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Medical device adverse events can be a daunting challenge for any manufacturer to address.
Not only is your reputation on the line, but so is the wellbeing of the patients using your device. Adverse events can cause serious injury, lasting harm, and even death. To put it simply, the stakes are high, making the proper handling of adverse events critical.
In this blog, we will explore the essential information about medical device adverse events and reporting requirements that manufacturers need to know, as well as the best practices for handling them as they arise.
A medical device adverse event refers to any negative or unintended incident that occurs as a result of using a product. Sometimes referred to as “incidents,” adverse events reveal compromises in the safety, effectiveness, or intended use of a medical device, and can range from minor to serious in terms of its impact on the user.
Adverse events can be caused by problems with the device itself, as well as issues related to the use of the device. In fact, the International Medical Device Regulators Forum (IMDRF) has identified dozens of categories for adverse events, including:
Patient device interaction
Manufacturing, packaging, or shipping problem
Material integrity problem
Improper or inadequate design
Human-device interface problem
The impact of adverse events may range from very minor to moderately severe. However, when these events become life-threatening in nature, they may be categorized as a Serious Adverse Event (SAE).
Serious Adverse Events are typically defined as an adverse event with any of the following outcomes:
Life-threatening injury or illness
Disability or permanent damage
Congenital anomaly/birth defect
In order to address and prevent future harm to patients, serious adverse events involving medical devices must be reported to regulatory agencies for formal investigation. The purpose of these investigations is to determine the adverse event’s specific cause, as well as communicating any potential threats to other users of the device in question.
In the United States, when a medical device contributes to a death or serious injury or poses a threat from a flaw or malfunction, companies are required to submit a medical device report to FDA.
This process is known as medical device reporting (MDR), a postmarket surveillance tool the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
The requirements for medical device reporting are detailed in 21 CFR Part 803. In the regulation, the FDA identifies three groups of mandatory reporters—medical device manufacturers, medical device importers, and device user facilities—each of which has separate and distinct requirements for reporting medical device adverse events.
Manufacturers must submit a report within 30 days of becoming aware of information from any source which suggests a marketed device may have caused a death or serious injury. The same is expected if the device experiences a major malfunction that could cause death or serious injury if it were to recur.
In general, manufacturers should use the mandatory reporting form, FDA Form 3500A. However, manufacturers may be required to submit a 5-day report when a reported event requires immediate remedial action, such as a product recall.
Importers must submit a report no later than 30 calendar days after they become aware of any information indicating that a marketed device contributed to a death or a serious injury. The same is expected if the device experiences a major malfunction that could cause death or serious injury if it were to recur. Much like manufacturers, importers can also submit reports on FDA Form 3500A.
Device user facilities must submit a report within 10 days of becoming aware of a significant adverse event believed to have caused or contributed to the death of a patient. For adverse events causing serious injury, device user facilities are required to report that incident to the device manufacturer within a period of 10 days. If the manufacturer is unknown, that report should instead be sent to the FDA.
Medical device user facilities must generate reports with the information outlined in 21 CFR 803.32, which generally correspond with the fields of Form FDA 3500A.
Though the regulations provide clear guidance on requirements for adverse event reporting, there is room for interpretation on how to most effectively handle adverse events.
Let’s take a look at three best practices you can follow to improve the adverse event reporting process—and how to limit adverse events entirely.
Serious adverse events require a sense of urgency from manufacturers. When one occurs, the reporting process triggers a chain of events that move rather quickly, so it’s critical you have a well-defined set of internal procedures in place.
You should have established written procedures for:
Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, including device-related complaints
A standardized review process or procedure for determining whether or not an event is a reportable event
Responsibility and roles for employees and management
Action plans for response, including immediate remediation actions
Timely communication and transmission of complete reports
Systems that ensure access to information that facilitate timely follow-up
Documentation of all medical device reports and information submitted and information used to determine if an event was reportable
Adverse event handling procedures should live inside your quality management system, where they can be easily located along with the rest of your internal SOPs. However, if you’re still using a paper-based QMS, this may be easier said than done.
With Greenlight Guru’s medical device eQMS platform, you have an end-to-end solution purpose-built for medical devices that allows you to link your latest approved procedures and protocols with a single click.
While your procedures are no doubt essential for proper handling of medical device adverse events, your employees depend on you for more personal guidance. An investment into training and education provides assurance that serious adverse events are properly handled. But even beyond that, it demonstrates your commitment to a culture of quality across the organization.
One oft-misunderstood aspect of medical device adverse event handling is defining what it means to “become aware” of a reportable event. When any employee becomes aware of a reportable event, the clock starts ticking on the window for response. This includes employees with regulatory, scientific, or technical responsibilities, as well as management.
Other considerations for training include:
Proper complaint handling and communication
Practices for identifying potential reportable events
Reporting cadence and formatting
Root cause analysis investigations
Managing training compliance is often easier said than done, as disconnected tools cause miscommunication and poor progress tracking. Thankfully, Greenlight Guru has a dedicated Training Management module within its QMS to connect people and the information they need to succeed. Easily assign training to individuals, set due dates, and keep track of tasks to ensure completion—all within your quality system with Greenlight Guru.
When we talk about handling medical device adverse events, we’re really talking about postmarket surveillance. Customer feedback and complaint management are essential to using a risk-based approach, especially across the product lifecycle.
Unfortunately, many MedTech companies find themselves chasing fragmented data across teams, locations, and systems. A lack of traceability, visibility, and access to current information prevents teams from seeing the big picture and understanding the impact of customer complaints.
A key solution here is automating the process for your complaint management workflow. Of course, this should also reside inside your QMS to help you track the correct action items to the right user or group — increasing your team's overall efficiency.
With Greenlight Guru’s Complaint Management Software, you’ll leverage a single, up-to-date workflow with management controls in place for your complaint process. Quickly determine whether feedback requires immediate action and if regulatory reporting is required. You can even automate tasks to generate reports for regulatory officials and document decisions for future reference.
The way your company responds after learning about a medical device adverse event is what sets industry leaders apart from other companies. To do this well, you must have the necessary systems in place for support. A healthy, purpose-built quality system is a key ingredient in this recipe for success.
Greenlight Guru’s end-to-end QMS solution makes it easy for medical device manufacturers to store and organize the critical data needed to complete and submit medical device reports to regulators within the allotted time frame. Our purpose-built system lets you easily and securely access data like product identifiers, lot numbers, lab data, and test results that relate to the specific adverse events being reported.
Ready to start handling medical device adverse events better than ever before? Contact us today for your free personalized demo of Greenlight Guru!
Looking for an all-in-one QMS solution to advance the success of your in-market devices that can integrate your post-market activities with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...