Analysis and Reflection on Suspected Medical Device Adverse Event Reporting in Guangdong Province in 2007: Possible Serious Injury
In Guangdong Province, three aspects were analyzed regarding the launch of medical device adverse event monitoring status. First, the reporting rate of medical device adverse events is still low, with insufficient community awareness of such events. By the end of 2007, most of the provincial and municipal medical device adverse event monitoring workstations (municipal workstations) were based in the cities' Food and Drug Administration or local pharmacognosy departments. However, most city-level workstations had not yet initiated the monitoring of adverse events related to medical equipment, lacked specialized staffing, and had no proper equipment configuration.
The municipal workstations showed a lack of understanding regarding the region’s medical device manufacturers, operating units, and user units. There was also a lack of specificity in carrying out publicity and training for medical device adverse event monitoring. Meanwhile, medical device manufacturing enterprises, business units, and user units lacked awareness of the importance and necessity of medical device adverse event monitoring. Awareness of security after the listing of medical devices and re-evaluation has yet to lead to the initiation of related work.
In summary, the overall reported rate of adverse events of medical devices in Guangdong Province, as well as the reported awareness, remains at a low level. Improvement depends on the support of relevant national policies and regulations and requires all levels of adverse event monitoring to increase efforts in the propaganda and training of Medical Device Adverse Event Monitoring. Special emphasis should be placed on promoting and training personnel involved in medical equipment production, management, and use to make them aware of the importance and necessity of medical device adverse event monitoring, thereby enhancing their reporting consciousness.
3.1 The Form of Suspected Medical Device Adverse Event Reporting
Guangdong Center received medical device adverse event reporting tables which are mainly basic paper report forms. The National Adverse Drug Reaction Monitoring Center has been encouraging the use of Epidata software for online submission via email after data entry. However, due to issues with devices and networks, this method has not been widely promoted among each reporting unit.
Additionally, the quality of filling in the received reports is not high, such as ambiguous or overly simple statements in the Loutian project. Handwritten report forms are often scribbled, making entry, analysis, and evaluation more difficult. Repeated verification of medical records also affects the progress of handling the report. To avoid or minimize these problems, wide publicity and training are needed. Professional seminars or training courses organized for reporting officers can help them master the use of Epidata software, improving the professionalism and standards of reporting staff, thereby enhancing the authenticity and accuracy of medical device adverse event report forms and reflecting the value of each report table.
3.2 Emergency Handling of Medical Devices in 2007
Five cases of suspected cardiopulmonary bypass pipeline adverse events were reported timely and handled appropriately, becoming a typical case of the Guangdong Center dealing with major medical device incidents. In the process of this incident, the highlights of the Guangdong Center's Medical Device regulatory system in handling emergencies were shown, but some problems were also exposed.
The highlights include:
(1) Linkage between various departments, information sharing, confirmed adverse events in a relatively short period of time, providing valuable information for further processing;
(2) Timely intervention by detection technology institutions shortened the time to confirm the cause of toxic substance-related adverse events;
(3) Reported units (hospitals) developed more complete adverse event processing rules and regulations, leading to timely discovery and reporting of adverse events, providing prerequisites and guarantees for properly handling the event within a shorter timeframe.
Problems identified include:
① An imperfect medical device adverse event monitoring network;
② Absence of relevant laws and regulations;
③ Lack of authoritative and accurate testing organizations for medical devices involved in adverse events;
④ Physician concerns leading to reporting delays.
Therefore, establishing and perfecting relevant laws and regulations, strengthening the construction of the medical device adverse event monitoring network, and increasing publicity and training of medical device adverse event monitoring have become top priorities.
4 Conclusion
With advancements in technology, the clinical use of medical devices has gradually increased, as has their frequency of use. Conducting medical device adverse event monitoring can effectively prevent and reduce medical device adverse events. Statistical analysis of collected data extracts effective early warning signals, providing data support for the re-evaluation of post-marketing medical device safety and offering a basis for further strengthening the monitoring of medical devices, thus protecting people's usage safety.