Reporting Adverse Events

In 20-odd years of contacts with professionals in the field of physical therapy, one of the most common misperceptions I have come across is the unfounded belief that the U.S. Food and Drug Administration (FDA) actually tests medical devices for safety and effectiveness. This is not the case. In reality, FDA's review process for medical devices only entails the review documentation provided by the device's manufacturer (which may include laboratory, animal and clinical testing results) to determine if there is evidence to demonstrate that there is reasonable assurance that the device is safe and effective.

Without actually testing the device for itself, FDA's review process is somewhat limited. For example, this process does not account for variations in product quality introduced during the manufacturing process.

Consequently, FDA's medical device review process is not able to detect all medical device problems before the devices are permitted to come into the hands of the physical therapist.

Because the FDA is aware of this potential problem, it has implemented post-market surveillance programs to detect device problems that only become apparent once the device has been used for some period of time. These programs include the Medical Device Reporting (MDR) regulation and the MedWatch program.

For its part, the MDR regulation mandates device-related adverse event reporting for device user facilities, manufacturers and importers of medical devices.

As discussed in more detail below, it is important for physical therapy providers and centers to understand that this regulation imposes a legal requirement for the reporting of certain adverse device events, the establishment of written MDR reporting procedures, and the establishment of certain related files.

On the other hand, the MedWatch program is not mandatory. However, it is a tool that the FDA has provided to encourage the participation of individual health care professionals (including physical therapists) to notify FDA and/or the manufacturer about serious adverse events and problems. FDA evaluates these reports to determine if they represent a previously unrecognized safety issue with the device. When FDA detects these problems, the agency will work with the manufacturer, or independently, to address and mitigate the risk presented by the device that were initially detected by the health professional or institution after the device received its marketing clearance from FDA.

Mandatory Reporting for Facilities

The MDR regulation is applicable in all traditional physical therapy settings as its scope includes hospitals, long-term health care facilities, ambulatory surgical facilities, outpatient treatment facilities and outpatient diagnostic facilities. These facilities are considered "device user facilities" under the regulation and need to comply with the requirements stated therein. It has been my experience that few, if any, physical therapy clinics have been aware of this legal requirement.

The MDR regulation imposes a legal requirement for device user facilities to submit a report of an adverse event whenever they receive or otherwise "become aware" of information that reasonably suggests the device has or may have "caused or contributed" to a "death" or "serious injury," including deaths or serious injuries that occur as a result of a device "malfunction," unclear device labeling and user error.

The MDR regulation also imposes a legal requirement for device user facilities to establish written MDR procedures that provide a system for the identification, communication, evaluation and submission of MDR reports.

There is also a requirement for these facilities to maintain records for each MDR report they submit to the FDA or the manufacturer that include the information that was evaluated to determine if the adverse event was reportable and copies of the submitted MDR reporting forms (FDA Forms 3500A).

Finally, device user facilities are also required to retain records of the information used to prepare the required annual reports.

The interests of patient safety require more than just establishing these procedures and records. In order for an MDR reporting system to be effective, the device user facility must provide training to its therapists and other personnel on the facility's mandatory reporting system. This will help assure that therapists and other personnel are able to monitor and report device-related problems in the facility to further the goal of promoting patient safety.

What to Report?

As noted above, the MDR regulation requires device user facilities to report adverse events involving "deaths" and "serious injuries." While the FDA has not presumed to define "death," it has provided a definition for "serious injury" which provides that a serious injury is an injury or illness that meets any one the following three criteria:

Is life-threatening;

Results in permanent impairment of a body function or permanent damage to a body structure;

Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Importantly, under the third criterion, there does not have to be any actual adverse outcome for the patient. It is sufficient that medical/surgical intervention was necessary to prevent any permanent impairment/damage.

This fact is often overlooked. As a result, many adverse events go unreported, potentially leaving problem devices on the field and placing other patients at risk.

When reporting adverse device events under the MDR regulation, device user facilities are required to provide all information that is "reasonably known" to them. This includes information found in documents in its possession and information that later becomes available as a result of reasonable follow-up within the facility. However, device user facilities are not required to evaluate or investigate an MDR reportable event by obtaining or evaluating information that is not reasonably known to it.

Relationship Between the Device and the Event

Experience has also shown that, even where some physical therapists were aware of the MDR reporting requirement, they were not always sure of the relationship that must exist between the suspect medical device and the death or serious injury. Under the MDR regulation, it is only necessary that the device may have "caused or contributed" to the death or serious injury. The FDA interprets "caused or contributed" to mean that a death or serious injury was or may have been attributed to a medical device or a medical device was or may have been a factor in a death or serious injury.

In some cases, adverse events meeting this definition have gone unreported because the therapist did not feel that the device's "role" in the event was "significant" enough. Under the regulation, it is not necessary for the device to have directly caused the death or serious injury in order for the event to be considered reportable.

Rather, if the information about the adverse event "reasonably suggests" that the device may have caused or contributed to a reportable event, then the event is considered MDR reportable. It is only necessary that the device MAY have been a factor contributing to a death or serious injury.

When Where and How to Report

The MDR regulation requires mandatory reports of adverse events to be submitted within a specified period of time. Failure to report these events in a timely manner can increase the exposure patients have to these device problems, potentially putting these patients at unnecessary risk.

For medical device user facilities, this period is measured from the day that the user facility "becomes aware" of an MDR reportable event. Device user facilities are considered to have "become aware" of an MDR reportable event when medical personnel (including PTs and PTAs) who are employed or otherwise affiliated with the facility become aware of information about the reportable event. This can occur at any time, such as a spontaneous observation during the course of care or during the review of test results.

Upon becoming aware of an adverse event involving a death, a device user facility is required to submit a report to the FDA within 10 working days after the day it became aware of the event. In addition, the user facility must also send a copy of the report to the device manufacturer if the manufacturer's identity is known.

Adverse events involving serious injuries must be reported to the device manufacturer within 10 working days after the day the facility became aware of the event. In the case where the manufacturer is not known, the user facility is required to send the report to the FDA within the same 10 working-day period.

The FDA provides a form for mandatory MDR reporting on its website. Mandatory reporting forms are known as the MedWatch form (Form FDA-3500A). As certain specific information must be entered in each field of the form, it is important to refer to the FDA's "Instructions for Completing the MedWatch Form 3500A." These instructions are also available on the FDA's website. As an alternative to printing, the Form FDA-3500A can also be filled out online.

As a guiding principle when filling out the Form FDA-3500A, device user facilities should capture as much of the "who, what, when, where, how and why" for the event in their MDR reports as possible. This will provide the best information upon which the the FDA or the device manufacturer can act to address the risk presented by the device problem.

Although the circumstances surrounding an MDR reportable event can sometimes be traumatic, it is also important to stick to the facts and avoid overstatements when reporting adverse events. For example, it is far more useful to state that a temperature probe was "hot to the touch" than it would be to overstate that a patient or clinician was "burned" when they touched the probe if there was no actual burn. Moreover, a precise and fact-based description of the event will ultimately save the facility a significant amount of time that could otherwise be necessary to respond to the manufacturer's or the FDA's inquiries regarding the severity of the injury and circumstances surrounding the incident.

In addition to filing individual MDR reports, device user facilities are also obligated to file annual summary reports with the FDA. Annual reports are required when a device user facility has submitted one or more MDR reports to the FDA or a device manufacturer within the past 12 months. In this case, the facility is required to submit an annual report to the FDA on an FDA Form 3419. As with the Form FDA 3500A, the annual reporting form and instructions are also available on FDA's website.

Annual reports are due to FDA by Jan. 1 of each year. In order to complete the FDA Form 3419, the facility must compile and submit information for each reportable event that occurred during the reporting period. This can be time consuming. However, facilities have the option to attach a copy of each FDA Form 3500A submitted to FDA and/or device manufacturers during the period as an alternative to compiling the summary information.

Voluntary Reporting

The voluntary MedWatch program is a useful tool for physical therapists working outside of a device user facility (e.g., home health) to report adverse events for which a mandatory report would not be required because the event occurred outside of a device user facility. This program serves as a mechanism for health professionals to report product problems that were noted spontaneously in the course of clinical care. The program also can be used to report adverse events occurring within a device user facility that do not require a mandatory report because they do not involve a death or serious injury.

Voluntary reports can be submitted by individual physical therapists or other health care professionals using the FDA Form 3500. Again, the FDA makes the FDA Form 3500 available on its website. While device user facilities that wish to file a voluntary report may also use FDA Form 3500, FDA prefers that they file using the mandatory FDA Form 3500A, as this form includes useful information not required on the FDA Form 3500.

As medical devices are becoming an ever increasing part of physical therapy, physical therapy providers also have an increasing role in the detection of these device problems to help ensure their safety and effectiveness. Through the MDR regulation and MedWatch program, the FDA has provided a meaningful way role physical therapy providers in the protection of patients' safety.

Evan P. Phelps works for Olsson Frank Weeda Terman Bode Matz, PC, in Washington, DC.