In order to comprehensively evaluate the quality of medical device adverse event reports in our city, and to discover and control medical device safety risks in a timely manner, on February 22, Xiangtan Municipal Administration for Market Regulation organized a special work on the quality assessment of medical device adverse event reports in the city . 14 medical device safety monitoring and evaluation experts from the Central Hospital, Xiangtan County People’s Hospital and other units participated in the evaluation.
This evaluation has passed the National Medical Device Adverse Event Monitoring Information System. From the 1026 report forms received by our city in 2021, 30% of the serious reports and 7% of the general reports will be randomly selected. 158 reports were evaluated. Evaluation experts strictly follow the “Suspected Medical Device Adverse Event Report Form Quality Evaluation Scoring Standards”, and mainly evaluate the authenticity, accuracy, completeness and standardization of the report. Finally, the Municipal Adverse Drug Reaction Monitoring Center will conduct random checks. Re-scoring is performed to ensure the accuracy of the assessment results. Judging from the evaluation results, the highest score is 100 points, the lowest score is 85.5 points, and the city’s average score is 96.31 points, reflecting the overall good quality of the city’s report.
In the risk discussion session, the evaluation experts pointed out that the report has common problems such as lack of important information and incomplete process description, exchanged the problems encountered in the monitoring work, and proposed how to improve the quality of the report and strengthen the application of monitoring results. Active and effective suggestions are put forward, with special emphasis on strengthening the attention and monitoring of high-value medical consumables, implantable medical devices, and centralized procurement of medical devices.
Extended reading
Adverse events of medical devices
Refers to various medical devices that have been on the market under normal use conditions that cause or may cause human injury. Harmful event.
Main reasons for adverse events of medical devices
1. Inherent risks of products (may be caused by design factors, material factors, clinical application factors, etc.);
2. The medical device is malfunctioning or damaged;
3. There are errors or defects in the instruction manual of the label product.
The significance of monitoring adverse events of medical devices
Through the monitoring of adverse events of medical devices, it can provide regulatory basis for drug supervision and management departments; it can reduce or avoid adverse events of similar medical devices The recurrence of events reduces the risk of patients, medical staff and other personnel using medical devices; it can further improve the performance and function requirements of medical devices, promote the development of new products, and promote the healthy development of my country’s medical device industry.
Common adverse events of medical devices in daily life
1. Sphygmomanometer
Sphygmomanometer is an instrument for measuring blood pressure, mainly divided into mercury column sphygmomanometer And electronic (aneroid) sphygmomanometer two categories. Suspicious adverse events that may cause or may cause human injury may occur during the use of the sphygmomanometer, mainly manifested as inaccurate measurement results, intermittent black screen, and no blood pressure value displayed.
2. Thermometer
A thermometer is an instrument for measuring body temperature, mainly in the form of glass thermometers, electronic thermometers and infrared thermometers. During the use of the thermometer, suspicious adverse events that may cause or may cause human injury may occur, mainly manifested as inaccurate measurement results, the mercury column does not rise/fall, and cannot be counted.
3. Blood glucose meter
A blood glucose meter is an instrument used by diabetic patients for self-monitoring of blood glucose. Suspicious adverse events that may cause or may cause human injury may occur during the use of blood glucose meters, mainly including inaccurate blood glucose measurement values, unclear blood glucose value display, and no screen display.
4. Contact lenses
Contact lenses are lenses that are worn on the cornea of the eye to correct vision or protect the eyes. During the use of contact lenses, suspicious adverse events that may cause or may cause human injury may occur, mainly including dry eyes, redness, pain, tearing, photophobia, blurred vision, congestion, and irritation.
5. Disposable infusion set
Disposable infusion set is mainly used for intravenous infusion in hospitals. Suspicious adverse events that may cause or may cause human injury may occur in the use of disposable infusion sets, mainly due to quality problems that make them unusable, such as liquid leakage, foreign objects, missing original parts, air filter blockage, etc. Serious adverse events were mostly infusion reactions such as chills and fever.
6. IUD
IUD is a contraceptive device placed in the uterine cavity, which is composed of various materials. Suspicious adverse events that may cause or may cause human injury may occur during the use of the IUD, mainly including ectopic ring position, irregular menstruation, lower abdominal pain, and pregnancy with the device.