Limits...
Legal and ethical issues in safe blood transfusion.

Chandrashekar S, Kantharaj A - Indian J Anaesth (2014)

Bottom Line: Small size of blood banks compromises blood safety.Accreditation of blood banks along with establishment of regional testing centres could pave the way to blood safety.The Food and Drug Administration (FDA) needs to clarify that procedures or tests meant for enhancement of blood safety are not illegal.

View Article: PubMed Central - PubMed

Affiliation: Department of Transfusion Medicine, Manipal Hospital, Bangalore, India.

ABSTRACT
Legal issues play a vital role in providing a framework for the Indian blood transfusion service (BTS), while ethical issues pave the way for quality. Despite licensing of all blood banks, failure to revamp the Drugs and Cosmetic Act (D and C Act) is impeding quality. Newer techniques like chemiluminescence or nucleic acid testing (NAT) find no mention in the D and C Act. Specialised products like pooled platelet concentrates or modified whole blood, therapeutic procedures like erythropheresis, plasma exchange, stem cell collection and processing technologies like leukoreduction and irradiation are not a part of the D and C Act. A highly fragmented BTS comprising of over 2500 blood banks, coupled with a slow and tedious process of dual licensing (state and centre) is a hindrance to smooth functioning of blood banks. Small size of blood banks compromises blood safety. New blood banks are opened in India by hospitals to meet requirements of insurance providers or by medical colleges as this a Medical Council of India (MCI) requirement. Hospital based blood banks opt for replacement donation as they are barred by law from holding camps. Demand for fresh blood, lack of components, and lack of guidelines for safe transfusion leads to continued abuse of blood. Differential pricing of blood components is difficult to explain scientifically or ethically. Accreditation of blood banks along with establishment of regional testing centres could pave the way to blood safety. National Aids Control Organisation (NACO) and National Blood Transfusion Council (NBTC) deserve a more proactive role in the licensing process. The Food and Drug Administration (FDA) needs to clarify that procedures or tests meant for enhancement of blood safety are not illegal.

No MeSH data available.


Related in: MedlinePlus

Organogram of Indian Blood Transfusion Service.Source: Action Plan for Blood safety Manual-NACO/NBTC[16]
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Figure 2: Organogram of Indian Blood Transfusion Service.Source: Action Plan for Blood safety Manual-NACO/NBTC[16]

Mentions: Many improvements seen in our country over the last decade and a half has been the result of licensing which laid down minimum requirements in terms of space, staff and equipment and also National Aids Control Organization (NACO) support for blood safety.[17] While the drugs controller is the regulatory authority, NACO/NBTC has been the main technical body to frame guidelines for the practice of transfusion medicine. The NBP is an offshoot of the National Aids Control Program.[18] NACO together with NBTC has played a pivotal role in improving blood safety by infrastructure development, setting up component separation units, promoting voluntary blood donation, training staff and has also laid down standards for blood banks in India [Figure 2].[19]


Legal and ethical issues in safe blood transfusion.

Chandrashekar S, Kantharaj A - Indian J Anaesth (2014)

Organogram of Indian Blood Transfusion Service.Source: Action Plan for Blood safety Manual-NACO/NBTC[16]
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4260301&req=5

Figure 2: Organogram of Indian Blood Transfusion Service.Source: Action Plan for Blood safety Manual-NACO/NBTC[16]
Mentions: Many improvements seen in our country over the last decade and a half has been the result of licensing which laid down minimum requirements in terms of space, staff and equipment and also National Aids Control Organization (NACO) support for blood safety.[17] While the drugs controller is the regulatory authority, NACO/NBTC has been the main technical body to frame guidelines for the practice of transfusion medicine. The NBP is an offshoot of the National Aids Control Program.[18] NACO together with NBTC has played a pivotal role in improving blood safety by infrastructure development, setting up component separation units, promoting voluntary blood donation, training staff and has also laid down standards for blood banks in India [Figure 2].[19]

Bottom Line: Small size of blood banks compromises blood safety.Accreditation of blood banks along with establishment of regional testing centres could pave the way to blood safety.The Food and Drug Administration (FDA) needs to clarify that procedures or tests meant for enhancement of blood safety are not illegal.

View Article: PubMed Central - PubMed

Affiliation: Department of Transfusion Medicine, Manipal Hospital, Bangalore, India.

ABSTRACT
Legal issues play a vital role in providing a framework for the Indian blood transfusion service (BTS), while ethical issues pave the way for quality. Despite licensing of all blood banks, failure to revamp the Drugs and Cosmetic Act (D and C Act) is impeding quality. Newer techniques like chemiluminescence or nucleic acid testing (NAT) find no mention in the D and C Act. Specialised products like pooled platelet concentrates or modified whole blood, therapeutic procedures like erythropheresis, plasma exchange, stem cell collection and processing technologies like leukoreduction and irradiation are not a part of the D and C Act. A highly fragmented BTS comprising of over 2500 blood banks, coupled with a slow and tedious process of dual licensing (state and centre) is a hindrance to smooth functioning of blood banks. Small size of blood banks compromises blood safety. New blood banks are opened in India by hospitals to meet requirements of insurance providers or by medical colleges as this a Medical Council of India (MCI) requirement. Hospital based blood banks opt for replacement donation as they are barred by law from holding camps. Demand for fresh blood, lack of components, and lack of guidelines for safe transfusion leads to continued abuse of blood. Differential pricing of blood components is difficult to explain scientifically or ethically. Accreditation of blood banks along with establishment of regional testing centres could pave the way to blood safety. National Aids Control Organisation (NACO) and National Blood Transfusion Council (NBTC) deserve a more proactive role in the licensing process. The Food and Drug Administration (FDA) needs to clarify that procedures or tests meant for enhancement of blood safety are not illegal.

No MeSH data available.


Related in: MedlinePlus