Adverse Event Reporting refers to the process mandated by law wherein the manufacturers, importers and users submit the report about events that resulted in or contributed to death, major injuries, or malfunction that may cause serious injury. In the US, this process is accomplished through FDA’s Medical Device Reporting according to the requirements of 21 CFR Part 803 via MedWatch or electronic gateways.
When to Report an Adverse Event?
An event is considered an adverse event and must be reported to FDA when the patient outcomes are any of the following:
- Death: Reporting of death due to an adverse event is mandatory, including the date of death if known.
- Potentially fatal: It is crucial to inform even if there is a possibility that the patient may be seriously harmed due to adverse events.
- Inpatient or outpatient hospitalization: Hospital admissions can occur because of adverse incidents or complications. Patients coming to emergency rooms should be investigated for possible adverse event implications prior to getting admitted to the hospital.
- A permanent injury or disability: Adverse events can lead to severe disruption in callers’ life in similar situations. One example of this type of scenario would involve a case where a caller has suffered an adverse event that affects his/her body in a permanent way.
- Defects at birth/congenital anomalies: It is crucial to report an indication of adverse outcomes resulting from the usage of a medical product by pregnant women or those trying to conceive a child.
- Prevention of Permanent Impairment or Damage: If you have reason to think that a healthcare product caused damage to an organ or body function, then the FDA must be informed.
- Other Important Medical Events: You must file a report regarding the medical or surgical method that occurred even when the event does not fit the definition of an outcome, provided the event could harm a patient.
Benefits of Adverse Event Reporting
Reporting systems are key to understanding adverse events and executing preemptive steps. Reporting adverse events constantly and regularly offers the following benefits:
- A better workplace and a safer patient environment: Constant reporting is important since it can contribute to enhancing the safety of patients. This is especially relevant when surgeons have so many unsafe cases. One out of ten hospital patients gets hurt while receiving treatment, and a quarter of surgeries are unsafe.
- Understand what contributes to system failures: It is important to report adverse events and cases of near misses according to best practices. All this information can be collected and used for improving the safety protocols or recovering from a failure in the system. Studying each of these cases can give the idea of the measures to implement to minimize the occurrences of these events in the future.
- Transparency & Trust within Facilities: According to the Bureau of Labor Statistics (BLS), there are various reasons as to why adverse events have not been fully reported. For instance, workers generally do not report adverse events due to the fear of losing their jobs, the incentive programs do not favor the reporting of adverse events and the regulations from OSHA hinder the collection of adequate data in the healthcare sector.
- A heightened sense of security & peace of mind: Reporting adverse event is not only about ensuring patient safety. Reporting adverse events also shields healthcare organizations from incurring liability claims as they reduce financial losses through reduction in payments for preventable hospital-acquired conditions. Therefore, it is prudent for the healthcare facility to report an adverse event as soon as it learns that it is responsible for it. This will ensure that all urgent steps are taken to meet patient needs and provide evidence of rapid actions taken towards resolving the situation when the case goes to trial.
