Medical device adverse event monitoring report released: electronic blood pressure monitor on the list

Cupping "pull out" blisters

Chinese medicine fumigation machine may become a stealth bomb

Yesterday, the State Food and Drug Administration announced the 2014 annual report on national medical device adverse event monitoring. The author knows that 8.8% of the suspicious medical device adverse events reported in various places are caused by the patient's own operation, and 13% of the incidents occur at home. Among them, the family's common medical device electronic sphygmomanometer is also on the list. The top three list of suspicious bad reports. Experts remind that family medical devices are also risky and should be calibrated and updated from time to time, purchased through regular channels, and guided by the instructions.

TechWeb.com.cn

Glossary

What is a medical device adverse event?

Speaking of adverse reactions and adverse events, the first reaction of the public is that there is a problem with the drug or device. However, adverse medical device incidents actually refer to all kinds of harmful events that occur in the normal use and cause or may cause harm to the human body.

Why are medical devices that are of good quality and under normal use also cause harm to the human body? This is mainly due to product design flaws, inaccurate or inadequate manuals that have been registered for review. At present, China's medical device adverse event monitoring is based on the "suspicious immediate report" principle to collect reports, as long as there are suspicious, they must be reported.

Report interpretation

How is the electronic sphygmomanometer on the list?

In terms of active medical devices, the top five are patient monitors, infusion pumps and syringe pumps, electronic sphygmomanometers, electrocardiographs and ventilators, accounting for 4.5% of the total number of reports. Don't say anything else, the electronic sphygmomanometer will basically have one in every family. How come it is on the list?

The author learned from the doctor that there was a grandfather who measured blood pressure at home and the sphygmomanometer showed normal for several days. This made the grandfather very happy, and immediately stopped taking antihypertensive drugs. The next day after the drug was stopped, there was a headache and chest tightness. When I went to the hospital for an examination, I found that my blood pressure was still very high. It was a problem with the electronic sphygmomanometer that was used in my home for several years.

Sun Jun, assistant director of the Jiangsu Provincial Center for Adverse Drug Reactions, reminded that the electronic sphygmomanometer is not as stable as the mercury sphygmomanometer during measurement, and there are problems such as rubber balloon leaking and insufficient battery power, and the mercury sphygmomanometer will have a mercury column leak. There are problems such as bubbles, mercury column breakage, mercury leakage, severe aging, and inaccurate indications. The product should be verified or updated every year.

The cupping wheel forgot the time and pulled out the blisters on the back.

According to the report, 8.8% of suspicious adverse events are handled by the patients themselves. According to the location of use, the report reported as “family” accounted for 13.0%.

In the family life, the commonly used medical equipment, in addition to the sphygmomanometer, also includes blood glucose meters, oxygen generators, cupping machines, etc., because of the convenient operation, the public's safety for these family medical devices is not much considered.

However, accidents caused by the use of home medical devices are frequently seen in newspapers. News reports such as "Cropping a large blisters at home cupping", "There is a mistake in online shopping for blood glucose meters, causing overdose of unmedicated drugs" is worrying.

The director of the Department of Dermatology, Nanjing Drum Tower Hospital told the Modern Express reporter that some patients had encountered some medical institutions in the community to "crank the cup", but the operator pulled out and forgot the time, the result is because of the negative pressure principle of the cupping, time It is difficult to pull out after long, and after the pull down, there are small blisters on the skin. "If you pull the cupping at home and don't have a good grasp of time, it is very likely that this danger will occur."

Chinese medicine fumigation machine is also risky, be careful of burns

In the report, the State Food and Drug Administration specifically notified three products: catheters, specific electromagnetic wave therapy devices and fumigation equipment. Among them, the third type of fumigation equipment is used in many cases.

It is understood that this fumigation equipment mainly refers to the fumigation of traditional Chinese medicine, using the combination of traditional Chinese medicine and fumigation device to generate and transport hot medicine vapor. From January 2010 to July 2014, the National Center for Adverse Drug Reaction Monitoring received 223 reports of suspected adverse events involving fumigation equipment. Among them, 93 cases were serious injuries, mainly including syncope, burns, scars, etc., including 2 cases of syncope, accounting for 2.1% of all serious injuries reported; 78 cases of different degrees of burns, accounting for 83.9%; cabin fall, explosion and other near events 13 cases, accounting for 14.0%. According to the case cited, in the process of using a fumigation treatment machine, the fumigation machine ejected a high-temperature drug mist, causing the patient to be burned at a second degree.

I have seen that many websites have home Chinese medicine fumigation machines for sale. However, if the temperature of these devices is too high, causing burns to the body, the consequences will be unimaginable.

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