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    • The PMDA address two conflicting goals the first is to

    2018-10-23

    The PMDA address two conflicting goals: the first is to assure the public that the devices are reasonably safe and effective; and the second is to avoid overregulation of manufacturers in the development of Class III or IV devices (Post-marketing measures for drug/medical devices). The PMDA shifted the regulatory standards to a less burdensome approach in all areas of medical devices and reduced the terms of device development. As a part of the implementation of reducing such terms for certain devices with little clinical data in the Japanese population, the PMDA has accepted clinical trials conducted in the US, European Union, or other countries. In these cases, reports of foreign as well as domestic AEs are an extremely important source of information. Registry, in collaboration with academic tranylcypromine as well as manufacturers, is a promising potential solution for PMS (Resnic and Normand, 2012). For example, Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) was very successful in monitoring the results of a left ventricular assist device in the real world and detecting hazard signals (Grady et al., 2015 Feb; Kirklin et al., 2014). J-MACS, the Japanese version of INTERMACS, has a system that sends an alert mail to the device company when healthcare professionals input an AE into the system (Japanese Registry for Mechanically Assisted Circulatory Support). AEs in combination with registry of follow-up data would provide both the number of events and number of devices implanted for a patient-year follow-up period. One possible drawback of registry is that the more patients that register with the device, the more difficult it would be to collect follow-up data (Smith et al., 2012). However, in the advent of trans-catheter aortic valve replacement (TAVR) in Japan, PMS with an AE alert mail system was embedded in a national TAVR registry formed by academic societies; and the system is designed to collect 5years of follow-up data (Japanese Registry of Trans-Catheter Aortic Valve Replacement).
    Conclusions
    Author Contributions
    Financial Disclosure This study was supported by internal funding from the Pharmaceuticals and Medical Devices Agency of Japan.
    Acknowledgment
    Introduction Prolonged or excessive bleeding is one of the most common complications after cardiac surgery. Postoperative bleeding requiring transfusions and surgical re-exploration remains an important complication because glycogen is associated with short- and long-term postoperative mortality, morbidity, prolonged hospitalization, and higher societal healthcare costs (Murphy et al., 2007). The mechanisms involved in perioperative bleeding are complex and involve disturbances in various physiologic systems including primary hemostasis, coagulation, and fibrinolysis. This may be caused by several surgical factors including cardiopulmonary bypass (CPB) and operative trauma. Together with primary fibrinolysis, platelet dysfunction, and hemodilution these mechanisms contribute to dysfunction of the coagulation, fibrinolytic, and inflammatory systems with postoperative coagulopathy and bleeding as a result (Paparella et al., 2004; Despotis et al., 2001). Consequently, the normal or generally accepted amount of blood loss after cardiac surgery is higher than most other surgical specialties and varies between 300–1500ml during the first 12h. The standard operating procedure is to insert chest tubes in order to evacuate this blood from the pericardial cavity postoperatively. However, if blood loss or clot formation is excessive the chest tubes often fail due to partial or complete blockage. The resulting stasis of blood and clots in the pericardial cavity leads to high fibrinolytic activity and consequently, maintenance of blood loss (Despotis et al., 2001; Philippou et al., 2000; Illig et al., 1997; Yavari and Becker, 2009; Vallely et al., 2009). This is also supported by the finding that during re-exploration for postoperative bleeding, removal of accumulated blood and clots by solely irrigating the pericardial space with a warm saline solution is enough to stop the bleeding instantly in a significant number of cases (Pelletier et al., 1998). Following on from this, a method of preventing blood and clots from accumulating in the pericardial space could hypothetically stop postoperative bleeding at an earlier stage and reduce bleeding complications. Continuous postoperative pericardial flushing (CPPF) was developed for this purpose.