Cardiac Implants

Decent Essays

Synopsis: Recall of Cardiac Implants in the Last Decade: What Lesson Can We Learn? This paper analyse 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. 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. The problem statement is to determine recall ratio of different categories of cardiac implant medical devices and the ratio of different recall reasons among cardiac implant medical devices. The reported death and serious injuries events need to be determined from the analysed recall reports. …show more content…

One is to address focus areas associated with adverse events by manufacturers. The major problem caused to recall related to device battery. Manufacturers need to check batteries after a defined period to prevent temporary or permanent loss of therapy caused by battery problems. The problems related to the software and data output also need to be addressed by manufacturers. It is also necessary to prevent the fracture of the stent and the defect of the balloon for stent design. The insulation of the leads should be addressed by the manufacturers, which can cause specific therapy delivery problems. In addition, the improve of the management of adverse events have been discuss. To ensure patients’ safety in relation to cardiac implants, providing safety information to the public and relevant stakeholders is a basic requirement. It is recommended that each regulatory authority provides a clear description and explanation of their recall classification system. Providing information on risk factors is to avoid adverse events occurring in the future in the context of patient …show more content…

2) Economic losses on the industry and health care payer side can be significant when large numbers of medical devices are recalled. Further, the negative impact resulting from a recall on the reduction of industry market shares needs to be considered. Strength: 1) Research of cardiac information has been performed in the PubMed, Science Direct and Scopus databases to increase the variation and validity of data. 2) The recall reasons from 103 reports have been sorted into five categories and 27 sub-categories in a table so that reader more easily to understand it. Weakness: 1) The authors were only able to review data in the English, German and Chinese language. Thus, there could potentially be important data missing from other countries that do not provide information in these languages. 2) The report selection and data extraction from each recall report could not be done by two researchers independently because of lack of language

Get Access