Dataset Information

Recalls of cardiac implants in the last decade: what lessons can we learn?

ABSTRACT:

Background

Due to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac implants in future. The increasing high incidence of clinical adverse events attributed especially to high-risk medical devices has led an advocated change from many stakeholders. This holds especially true for devices like cardiac implants, with their high-risk nature and high complication rates associated with considerable mortality, due to their frequent use in older populations with frequent co-morbidities. To ensure patients' safety, the objective of this study is to analyze different cardiac implants recall reasons and different recall systems, based on an overview of the recalls of cardiac implant medical devices in the last decade. On the basis of the results from this structured analysis, this study provides recommendations on how to avoid such recalls from a manufacturer perspective, as well as how to timely react to an adverse event from a post-surveillance system perspective.

Methods and findings

A systematic search of cardiac implant recalls information has been performed in the PubMed, ScienceDirect and Scopus databases, as well as data sources in regulatory authorities from 193 UN Member States. Data has been extracted for the years 2004-2014 with the following criteria applied: cardiac implant medical device recalls and reasons for recall, associated harm or risk to patients. From the data sources described above, eleven regulatory authorities and 103 recall reports have been included in this study. The largest cardiac implant categories include ICDs 40.8%, pacemakers 14.5% and stents 14.5%. Regarding the recall reasons, the majority of reports were related to device battery problems (33.0%) and incorrect therapy delivery (31.1%). From a total of 103 recall reports, five reported death and serious injuries. Our review highlights weaknesses in the current cardiac implant recall system, including data reporting and management issues and provides recommendations for the improvement of safety information and management.

Conclusion

Due to the mortality associated with the nature of cardiac implants, the traceability and transparency of safety hazards information is crucial. By a structured analysis of recall reasons and their efficient management, important knowledge is gained to inform an effective safety-reporting system for monitoring the safety of cardiac implanted patients, ideally by building up cardiac implant registries worldwide in the future.

SUBMITTER: Zhang S

PROVIDER: S-EPMC4427435 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

Recalls of cardiac implants in the last decade: what lessons can we learn?

Zhang Shixuan S Kriza Christine C Schaller Sandra S Kolominsky-Rabas Peter L PL

PloS one 20150511 5

<h4>Background</h4>Due to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac implants in future. The increasing high incidence of clinical adverse events attributed especially to high-risk medical devices has led an advocated change from many stakeholders. This holds especially true for devices like cardiac implants, with their high-risk nature and high complication rates associated with consi ...[more]

PMID: 25962074

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Project description:ObjectiveAlthough medication abortion has become more common in high-income countries, the procedure has not yet met early expectations for widening access to abortion. High-quality evidence can serve as a catalyst for changes in policy and practice. To direct research priorities, it is important to understand where quality evidence is concentrated and where gaps remain. High-income countries have developed a body of evidence that may have implications for the future of medication abortion. This literature review assesses the characteristics and quality of published studies on medication abortion conducted in the last 10 years in high-income countries and indicates future areas for research to advance policy and practice, and broaden access.Study designA structured search for literature resulted in 207 included studies. A framework based upon the World Health Organization definition of sub-tasks for medication abortion was developed to categorize research by recognized stages of the medication abortion process. Using an iterative and inductive approach, additional sub-themes were created under each of these categories. Established quality assessment frameworks were drawn upon to gauge the internal and external validity of the included research.ResultsStudies in the US and the UK have dominated research on MA in high-income countries. The political and social contexts of these countries will have shaped of this body of research. The past decade of research has focused largely on clinical aspects of medication abortion.ConclusionResearchers should consider refocusing energies toward testing service delivery approaches demonstrating promise and prioritizing research that has broader generalizability and relevance outside of narrow clinical contexts. Although medication abortion is more commonly available worldwide, it is not being used as often as people thought it would be, particularly in high income countries. In order to encourage changes in policy and practice that would allow greater use, we need good quality evidence. If we can understand where we do not have enough research and where we have good amounts of research, we can determine where to invest energies in further studies. Many high-income countries have produced research on medication abortion that could influence policy and practice in similarly resourced contexts. I conducted a literature review to be able to understand the type and quality of research on medication abortion conducted in high-income countries in the past 10 years. I conducted the review in an organized way to make sure that the papers reviewed discussed studies that I thought would be important for answering this question. The literature review found 207 papers. Each of these papers were reviewed and organized them by theme. I also used existing methods to determinine the quality of each study. Most of the research came from the US and the UK. Furthermore, most of the research conducted in the past 10 years was focused on clinical studies of medication abortion. In future studies, researchers should focus more on new ways of providing medication abortion to women that offers greater access. Also, the studies should be designed so that the results have meaning for a broader group of people or situations beyond where the study was done.

Dataset Information

Recalls of cardiac implants in the last decade: what lessons can we learn?

Background

Methods and findings

Conclusion

Publications

Recalls of cardiac implants in the last decade: what lessons can we learn?

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