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.

Fig 1. Flow Diagram.

Fig 1 shows the process of selecting recall reports as Flow Diagram in line with the PRISMA guidelines. The Flow Diagram includes two search methodologies; the link one is the process of a systematic search performed for English articles in academic databases; the right one is from data sources provided by different regulatory authorities from 193 United Nations Member States. A total of 103 recall reports have been analyzed in this study.

Fig 2. Product categories of recalled cardiac implants.

Fig 2 indicates the recall rate of six different cardiac implant categories in the 103 recall reports analyzed in this study. Of all 103 recall reports, the ratio of categories is shown: ICDs 40.8%; pacemakers 14.5%; stents 14.5%; as well as CRTs 12.7%; leads 9.7% and implantable artificial organs 7.8%.