Medical device manufacturers have developed sophisticated quality assurance and quality control systems over the years. Such developments allow them to drastically improve the safety of medical devices industrywide. However, no matter how carefully manufacturers refine and monitor their systems, they can’t guarantee 100% risk-free output. That’s where medical device reporting comes in and creates an essential safeguard in the field.
Medical device adverse event reporting is an important aspect of ensuring the safety and effectiveness of medical devices. Adverse events, such as device malfunctions, infections, and injuries, can have serious consequences for patients and healthcare providers. By reporting these events, manufacturers, regulatory agencies, and healthcare facilities can identify and address potential safety issues early, and work to improve the overall performance of medical devices and prevent future adverse events.
However, there are some discrepancies between medical professionals responsible for reporting adverse events. Here’s how that can hurt organizations and how to mitigate it.
How Lack Of Standardized Training Undermines Medical Device Reporting
Without a system in place to train professionals on the best methods and timing for optimal reporting, risky medical devices can fall through the cracks. This in turn can cause unnecessary harm and damage to people and organizations. According to the FDA, less than 0.5% of medical malpractice cases were officially reported. Underreporting adverse events related to medical devices leads to wasted opportunities to gather data for preventing similar events. Such data could also aid in the development of safer future medical devices. Anyone can report medical device adverse events directly to the FDA: patients, home healthcare workers, pharmacists, nurses, physicians, attorneys, and even patient family members. Manufacturers are actually required to report medical device adverse events. However, the HHS Office of Inspector General estimates that only 14% of adverse events make it to the FDA.
A study in the Korean Journal of Medical Science shows that differences in perspectives with regard to both recognizing and determining medical device adverse events can undermine reporting industrywide.
In the study, they mention that a possible solution to this problem would be to educate healthcare workers on effective medical device reporting as they are the first line of defense in stopping medical device adverse events. To do this, researchers would need to develop a standardized training program that educates healthcare workers and other potential front-line reporters on efficiently identifying and reporting such adverse events. Afterward, they would apply it until the training system proves itself consistently. Finally, organizations could distribute it internationally, leading to quick and consistent medical device adverse event reporting. This process would then standardize the reporting process and hopefully improve reporting rates. Both the preemptive interventions and insights from proper reporting can exponentially help avoid any harm or damage down the line.
What You Can Do To Mitigate Risk
We hope the training in this study inspires international standardized systems to help professionals identify adverse events early and effectively. However, if you’re involved with organizations that rely on medical devices, you can’t afford to wait for that day.
So how do you mitigate the spread of medical device adverse events? While issues with medical device reporting are delaying the flow of information, the FDA still receives over 10,000 reports daily. Device Events offers a simple, intuitive search tool to quickly sift through them for exactly what you need. Device Events’ software is perfect for parsing through the seemingly endless information available in the FDA’s medical device reporting databases. Search through millions of medical device adverse event reports and filter for only the most relevant information with our software. Using it for more accurate and efficient data gathering can help your organization catch an emerging pattern of device failures in your organization without waiting for more to accumulate until an external power decides to recall medical devices.
If you are looking to leverage the power of information for your organization, contact us to learn how we can help you achieve it.