China, Beijing Fu Wai Hospital in Medical Professor Zhang Shu recently held in Hangzhou, China electrophysiology and cardiac pacing on the Eighth Conference of sudden cardiac death in China published in the latest developments and treatment sounded to the public Alarm: China has more than 50 million people each year die of sudden cardiac death, that every day there are at least 1480 people died in China. Prevention and treatment of sudden cardiac death in an effective way is to install a pacemaker, however, sudden cardiac death because people do not understand, there is concern on the installation of implantable devices, so my pacemaker very limited number of actual installation. Experts believe that, at present, in our promotion and application of cardiac pacemakers very difficult task. Know where the risk of Sciences
Reporter learned from China, Beijing Fu Wai Hospital in Medical Huawei Professor, Professor Zhang Shu-led, the 31 hospitals participating in the national “15″ scientific and technological project, “Implantable Cardiac Rhythm ICD Clinical application and prevention of sudden cardiac death “, in Beijing, Guangzhou and Xinjiang were selected by 20.6 million, 149,000, 160,000 urban residents, selected in Shanxi 16.2 million rural residents, to monitor the incidence of sudden cardiac death. The study for the first time that our country the incidence of sudden cardiac death, or 544,000 / year, and the male was higher than in females. Professor Zhang Shu told reporters can not predict sudden cardiac death, progression of the disease very fast, and mostly occurs in hospitals, where the extension of 1 minute each time, the chances of survival of plummeted 10%. The reasons behind sudden death caused by ventricular fibrillation, and pacemaker could continuously monitor the heart rhythm, find any fast, slow or irregular heart beat. When the detected tachyarrhythmias, it will be within ten seconds set by medical treatment prior to correct abnormal heart rhythm, the success rate is almost 100%. Pacemaker implantation in the surgery, the doctors need to be embedded in pacemaker patients on the chest, heart pacemaker function in complete closure of incision after the test. At present, many patients implanted device classes exist concern the treatment. Professor Zhang Shu vividly explained: “For example, people with poor eyesight to wear Glasses . The process of wearing glasses will encounter some problems, such as incompatible, sports is not convenient, glasses, etc. need to be replaced with a long time, but it is not because these problems without glasses, after all, the benefits it brings a lot more than the negative impact . The same is true cardiac pacemaker. Cause for concern, most Heart disease Patients with higher than average risk of sudden death in 5 to 10 times, for these patients in advance if a pacemaker installed in more than ten seconds after the onset of symptoms, the pacemaker can save the patient over. ” Wireless technology to improve the quality of treatment
Pacemaker experienced 50 years of development, the development of its technology in the treatment of sudden cardiac death had a profound significance. Pacemaker form smaller, more powerful. Pacemaker now only watch dial so great. Worth noting that in the academic conference debut of China’s first wireless telemetry communication with the heart pacemaker, so that prevention and treatment of sudden cardiac death and pacemaker technology is scaled to a new level. The clinical experts said that Medtronic developed by the new pacemaker implants made more convenient, efficient management of cardiac status of patients more time. The wireless telemetry capabilities, embedded management optimization can improve the implantation process, shorten the follow-up time. Expert further explained that the general requirements for the conventional pacemaker to a hospital department for patients with postoperative examination, the doctor will need to put patients first installation of a programmable pacemaker above to receive data transmission; and wireless technologies from wireless transmission of data stroke device function can be realized within a certain distance from checking, data set can be adjusted through wireless means, in the implantation process is also required for the initial setup can be completed wireless, programmable from the first no longer routine pump device implantation need to be placed as a sterile area, to simplify surgical procedures. In addition, this pacemaker can track and manage patients with heart failure symptoms, to provide the necessary shock to the heart to terminate the abnormal rhythm of potential and can generate a small pulse to synchronize ventricular contraction of the heart to more effectively help the blood to the body .
Posts Tagged ‘Pacemakers’
Promote the use of cardiac pacemakers and arduous tasks – the heart pacemaker – Medical Devices Industry
Wednesday, September 1st, 2010Medical Device – Classifications and Guidelines Set in the Product’s Assembly
Sunday, February 7th, 2010A medical device should not be placed for sale in the market unless it passes industry standards. This is generally because they are used to respond to medical necessities of end users. Equipment irregularities may not just be a reason for hazards on the life of the patient. Even medical professionals are not exempted from unhygienic medical machineries. This is why federal guidelines need to be met.
Federal guidelines are standards set for any item in the market. The Food and Drug Administration or FDA oversees the manufacture of medical devices. Find out how FDA categorizes the industrial items and see the standards behind these industrial products’ assembly.
Three classifications for medical devices
The FDA utilizes Class I, Class II and Class III to simply classify medical devices. Class I devices are those with general controls. Class II are those that mix special and general controls in the facets of the medical gadget. Class III are those that need FDA premarket approval.
Class I medical devices include basic gadgets such as bandages, bedpans and gloves. These devices need safety, sanitation and other medical procedures no matter how less the risk they render to the end user. Class II, on the other hand are devices that pose greater risks. Included on the list are x-ray machines, suture materials and surgical needles. Class III are considered the most hazardous of all medical tools and concrete samples include bone implants and pacemakers.
Guidelines for assembly of medical devices
The federal standards are created in assuring that the medical device is sanitized and more efficient. Both consumers and health practitioners will see the relevance in these guidelines. The necessary steps include registration, listing, premarket notification, premarket approval, investigational device exemption, quality system regulation and labeling requirements.
Registration is that stage of the process where the business should register the medical tool. Renewal is made every year. Listing is that step where the business owner – whether an exporter, manufacturer or remanufacturer – must enlist all the facilities with the FDA. Premarket notification is significant before the end products are marketed while premarket approval is required for any Class III medical device.
Investigational device exemption is different from all the rest of the processes since it is needed only for a certain purpose. This is required when clinical testing is the topmost purpose of the product. On the other hand, both quality system regulation and labeling requirements should be met by the manufacturer. Quality system regulation is that process where facilities for packaging, manufacturing, labeling and storing are inspected. Labeling requirements oversee not just the product label but the details explained on the literature of the medical device.
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