Abstract

PHARMACOVIGILANCE OF MEDICAL DEVICES AND DIAGNOSTICS IN A BLOOD BANK

Mohammed Daiyaan Khan*, Faiz Mohammed Ismail and Mahendra Kumar B. J.

ABSTRACT

Whole blood and red blood cells meet the generally accepted definition of medicines. They are among the most widely prescribed therapies and are credited with saving millions of lives each year. Medical devices and diagnostics used in blood bank are not without risks and can lead to complications. This observational study was conducted over a period of 6 months in a selected blood bank with the primary aim to implement pharmacovigilance in the form of materiovigilance to not only study but help improve the quality and safety involved in blood transfusion during collecting, collating, analysing, and disseminating information on a common set of adverse reactions due to transfusion of blood and blood products. Information obtained will be useful to build safer systems, efficiently use valuable health resources and deliver better patient care. During the study a total of 200 healthy donors were observed and inquired for any adverse reactions such as itching, irritation, pain, rash, redness. Swelling and bleeding occurredduring the blood transfusion which could be due to the medical devices. In the 200 donors we observed 40 donors had one or more adverse reactions. 39 (19.5%) had redness, 32 (16%) had swelling, 21 (10.5%) had pain, 16 (8.0%) had bleeding, 12 (6%) had itching, 7 (3.5%) had irritation and the other 2 (1%) had dizziness. The adverse effects of most used medical devices and diagnostics were studied, there is a chance of regular occurrence of mild and sometimes severe reactions. Irrespective of the severity, measures to prevent or treat these reactions must be taken.

Keywords: Medical Devices, Diagnostics, Blood Bank, pharmacovigilance, materiovigilance.