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Maharashtra FDA to help blood banks across state to adopt good haemovigilance practices for safe blood

Shardul Nautiyal, Mumbai
Wednesday, February 21, 2018, 08:00 Hrs  [IST]

The Maharashtra Food and Drug Administration (FDA) will soon roll out a series of workshops in association with blood banks across the state to adopt safe blood transfusion practices under the Haemovigilance Programme of India (HvPI) as envisaged in the National Blood Policy based on a consultative approach. There are currently 306 blood banks in the state.

HvPI is aimed at collecting vital data to increase safety, reliability of the blood transfusion process and introduce required changes in the existing policies. According to experts, HvPI will increase the safety and quality of the entire process from donation to transfusion. It will help improve standards, systems and processes and bring about required changes in the applicable policies, despite being a voluntary exercise.

Haemovigilance helps document the blood transfusion chain from blood donors to recipients and to help detect any adverse blood transfusion reaction during its usage. Besides documenting adverse reactions to recipients, haemovigilance helps in getting details pertaining to collection, investigation, its analysis and transfusion of blood or blood components.

“All blood banks and hospitals should adopt haemovigilance as it will ensure patient safety during blood transfusion. We will rope in blood bank officials and experts to raise compliance levels in all blood banks to ensure safe and consistent blood supply through adoption of haemovigilance and technology,” according to Maharashtra FDA Commissioner Dr Pallavi Darade.

Launched by National Institute of Biologicals (NIB) on December 10, 2012, 900 blood banks out of 3,000 licensed blood banks have been enrolled under HvPI attached to blood banks, government and private hospitals to collect data in transfusion reaction reporting form (TRRF) through a software, Haemo-Vigil, indigenously developed by IT division of NIB. This data is aimed at generating evidence based recommendations for safety related regulatory decisions.

The reporting system under the HvPI is systems oriented, independent of any authority and confidential. It offers expert analysis and is responsive. NIB and Indian Pharmacopoeia Commission (IPC) function as the co-ordinating centre between the reporters and regulators.

Reports are evaluated by experts who understand the clinical circumstances and are trained to recognise underlying systems causes through a Haemovigilance Advisory Committee (HAC).

Traceability of events related to blood transfusion is done through proper documentation which in turn leads to effective recommendations to be accepted and acted upon. Besides this, the identities of the patient, reporter and institution are never revealed to third party going by the clause for confidentiality.


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