for almost one-third of all reports from manufacturers (GAO, 1997). Mandatory user facility reports account for less than 3 percent of the reports in Table 4.1. This number is, however, somewhat deceptive because FDA attempts to eliminate duplicate reports from the statistics so that a facility report that goes to both FDA and the manufacturer (and then to FDA) is not counted twice. (Facilities are supposed to report to FDA directly only if an event involves a death or the manufacturer of a device is not known.) Voluntary reports from health care professionals and consumers also account for a small percentage of reports (about 3 percent each year). Unlike some patient safety programs described later in this chapter, FDA does not require or encourage reports of close calls from user facilities. In contrast, manufacturers are required to report device-related malfunctions, including those that could cause a death or serious injury if they recurred. When close calls involve situations with the potential to recur and cause harm, reports of such events may provide valuable signals if manufacturer and FDA analysts are prepared to notice them. FDA sometimes discovers deficiencies in manufacturer reporting of adverse events and product problems (or their systems related to such reporting) during quality systems inspections, through investigations of incidents, and in other ways. The agency typically responds with letters that

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Safe Medical Devices for Children TABLE 4.1 Adverse Event Reports Submitted to FDA, Late 1984 Through December 2004   <1985 1985 1986 1987 Manufacturer reportsa Death 13 585 543 516 Injury 109 9,483 11,738 9,589 Malfunction 28 8,812 7,096 7,596 Other 2 62 10 5 SUBTOTAL 152 18,942 19,387 17,706 User facility reportsb Death   Injury Malfunction Other SUBTOTAL 0 0 0 0 Distributor and importer reportsc Death   Injury Malfunction Other SUBTOTAL 0 0 0 0 Voluntary reportsd Death   31 27 21 Injury   345 482 288 Malfunction   520 472 349 Other 22,602 2,097 2,170 1,827 SUBTOTAL 22,602 2,993 3,151 2,485 Summary reportse 0 0 0 0 GRAND TOTAL 22,754 21,935 22,538 20,191

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Safe Medical Devices for Children 1988 1989 1990 1991 1992 1993 1994 565 730 951 1,133 1,528 1,339 1,870 8,366 9,845 11,809 18,521 52,894 61,885 79,537 6,677 9,298 16,840 24,796 21,583 45,608 48,629 7 7 4 15 13 38 35 15,615 19,880 29,604 44,465 76,018 108,870 130,071   7 287 250 266 2 1,285 1,229 2,338 6 1,083 988 989 0 142 337 554 0 0 0 15 2,797 2,804 4,147   11 18 49 251 1,103 1,803 33 139 274 6 13 121 0 0 0 0 301 1,273 2,247 32 19 319 32 4 5 61 194 364 140 54 77 280 1,292 294 255 252 85 95 167 1,508 1,716 1,664 1,894 3,610 4,439 3,013 2,015 2,236 2,302 2,605 3,781 4,615 3,465 4,876 0 0 0 0 0 0 0 17,851 22,182 32,209 48,261 83,731 116,412 141,341

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Safe Medical Devices for Children   1995 1996 1997 1998 Manufacturer reportsa Death 1,773 1,389 1,019 1,021 Injury 51,752 38,236 31,122 18,554 Malfunction 50,125 37,830 32,833 31,960 Other 28 631 2,299 2,485 SUBTOTAL 103,678 78,086 67,273 54,020 User facility reportsb Death 211 346 326 276 Injury 2,315 3,173 3,892 2,556 Malfunction 780 1,091 1,293 860 Other 657 697 657 446 SUBTOTAL 3,963 5,307 6,168 4,138 Distributor and importer reportsc Death 19 27 35 13 Injury 1,661 3,606 1,364 189 Malfunction 164 213 169 289 Other 169 150 70 50 SUBTOTAL 2,013 3,996 1,638 541 Voluntary reportsd Death 73 63 67 75 Injury 1,559 864 835 963 Malfunction 1,367 1,494 1,299 1,523 Other 782 565 405 391 SUBTOTAL 3,781 2,986 2,606 2,952 Summary reportse 2,755 6,292 21,682 36,190 GRAND TOTAL 116,190 96,667 99,367 97,841 NOTE: Represents most current data (March 31, 2005) for period through December 31, 2004. Yearly report counts are updated periodically to account for delayed data entry issues (e.g., backlog of reports not entered). aReceived since December 1984 (MDR Regulation, December 13, 1984). bReceived since 1992 (Safe Medical Devices Act of 1990). cReceived since 1992 (Safe Medical Devices Act of 1990). Distributors reported since December 19, 1998 (FDA Modernization Act of 1997).

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Safe Medical Devices for Children 1999 2000 2001 2002 2003 2004 TOTAL 905 1,017 1,366 1,266 1,466 1,879 22,874 13,073 13,646 17,354 17,955 18,832 22,769 517,069 29,199 27,683 29,418 36,988 37,270 18,563 528,832 3,140 3,132 2,960 3,544 4,222 3,645 26,284 46,317 45,478 51,098 59,753 61,790 46,856 1,095,059 233 211 240 200 200 217 3,267 1,777 1,568 1,625 1,448 1,156 1,034 25,398 738 654 675 729 1,146 1,405 12,437 264 323 274 303 362 460 5,476 3,012 2,756 2,814 2,680 2,864 3,116 46,581 11 11 9 7 1 3 214 85 55 142 117 198 255 10,829 711 536 206 313 701 184 3,932 78 619 210 297 95 56 1,934 885 1,221 567 734 995 498 16,909 54 92 102 104 153 115 1,449 899 1,397 1,223 1,246 1,200 1,299 15,001 1,416 1,245 1,513 1,773 1,820 1,759 19,206 319 373 411 522 587 538 51,940 2,688 3,107 3,249 3,645 3,760 3,711 87,596 36,969 46,075 65,818 79,189 91,192 97,698 483,860 89,871 98,637 123,546 146,001 160,601 151,879 1,730,005 dReceived from 1973 to 1992 (Medical Device Laboratory Product Problem Reporting Program) and 1992 to present (MedWatch). eReceived from manufacturers that have been granted exemptions (beginning 1995) from reporting individual adverse events. SOURCE: Division of Surveillance Systems, FDA Center for Devices and Radiological Health.

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Safe Medical Devices for Children outline the problems and needed corrections. Only rarely are criminal penalties sought.1 FDA staff could not cite cases in which user facilities had been penalized for failure to comply with their mandatory reporting obligations (personal communication, Thomas P. Gross, M.D., Director, Division of Postmarket Surveillance, CDRH, January 28, 2005). Table 4.2 shows the number of reports submitted that identified adverse events as involving patients under age 21. (These data were supplied by FDA from their internal database. As noted above and in Chapter 3, the public database does not include information on age or birth date.) The table shows no entries for the summary reporting option because this option does not require information on patient age. The numbers presented in Table 4.2 are undoubtedly an undercount of all reported events that involved children (leaving aside all actual events). The fields on the reporting form that request birth date or age information are sometimes not completed, perhaps because the information is not immediately available to the reporter. In FDA’s analysis of reports of patient entanglement in hospital bed side rails—an event associated with high rates of death (65 percent of reports) and injury (23 percent of reports)—age was not included for 36 of 111 of the reports in MAUDE (Todd et al., 1997a,b). Of the 75 cases for which age data were provided, 5 percent involved patients under age 17. Even if event reporting were more complete, it would be difficult to assess the extent of a problem without knowing the population at risk (the denominator problem as discussed elsewhere in this report and in Appendix D). Box 4.1 presents several excerpts from reports to FDA of adverse events that involved children. The examples (which include the full narrative text of the reports) illustrate that reports vary greatly in the amount and usefulness of the information provided. Some offer a relatively clear picture of an event; others are incomplete. Reports nearly always focus on the immediate circumstances surrounding an event and thus are limited in the extent to which they point to contributing system factors, for example, understaffing. These examples of reports make evident some of the challenges in investigating adverse event reports, especially when the investigator is organizationally removed from the event, as is usually the case for manufacturer or FDA staff. For example, although manufacturers (and FDA) can often follow up with reporters to collect additional information, manufacturers may not have access to the device for inspection, and important information 1   To cite one noteworthy exception, in 2003, Endovascular Technologies, a subsidiary of a major device manufacturing company, entered guilty pleas on 10 felony charges involving failure to submit problem reports to FDA and paid more than $92 million in civil and criminal penalties to settle the case (Bren, 2003; Hilzenrath, 2003; Jacobs, 2003; Ostrov et al., 2003). The unit admitted to failing to report 2,600 incidents of serious adverse events (including 12 unreported deaths and 57 unreported emergency surgeries) or malfunctions between 1999 and 2001. Instead, it reported only 172 malfunctions. FDA learned of the suppressed reports through an anonymous letter from concerned company employees.

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Safe Medical Devices for Children TABLE 4.2 FDA Adverse Event Reports Involving Individuals Under Age 21 (1999–2004)a   1999 2000 2001 2002 2003 2004 TOTAL Manufacturer Death 29 39 94 101 96 92 451 Injury 513 483 838 948 1,040 1,371 5,193 Malfunction 523 540 795 1,279 980 438 4,555 Other 185 162 195 147 173 190 1,052 SUBTOTAL 1,250 1,224 1,922 2,475 2,289 2,091 11,251 User Facility Death 17 10 23 19 14 12 95 Injury 134 131 172 107 76 78 698 Malfunction 69 41 61 48 70 64 353 Other 28 17 22 32 39 32 170 SUBTOTAL 248 199 278 206 199 186 1,316 Importer Death 0 1 1 0 0 0 2 Injury 7 1 10 43 53 24 138 Malfunction 11 3 13 73 115 42 257 Other 4 19 6 8 2 0 39 SUBTOTAL 22 24 30 124 170 66 436 Voluntary Death 7 9 9 15 12 15 67 Injury 86 86 111 141 115 144 683 Malfunction 84 70 133 135 138 156 716 Other 25 31 27 35 38 26 182 SUBTOTAL 202 196 280 326 303 341 1,648 GRAND TOTAL 1,722 1,643 2,510 3,131 2,961 2,684 14,651 aNot all reports include information on patient age. SOURCE: Division of Surveillance Systems, CDRH. about the device (e.g., brand and model number and even manufacturer) may not have been documented. A later section of this chapter returns to these and other limitations of adverse event reporting programs. When FDA receives an adverse event or device malfunction report from a manufacturer or other party, it (actually a contractor) checks the report, codes certain information if it has not been coded already by the reporter, and enters the report into the database.2 FDA has developed codes for both clinical outcomes (e.g., cerebral hemorrhage) and device outcomes (e.g., 2   The description of the event review process and the discussion of analysis priorities are based on an April 15, 2004, presentation to the committee by Thomas P. Gross, M.D., Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH, and a June 24, 2004, presentation by Rosalie Bright, Epidemiologist, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH (see, Gross 2004; Bright, 2004).

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Safe Medical Devices for Children BOX 4.1 Excerpts from Examples of Reports Involving Children in FDA Adverse Event Databasea Device: Circumcision clamp FDA Device Classification: Clamp, circumcision Problem Description Circumcision using [circumcision] clamp. Clamp was loose, resulting in laceration of the glans penis with loss of tip. Infant was transferred to another hosp for urologic consultation and surgery to repair damaged penis. (MAUDE Report No. 257649) Device: Vacuum extractor FDA Device Classification: Extractor, vacuum, fetal Problem Description Infant boy was delivered at [time] on [date]. Delivery was complicated by a prolonged second stage. Infant suffered hemorrhage beneath scalp at birth. Infant was admitted to neonatal intensive care unit and was placed on ventilator at [time]. Infant expired at [time] on [date]. The cause of death was the hemorrhage. It is speculated that the hemorrhage resulted from the use of a vacuum extractor with a defective gauge. Gauge on the device registered in the green “safe” zone even though excess vacuum was being produced. This defect was confirmed by testing the device using a pressure transducer. There would have been no way the user of the device would have known that the gauge was defective and that a dangerous level of vacuum was being produced … Device manufacture date is 1/17/96. (MDR Access No. M763107) Device: Nasal dressing FDA Device Classification: Bandage, liquid Problem Description The nasal dressing was placed in the pt in 2004 subsequent to sinus surgery. Two days later the nasal dressing fell apart while trying to remove it. The hosp health professional tried to remove the dressing again in 2004 and was unable to do so. The next day the dressing was surgically removed. Manufacturer Response User was not able to provide lot number, therefore mfg data is unavailable. The device did not fail, but was apparently cut or teased apart in an attempt to remove it. Surgically removed sample showed the pvc pouch with foam inside was fully intact, three weeks following initial surgery; indicating that the core of the product did not come apart; but was wedged and had to be surgically removed. User selected a 3 cm adult size contributing to the difficulty of removal. More suitable choices, when dealing with a small child’s anatomy, include: the smaller removable dressing; model rr 200 which is 1/3 smaller than the device used. The dissolvable dressing; commonly used for pediatric cases because they can be trimmed to fit any size/shape anatomy, and do not require physical removal. (They dissolve away over time.) (MAUDE Report No. 1064611-2004-00002)

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Safe Medical Devices for Children Thus, they include both serious adverse events and close calls. Accredited health care organizations are expected to have internal policies and procedures for analyzing and responding to sentinel events, including the application of a root-cause analysis. Certain sentinel events are reviewable by the Joint Commission when voluntarily reported by hospitals or when otherwise identified (e.g., through a newspaper story or a patient report). One type of reviewable event is a perinatal death that is not related to a congenital condition in an infant with a birth weight greater than 2,500 grams. A root-cause analysis of the 84 such events reported between 1995 and 2004 found that the most frequent contributing factor was communication problems (JCAHO, 2004). Between 1995 and the end of 2004, the Joint Commission reviewed nearly 3,000 sentinel events (JCAHO, 2005b). The organization continues to be concerned about a low level of voluntary reporting, which limits the utility of the effort as a source of information about the nature and causes of events. One early review of the Joint Commission program suggested that if it had had the same yield as New York’s event reporting program, it would have received as many as 21 times the reports it actually did during the period reviewed (Wald and Shojania, 2001a). ECRI The most comprehensive private program of adverse event reporting and analysis related to medical devices is maintained by ECRI, a private nonprofit health services research and technology assessment organization. Among other activities related to patient safety, ECRI gathers and investigates reports of incidents involving medical devices from health care providers, patients, and manufacturers around the world. It provides investigative and consulting services to health care providers, governmental health agencies, and other organizations. Each year the organization receives more than 1,000 high-quality reports of medical device adverse events and publishes scores of original hazard reports on specific device models as well as problems generic to classes of medical devices. In 1973, ECRI’s problem reporting program served as a model for the newly emerging FDA Device Experience Network. ECRI’s monthly journal, Health Devices, includes independent medical device evaluations (e.g., recent evaluations of infusion pumps [ECRI, 2004c]) and reports on device safety. Another publication, Health Devices Alerts, provides weekly reports on medical device hazard and recall information, product safety alerts, reported problems and recommended responses, and published research on medical devices. In addition to the reports on circumcision clamps cited earlier, a number of ECRI reports

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Safe Medical Devices for Children have dealt with safety issues related to devices used with children, including incubators, cribs, ventilators, and automated external defibrillators. Under contract to FDA, the organization developed the education and training materials for recognition, investigation, and root-cause analysis of medical device adverse events for the pilot MedSun program. ECRI also assists in the analysis of the MedSun problem reports. In addition, ECRI has a contract with FDA to help harmonize FDA’s medical device product codes with the Global Medical Device Nomenclature (GMDN). It recently drafted a white paper for FDA on the automatic identification of medical devices. CONCLUSIONS AND RECOMMENDATIONS One theme of this report is that an effective regulatory program for evaluating and monitoring the safety of medical devices in general is a necessary foundation for efforts to safeguard children in particular. Thus, steps to improve FDA’s programs for the reporting of adverse device events overall should benefit children as well as adults. To promote more focused attention to pediatric issues, Chapter 7 includes a recommendation (7.1) that FDA identify a focal point of responsibility for pediatric issues within the Center for Devices and Radiological Health to evaluate the adequacy of the Center’s use of pediatric expertise and its attention to pediatric issues in all aspects of its work to promote medical device safety. Another theme of this report is that medical device safety is a shared responsibility. The recommendations below start with FDA but extend to include manufacturers, health professionals, user facilities, and patients and families. Chapter 7 extends this discussion. Within FDA, adverse event reporting and improvement should be understood in the entire context of the agency’s activities to protect patients and promote medical device safety from the early stages of device development through the end of a device’s useful life. These activities include guidance for developers of devices, premarket evaluations, systematic postmarket clinical studies of selected devices, public health notifications and additional information for users of devices, quality system inspections of manufacturers, and other strategies. The FDA program itself should be seen as part of a more expansive system of public and private programs and actions to safeguard patients and improve health outcomes. FDA Adverse Event Reporting As part of a larger system of postmarket surveillance and device safety regulation, a passive or spontaneous program of reporting has a role to play in detecting unexpected device problems (including problems with the use

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Safe Medical Devices for Children of a device) and increasing understanding of certain already recognized problems. Adverse event reports may provide the first signal that a problem exists with a device or its use or both. Adverse event reporting is particularly important for medical devices in pediatric use because events involving children are often unusual, are sometimes extreme, and identify problems in a patient population that often has not been studied before a device is marketed. Certainly, this report and many other analyses of spontaneous event reporting programs across diverse realms make clear that such programs have significant limitations. These limitations include underreporting, poor-quality reports, delayed reports, reports of problems not associated with a device (i.e., false-positive reports), and lack of information needed to compute and compare rates of events. Efforts to investigate a worrisome event report may be frustrated by distance in time and place from the event, with consequent loss of critical information about the circumstances surrounding the event and unavailability of the suspect device or devices for analysis. The adequacy of FDA resources for event analysis is also a concern. Initiatives to increase the spontaneous reporting of adverse events present a dilemma. On the one hand, there is general agreement that serious events are underreported; on the other hand, there is concern that increased reporting would likely bring an increase in reporting not only of serious events but also of “noise,” that is, reports that are of no real interest, that are so poorly prepared as to be useless, or that do not even involve device problems or adverse events. Such reports waste the resources of all involved. Nonetheless, the committee believes it is important for FDA to sustain and improve its adverse event reporting program and demonstrate its value. One objective should be to improve links between the reporting program and various FDA databases, including the databases for device recalls, enforcement, and public health notifications. For example, someone reporting or considering reporting a device problem through the online MedWatch option should be able to link easily and clearly to public health or recall notifications related to the device in question. FDA should also consider how to encourage reporters to identify when an event involves a child. In some cases, a facility reporter or a manufacturer will know that an incident involved a child without having the child’s exact age. It would be desirable to give such reporters an explicit opportunity to mark whether an event involved a child (age unknown). (The committee recognizes that changing the adverse event reporting form is a major, complicated undertaking, but encourages that this change be evaluated the next time that FDA or Congress considers revisions.) Recommendation 4.1: FDA should collaborate with industry, health care professionals and organizations, and parent and patient advocates to

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Safe Medical Devices for Children focus more attention on adverse device events, including events involving children; promote linkages between adverse event reporting systems, various FDA databases, and other safety programs; update product labeling, patient information, and other communications to promptly reflect safety-related findings from analyses of adverse event reports; and issue yearly reports on results from adverse event analyses, including findings involving children. Recommendation 4.2: FDA should continue educational and communication programs to promote recognition and useful reporting of serious adverse device events and device problems by hospitals and other user facilities. Such encouragement should continue whether or not requirements for mandatory reporting by user facilities are eventually eliminated with the effective implementation of the MedSun program. Reporting by user facilities of events possibly related to devices should continue to include deaths, serious injuries, and device malfunctions. In addition, as suggested earlier in this chapter, FDA should continue its efforts to educate providers about HIPAA and the legality and value of providing information to support postmarket surveillance. Such information includes not only adverse event reports but also data for required postmarket studies as discussed in Chapter 6. The legislation creating pilot MedSun program provided that mandatory reporting requirements for user facilities should end when the program is fully implemented. Before that happens, the evaluation of the program should consider MedSun’s performance both as an active surveillance system (e.g., responding to FDA inquiries, conducting special studies) and as a spontaneous reporting system for detecting serious unexpected device events. Given that many manufacturer investigations and reports of adverse events start with reports from user facilities, one question is whether it is prudent to eliminate mandatory reporting for these facilities, even if the limitations of such reporting are recognized and facilities are not sanctioned for failure to report. It would be unfortunate if user facilities felt even less responsibility to report serious events and deaths in the future. The careful evaluation of the pilot MedSun program will be critical. Although a formal evaluation is premature given that the pilot program is not fully implemented, FDA should be putting in place the data collection resources it will need for the evaluation. The evaluation should include an assessment of the extent to which reporting by non-MedSun facilities generates signals of significant device problems that are not reported by MedSun

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Safe Medical Devices for Children facilities (because they did not experience them or because they either did not detect them or did not report them). It is important for FDA to audit participant performance, including the periods when initial participants rotate out of the program and new facilities replace them. Recommendation 4.3: FDA’s plan for evaluating MedSun’s performance as a replacement for and improvement on mandatory user facility reporting should include, among other elements: assessment of ongoing program and participant facility success in educating facility personnel about identifying, evaluating, and reporting adverse device events and improving the quality, timeliness, and usefulness of event reports; determination of the extent to which the sample of MedSun participating hospitals—including children’s hospitals—represents the relevant range of facility characteristics and experiences, including representation of both academic medical centers and community hospitals and sufficient representation of facilities with device-oriented specialties and procedures; comparison with the mandatory user facility reporting system, including the extent to which either program produced reports for FDA or manufacturers of emerging hazards, important close calls, or other significant events (including those involving children) that were missed or delayed by the other; and evaluation of the active surveillance components of the program in reducing harm to patients, promoting constructive communication between facilities and FDA, and improving timely knowledge of the nature and extent of selected device problems, including errors in the use and design of devices. Prior to formal evaluation of MedSun, the committee encourages FDA efforts to extend to other institutions the lessons the agency and participants learn as they implement the program. For example, after their value has been assessed and revisions considered, the training materials developed for MedSun participants could be made more widely available. It is reasonable to provide MedSun participants with incentives to participate, but the written materials used in the program are only a small part of these incentives. Likewise, FDA should consider whether the information in the newsletter provided for MedSun participants could be used, at least in part, as a communication tool to inform interested parties in other facilities and encourage timely, complete, and appropriate reporting of adverse device events and other device problems to manufacturers and FDA. Despite the agency’s claim

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Safe Medical Devices for Children that its discontinued user facility newsletter had served its purpose, the problems of facility underreporting and poor-quality reporting remain significant. The committee commends FDA for the oversampling of children’s hospitals in the MedSun program. The MedSun participating children’s hospitals should be considered not only as a particular resource for investigation of safety questions related to children but also as a resource or base for a broader set of device safety activities involving children’s hospitals, CHCA, and NACHRI. Recommendation 4.4: Within the pilot MedSun program, FDA and participating children’s hospitals should serve as a resource for the broader involvement of children’s hospitals in patient safety programs to identify, evaluate, respond to, or prevent problems with the use and design of medical devices. In addition, FDA should promote efforts to link or otherwise employ event reporting, device recall, safety notification, and other databases within and outside FDA to better assess and report on device safety issues involving children. Information generated by MedSun could also prove more broadly useful. For example, it could be shared with academic clinicians and engineers to stimulate studies to identify device redesign or other strategies to prevent identified problems. This chapter has noted the lack of a practical, precise coding scheme for medical devices that allows identification of specific models and brands of implants and other devices. Chapter 6 includes a recommendation (6.2) for the development and adoption of common device coding and other standards and approaches for capturing and linking use and outcomes data for medical devices. Manufacturers Sophisticated manufacturers recognize good adverse event reporting as a resource to help them learn about and correct problems with existing devices and identify areas for design refinement or product innovation. If adverse event reporting programs for devices are to improve device safety, manufacturers must receive timely and useful event reports, maintain sound procedures for evaluating these reports, and respond to identified problems on a timely basis. FDA regulations provide detailed direction on manufacturer responsibilities, and site inspections include a review of manufacturer compliance. In addition to designing and redesigning devices to protect against unsafe use, promoting the safe use of devices is another important responsibility of device manufacturers. For some complex, high-risk implants and other devices, safe and effective use may require professionals to develop

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Safe Medical Devices for Children new procedural and assessment skills. Some manufacturers have established mechanisms to develop and evaluate the competency of professionals to use such devices, and expectations for training and competency may be reflected in the labeling of the device. Training associated with such devices should cover the identification and reporting of adverse events. Recommendation 4.5: When FDA mandates or agrees to device labeling that requires professionals to be trained in the safe and appropriate use of a medical device, the training should include information on the identification of adverse events, voluntary adverse event reporting under MedWatch, and user facility and manufacturer medical device reporting (MDR) requirements. In addition, for complex devices that involve monitoring or operation by patients or families, manufacturers should provide directions about when and where to seek help, advice on reporting problems, and instructions, warnings, and troubleshooting guidelines that are understandable to nonprofessionals. Some manufacturers already have strong patient education and assistance programs. For certain home-use devices, FDA should consider requirements that manufacturers of certain devices (e.g., the orthodontic headgear mentioned earlier) affix labels stating that injuries related to the device can be reported to FDA. FDA inspections of manufacturers should continue to include, as part of quality systems inspections, attention to complaint handling and event investigation and reporting. As discussed in Chapters 3 and 7, such inspections are occurring substantially less frequently than required by law. Health Professionals and Professional Organizations For many if not most medical devices, health care professionals who care for children occupy the critical intersection between device manufacturers and children and their families. They are well positioned to understand devices, evaluate their successes and failures with individual children, receive early warning of problems through professional networks, and determine what kinds of education health care workers—and patients or families—need to use devices safely. Significant complications with devices are often first reported at professional meetings without prior reporting to FDA, manufacturers, or other patient safety programs. Child health professionals are thus an essential but underdeveloped resource for identifying and reporting adverse device events. The challenge is how to better employ this resource to protect patients. One difficulty is that pediatricians and other child health professionals are bombarded with advice, guidance, directives, and educational materials of all sorts. The likelihood that these incoming messages will change behav-

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Safe Medical Devices for Children ior (or even be read) should certainly not be assumed, especially if financial and other pressures work in opposing directions. Nonetheless, incremental opportunities exist to improve recognition by child health professionals that medical device problems are reportable events, that reporting events has the potential to stimulate product and process improvements to benefit children, and that reevaluation rather than acceptance of certain common problems may be warranted. For example, following direct mailings, continuing medical education, and other efforts to increase reporting by professionals to the Vaccine Adverse Event Reporting System (VAERS), the proportion of all vaccine adverse event reports that were attributed to health care professionals increased from 11 percent in 1991 to 35 percent in 2001 (Zhou et al., 2003). The committee recognizes that medical device reporting involves a vastly larger array and diversity of products, but FDA can collaborate with professional societies to set priorities for educational efforts. The agency can work with pediatric and other professional societies and journals, residency programs, and other resources to add messages about recognizing and reporting adverse device events to the messages that are already being disseminated about reducing health care errors and improving the quality of care for children. In discussions with professional groups such as the American Academy of Pediatrics (AAP) and others, the committee found a general willingness of the groups to become more involved in efforts to promote the safe use of medical devices with children (AAP et al., 2004b; ACC, 2004; ATS, 2004a). These efforts encompass both the reporting of adverse events and the expanded use of registries as well as other means of developing better information about the short- and long-term outcomes of medical device use. Recommendation 4.6: Medical, surgical, and other organizations or societies that include health professionals who care for children should establish working groups to evaluate problems as well as benefits in the pediatric use of devices of particular importance to their practice; collaborate with existing public and private patient safety initiatives to add or expand attention to safe and appropriate use of medical devices with children; establish standards for professional education and competency in the use of these devices; and include as professional competencies the identification and appropriate reporting of device problems and the successful communication with patients and families about how to prevent, recognize, and respond to device problems.

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Safe Medical Devices for Children Information from adverse event and case reports as well as systematic clinical studies and registry-based research will help provide a stronger evidence base for pediatric practice guidelines and standards of competency. These guidelines and standards should, in turn, reduce the unsafe and unnecessary use of devices. Hospital and Other Device Safety Programs Hospital and other patient safety programs that now focus almost exclusively on errors or problems involving other medical products and services can extend their reach. For example, for devices used with children, possible targets for such programs include certain types of common workarounds that have not been assessed adequately to determine the extent to which they constitute reactions to device problems, pose risks of their own, or warrant reconsideration of the way devices are used or designed. One objective of the MedSun program is to encourage more coherence in user facility device safety programs. Children’s and other hospitals generally lack the kind of obvious focal point for medical device safety that pharmacists provide for drugs. Clinical engineering units, risk management departments, an array of clinical units, quality assurance programs, materials management divisions, purchasing departments, and other units share a fragmented and incomplete accountability for device safety. Recommendation 4.7: Children’s hospitals and other user facilities should establish a focal point of responsibility for medical device safety. Tasks include reviewing and monitoring the adequacy of institutional programs in areas such as tracking of safety alerts and recalls, responding to safety alerts and recalls, training in adverse event evaluation and reporting, and factoring safety data or evaluations into device purchase decisions. FDA should also charge its home health committee with investigating the role of home health agencies and vendors that supply home medical equipment in reporting adverse events and examining what might be done to support these providers. It is important that these organizations focus on identifying and resolving problems, but it is also important that serious problems be reported to manufacturers and FDA. A better understanding of problems with devices used in the home may promote refinements in the design of such devices, changes in the selection and monitoring of devices for home use, and improved information and training for patients and families.

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Safe Medical Devices for Children Resources for Patients and Families Given the continued movement of complex care into the home, FDA should seek more creative ways to publicize its device safety activities and resources to patients and families, particularly families caring at home for children who rely on complex, life-sustaining medical devices. The CDRH checklist on medical devices for home use is a good model that should be more widely disseminated, including by professional and provider groups such as AAP and NACHRI. Adverse event reporting will hardly be a first priority for families who confront a problem with a device. Troubleshooting and getting assistance from health care professionals, manufacturers, and home care agencies or vendors will take precedence, especially if the problem involves a life-supporting device. Nonetheless, some families may appreciate the opportunity to report their experiences with device problems further, for example, by sharing what happened and what was learned with other families through various kinds of family and patient support groups. Some families may learn that they can report problems to FDA. The agency sensibly advises consumers who wish to report adverse events to seek the assistance of their physicians, who can provide clinical and technical details that may be important in understanding and describing the nature of the problem. Some patients and families, however, may wish to report directly to FDA without involving a physician. They may, for example, worry about alienating a physician they depend on by complaining about a device that the physician prescribed. They may also feel that a physician has ignored or dismissed their observations about a problem because their description of an event or problem was not technically sophisticated. Such dismissal risks overlooking real problems observed by those who are with the patient for extended periods. Although FDA may have qualms about the quality and utility of the information received from patients and families, it still should offer consumers easier opportunities to report. As discussed earlier, the consumer who wishes to report a problem through the agency’s MedWatch program now faces instructions that are not written with the layperson in mind. FDA should enlist its home health committee and others in advising on the creation of a simpler event reporting form in lay language for consumer reporting of events. (Again, the committee recognizes that changes in Form 3500 or 3500A involve a lengthy process.) The agency’s online reporting option could also be modified to provide additional explanations and assistance aimed specifically at lay users. Ideally, the online reporting option would also be designed to provide some feedback to reporters, for example, by directing consumers to additional resources such as advice on discussing concerns with a manufacturer or vendor and instructions about returning a

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Safe Medical Devices for Children device (with problem documentation) to a manufacturer or vendor. It could provide links to reports on safety problems with a device that is the subject of a consumer’s report. The committee recognizes that it is not feasible to provide individualized feedback for each consumer report, but information technologies have the potential to allow more than a computerized thank you or acknowledgment of a report. Recommendation 4.8: FDA should continue to improve and expand its medical device safety resources for patients and families and its focus on devices used in the home and community by working with patient, family, and consumer organizations, providers, and industry to make it easier for patients or their families to report device problems to manufacturers or FDA and to learn about resources to support the safe use of medical devices; making online reporting and information resources more accessible by using language and directions appropriate for lay users; and enlisting hospitals, home care agencies and vendors, and other professional and provider groups to promote patient and family understanding of how to use devices safely, when and how to seek help, and when and how to report problems. The recommendations above cover many areas for improvement in the agency’s adverse event reporting program for medical devices. At the same time, Congress and FDA deserve credit for past and continuing efforts to improve the program. These efforts include, for example, creating an online reporting option, developing computerized aids to screen reports and identify problems, creating a more active surveillance initiative in the pilot MedSun program, and using adverse event reports to inform the agency’s human factors research program. In addition to continuing efforts to improve the existing program and fully implement the MedSun program, FDA is investigating additional forward-looking or prospective strategies based on automated patient information systems that would not only improve the detection and investigation of adverse events but also identify device hazards or hazardous practices before they cause harm to patients. The agency recognizes that this strategy requires improved means of identifying medical devices for purposes of analyzing and responding to adverse event reports. In particular, codes for use in the medical record should allow identification of both the manufacturer and model of a device rather than, as now, a general category of device (e.g., apnea monitor). The next chapter of this report shifts attention to a different dimension of postmarket surveillance of medical devices. It examines the monitoring by FDA of postmarket studies required by FDA.