In the United States, the FDA has established the MedWatch electronic medical device reporting system to help facilitate post-market reports of adverse events for medical devices. Under the system, manufacturers, device user facilities and device importers are obligated to report medical device adverse events; and health care providers, patients or consumers may submit voluntary reports.
In Europe, the analogous system for post-market medical device adverse event reports is known as the Medical Device Vigilance
In the United States, medical device manufacturers are held accountable to providing reports of known adverse events causing death, adverse events causing serious injury and device malfunctions. Under the MEDDEV Vigilance System, manufacturers are required to file reports for two types of events: incidents and field safety corrective actions.
The European Commission defines an Incident quite broadly in its guidance document for MEDDEV Vigilance: incidents include any malfunction or deterioration in device characteristics or performance, or any defect in labeling or instructions for use which might, directly or indirectly, lead to or have led to the harm or death of a patient or user. The use of "incident" here can be seen as analogous to the use of "adverse event" by the FDA.
A Field Safety Corrective Action (FSCA) is defined as any action taken by a manufacturer to reduce a risk of death of serious deterioration of health associated with the use of a medical device that is already available on the market. FSCAs can include a number of different actions, including exchanging or modifying the device, accepting a return, or even conducting follow-up with a patient or clinician and advising on the use of a device.
The European Commission has established detailed requirements that dictate circumstances under which manufacturers should submit a MEDDEV Vigilance Report. Any event that meets all of the following three basic reporting criteria is considered to be an incident and should be reported to the relevant authorities.
A: An event has occurred.
An event could include things like a malfunction of the device, failure of the device to perform in accordance with its intended purpose, unanticipated adverse side effects of the medical device, destruction of the device (e.g. the device caught fire), or negative interactions with other substances or products.
B: The manufacturer's device is suspected to be a contributory cause of the incident
Although it may not always be clear whether a manufacturer's device contributed to an adverse event, the European Commission instructs manufacturers to err on the side of caution in complex situations and file a report, even when there are multiple drugs or devices involved that could have caused the incident.
C: The event led, or might have led, to one of the following outcomes:
Death of a patient, user, or another person
Serious deterioration in health (serious injury) of a patient, user or
Serious deterioration of health includes things like the development of a life-threatening illness (e.g. the medical device was contaminated with bacteria and implanted in the patient), permanent impairment, fetal death, or any condition requiring medical or surgical intervention to prevent permanent or life-threatening illness or damage.
To ensure the safety and effectiveness of medical devices and avoid the financial and legal liabilities associated with a device recall, medical device manufacturers must begin to assess and understand device risk during the product design stage of medical device development.
Greenlight Guru's eQMS Software is purpose-built to support integrated quality and risk management efforts from the initial capture of user needs in the design phase through the entire product life cycle, all while offering out-of-the-box compliance with the ISO 13485: 2016 quality requirements that are necessary for medical devices entering the European marketplace.