Safe Medical Devices for Children (2006) / Chapter Skim
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4 Identifying and Understanding Adverse Medical Device Events
4 Identifying and Understanding Adverse Medical Device Events
Pages 112-182
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From page 112... ...
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.
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From page 113... ...
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.
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From page 114... ...
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.
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From page 115... ...
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.
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116 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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From page 117... ...
IDENTIFYING AND UNDERSTANDING ADVERSE MEDICAL DEVICE EVENTS 117 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 continued
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From page 118... ...
. cReceived since 1992 (Safe Medical Devices Act of 1990)
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From page 119... ...
from reporting individual adverse events. SOURCE: Division of Surveillance Systems, FDA Center for Devices and Radiological Health.
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. The unit admitted to failing to report 2,600 incidents of serious adverse events (including 12 unreported deaths and 57 unreported emergency surgeries)
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From page 121... ...
may not have been documented. A later section of this chapter returns to these and other limitations of adverse event reporting programs.
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From page 122... ...
Infant suffered hemorrhage beneath scalp at birth. Infant was admitted to neonatal intensive care unit and was placed on venti lator at [time]
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From page 123... ...
Manufacturer Response The suspect device was discarded by user facility. Lot info is not available.
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In fiscal year 2003, the major problems identified through analysis of adverse events
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From page 125... ...
are supposed to monitor their event reports for trends and changes in frequency or severity of adverse events. Such monitoring could prompt further investigation and action (e.g., a recall)
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From page 126... ...
The examples do not attempt to represent proportionately the distribution of reported (much less actual) adverse events by type of device, problem, or reported consequences.
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From page 127... ...
Other vignettes describe problems associated with long-term use of an implanted or partly implanted device, that is, problems that cannot be expected to be evident in the relatively short-term clinical studies that are usually submitted as part of the FDA approval or clearance process for medical devices. Absent systematic long-term studies of medical device safety and effectiveness, such adverse events -- as well as rare shortterm events -- may only slowly reveal themselves in usual clinical care.
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From page 128... ...
Consistent with the clinic's patient safety and quality improve ment policies, the doctor reported the problem internally. The clinic patient safety officer found other reports in the medical literature of aspirated hypodermic syringe caps, some involving deaths.
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From page 129... ...
As in this incident, inexperienced users of a device -- even a "low-tech" circumcision clamp -- contribute to adverse device events, but deficient hospital systems of training and credentialing for procedures -- which would likely not be mentioned in an ad verse event report -- can play a role. The physician, a new pediatric resident, was preparing to cir cumcise newborn baby John.
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From page 130... ...
130 SAFE MEDICAL DEVICES FOR CHILDREN Device involved: Circumcision clamp. Proximate cause: Use error: physician failed to determine that the device used met use specifications and was undamaged.
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From page 131... ...
Orthodontic headgear is commonly prescribed by orthodontists to correct the alignment and position of the teeth. Safe use of devices by patients or families depends on their ade quate education and understanding of safety issues, including how
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From page 132... ...
Proximate cause: Device design, including hazardous points, al lowed dislodgement from user movement during sleep. Institutional/systemic factors: Poor communication about a hazard with rare but sometimes severe consequences; continued profes sional use of hazardous device design despite subsequent develop ment and marketing of safer devices for most situations.
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From page 133... ...
Several weeks later, through the same informal communication channel, they learned that the manufacturer was recalling the device, and several days later, the risk management department received a letter to that effect. All involved were surprised to see subsequent news stories about problems at a prominent academic medical center whose physicians had not been promptly notified of the bronchoscope problem and recall because the notification letter had been misdi rected.
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Comment: Devices may not be initially suspected as sources of infection, and making a definitive link can involve considerable investigation and testing. Manufacturers and hospitals have room for improvement in managing device recalls.
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From page 135... ...
For operators of medical de vices, understanding of and adherence to safe procedures for enter ing and checking patient and treatment data for medical devices is critical. Familiarity with the routines of data entry can lead opera tors to take shortcuts, forego cross-checking or rechecking of infor mation, and assume incorrectly that a device is operating consistent with the treatment plan.
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From page 136... ...
. For a report on serious radiation device adverse event involving soft ware, see Doyle (2000)
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From page 137... ...
Proximate cause: Tension from fixed distance between internal and external discs of the g-tube, which caused pressure on the tissues of the child's growing abdominal wall; embedding of corners of triangular-shaped internal retention disc not noticed, possibly due to the child's inability to communicate discomfort in a specific manner. Institutional/system factors: Lack of procedures to evaluate dis tress in patient with communication limitations; lack of adequate protocol for monitoring implanted devices in such patients; tube placed by radiologist who would not be expected to be involved in follow-up management of the device; no apparent hand-off of de vice management to other physician involved in child's care.
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From page 138... ...
As in this story, treatments once confined to hospitals are also taking place in the home and school. Parents and others now provide care and cope with medical devices -- and problems -- that formerly were the domain of health professionals.
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From page 139... ...
Subsequently, Katie's mom took the girl to the hospital's emergency room for all of her antibi otic doses until the infection resolved. Devices involved: Portable IV infusion pump.
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140 SAFE MEDICAL DEVICES FOR CHILDREN sulted a craniofacial group that offered "stretching" of the child's midface using a process similar to that used earlier to widen his palate. The process, which is common in orthodontal work, is called distraction osteogenesis.
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From page 141... ...
Other comment: Absent systematic clinical studies, physicians us ing complex devices may lack adequate instructions about safe and effective methods of application and appropriate patient follow-up and monitoring. They likewise may lack sufficient information about the prospect of long-term benefits and short-term and long term harms to guide clinical and family decisions about the use of a device with children.
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From page 142... ...
Institutional/system factors: Possible slow detection of problem due to underreporting. Design factor: Device large relative to size of very young child with cerebral palsy (average 4-year-old girl with cerebral palsy weighs 24 pounds compared to normal weight of 35 pounds)
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From page 143... ...
Elizabeth, a 16-year-old with cystic fibrosis, had a "port-o cath" central venous catheter placed when she was 6 years old. This catheter had provided intravenous access for countless admis sions and treatments for pneumonia, each requiring long courses of antibiotics.
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From page 144... ...
In this vignette, an interventional radiologist attempted to remove a clot from the end of a central venous catheter using a procedure that had been re ported in the literature but not systematically evaluated. During the procedure, the tip of the original patient's central line sheared off and immediately drifted into the end of a vein within the lungs.
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From page 145... ...
Institutional factors: Lack of expertise and training in procedure; lack of opportunity for learning and early problem identification by others due to failure to report adverse event. Design factor: Catheter prone to clotting.
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From page 146... ...
The result was fatal when a child's oxygen tubing, under pressure, was inad vertently connected to his IV pump. Although training nurses to assemble devices is important, a device design that would prohibit such a deadly hook-up would be more effective at avoiding this human error.
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From page 147... ...
The noisy, busy environment of the neonatal intensive care unit contributed because nurses did not hear the device's alarm. Brittany, a 2-week-old newborn in the intensive care nursery of a hospital, was resting inside of the protected world of her isolette (incubator)
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From page 148... ...
. SOURCES OF ADVERSE DEVICE EVENTS The stories above illustrate many sources of adverse device events and close calls.
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From page 149... ...
, or children who will use the device · Undue reliance on labeling as a means of educating clinicians, parents, and patients about safe and effective use of a medical device User facility administrative and patient safety systems · Inadequate policies and procedures for purchasing safe and appropriate devices · Inadequate systems for monitoring and responding to recalls, safety advi sories, and other warnings continued children's eyes or the interaction between a child's body and a material used in a device. The source may also be as ordinary as a typing or data entry error for a programmable device, an error which, although mundane, can have tragic consequences for an individual child and family.
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From page 150... ...
used in the repair of hernias SOURCE: A starting point for the categories used here was the classification scheme devised by ECRI for its Medical Device Safety Alert database (see http://www.mdsr.ecri.org/) ; see also Bruley, 1994; FDA, 2002n; ECRI, 2005.
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From page 151... ...
In other cases, extended investigation may be required to determine that a bad outcome or adverse event is related to a medical device. Infections, which can have many possible causes, are a case in point.
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From page 152... ...
A recent estimate of underreporting of medical device-associated adverse events came from an analysis of data from National Electronic Injury Surveillance System (NEISS) , which has information on consumer productrelated injuries based on emergency department records from a probability sample of hospitals (Hefflin et al., 2004)
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From page 153... ...
In some respects, informal communication might be viewed as a "workaround," a way of compensating for some of the inadequacies of formal surveillance programs. Contributors to Underreporting Several of the vignettes presented earlier in this chapter described failures to report adverse events and also suggested some of the reasons for
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From page 154... ...
It is the committee's sense that confusion about HIPAA and the legal discretion of user facilities and professionals to disclose patient information related to adverse events to FDA or manufacturers remains a problem. The actual instructions for Form 3500A for reporting adverse events do not mention HIPAA, although MedWatch has a notice about HIPAA that is displayed on the page that includes links to forms and information about reporting safety problems.
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From page 155... ...
One long-time observer of medical device regulation suggested that competitive pressure "is a powerful deterrent [to reporting events] , leading companies to file no more than the least amount necessary under a law- 3MedSun training materials distinguish between accident (adverse event)
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From page 156... ...
This shift reflects, in part, the progress in biomedical science and engineering that allows more adults and children, first, to survive severe medical problems and, second, to live at home with supportive technologies. Little information is available about medical device safety or adverse events in the home (see, e.g., CHCPR, no date; Lantos and Kohrman, 1992; AAP, 2000b; Tucker, 2004; Bruno and Ahrens, 2005)
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From page 157... ...
Identifying, Documenting, and Investigating Possible Adverse Events The identification, reporting, and investigation of adverse events, device problems, and close calls is an important task that is most reliably performed in the context of clearly defined organizational structures and procedures maintained by manufacturers, health care providers, FDA, and other relevant organizations (e.g., engineering consulting groups)
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From page 158... ...
In some cases, investigations are Awareness of adverse device event or possible adverse event (injury, death, problem, close call)
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From page 159... ...
(Limits on communication with infants and young children may also contribute to adverse events, for example, when children cannot provide important information about what they are experiencing or when fear interferes with their ability to cooperate with a procedure.) Participants may also provide incon 4To cite one recent case, as part of its program to analyze products returned from physicians, one company identified a small number of implanted defibrillators that had a battery shorting problem that could lead to rapid battery depletion (Medtronic, 2005)
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From page 160... ...
When adverse events are analyzed, one question is whether the type of event is occurring uniquely or more frequently among patients who are treated with a particular medical device. As discussed further in Appendix D, answering this question requires data about both the frequency of the event in question (numerator data)
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From page 161... ...
FDA analysts may also seek data on adverse events from public health databases, as in the investigation of meningitis cases among recipients of cochlear implants cited above and discussed in Chapter 6. In addition, data from premarket clinical studies may be evaluated.
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From page 162... ...
As reported by GAO, an FDA analysis found that approximately 25 percent of all classified device recalls were linked to adverse event reports, but about half of recalls involving Class I devices were associated with such reports (GAO, 1997)
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From page 163... ...
The committee did not investigate FDA procedures for issuing and following up on safety alerts, but it does have some concerns about whether FDA has adequate resources to analyze adverse event reports and to develop responses for problems that are not seen as high-priority but that nonetheless may pose real risks to children in particular. The problems with orthodontic headgear are a case in point.
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From page 164... ...
FDA INITIATIVES TO IMPROVE ADVERSE EVENT REPORTING AND RELATED ACTIVITIES FDA clearly recognizes limitations of adverse event reporting programs in general as well as particular concerns with its own program. Sometimes with congressional direction, it has undertaken or planned a number of
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From page 165... ...
For the most part, their focus is general, although some include attention to pediatric issues. MedSun Compared to the agency's primary spontaneous or passive event reporting program, the pilot MedSun program was created as a less inclusive but more intensive effort to better identify and understand problems with the safe use of medical devices.
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From page 166... ...
The program provides three hours of training in reporting adverse events or close calls. In addition, the contractor and FDA have organized two conferences for MedSun participants, and they have made or plan to make slide sets on special topics (e.g., pediatrics)
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From page 167... ...
For example, the agency supported a study to compare possible device surveillance strategies and evaluate whether computer-based surveillance could reliably detect device adverse events and hazards, which were defined as "a state of increased risk related to device use" (Samore et al., 2004, p.
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From page 168... ...
, and one goal was to identify hazards before they caused harm. This approach yielded more information on adverse events than the hospital's voluntary adverse event reporting system, but it missed some important events.
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From page 169... ...
Additional Activities Another FDA initiative is the use of Systematic Technical Assessment of Medical Products (STAMP) teams to examine adverse events, including deaths and serious injuries, associated with selected devices (FDA, 2004v)
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From page 170... ...
Most patient safety programs do not emphasize adverse device events as such. State Reporting Program: New York A number of states, including New York, Pennsylvania, and Oregon, have created some form of adverse event or patient safety reporting program.
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From page 171... ...
Private Reporting Programs A variety of other private organizations concerned with health care quality and patient safety include some attention to safety problems with medical devices. For example, the Institute for Safe Medication Practices has described hazards linked to the design or use of medical devices used to administer medications.
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From page 172... ...
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.
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From page 173... ...
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.
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From page 174... ...
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.
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From page 175... ...
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.
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From page 176... ...
Recommendation 4.3: FDA's plan for evaluating MedSun's perfor mance as a replacement for and improvement on mandatory user facil ity reporting should include, among other elements: · assessment of ongoing program and participant facility success in educating facility personnel about identifying, evaluating, and re porting 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 rep resentation of both academic medical centers and community hospitals and sufficient representation of facilities with device-oriented special ties 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.
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From page 177... ...
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.
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From page 178... ...
Training associated with such devices should cover the identification and reporting of adverse events. Recommendation 4.5: When FDA mandates or agrees to device label ing 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 un der MedWatch, and user facility and manufacturer medical device re porting (MDR)
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From page 179... ...
. 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.
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From page 180... ...
Tasks include reviewing and monitoring the adequacy of institutional programs in areas such as tracking of safety alerts and recalls, respond ing 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.
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From page 181... ...
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.
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From page 182... ...
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.
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