Study On The Evaluation And Control Measures Of Risk The Of Safety Implantable Cardiac Pacemakers

Medical equipment and medicines, special commodity belongs to mend his ways to save him, its safety and efficiency is directly related to people’s health. Any medical equipment is of zero risk and absolute security. Any listed approved medical devices are just an acceptable risk products, there are potential risks in product design, production and use of the process.The purpose of this research: through the analysis of the implantable cardiac pacemaker suspicious adverse event reports and typical cases, found that the risk of product design, production and use of links, puts forward the risk control measures. The fundamental aim is to find out the main factors of the occurrence of implantable cardiac pacemaker adverse events, and puts forward suggestions of risk control, do turn material resources to good account, thereby improving the implantable cardiac pacemaker use security, has the vital significance to guarantee the life safety of patients.Research methods: This paper adopts literature analysis, data statistics, case analysis and other methods and risk management of medical equipment to find problems and propose solutions to the problem. This research through adverse event characteristics and common risk analysis of implantable pacemakers, the paper puts forward the risk control measures. The aim is to improve the clinical understanding of implantable cardiac pacemaker to security, and then pay attention to the prevention of preoperative,intraoperative standardized operations, strengthen postoperative follow-up of patients with pacemaker and knowledge education, early diagnosis and active treatment of all kinds of adverse events, to ensure the safe use of implantable cardiac pacemaker.Results: fill status from domestic artificial cardiac pacemaker safety of lack of data,also to explore the monitoring work on the adverse event of medical instruments of data collection and utilization of effective utilization way, as artificial cardiac pacemaker safety supervision and improve the use safety of the accumulation of more detailed information,has a certain academic value and Application value. For exploring the mode of medical devices adverse event monitoring and re evaluation work, improve the level of riskmanagement of medical devices in China, the timely discovery, control risk, so as to avoid damage incidents from recurring, provides the important basis.Conclusion: The main problems of the safety of the implantable pacemaker are summarized, and the risk factors and control measures of the safety of implantable pacemaker are analyzed by using the case analysis method. The implantable pacemaker prospective sentinel surveillance found that the incidence of suspicious adverse events after implantation of implantable cardiac pacemaker was 0.69%, are serious adverse events,belonging to the rare range. From the country involved in the number of suspicious medical devices related to implantable cardiac devices, involving a report of 645 cases, severe adverse events in 341 cases, accounting for 52.87%, due to the number of specific implanted pacemaker is unable to grasp, because the incidence of suspicious adverse events.Comprehensive monitoring data, literature and expert advice: at present, the incidence of adverse events in our country is not high, but once the degree of serious, therefore, the evaluation of the risk of the product is acceptable, but need to focus on monitoring,strengthen supervision. Although through the monitoring of key, the initial grasp of the implantable cardiac pacemaker incidence, but there are still the following problems: one is lack of risk signal collection, namely adverse events still exist the underreporting, can not fully understand risk picture for implanted cardiac pacemaker, for early detection of early stage risk control difficult; on the other hand, due to the limitation of time, the sentinel surveillance of the patients were followed up for only six months after implantation, for long-term implantation some risk signal in-depth investigation, analysis, data mining also significantly less may exist some hidden risks signal is not identified. As a result, the risk monitoring of implantable cardiac pacemaker needs a long time.