scholarly journals Regulation of Blood and Blood products in India, USA and EU

2018 ◽  
Vol 6 (2) ◽  
pp. 72-84
Author(s):  
Swati Gupta ◽  
Harvinder Popli

Blood and blood products are precious commodity which gives life to another person. Though we have immense discoveries and invention in science and technology, yet we cannot make blood hence, human blood has no substitute. The availability of safe blood and blood products is essential for diverse modern healthcare services including some surgeries, treatments for cancer, chronic medical conditions, trauma care, organ transplantation, and childbirths that ultimately improve life for millions of patients who are need of transfusion annually. We do not have yet well-defined and stringent regulatory framework for blood products regulation. Frailty may arise from the inability of governments to enforce laws, regulations, and policies and personnel who may not aware or cannot follow quality assurance and/ or good manufacturing practices. While the health sector in developed nation has made outstanding accomplishments in the past few decades. The study sheds on the overview of blood transfusion system in India and other developed nations. There were a mix of methodologies, including literature review (government documents), interviews with key officials in Indian Red Cross Society and analysis of data was used. Results of analysis showed that there are several areas that need to be addressed as it potentially affect the timely availability of safe blood products, which calls for strengthening the planning and monitoring of blood transfusion services.

2019 ◽  
Vol 7 (4) ◽  
pp. 1-7
Author(s):  
Sravya Sree ◽  
Pasikhanti Shailaja

Haemovigilance is an urgent need of the country to identify and prevent occurrence or recurrence of transfusion related adverse reactions, thereby to increase the safety and quality of blood transfusion and blood products administration. Haemovigilance is an organised scheme of monitoring, identifying, reporting, investigating and analysing adverse events and reactions pertinent to transfusion and manufacturing blood products. Thus the information collected will facilitate corrective and preventive actions to minimise the potential risks associated with blood collection, processing and transfusion to patients. Indian Pharmacopoeia Commission has started a Haemovigilance Program of India (HvPI) in 2012 under its Pharmacovigilance Program of India (PvPI) in collaboration with National Institute of Biologicals (NIB), Noida, Uttar Pradesh, under Ministry of Health and Family welfare, Government of India with a primary objective to track adverse reactions/events and incidences associated with blood transfusion and blood product administration. The main objective of this article is to brief (s) about the system which monitors each and every step of transfusion reaction.


Author(s):  
Indu Singh ◽  
Janelle Guerrero ◽  
Michael J. Simmonds

Hereditary Hemochromatosis (HH) is a disorder where iron and ferritin concentrations in a patient's blood are much higher than normal healthy levels. The main therapeutic intervention for individuals with HH is removing 300-500 mL of blood every few months to maintain ferritin concentration within acceptable ranges. The blood collected during these venesections is usually discarded as there is a belief that blood with high levels of ferritin are not suitable for blood transfusion purposes. Australian Red Cross Blood Services voluntarily collects blood from donors for subsequent use in blood transfusion. Annually more than 700 thousand units are transfused within Australia and there is a constant need for new donors given the significant imbalance between supply and demand of blood products. Besides red cell transfusions, the Red Cross also issues donor blood for development of many other blood products essential for patient health care. The HH blood can currently be used for other blood products if not for red cell transfusion. However, there is evidence to suggest that there is no significant difference between the red cells of the normal healthy population compared to those from HH patients. Australian Red Cross has developed a mobile computer application (High Ferritin “app”) as they have started collecting blood from HH patients. Though there is little or no awareness about the existence and use of this High Ferritin app in general HH population, their doctors and nurses collecting their blood for therapeutic purposes. This chapter describes possibility of saving and utilizing the blood collected from hemochromatosis patients for therapeutic purposes. A national hemochromatosis patients registry, in collaboration with High Ferritin app (HFa) developed by Australian Red Cross Blood Services, accessible to the patients, their doctors and Red Cross Blood Collection Sservices 24 hours a day anywhere in the country can allow the patients to donate the blood collected for therapeutic purposes at any affiliated blood collection center in the country after they automatically get a message either by email or text message after their blood results have been reviewed by their doctor and they are required to go for venesection.


2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Agnes Asare Bediako ◽  
Rasheed Ofosu-Poku ◽  
Andrews Adjei Druye

Errors in transfusion of blood and blood products can lead to preventable morbidity and mortality. Nurses constitute a significant aspect of the transfusion process as they are the last in the chain of getting blood directly to the patient. They must, therefore, be conversant with the current standard of national and international guidelines on blood transfusion and appropriate management of adverse transfusion events. This study assesses the knowledge and practices of blood transfusion safety among nurses at Komfo Anokye Teaching Hospital. A descriptive cross-sectional design was employed, and structured questionnaire (Routine Blood Transfusion Knowledge Questionnaire) was used to collect data from 279 nurses from seven clinical directorates of the hospital. The data were processed with Stata version 14.0. Variables were analyzed using descriptive statistics, and relationships were drawn using inferential statistics. Over 90% of the respondents had a minimum of a diploma in nursing or midwifery, 63% had performed blood transfusion at least 5 times, and 46% had never received any training on blood transfusion. The mean score obtained in all four categories of blood transfusion knowledge assessed was 29, with 54% of the respondents scoring below the mean. The highest overall score on knowledge was 53%. This indicates that nurses had poor knowledge regarding safe blood transfusion practices as stipulated in the clinical guidelines for blood transfusion by Ghana’s National Blood Service. There was no statistically significant relationship between training/experience and knowledge of safe blood transfusion practices. Regular and continuous update training and audit are needed to safeguard patient safety during blood transfusion.


Author(s):  
R. A. Cumming

SynopsisThe use of blood has greatly increased during the past 25 years. One of the most important advances during this period is related to the development of methods of isolating, concentrating and storing the individual components of blood for specific clinical requirements. Along with this, new problems in science and technology, blood-donor organisation and medical care and the recruitment and training of staff have emerged. The opinion is advanced, that in the future, the efficiency of blood transfusion lies in its establishment as a separate discipline.


2021 ◽  
Author(s):  
Amar Ibrahim Omer Yahia

Maintaining international health security requires proactive and reactive activities and actions to minimise the negative impact of any health event that threatens public health. Blood transfusion services are a critical part of healthcare services, and blood and blood products can neither be synthesized nor stored for a long period. So, proper management of blood supply and blood demand is mandatory to preserve adequate safe blood. A failure to manage blood inventory and the resulting blood shortage are considered national and international health security threats because maintaining an adequate supply of safe blood is lifesaving for many patients. Blood shortages lead to the failure of blood transfusion services that ends with the collapse of the health system and health insecurity if health authorities do not take immediate corrective action. An imbalance between blood supply and blood demand is not only a threat to health security, but also poses some of the greatest threats to the national and international economy and security. The perception of health issues as an international health security threat is associated with benefits through attracting political and decision-makers’ attention and support. The global health policies and international health regulations concerning the management of blood supply and blood demand should be implemented and updated regularly. The information provided by this chapter addresses the management of blood supply and blood demand as an international health security issue and provides guidance in planning for proper management of blood inventory to avoid a sudden blood shortage and its catastrophic consequences.


1974 ◽  
Vol 14 (160) ◽  
pp. 337-343 ◽  
Author(s):  
Z. S. Hantchef

Although mention of blood transfusion dates back to the origin of medicine, it may be said that the genuine history of transfusion starts at the beginning of our century.Since then transfusion has passed through several decisive phases, but it is only in the past twenty years that it has made spectacular progress and has become one of the essential components of modern medicine.


2021 ◽  
Vol 10 (12) ◽  
pp. 861-865
Author(s):  
Lekshmi Leela Rajan ◽  
Suma M.S. ◽  
Harikumar S.

BACKGROUND Transfusion of blood and blood products is an essential component of patient care in various health care settings. Blood is collected from non-remunerated donors. Many infections can spread through the transfusion of blood and blood components. Testing of donor blood for infectious agents prior to transfusion of blood products increases blood safety. Mandatory testing of five transfusion transmitted infections is done prior to transfusion following manufacturer’s instructions and quality specifications. Prevalence study will help the blood transfusion services to select and implement the strategies effectively for blood safety. METHODS This is a descriptive study based on retrospective collection of data from available records. Donor results were recorded and maintained to ensure the traceability of specific donor. The data was collected from the blood donor records and registers pertaining to the 10 year period from 2007 to 2016. Samples seroreactive for human immunodeficiency virus (HIV) antibodies, hepatitis B, hepatitis C, malaria and syphilis were recorded and analysed. RESULTS A total of 1,73,027 donors donated blood during the ten-year period. Of these 1, 65,824 were males and 7203 were females. Male to female ratio was 23:1. Hepatitis B surface antigen (HBsAg) seroreactivity is the most common which came to about 419 in this 10-year period with a prevalence rate of 0.24 % or 24 reactive cases in every 10,000 donors. Prevalence rate of Hepatitis C and HIV infection was 0.09 % and 0.035 % respectively. Rapid plasma reagin (RPR) and malaria reactivity was 0.02 %. CONCLUSIONS As safe blood supply is an important strategy of blood transfusion services, newer diagnostic tools should be implemented nationwide to overcome the problems with the window period and to detect infections with variant strains. KEY WORDS Prevalence, Transfusion Transmitted Infections, HIV, Hepatitis B and Hepatitis C, Syphilis


1998 ◽  
Vol 21 (6_suppl) ◽  
pp. 42-51
Author(s):  
T. Bonfini ◽  
P. Accorsi ◽  
M. Dell'isola ◽  
R. Giancola ◽  
V. Catinella ◽  
...  

Over the past few years, hemopoietic transplant has evolved from an investigational phase to routine therapy, thus becoming a potentially curative strategy for a large variety of diseases. Several transplant situations are still outstanding and the need for ex vivo graft manipulation for different transplantation products is growing. To obtain an ideal graft, many different methods, even sophisticated manipulations, may be required. Since transplantation products play an important role in disease outcome, the assessment of graft quality to ensure standard compliance is needed. The development of a regulatory approach to these new manipulated hematopoietic products is very complex and should come under current Good Manufacturing Practices (cGMPs). Manufacturing approach to these new blood products must be urgently introduced to accounting Quality System in Transfusion Medicine. The best way to develop compliance with standards, in agreement with internationally accepted criteria, is, likely, an accreditation system in transplantation programs.


2015 ◽  
Vol 7 (1) ◽  
pp. 49-57 ◽  
Author(s):  
Hicran ÇAVUŞOĞLU ◽  
Nebahat BORA GÜNEŞ ◽  
Hatice PARS

2015 ◽  
Vol 3 (2) ◽  
pp. 201-218
Author(s):  
Francis Chuma Osefoh

Some of the renowned world tourism countries have special peculiarities in character in terms of their nature reserves and built environments; that made them stand out for their attractions and visits. These qualities range from conservation and preservation of nature reserves, built environments- epoch architectural supports over the years; historical heritage; political; religious; socio-economic; cultural; and  high technology that enhance culture. The virtues of multi- ethnic groups and multi- cultural nature gave Nigeria a rich cultural heritage, and she is blessed with natural wonders, unique wildlife, and a very favorable climate. More often than not less attention and importance are placed over the nature reserves and built environments to the detriment of tourism in lieu of other sectors. Summarily the country lacks the culture of conservation and preservation of her abundant resources to promote cultural tourism. Case study strategy was applied in the research tours with reports of personal experiences, documentaries and analyses of sites visited in Europe and Nigeria were highlighted with references to their attributes in terms of structures and features that made up the sites as relate to culture and attraction.The task in keeping rural, city landscapes and nature reserves alive stands out as the secret of communication link from the past to present and the future; which tourism developed nations reap as benefits for tourist attraction.


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