Recently, the State Food and Drug Administration issued the "national medical device adverse reaction monitoring annual report (2014)". Report includes medical device adverse event report situation, medical device adverse event reporting statistical analysis, of catheter, specific electromagnetic wave treatment instrument, fumigation equipment three medical equipment products safety problems to take measures, comprehensively reflects the 2014 China medical device adverse event monitoring work.
Million population report reflects the situation in the provinces is not balanced
Medical equipment and pharmaceuticals has certain risk, especially those with the human body for a long time to contact, use for a long time, medical device that is implanted in the body, in the diagnosis and treatment of the disease at the same time, inevitably exist corresponding risk. Only through a monitoring and management of adverse events that occurred in the use of hospital medical equipment market, to maximize the potential risk of medical equipment control, in order to ensure medical equipment safe and effective use.
Reporters learned that the medical device adverse events and quality accidents, medical malpractice is different. Experts pointed out that the medical device adverse event is mainly due to the design defects of the products, has registered Audit Manual inaccurate or inadequate etc. reason, but the quality of the product is qualified. The medical device quality accident mainly refers to its quality does not meet the registration requirements of the product standards and other accidents. Medical malpractice refers to the medical institutions and medical personnel in medical activities, in violation of medical and health management laws and administrative regulations, departmental regulations and norms of medical care, routine, negligence in patients with physical damage in the accident.
Statistical analysis showed that the 2014 the medical device adverse event report showed a good momentum of development, report continued growth in the number has exceeded 26 million copies of average million population reported number has reached 198. Among them, use the unit reported 208107, accounted for 78.5% of the total number of the report; production enterprises reported 6122, accounted for 2.3 percent of the total number of reported; business report 50348, accounting for 19% of the total number of reported; and 666 copies of reports from individuals; 42.7% of the report deals with class III medical devices, 36.7% of the report relates to class II medical devices, 18.2% of the report relates to class I medical devices.
In 2014, the national adverse drug reaction monitoring center received a total of 98 samples of adverse event reports of death and 40920 copies of serious injury incident report, a total of 41018, accounted for 15.5% of the total number of suspected adverse event reporting and 34599 for 2013 growth the 18.6%. In accordance with the requirements of the medical device adverse event monitoring and re evaluation management approach (Trial) ", the second, three types of medical equipment production enterprise shall be in before the end of January of each year to a year of medical device adverse event monitoring were summarized and analyzed, and fill in the medical device adverse events of the year summary report form and report it to the local province, autonomous regions and municipalities directly under the central government, medical device adverse event monitoring agencies.
In 2014, the average number of suspicious medical device adverse events in our country was 198, compared with 2013 growth of 19 copies, but the development of the provinces is not balanced, the number of reports. The total number of reported cases is growing, and the number of million people reporting can better reflect the increase in the number of reports.
Production enterprises reported adverse reactions to be strengthened
Overall, the device is still the main source of adverse events reported in the use of equipment units. Compared to 2013, the proportion of the production enterprises to submit a report has declined, and its use of the safety of the first person in the position of the responsible person does not match, the consciousness of its performance should be improved. In addition, the proportion of business reports also fell by 3.1 percentage points. In 2014, the number of registered users reached 174372, compared with 2013 increased by 17.4%. 34.5% of all registered users in the user submitted a report of adverse events. In a system of registration 9255 production enterprise users have 3328 submitted a report, 36.0%, than 2013 increased 5.5%; registered 75002 business users have is 209.25 submitted a report, 27.9%, than 2013 increased by 12.3%; registration 90115 home use units in have 35827 submitted the report, accounted for 39.8%, than 2013 improve the 15.2%.
At present, some enterprises and part of the medical staff believe that medical problems and not related to their own, and do not pay attention to the declaration of medical device adverse event monitoring actually in varying degrees affected the safe use.
Take active measures to deal with the safety of medical devices
Reporters learned that, in 2014 the relevant departments issued a total of medical devices adverse event information bulletin 3, involving the catheter, specific electromagnetic wave therapy apparatus, fumigation equipment three products.
Data show that the clinical use of the risk of urinary tract infection, urinary tract infection, bladder rupture caused by the catheter part of the retention in vivo, the patient caused two injuries, etc.. Analysis of the main reasons are: catheter in transportation and storage caused by improper packing damaged, urethral catheterization sterilization is not complete, in vivo retained for a long time, extubation suffers pull pull and balloon in liquid is injected into the excess. The risk of causing harm to reduce adverse events occur repeatedly, experts remind clinical medical and nursing staff should read the detailed instructions for use, strictly according to operating procedures, proficiency in catheter, indwelling urethral catheter care and extubation in link operating essentials; remind production enterprises improve the product instructions, attention after the listing of products safety information, improve the safety and effectiveness of clinical use of products. In addition, specific electromagnetic wave therapeutic apparatus using clinical risk first performance for personal injury, such as skin itching, rash, swelling, blisters, burns and other; secondly, the performance of the equipment fault is characterized in that the treatment head, a protective cover off, power is not stable, aging wiring wear, short circuit etc.. To strengthen specific electromagnetic wave therapeutic apparatus is safe to use and reduce adverse events repeat the risk of harm, professionals pointed out that users should strictly according to the product use instructions and safety precautions to use therapeutic instrument, never timeout length, ultra distance, super indications for use; use unit should strengthen equipment daily check and maintenance, in particular to check before using the coping power line and a support arm lines, such as the discovery of wear and aging, etc., discontinue use immediately and replacement parts. To remind the production enterprises to improve the protection measures to further improve the safety and reliability of the product. Fumigation equipment for clinical use is a major risk of syncope, burns, shock, crash, explosion cabin. Problems in the performance of the fumigation equipment mainly include the easy to be blocked by the condensate water return passage, the temperature and liquid level sensing device, the failure of the timing device, and the material strength of the structural joints.
In order to reduce the adverse events recurring risk of harm, drug administration departments remind clinical medical staff and users should strictly abide by the various types of equipment of indications, in accordance with the instructions required maintenance, operation and use of equipment, it is recommended production enterprises improve protection measures, to improve the reliability of products, to strengthen after-sales maintenance services. At the same time, strengthen the reporting of adverse drug reaction monitoring of medical devices.