FDA moves to ease blood donor requirements

The United States Food and Drug Administration has released two draft guidelines and a revised final guideline that relaxes its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to receive blood without significantly increasing the risk to donors and patients.

On May 23, the Center for Biologics Evaluation and Research released two draft guidelines titled Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility, and Source Plasma Quarantine Requirements, and Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy. The guidelines would permanently enforce the regulatory discretions the FDA instituted at the start of the COVID-19 pandemic to ensure there were no shortages 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The first draft guidance would permanently apply regulatory discretion to the April 2020 guidance titled Alternative Procedures for Blood and Blood Components During the COVID-19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 then, the agency’s guidance release says it has concluded that the steps it has taken to reduce regulatory requirements have not materially increased the risks to donors or recipients and has encouraged it to make those permanent measures.

“Since the publication of the April 2020 guidelines, we have received numerous comments from the blood industry asking us to continue to allow exceptions and alternatives beyond the public health emergency related to COVID-19, because the changes have increased the availability of blood and blood components while maintaining the safety of blood and blood components and without compromising the health of blood donors,” the FDA said. “In addition, blood establishments have asked us to provide our recommendations before the end of the public health emergency in order to reduce the operational burdens associated with changes to standard operating procedures and blood establishment information systems.”

In the first draft of the guidelines, the FDA indicates that if the source plasma must be quarantined for 60 calendar days, it will use regulatory discretion not to go after donation centers if they release the plasma for a use after only 45 days according to April 2020 guidelines.

Similarly, while regulations require blood establishments to collect incomplete donor information within 24 hours of a donation, the FDA says it will allow that timeframe to increase to 72 hours after a donation.

Finally, the April 2020 guidelines provided exceptions for the use of blood and blood component donations that did not meet certain blood pressure, pulse, weight, and frequency of donation donations. To ensure the health of blood donors, the FDA advises that blood establishments must continue to comply with regulatory requirements regarding who is eligible to donate blood and must not collect blood from donors who are not eligible to donate blood by because of their state of health.

“In other words, blood establishments should continue to assess donors’ blood pressure, pulse, weight, frequency of donation, pregnancy history, and red blood cell loss on the day of donation and prior to donation. collection, and not collect from ineligible donors,” the agency said. mentioned.

However, regulators say there are certain circumstances in which they do not intend to take regulatory action, such as where an error has occurred during the donor eligibility determination process and has was discovered later.

In their second draft guidelines, the FDA gives more details about donor blood pressure and pulse. Under its regulations, the agency generally does not allow donations from people whose blood pressure is too low or too high, or from people whose pulse is below 50 bpm. In either case, doctors must certify that a donor is healthy enough to donate. There is an exception where people with less than 50 bpm are eligible to donate blood if the doctor classifies them as athletic.

Over the years, the FDA says it has received feedback from blood donation establishments that the requirement for a physician is too onerous because physicians are not always available for examinations to determine health status. donors.

“The FDA has considered these comments and agrees that some flexibility is warranted with respect to the medical oversight of the responsible physician,” the agency said. “Specifically, we agree that it is not always necessary to have a responsible physician examine a donor whose blood pressure readings fall outside the specified limits to protect the health of the donor. blood pressure outside specified limits may indicate that a donor is not in good health, the health of the donor is adequately protected when the responsible physician makes a medical decision by telephone or other off-site consultation that the donation does not will have no adverse effect on the health of the donor and documents this determination.

Additionally, the FDA states that a physician is not required to determine that someone with less than 50 bpm is athletic as long as the donor self-declares to be athletic.

Revised final guidelines released alongside the two draft guidelines address the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) through blood and blood components.

“These guidelines supersede guidance of the same title dated April 2020 and updated August 2020 (2020 guidance),” the FDA said. “We have removed recommendations to defer blood donors indefinitely for: 1) geographical risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom (UK) from 1980 to 1996 and for time spent in France and Ireland from 1980 to 2001, and 2) receiving a blood transfusion in the UK, France and Ireland from 1980 to present We also provide recommendations for the requalification of persons previously deferred for these geographic risk factors, provided they meet all other eligibility requirements.

FDA regulations stated that people who may have been exposed to certain prion diseases, also known as transmissible spongiform encephalopathies (TSEs), are not eligible to donate blood because they pose the risk of transmitting disease to recipients of blood and blood components. Specifically, the question has to do with mad cow disease or bovine spongiform encephalopathy (BSE), a type of TSE feared in the 1990s and early 2000s.

However, according to the most recent research conducted by the UK government, the FDA says the risk of the disease spreading is minimal and the agency believes it is more beneficial to lift the restrictions.

“We are modifying the geographic reporting 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)]“These risk assessment models, which the FDA has independently assessed, demonstrate that in the UK the current risk of transmission of vCJD through blood and blood components would expose transfusion recipients at no or minimal additional risk of vCJD in the future, and, for blood components that are reduced in leukocytes, the possible risk is 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.

© 2022 Society of Regulatory Affairs Professionals.

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