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FDA takes steps to relax blood donor requirements

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Posted 23 May 2022 | By Ferdous Al-Faruque 

FDA takes steps to relax blood donor requirements

2708 The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to receive blood while not significantly increasing risk to donors and patients.
On 23 May, the Center for Biologics Evaluation and Research published two draft guidances titled Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements, and Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy. The guidances would permanently apply regulatory discretions FDA instituted at the start of the COVID-19 pandemic to ensure there wasn’t a shortage of blood and blood components.
The first draft guidance would permanently apply regulatory discretion to the April 2020 guidance titled Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency. Since, issuing the guidance the agency says it has concluded the steps it took to reduce regulatory requirements have not significantly increased risks to donors or recipients and encouraged it to make those measures permanent.
“Since publication of the April 2020 guidance, we have received numerous comments from the blood industry requesting that we continue to permit the exceptions and alternatives beyond the public health emergency related to COVID-19 because the changes have increased availability of blood and blood components while maintaining safety of blood and blood components and without compromising the health of blood donors,” FDA said. “Further, blood establishments have requested that we provide our recommendations before the end of the public health emergency to reduce the operational burdens associated with changes in standard operating procedures and blood establishment computer systems.”
In the first draft guidance FDA says that while source plasma needs to have a 60-calendar day quarantine hold, it will use regulatory discretion to not come after donation centers if they release the plasma for use after only 45 days per the April 2020 guidance.
Similarly, while regulations require blood establishments to collect incomplete donor information within 24 hours of a donation being made, FDA says it will allow that time frame to increase to 72 hours after a donation.
Finally, the April 2020 guidance made exceptions for the use of blood and blood component donations that didn’t meet certain blood pressure, pulse, weight and donation frequency donations. To ensure the health of blood donors, FDA says blood establishments need to keep following regulatory requirements for who is eligible to donate blood and must not collect blood from donors ineligible to donate based on their health.
“In other words, blood establishments must continue to assess donors’ blood pressure, pulse, weight, donation frequency, pregnancy history and red blood cell loss on the day of donation and prior to collection, and not collect from ineligible donors,” the agency said.
However, regulators say there are certain circumstances where they don’t intend to take regulatory action such as when an error occurred during the donor eligibility determination process and was discovered later.
In their second draft guidance, FDA goes into more specifics on donor blood pressure and pulse. Under its regulations, the agency typically doesn’t allow donations from people with blood pressure that is too low or too high, or from people with a pulse lower than 50 bpm. In both requirements physicians must certify a donor is health enough to donate. There is an exception that people with less than 50 bpm are eligible to donate blood if the physician categorizes them as athletic.
Over the years, FDA says it has received feedback from blood donation establishments that the physician requirement is overly burdensome as physicians aren’t always available for examinations to determine the health of the donors.
“FDA has considered these comments and agrees that some flexibility is warranted with respect to the responsible physician’s medical oversight,” the agency said. “Specifically, we agree that having a responsible physician examine a donor with blood pressure measurements outside the specified limits is not always necessary to protect donor health. While blood pressure measurements outside the specified limits may indicate that a donor is not healthy, donor health is adequately protected when the responsible physician makes a medical determination by telephonic or other offsite consultation that the donation will not adversely affect the health of the donor and documents that determination.”
Furthermore, FDA says a physician isn’t needed to determine someone with less than 50 bpm is athletic as long as the donor themselves report being athletic.
The revised final guidance published alongside the two draft guidances addresses the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.
“This guidance supersedes the guidance of the same title dated April 2020 and updated August 2020 (2020 guidance),” FDA said. “We removed the recommendations to defer indefinitely blood donors for: 1) geographic risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom (U.K.) from 1980-1996 and for time spent in France and Ireland from 1980-2001, and 2) receipt of a blood transfusion in the U.K., France, and Ireland from 1980-present. We also provide recommendations for requalification of individuals previously deferred for these geographic risk factors, provided they meet all other eligibility requirements.”
FDA’s regulations had stated that people who may have been exposed to certain prion diseases, also known as transmissible spongiform encephalopathies (TSE), are ineligible to donate blood because they carry the risk of transmitting the disease to blood and blood component recipients. More specifically, the issue has to do with the Mad Cow Disease or bovine spongiform encephalopathy (BSE), a type of TSE, scare of the 1990s and early 2000s.
According to the most recent research conducted by the British government however, FDA says the risk of spreading the disease is miniscule and the agency thinks it’s more beneficial to lift the restrictions.
“We are changing the geographic deferral recommendations for vCJD risk based on new information in the risk assessments published by [U.K.’s Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), and Medicines and Healthcare Products Regulatory Agency (MHRA)],” FDA said. “These risk assessment models, which FDA has independently evaluated, demonstrate that, in the UK, the current risk of vCJD transmission by blood and blood components would expose transfusion recipients to no or minimal additional risk of vCJD in the future, and, for blood components that are leukocyte reduced, the possible risk is even further reduced.”
“We have determined that our recommendations will simplify the donor screening process and increase the number of eligible donors while maintaining the safety of blood and blood components,” the agency added.


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