Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on February 22, 2023 by The Health Master
FAQs – on Blood Bags and its Testing
Q. 1: Whether Blood Bags are notified under Medical Devices Rules 2017 ?
Ans: Single, double, as well as quadruple Blood bags used for blood collection and component preparation are notified “Medical Devices” as per Medical Devices Rules 2017.
Q. 2: Where to purchase the Blood Bags from ?
Ans: Blood centers has to purchase these blood bags from licensed dealers, distributors or manufacturer only.
Q. 3: Whether every batch of Blood Bags is required to be tested ?
Ans:
- 1. Yes, every batch of these blood bags required to be tested by the manufacturer of the blood bags
- 2. CoA of the blood bags supplied by the manufacturer is to be kept by the Blood Centres.
- 3. Blood Centres has to follow SOP submitted to LA of the state regarding testing of blood bags
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Q. 4: Where the Blood Bags are to be tested from ?
Ans: Blood bag is to be tested from FDA Approved private Medical Device testing Laboratories only having approval under Medical Devices Rules 2017 on Form MD-40.
Q. 5: Whether Test report of Blood Bag on Form 39 is legal ?
Ans: Test Reports issued on Form 39 by the drug testing Laboratories under Drugs and Cosmetics Rules 1945 is not legally valid.
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Q. 6: ON which Form the Test report of Blood bag is to be issued ?
Ans: The test report must be issued under Medical Devices Rules on Form MD-32.
Q. 7: Whether sterility testing of Whole Human Blood and its components are mandatory ?
Ans: Yes, Whole Human Blood and its components are “Drug” and required to be tested for Sterility in addition to other tests.
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