Guidelines on the Safety and Vigilance of Medical Products and Health Technologies

Reporting suspected adverse events with medical devices

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: 

1. A malfunction or deterioration in the characteristics or performance.
2. For IVDs where there is a risk that an erroneous result would either (1) lead to a patient management decision resulting in an imminent life-threatening situation to the individual being tested, or to the individual’s offspring, or (2) 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
3. Unanticipated adverse reaction or unanticipated side effect
4.  Interactions with other substances or products
5.  Degradation/destruction of the device (e.g. fire)
6. Inappropriate therapy vii. 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:

1. Death of patient, user or another person.
2. A serious deterioration in state of health of a patient, user or other person in the form of:
   1. life-threatening disease/illness
   2. hospitalization or prolonged hospitalization
   3. permanent damage, injury or impairment of a body function.
   4. necessary medical or surgical treatment to prevent life-threatening illness, permanent injury
   5. 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.
   6. 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 (Annex 4). The poor-quality medicinal product reporting form (Annex 6) can be used to report any defect in the medical devices.

Conditions where reporting is not required include:

1. Deficiency of a device found by the user prior to its use.
2. Adverse event caused by patient conditions.
3. Service or shelf life of the medical device exceeded.
4. Protection against a fault functioned correctly.
5. Expected and foreseeable side effects.
6. Negligible likelihood of occurrence of death or serious injury.

Reporting poor quality medical products and health technologies.

All healthcare providers in the private and public sector shall alert PPB on product quality issues. The poor-quality issues may include colour change, separation of components, powdering, crumbling, caking, moulding, change of odour, mislabelling, incomplete pack, suspected contamination, questionable stability, defective components, poor packaging/poor labelling, therapeutic failures and receiving expired products. Others include: haemolysed containers, blood with clots, leaking, change in colour, broken seals for Fresh Frozen Plasma (FFP) for blood and blood products, thawed products (FFP). Rusting, broken seals, defective, lack of packaging integrity for the health technologies. This shall be reported to the Board using the form for reporting poor quality medical products and health technologies (Annex 6). Post marketing surveillance shall be conducted routinely to ensure that medical products and health technologies in the Kenyan market are safe, of quality and efficacious. (ref :Guidelines on the Safetyand Vigilance of MedicalProducts and HealthTechnologies, pharmacy and posons board).

Additional reference :MEDDEV 2.12-1 rev. 8

Obligations to the marketing authorization holders 

Safety and vigilance of medical devices.

The MAH shall establish and maintain a vigilance system for the notification and evaluation of incidents and field safety corrective actions (FSCA) for medical devices. The manufacturers as well as MAHs of medical devices are obliged to report these incidents. On identifying a significant increase or trend of events or incidents that are usually excluded from individual reporting the manufacturer or the MAH shall report to the Board. The manufacturer should have suitable systems in place for proactive scrutiny of trends in complaints and incidents occurring with their devices. Field Safety Notices (FNA) and Field Safety Corrective Actions (FSCA) including those based on incidents occurring outside Kenya shall be reported to the Board in periodic summary reports. The reports shall include the full details of vigilance issues, including the status of any Field Safety Corrective Actions or Notices. They shall be completed using the current version of the MEDDEV reporting template. The MAH may be requested by the Board to conduct a concise critical analysis of the safety and performance of the medical device or IVD and submit results within a specified time frame.

The following timelines apply for the reporting of incidents that have occurred in Kenya:

1. Serious public health threat: Immediately (without any delay that could not be justified) but not later than 2 calendar days after awareness of this threat.
2. Death or Unanticipated serious deterioration in state of health: Immediately (without any delay that could not be justified) after the manufacturer has established a link between the device and the event but not later than 10 elapsed calendar days following the date of awareness of the event.
3. Others: Immediately (without any delay that could not be justified) after the manufacturer established a link between the device and the event but not later than 30 elapsed calendar days following the date of awareness of the event. The regulatory actions taken by the Board may include: recalling the device, reclassifying it, ordering a redesign from the manufacturer or other.