Medical device vigilance, as known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical devices. Its primary purpose is to protect and improve safeguards for patients, users and others by preventing or reducing the likelihood of reoccurrence of incidents elsewhere. The term “vigilance report” encompasses Incident Reports and Field Safety Corrective Action (FSCA) reports. The European Medical Devices Directive (93/42/EEC) and In-Vitro Diagnostic Devices Directive (98/79/EC) state that medical device manufacturers are legally required to report adverse incidents and Field Safety Corrective Actions (FSCAs) to the Competent Authorities.
A proactive and comprehensive vigilance system is required to be in place by the manufacturer of certain medical devices to ensure all incidents are captured, collated, investigated and, where applicable, reported per national and regional requirements. Furthermore, where devices are used in combination with active pharmaceutical ingredients, it is important that the surveillance system is meeting the regulatory requirements of both the drug and device component where the marketing authorization holder is also the manufacturer of the device component.
According to MEDDEV 2.12/1, an incident report must be filed if a device malfunction, deterioration in device performance, inadequate instructions, or inadequate labeling results in death or serious injury, or may lead to death or serious deterioration in state of health if it were to recur. The incident must be reported to the Competent Authority (CA) of the member state where the incident occurred.
If a manufacturer takes an action to reduce the risk of death or serious deterioration in health, such as a recall, a Field Safety Corrective Action (FSCA) report must be distributed to CAs in the member states where the device is being marketed as well as the CA where the manufacturer or their AR is located.
Reporting suspected adverse events with medical devices in Kenya
The safety and performance of medical devices have great and direct impact on patient safety. Errors, failure and defects in medical devices may have serious consequences for patients and healthcare professionals.An event/incident due to a medical device that meets the following three criteria shall be reported to the Board:
a. An event has occurred. It may include but not limited to:
- A malfunction or deterioration in the characteristics or performance.
- For IVDs where there is a risk that an erroneous result would either
- lead to a patient management decision resulting in an imminent lifethreatening situation to the individual being tested, or to the individual’s offspring,
- cause death or severe disability to the individual or fetus being tested, or to the individual’s offspring, all false positive or false negative test results shall be considered as events. For all other IVDs, false positive or false negative results falling outside the declared performance of the test shall be considered as events.
- Unanticipated adverse reaction or unanticipated side effect
- Interactions with other substances or products
- Degradation/destruction of the device (e.g. fire)
- Inappropriate therapy
- An inaccuracy in the labelling, instructions for use and/or promotional materials. Inaccuracies include omissions and deficiencies. Omissions do not include the absence of information that should generally be known by the intended USERs.
b. The medical device is considered to be the contributing cause of the incident.
c. The incident caused or could have caused one of the following outcomes:
- Death of patient, user or another person.
- A serious deterioration in state of health of a patient, user or other person in the form of:
- life-threatening disease/illness
- hospitalization or prolonged hospitalization
- permanent damage, injury, or impairment of a body function.
- necessary medical or surgical treatment to prevent life-threatening illness, permanent injury.
- any indirect harm caused by incorrect diagnostic or In Vitro Diagnostic Device (IVD) test results or caused by the use of In-vitro fertilization (IVF) / Assisted reproductive technology (ART) equipment used in accordance with the manufacturer’s instructions for use.
- fetal death, fetal injury, or congenital abnormalities
Events that do not have a serious outcome, e.g due to the intervention of healthcare professionals, must also be reported. The reason for this is that a similar event could have resulted in death or serious deterioration of the health of the patient, user or third person if there was no intervention before the incident developed. Any incident, whether the fault is due to technical faults or defects in the equipment, instruction manual, marking, use or maintenance of the equipment must be reported even when in doubt.
All incidents related to medical devices shall be reported to the Board using the medical devices incident reporting form . The poor-quality medicinal product reporting form can be used to report any defect in the medical devices.
Conditions, where reporting is not required, include:
- Deficiency of a device found by the user prior to its use.
- Adverse event caused by patient conditions.
- Service or shelf life of the medical device exceeded.
- Protection against a fault functioned correctly.
- Expected and foreseeable side effects.
- Negligible likelihood of occurrence of death or serious injury.
