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ADVERSE EVENTS MONITORING REPORT FOR YEAR 2015 – CHINA FDA

On May 27, 2016, the China Food and Drug Administration issued the annual monitoring report of medical device adverse event for 2015, which included an overview of medical device adverse events, statistical analysis, measures for ensuring the safety of medical x-ray angiographic machines, external defibrillators and low-frequency electromagnetic therapy equipment etc. The report comprehensively reflects the monitoring work of medical device adverse events in 2015.

In general, there had been a good momentum in the development of medical device adverse event reporting, the number of which increased to 320,000. The average number of reports for every million people had reached to 240. Among these reports, devices in the field have accounted for 259,219 reports which represented 80.6%; manufacturers had submitted 5,352 which represented 1.7%; enterprises have submitted 56,315 representing 17.5%.

There were 364 reports from individuals; 41.6% of the reports involves Class 3 medical equipment,

39.3% involved Class 2, with 15.6% involving Class 1.

Overview of National Medical Device Adverse Events

In 2015, the work of national medical device adverse event monitoring program maintains in steady development, with over 320,000 reports of alleged adverse events. While the number of reports is increasing, the quality of reporting also improved, providing a good basis for analysing and evaluating the risk of the listed medical devices.

 

(1)  Overview of national adverse event of medical device (2015)

 

In 2015, National Adverse Drug Reaction Monitoring Centre had received 321,254 “Reports of Alleged Medical Device Adverse Event”, which rose by 21.1% since 2014. In total, National Adverse Drug Reaction Monitoring Centre had received 1,322,059 reports from January 1, 2002 to December 31, 2015. (Chart 1-1)

 

Chart 1-1 Number of National Reports of Alleged Medical Device Adverse Events (2002 – 2015)

 

1.Number of reported adverse events of death and serious injury

 

In 2015, National Adverse Drug Reaction Monitoring Centre has received 184 adverse event reports involving death and 47,065 of serious injury. In total, there are 47,249 reports, an increase of 15.2% from 2014 (Chart 1-2). The number of reported adverse events involving death and serious injury represents 14.7% of all reports, a decrease by 0.8% from 2014.

 

 

Chart 1-2 The comparison of report numbers for national adverse events of death and serious injury

 

 

2.Average number of reports for every million people

 

In 2015, the number of report of medical device adverse event for every million people in China is 240, showing an increase of 42 reports from 2014. (Chart 1-3)

 

 

Chart 1-3 Comparison of the average numbers of reports for every million people in China (2011-2015)

 

 

3. Number of registered users

 

Until December 31, 2015, There have been 198,536 registered users (including medical device manufacturers, and importers) in the monitoring system of national medical device adverse event. The number of medical device manufacturer users is 10,344, representing 5.2% of the entire user database; The number of medical device enterprise users is 91,322 representing 46.0%; The number of device users is 96,870 which takes up 48.8% (Chart 1-4).

 

 

Chart 1-4 National registered users in the monitoring system of medical device adverse event

 

In 2015, the total number of registered users(including medical device manufacturers, enterprises and device users) rose by 13.9% from 2014. The medical device manufactures, enterprises and device user exhibited a rise of 11.8%、21.8% and 7.5% respectively (Chart 1-5).

 

 

Chart 1-5 Classification and comparison of national registered users in 2014 and 2015

 

Statistical Analysis of Medical Device Adverse Event Report in 2015

 

(1)  Statistical analysis of information source

 

In 2015, among the medical device reports of adverse event, device users have submitted 259,219 reports, which takes up 80.6% of the total; manufacturers have submitted 5,352, taking up 1.7%; enterprises submitted 56,315, taking up 17.5%; There are 364 reports from individuals, which represents 0.1%; and another 4 reports were with unknown source (Chart 2-1).

 

 

Chart 2-1 Source of reports of medical device adverse event in 2015

 

Overall, device users were the main sources of adverse event reports. Compared to 2014, the proportion of the reports from manufacturers had declined, which is contradictory to their positions who bear the primary responsibilities towards the safety of medical devices. Thus, their consciousness to fulfill obligations should be strengthened.

 

(2) Statistical analysis of the extent of injury in adverse events

 

In 2015, among all the medical device reports of adverse event, there were 184 reports of deaths, which takes up 0.05% of all reports: the number of serious injury reports was 47,065 which takes up 14.7%; another 274,005 reports were in other extent of injury, taking up 85.2% (Chart 2-2). In absolute quantities, reports of each extent of injury have increased. This year, the proportion of each extent of injury is similar to 2014.

 

 

 

Chart 2-2 The extent of injury in medical device adverse event of 2015

 

(3) Statistical analysis of the classification of medical device management

 

In 2015, among all the medical device reports of adverse event, there are 133,548 reports that involve Class 3 medical device, representing 41.6% of all the reports; the number of reports of Class 2 medical device 26,284 (39.3%); the report number for Class 1 medical devices was 50,213 (15.6%); Other reports of unknown category tallied 11,209 (3.5%). The statistic indicates that, Class 2 and 3 represented the majority of the reports, which conform to the risk levels of medical devices (Chart 2-3).

 

 

Chart 2-3 The classification of product management in medical device adverse event report of 2015

 

 

(4) Statistical analysis of the product category of medical device

 

According to the existing “Medical Device Product Categorisation”, there are 43 categories involved in the medical device reports of adverse events in 2015, representing all the categories mentioned in “Medical Device Product Categorisation”. Please refer to Table 2-1 for the top 10 categories. Compared to 2014, there are hardly any changes to the product categories of top 10 but some slight changes to the rankings of some products

 

 

Table 2-1 Top 10 product categories of medical device adverse event 2015

 

 

(5) Statistical analysis of the names of medical device

 

Among the medical device reports of adverse events in 2015, the top 10 passive medical devices of the most reported are:

 

    • disposable infusion sets
    • disposable sterile syringe
    • intrauterine device
    • intravenous catheter
    • corneal contact lens
    • glass thermometer
    • catheter bag
    • medical adhesive tape
    • common sphygmomanometer, and
    • urinary catheter.

 

They represented 36.45% of all the reports. Please refer to Table 2-2.

 

 

Table 2-2 Top 10 passive medical devices of the most reported

 

 

Among the medical device reports of adverse events in 2015, the top 10 active medical devices are:

 

    • patient monitor
    • infusion / syringe pump
    • electronic sphygmomanometer
    • haemodialysis machine
    • ECG
    • Glucometer,
    • Respirator
    • Electronic thermometer
    • Infant Incubator, and
    • radiation therapy equipment

All of these take up 7.23% of the all reports. Please refer to Table 2-3.

 

 

Table 2-3 The top 10 active medical devices of the most reported

 

(6) Statistical analysis of the using places of medical devices

 

Among the medical device reports of adverse event in 2015, There were 232,641 reports in which “medical organisations” were using medical devices, representing 72.4% of all reports: the number of reports for family use was 39,632, which represents 12.3%; the number of reports for other places was 8,438, which represents 2.6%; another 40,543 reports were of unknown places, taking up 12.6% (Chart 2-4). The complexity of places is one of the factors that need to be considered when analysing the causes of adverse events.

 

 

 

Chart 2-4 The usage of medical device in adverse event report of 2015

 

 

 

Risk Assessment of Medical Device & The Main Measures

 

 

(1)  The issuance of “Notification of Medical Device Adverse Event”

 

In 2015, CFDA has issued 3 sessions of “Notification of Medical Device Adverse Event”, which involves medical x-ray angiography machine, external defibrillator and low-frequency electromagnetic therapy equipment.

The errors of angiography machine are the main risks for the clinical use of medical x-ray angiography. These errors mainly are no radiation, failure to start device, system halted, automatic shut-down, unclear image, image unable to save, C-arm unable to lock and operating table unable to move etc. Among the most reported errors are bulb and operating desk. To reduce the risks of injury caused by repeated adverse events, it is suggested that manufactures strength the monitoring of easily aging and consumable parts in product design. and, if necessary, increase alarm information in order to facilitate users’ identification; strengthen the training of use for medical organizations, which includes device’s operating procedure, requirements of operating environment, the life time of consumable parts etc. It is also suggested that medical organizations read the instruction carefully, get familiar with operating procedure and warnings, and ensure the operating environment In accordance with the instruction.

The main risks of the clinical use of external defibrillator are: defibrillation functioning failure, monitor / recorder failure or disorder. To reduce the risks of injury caused by repeated adverse events, according the relevant requirements of national standards, industrial standards and random documents of external defibrillators, we suggest the using units to establish and strictly enforce the routine of maintenance mechanism for external defibrillators; Manufactures should take  the particularity of external defibrillators (high risk, low frequency of use) into consideration, facilitate the maintenance by the design of “machine pleasing human”, and enhance the reliability design of key parts to lessen the equipment failures.

The main risk of the clinical use of low-frequency electromagnetic therapy equipment is electric harm, whose manifestations are skin allergies, scald, burns, sting, pain and muscle numbness etc; the equipment failures mainly express in power leakage, no output or output unstable and pads / lead wires damage, etc. To ensure the safety of using low-frequency electromagnetic therapy equipment and to reduce the possibility of adverse events, users are warned to beware of these :(1) Strictly control the indications and contraindications, with proper use of the product in accordance with instructions. Avoid improper use such as exceeding power output and timeout. Ensure that the environment and conditions of using equipment are in compliance with requirements.

 

(2) Enhance daily checks and maintenance of the equipment, and timely replace the worn / consumable parts.

 

(2) The issuance of “Medical Device Alert”

 

In 2015, The Monitoring Centre for Adverse Drug Reaction has issued 9 sessions of “Medical Device A”, which includes 52 articles of information about safety that overseas medical device monitoring organizations had issued, involving products such as intravascular recycling clamp, anesthesia breathing circuit, defibrillator, insulin pump, breathing machine and IOL etc.

Tips for monitoring medical device adverse events

 

  1. A medical deviceis any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

 

(1) Diagnosis, prevention, monitoring, treatment or alleviation of disease;

(2) Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

(3) Investigation, replacement, or modification of the anatomy or of a physiological process;

(4) Support and maintenance of life;

(5)  Control of conception;

(6) Providing information for medical or diagnostic purpose, by inspecting samples from human body.

  1. A medical device adverse eventis the occurrence of various events that cause or may cause harm to the human body under the proper use of registered, recorded or qualified medical devices.

According to the extent of injury and causes of medical device adverse event, the medical device manufactures should take measures to warn, check, repair, re-label, modify the specification, upgrade software, replace, recall and destroy etc.

At present, The adverse event monitoring centre of China collects reports according to the principle of “to report as long as it’s suspicious”, which refers to adverse event report of medical devices.

  1. The monitoring of medical device adverse eventis the process of discovery, report, research, evaluation and controlling of medical device adverse events.

 

  1. A serious medical device adverse eventcan be one of the below:
    • death;
    • life-threatening event;
    • permanent damage to body function or body structure;
    • event that requires taking medical measures to avoid such damage above;
    • all the events mentioned above caused by medical equipment failure or other available problems.

 

  1. The differences between medical device adverse eventand quality defects & medical malpractice”

A medical device adverse event is mainly caused by flaws of product design, inaccuracy or insufficiency of instructions that have been registered and reviewed. However, its products are qualified.

The medical device quality defects occur when the product’s quality does not meet the registration standards.

Medical malpractice mainly refers to the harm and damage to human body caused by medical staff’s disregard of medical and health management laws, departmental rules and clinical nursing standards and conventions.

 

  1. The average number of reports for every million peopleis the average number of alleged adverse event reports of medical device that have been received among every million of population

 

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