Welcome to the website of Nantong Huen Medical Equipment co. LTD!
Contact us

mobile: 13912875678


Address: shigang town industrial park, tongzhou district, nantong city (north of shijiang road)

Home > News > detail

How to reduce the occurrence of medical device adverse events

Time:2017-8-4 17:40:49
Medical devices, whether from the diagnosis of disease or from the medical device income, in the medical profession status is rapidly rising, medical device supervision also faces new challenges. Since the implementation of the measures for the supervision and administration of medical device use quality in February 1, 2016, it has been stipulated that the medical device manufacturers should promptly and handle adverse events. It is pointed out that the medical instruments are the focal point of the use of the medical equipment in the monitoring, evaluation, retrospective and recall of the medical devices.
Medical adverse events occur on the frontline
With specific examples, such as: it is understood that the pre dialysis flushing pipeline in hemodialysis center, found out Water Leakage arterial extracorporeal circulation pipeline, timely replace the line, but fortunately did not cause infection accident. Through this incident, department personnel immediately notify clinical departments, immediately check the same batch of product use details.
In order to reduce the occurrence of medical device adverse events, it is necessary to further strengthen the construction of laws and regulations, and standardize the reporting procedures and management measures for adverse events. There are practical ways that hospitals can draw on them:
Establish a team system for adverse events in hospitals. Its functions are mainly the inspection, supervision and assessment of the use of medical devices in the whole hospital. The individual is responsible for the specific work, day-to-day management of hospital equipment division is responsible.
The head of each clinical department and the head nurse are responsible for adverse event monitoring. In order to make the safety monitoring work more effective, when the medical equipment is being used in different departments, the Department designated a special person to be responsible for the safety registration of the use of the equipment.
Countermeasures for medical adverse events
In the event of an emergency medical malpractice, it must be done:
Immediately stop the use of the product, the whole batch of all sealed, do a good job registration, the transfer of hospital equipment division.
To complete the registration of adverse medical event registration forms and hand them over to the hospital equipment department.
To report the adverse events to related departments.
After the adverse event of medical devices, it is necessary to do event tracking, collection, analysis, processing, feedback, and how to improve the work afterwards.
To investigate the occurrence of adverse events in medical devices, to investigate systematically the incidents of registration of adverse incidents and to investigate the specific circumstances of the incident and the current progress.
The hospital monitoring group to analyze the events, summed up the exact cause of the incident is what, and to give the event qualitative level, after the hospital departments were informed to prevent such incidents from happening again. Monitoring, attention and tracking of equipment with moderate risks shall be suspended or stopped using equipment, materials and equipment with serious and catastrophic risks.
Replacement products for nonconforming products.
Periodically carry on the statistics to the bad incident, form the database.
Put forward suggestions or suggestions for the improvement of bad accidents.
The regular emergency treatment of the organization of personnel training for the prevention of adverse events, events. All units work to implement, medical equipment adverse accident can get very good improvement