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 a great and direct impact on patient safety. Errors, failures and defects in medical devices may have serious consequences for patients and healthcare professionals. The Board shall require reporting of 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: 

1. A malfunction or deterioration in the characteristics or performance.
2. All false positive or false negative test results for IVDs, where there is a risk of causing an imminent life-threatening situation, death, or severe disability to the individual or fetus being tested or to the individual’s offspring, shall be considered as events. For other IVDs, false positive or false negative results falling outside the declared performance of the test shall also 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. The absence of information that should generally be known by the intended users is not considered as omissions.

B. The incident considers the medical device to be the contributing cause.

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.

Healthcare professionals must also report events that do not have a serious outcome, for example, due to their 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 it involves technical faults, defects in equipment, instruction manuals, markings, use, or maintenance, even in cases of doubt. You must report all incidents related to medical devices to the Board using the medical devices incident reporting form (Annex 4). You can report any defect in medical devices using the poor-quality medicinal product reporting form (Annex 6).

Reporting is not required for conditions where:

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, mounding, change of odour, mislabeling, incomplete pack, suspected contamination, questionable stability, defective components, poor packaging/poor labelling, therapeutic failures and receiving expired products. Others include: hemolyzed 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. You shall report this to the Board using the form for reporting poor quality medical products and health technologies (Annex 6).We will conduct routine post-marketing surveillance to ensure the safety, quality, and efficacy of medical products and health technologies in the Kenyan market. (ref :Guidelines on the Safety and Vigilance of Medical Products and Health Technologies, pharmacy and poison’s board).

Additional reference :MEDDEV 2.12-1 rev. 8

Obligations to the marketing authorization holders 

Safety and vigilance of medical devices.

The MAH must establish and maintain a vigilance system for incidents and FSCA for medical devices. Manufacturers and MAHs have an obligation to report incidents. If they identify a significant increase in excluded events, they must report it to the Board. Manufacturers should have proactive systems for scrutinizing complaints and incidents. They shall report FNA and FSCA, even those occurring outside Kenya, to the Board in periodic summaries. The reports shall include full vigilance details, including the status of any corrective actions. Use the current MEDDEV reporting template for completion. The Board may request a concise critical analysis of safety and performance from the MAH within a specified timeframe.

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.