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 require medical device manufacturers to report adverse incidents and Field Safety Corrective Actions (FSCAs) to the Competent Authorities.
The manufacturers of certain medical devices require a proactive and comprehensive vigilance system to ensure that they capture, collate, investigate and where applicable, report per national and regional requirements all incidents.
Using devices which are 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. Especially where the marketing authorization holder is also the manufacturer of the device component.
Filling an incident report if a device malfunction, deterioration in device performance, inadequate instructions, or inadequate labelling results in death or serious injury, or may lead to death or serious deterioration in state of health if it were to recur according to MEDDEV 2.12/1. Report the incident occurred to the Competent Authority (CA) of the member state.
Distributing a report to CAs in the member states if a manufacturer takes an action to reduce the risk of death or serious deterioration in health, such as a recall, or a Field Safety Corrective Action (FSCA) especially where the device is being marketed as well as the CA where the manufacturer or their AR is located.
Medical devices suspected adverse events reporting in Kenya
The safety and performance of medical devices have a great and direct impact on patient safety. Errors, failures and defects in medical devices have serious consequences on patients and healthcare professionals. Report to the board an event/incident due to a medical device that meets the following three criteria.
a. An event has occurred. It may include but is 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 life-threatening 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. The intention to omit does not encompass the absence of information that users should know.
b. Consider the medical device as 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, or 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
Report all events even those without serious outcomes e.g. due to healthcare professional intervention. 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.
Report any incident, whether the fault is due to technical faults or defects in the equipment, instruction manual, marking, use or maintenance of the equipment even when in doubt.
Report to the Board all incidents related to medical devices using the medical devices incident reporting form. Use the poor-quality medicinal product reporting form to report any defect in the medical devices.
Conditions, where You do not require reporting, include:
- Deficiency of a device found by the user prior to its use.
- Patient conditions cause the adverse event.
- 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.