Safe Medical Devices for Children (2006) / Chapter Skim
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7 Children and Medical Device Safety: A Shared Responsibility
7 Children and Medical Device Safety: A Shared Responsibility
Pages 229-249
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From page 229... ...
This report has noted that drugs and devices differ in a number of significant ways and that Congress and FDA have reasonably recognized those differences. At the same time, previous chapters of this report have also raised concerns about the limitations of adverse event reporting and analysis and the monitoring of -- and public availability of information from -- postmarket studies of medical devices.
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From page 230... ...
The Center for Devices and Radiological Health (CDRH) has recently created a pediatric webpage, a useful step to encourage attention to pediatric concerns related to medical devices.
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From page 231... ...
representing all groups indicated that the cost of developing pediatric med ical devices is the most significant barrier to the development of new pediatric medical devices. The economic challenges noted include not only the limited size of the pediatric device market, but also that the return on the investment required to develop and test pediatric devices usually falls below the profit goals of most medical device companies (p.
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From page 232... ...
The final section emphasizes that assuring the safe design and use of medical devices is a shared responsibility. FDA PERFORMANCE OF POSTMARKET SURVEILLANCE OF MEDICAL DEVICES The basic goal of FDA's program of adverse event reporting and postmarket studies for medical devices is to protect patients from harm by identifying and evaluating potential or actual safety problems with legally marketed devices.
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From page 233... ...
If the monitoring of postmarket study commitments is simply an addition to the workload of those responsible for evaluating adverse event reports and other postmarket surveillance activities, then progress in monitoring may be offset by reduced performance in other areas. The agency has until 2007 to submit a required report to Congress on the extent to which companies comply with postmarket study commitments.
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From page 234... ...
Adequacy of Postmarket Studies With respect to whether FDA-ordered postmarket surveillance studies last long enough or are adequate to assess the impact on device performance and longevity of children's active lifestyles or their growth and development, the committee lacked sufficient information to identify such studies and answer the questions posed to it. From the information it did locate, the committee expects that many important questions about longterm outcomes remain unstudied.
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From page 235... ...
Given that there is no shortage of important questions, Chapter 6 listed some criteria that could be used by FDA and others to set priorities for postmarket studies of medical devices. Adverse Event Reporting Judgments about the adequacy of the FDA program of adverse event reporting must take into account the generally recognized problems with such reporting described earlier in the report.
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From page 236... ...
Improved coding will strengthen multiple facets of postmarket surveillance. Although its work focuses on device safety in the United States, FDA also participates in international efforts to harmonize regulatory policies, share reports on serious device problems in a timely fashion, and promote effective manufacturing facility inspection and other programs to assure device safety in global markets.
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From page 237... ...
More than is the case for drugs, administrative separation could limit the extent to which information gained in postmarket surveillance of devices feeds back into premarket evaluations and other activities and vice versa. It may also be considerably more difficult for devices than for drugs to draw adequate clinical and technical expertise from various government agencies to help support a separate unit.
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From page 238... ...
. The performance plan also explicitly characterized several areas within CDRH as "not working well." These areas included postmarket surveillance of medical devices, inspection of device manufacturers, and radiation safety.
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From page 239... ...
In the Medical Device User Fee and Modernization Act of 2002, Congress authorized additional appropriations for postmarket surveillance activities -- $3 million for FY 2003, $6 million for FY 2004, and "such sums as may be necessary" in subsequent years. After this endorsement of the agency's need for additional resources, Congress did not, however, appropriate the additional funds (personal communication, Thomas P
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From page 240... ...
Given the scarcity of information about the safety and effectiveness of medical devices used with children, this report has argued for greater openness and availability of findings from device studies required by FDA. Efforts to apply or strengthen safety regulations have the potential to discourage certain innovations.
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From page 241... ...
SHARED RESPONSIBILITIES FOR MEDICAL DEVICE SAFETY Context: Shared Responsibilities for Patient Safety FDA programs to protect public health operate within a broader system of shared responsibilities for patient safety and health care quality. In the past two decades, individual and collaborative initiatives to improve the quality of health care and protect patients from harm have grown remarkably and been the subject of many reports (see, e.g., IOM, 1990, 1992, 2000c, 2003, 2004b; AHRQ, 2001, 2003, 2004)
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From page 242... ...
The focus on medications reflects analyses of medical errors in which medication mishaps figure prominently, although some of these mishaps also involve errors in device use or shortcomings in device design as described in Chapter 4. Like most patient safety initiatives, those focusing on children also tend not to feature medical devices.
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From page 243... ...
· If the manufacturer of your child's implant has asked you to do so, inform them of your new address when you move. Medical Device Safety The sharing of responsibilities for making safe medical devices available for use with children extends throughout the medical device product cycle depicted in Chapter 1.
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From page 244... ...
When manufacturers undertake postmarket studies directed by the FDA, they also seek approval of the study plan. As it regulates and guides the evaluation of medical devices, FDA operates as part of a substantial research infrastructure in the United States that assigns varying degrees of responsibility for overseeing the scientific and ethical soundness of clinical research to a range of parties.
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From page 245... ...
This potentially makes the process for evaluating devices before market approval less powerful and increases the burden on postmarket surveillance. The world of medical device development and evaluation is diverse.
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From page 246... ...
As described in Chapter 3, FDA operates within a set of statutory restrictions and traditions that have limited the sharing of information about findings of device studies, especially studies conducted following initial approval or clearance of a product for marketing. This report has argued for less secrecy and more openness in the sharing of information related to the potential benefits and harms of medical devices.
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From page 247... ...
Shared Responsibilities: Safe Use of Safe Medical Devices Whereas manufacturers have the lead responsibility for the safe manufacturing of effective medical devices that are designed to minimize opportunities for unsafe use, health care professionals and providers have lead responsibility for the safe and appropriate use of devices. The emphasis in discussions throughout this report has been on institutional environments that help health care professionals and others do what they are supposed to do correctly and consistently.
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From page 248... ...
In general, however, much more can be done by primary care and specialist physicians, hospitals, home care providers, manufacturers, and FDA to help patients and families meet their responsibilities for using medical devices safely. Shared Responsibilities: Postmarket Surveillance and Evaluation of Long-Term Safety and Effectiveness Reflecting its charge, this report has focused primarily on FDA's responsibilities for postmarket surveillance of medical devices, including devices used with children.
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From page 249... ...
It must use its position both to strengthen its own programs and to encourage others to recognize and meet their shared responsibilities for identifying, understanding, and preventing problems with the design, evaluation, manufacture, maintenance, and use of medical devices. As stressed throughout this report, successful programs of postmarket surveillance to protect all those whose health depends on safe and effective medical devices are an essential foundation for efforts to protect children in particular.
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