Be Alert to the Risk of Infant Incubator.

Author: Release time:2016-08-26 Browse10304Second

According to the Chinese Medicine reported Beijing news recently, the State Food and Drug Administration released this year 1~4 medical device adverse event information, to remind the attention of infant incubator, microwave therapy, intermediate frequency treatment instrument, high frequency electric knife four kinds of medical devices use risk.

In 2002 ~2012, the national adverse drug reaction monitoring center received the baby suspected medical device adverse event incubator report 332, mainly for temperature control, ventilation system failure, rash, scratch, 4 cases in which the temperature control in 167 cases, 50 cases of failure, scratch the ventilation system. In order to promote the safe use of the infant incubator, the State Council reminds the clinical medical staff to operate strictly according to the standard of diagnosis and treatment, and to strengthen the maintenance and repair. Production enterprises should strictly control the quality of products, and strengthen the operation of the user's training.

In 2002 ~2012, the national adverse drug reaction monitoring center received reports of suspected medical device adverse events on microwave therapeutic instrument in 284, mainly for the high temperature, burns, leakage, power output instability, which burns in 71 cases, 22 cases of high temperature, the leakage of 14 cases. In order to promote the safe use of microwave therapeutic instrument, National Bureau to remind the medical staff in the process of using and closely observe the patient response, if any abnormal situation, timely treatment; operate strictly according to the standard of diagnosis and treatment, pay attention to product contraindications to use; to strengthen the maintenance of microwave therapy apparatus, in strict accordance with product instructions before use to check the equipment; production enterprises should be strict product quality, strengthen the operation and use of personnel training, improve the service level of customer service.

2002 ~2012, the national adverse drug reaction monitoring center received a total of about 104 cases of suspected medical device adverse event reports, the main manifestations of skin redness, burns, electric shock like paralysis, etc.. In order to promote the safe use of frequency treatment instrument, National Bureau to remind the medical and health institutions and medical personnel in strict accordance with the instructions of operation, strict selection of indication; strengthen the periodic inspection of the electrode maintenance; production enterprises should improve the anti-jamming capability of products, increase of electrode aging tips, strengthen the operation and use of personnel training to improve the service level of customer service.

National Center for ADR monitoring from 2002 ~2012 received reports of suspected medical device adverse events for high-frequency electric knife in 316, which is equipment failure has 220, accounting for 69.62%, for patients with injury has 96, accounting for 30.38%. In order to reduce the recurrence of injury, the National Bureau to remind the medical staff and operators to strengthen risk awareness, strengthen safety training, operate in strict accordance with product instructions; regular inspection and maintenance of equipment; use of the quality of the negative plate, to eliminate the negative plate of electric knife repeated use of disposable; production enterprises should strictly control the quality of products to strengthen the training of the operator, improve the service level of customer service.