The Future

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Chapter: Pharmacovigilance: Surveillance for Medical Devices - USA

Given the complexity of devices and the varied environments in which they are used, multiple approaches to detecting and assessing their potential safety and/or effectiveness are warranted.


Given the complexity of devices and the varied environments in which they are used, multiple approaches to detecting and assessing their potential safety and/or effectiveness are warranted. FDA has recognized this need and has strived to enhance existing mechanisms and develop new approaches to build an integrated system for postmarket surveillance and risk assess-ment that will help manage the risks of medical devices in as effective a way as possible given limited resources.

The agency also fully appreciates that information that is learned about a product’s performance in the ‘real world’ is essential to continual product improve-ment, increasing patient benefit, and mitigating poten-tial harm. Such information is part of the total product life cycle and affects, among others, device design and testing, clinical assessment for investigational indica-tions, and postmarket oversight. All of the elements of an effective system for postmarket surveillance and risk assessment must be used in concert with other agency activities to fully realize the benefits of the total product life cycle concept.

Although MDR will continue to be a key element of the system, many enhancements are envisioned. Increasing use will be made of effective means of report triage (e.g. auto-screen and summary report-ing), so that more resources can be devoted to detect-ing unknown problems. Reports will be increasingly submitted electronically, eventually by the device industry as a whole, allowing for more efficient and error-free processing. A revamping of the coding thesaurus, allowing for more complete and sophisti-cated coding of both patient and device outcomes, will aid problem detection. Datamining, already in use by our drug colleagues, is being explored as an analytic aid in identifying potential signals of public health problems among the ever-burgeoning number of reports of device-related AEs. And lastly, the MDR system will continue to become even more interna-tional as device nomenclature is standardized and the exchange of vigilance reports grows.

MedSun will be of ever-increasing importance as it expands, and consolidates, its network of health-care facilities across the US. By working closely with these facilities, MedSun aims to: (1) signifi-cantly reduce barriers to reporting; (2) emphasize error prevention, risk mitigation, and risk communication; and (3) enhance each institution’s culture of safety. In addition to enhanced passive surveillance, MedSun will provide the means to conduct active surveillance in these institutions via real-time queries/surveys or targeted studies of important potential device prob-lems. Given certain issues, denominator data may also be obtained – a significant contribution given the problems previously noted with reliable numerator and denominator data.

Other efforts are also underway to expand FDA’s approaches to active surveillance. Based on the initial work (Hefflin et al., 2004), FDA continues to collabo-rate with the CPSC in the use of its National Electronic Injury Surveillance System to help define the public health burden of device-related injury and, ultimately, to help identify or refine signals of potential device problems. The agency is also collaborating with the Center for Medicare and Medicaid Services (CMS), as well as other agencies, in the exploratory use of Medicare data to assess the frequency of designated device-related complications in the elderly. Lastly, based on initial findings (Samore et al., 2004), vari-ous methodological approaches to active surveillance, including direct observation of intensive care unit staff performance, are continuing to be explored in a collaborative effort with a major tertiary care facility.

Aside from the significant additions to surveil-lance as noted above, the future system will rely more and more on formal studies to address potential safety/effectiveness issues or to refine our understand-ing of those issues. Recently, a new emphasis has been placed on agency-mandated post-approval stud-ies as a condition of approval for high risk devices, and their oversight has been moved from pre- to post-market staff. These studies will increasingly address important postmarket device issues using effective observational study methodology. The public will be informed of the status of these studies and interven-tions (aside from changes to the product labeling) will be considered based on study findings. In concert with this effort, and although limited to date, targeted use of the Section 522 authority will continue to be made. Both of these efforts are designed to help the agency strike the right pre-/postmarket balance in terms of the information needed to assure reasonable safety and effectiveness prior to marketing, and continued product safety and effectiveness in the ‘real world.’

In the future, the agency will increasingly use other sources of data to address important device issues. National registries, maintained by professional soci-eties, have become an increasingly important means to address short-term safety issues. Previously cited have been recent examples of use of such registries to address complications with hemostasis devices (Tavris et al., 2004) and operative mortality associ-ated with transmyocardial revascularization (Peter-son et al., 2004). Importantly, CMS has recently based reimbursement for use of selected breakthrough technologies (e.g. left-ventricular assist devices and carotid stents) on the contingency that entities who wish to be reimbursed must enter patient outcome data into nation-wide registries. FDA is working with CMS, and others, to help develop these registries. FDA is also further exploring the use of national Medicare claims data with CMS and academic researchers to assess its potential utility as a means to address postmarket device issues.

Finally, FDA is making significant efforts to address more fundamental ‘information infrastruc-ture’ issues related to lack of and/or poor documen-tation of device-related AEs in medical records, as well as lack of device-specific identifiers in major healthcare datasources (as alluded to previously). The former is well known and is related to multiple causes. The agency will be conducting a series of ‘think-tank’ workshops to develop possible solutions that may be pilot tested. Other efforts, in parallel with further development of the GMDN, will explore refinement and use of electronic systems, such as bar coding radiofrequency tagging, to link more specific device information to healthcare records. Success in these two fundamental endeavors would markedly advance the ability of the agency, and healthcare researchers, to conduct effective postmarket surveillance and risk assessment.

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