Patient Safety Day - Medical Device Incident Reporting

What is a medical device? A product used in healthcare for the diagnosis, prevention, monitoring or treatment of an illness or handicap. This does not include a medicine. There is a wide array of medical devices ranging from sterile dressings and wheelchairs to glucometers, infusion pumps, cardiac pacemakers and implants to name a few. The term medical device also covers in-vitro diagnostic test kits, reagents, calibrators and related software. Examples include blood group test kits, HIV kits and blood glucose monitors. Have you heard of Adverse drug reactions or side effects? If yes, you might appreciate that this is a highlight of products that fall under the category of pharmaceuticals and cosmetic products.

What is a medical device incident (MDI)? A medical device incident (MDI) is defined as an incident related to the failure of a medical device, deterioration in its effectiveness, or inadequacy in its labeling or directions that led to the death or serious deterioration in health of a patient, user, or other person OR could do so were it to recur. Example: An infusion pump stopped due to a malfunction but failed to give an alarm and the patient received an under-infusion of antibiotics, resulting in septic shock that prolonged the patient's stay in hospital.

Who should report? Anyone can report – professionals, caregivers, distributors, wholesalers, retailers etc. can all report any incident regarding a medical device. You do not need to be 100% sure that the untoward effect was due to the medical device but a suspicion itself can allow you to report.

Remember: When in doubt, report! Mandatory reporting of medical device incidents (MDIs) applies to all classes of medical devices: Class A, B , C & D.

How do we Report in Kenya? You can contact the hospital or healthcare outlet from which the device was purchased as an end-user and share the complaint with them for further investigation. Also, Importers and distributors play a huge role in reporting especially for class C& D products that are usually not used by the patients directly. All these incidents are reported to the Pharmacy and Poisons Board (PPB). You too can report directly to PPB as below:

Pharmacy and Poisons Board has a medical device department that has a green form related to medical incidences (FOM019/MIP/PMS/SOP/001). This can be easily downloaded from the Pharmacy and Poisons Board website.

What can I do to prevent adverse incidents from happening? only purchase devices from authorized vendors – those that have been validated by PPB, read the instructions for use thoroughly before use, ensure that the device is serviced regularly and maintained appropriately, report incidents to PPB and the manufacturer.