Blood donor eligibility would be based on individual assessment under new guidelines

19 ON VENTILATORS RIGHT NOW. THE FOOD AND DRUG ADMINISTRATION RELEASED A DRAFT GUIDANCE THAT WOULD CHANGE WHO IS ABLE TO DONATE BLOOD. IF APPROVED, THE DRAFTED GUIDELINES WOULD DETERMINE BLOOD DONOR ELIGIBILITY BY A CASE BY CASE BASIS. KETV NEWSWATCH 7 SCOTT LARSON JOINS US LIVE WITH WHAT THIS MEANS FOR BLOOD BANKS. GO. BILL COHEN IS A SPOKESMAN WITH THE NEBRASKA COMMUNITY BLOOD BANK, TOLD ME THEY’VE ADVOCATED FOR THESE PROPOSED GUIDELINE CHANGES FOR A LONG TIME AND THAT THE FDA’S RECOMMENDED CHANGES TO THE CURRENT SYSTEM IS ANOTHER STEP IN A LONG PROCESS TO ALLOWING AS MANY PEOPLE AS POSSIBLE TO SAFELY DONATE BLOOD. FOR DECADES, THE FEDERAL POLICIES HAVE PREVENTED US FROM FULLY EMBRACING SOME POTENTIAL DONORS. KERRY LUNDEEN, WITH THE NEBRASKA COMMUNITY BLOOD BANK, HOPES THAT WILL CHANGE NOW, SINCE THE FDA IS PROPOSING NEW GUIDELINES ON BLOOD DONOR ELIGIBILITY IN LARGE GENE, A DONOR POOL INCREASING, THAT IS REALLY GREAT FOR OUR HOSPITALS AND OUR PATIENTS LOCALLY TO HAVE MORE PEOPLE BE ABLE TO POSSIBLY DONATE BLOOD. THE GUIDELINES WOULD ALLOW PREVIOUS FULLY DEFERRED PEOPLE TO DONATE BLOOD DUE TO SCIENCE BASED, GENDER INCLUSIVE CRITERIA. IT WOULD ALSO REVISE THE DONOR HISTORY QUESTIONNAIRE AND ELIMINATE TIME BASED DEFERRALS FOR HOMOSEXUAL MEN. THE AMERICAN RED CROSS SAID IN A STATEMENT. THE RED CROSS IS PLEASED THE FDA HAS PROPOSED TO DETERMINE BLOOD DONOR ELIGIBILITY USING GENDER INCLUSIVE, INDIVIDUAL RISK BASED ASSESSMENT, REGARDLESS OF SEXUAL ORIENTATION. THE STATEMENT CONTINUES. THERE’S MORE WORK TO BE DONE AND WE WILL CONTINUE TO PROVIDE DATA TO THE FDA IN SUPPORT OF FURTHER PROGRESS. DR. PETER MARKS WITH THE FDA SAYS THE GUIDELINES WILL STILL MAKE IT SAFE FOR DONORS AND RECIPIENTS. THIS APPROACH WILL NOT CHANGE THE TESTING POLICIES AND PROCEDURES THAT ARE REQUIRED OF BLOOD. ESTABLISH LIMITS. BUT AS TIME RESTRICTIONS ARE STILL REQUIRED TO TEST ALL DONATIONS FOR CERTAIN RELEVANT TRANSFUSION TRANSMITTED INFECTIONS, INCLUDING HIV B AND HEPATITIS B AND C VIRUSES. THE FDA PUT OUT THIS DRAFT GUIDANCE LAST WEEK AND NOW HAS A 60 DAY WINDOW FOR PUBLIC COMMENT AND FEEDBACK ON THOSE PROPOSED CHANGES. YOU CAN SHARE THOSE THOUGHTS BY VISITING THIS STORY ON KETV DOT COM AND CLICKI

The Food and Drug Administration released a set of proposed guidelines that would determine blood donor eligibility based on individual assessment.In late January, the FDA put out a set of proposed changes to current rules and guidelines that would allow previously deferred individuals from donating blood."If we can increase the amount of people that are eligible, then we're looking to increase that 3 percent to something higher and help our local hospitals and patients and blood supply," Kari Lundeen with Nebraska Community Blood Bank said.Previously, the FDA had in place a policy that issued a lifetime deferral on blood donations for gay and bisexual men in order to reduce the chance of HIV in the blood supply. That was revised in 2015 when the FDA made it a 12-month deferral for men who have sex with men. The policy was again changed in 2020 to the current 3-month deferral.In a statement sent to KETV the American Red Cross said, in part: "The Red Cross is pleased the FDA has proposed to determine blood donor eligibility using gender-inclusive, individual risk-based assessment regardless of sexual orientation...There is more work to be done, and we will continue to provide date to the FDA in support of further progress.The draft would eliminate time-based deferrals for men who have sex with men, the current donor history questionnaire would be revised, and a prospective donor who doesn't report having new or multiple sexual partners may be eligible to donate - among other details.The process involves a public comment period , final guidance, revised donor questionnaires and an update on operational procedures, information systems and staff training.To give comments of any kind please follow this link. To read the release from the FDA click here.

OMAHA, Neb. —

The Food and Drug Administration released a set of proposed guidelines that would determine blood donor eligibility based on individual assessment.

In late January, the FDA put out a set of proposed changes to current rules and guidelines that would allow previously deferred individuals from donating blood.

"If we can increase the amount of people that are eligible, then we're looking to increase that 3 percent to something higher and help our local hospitals and patients and blood supply," Kari Lundeen with Nebraska Community Blood Bank said.

Previously, the FDA had in place a policy that issued a lifetime deferral on blood donations for gay and bisexual men in order to reduce the chance of HIV in the blood supply. That was revised in 2015 when the FDA made it a 12-month deferral for men who have sex with men. The policy was again changed in 2020 to the current 3-month deferral.

In a statement sent to KETV the American Red Cross said, in part: "The Red Cross is pleased the FDA has proposed to determine blood donor eligibility using gender-inclusive, individual risk-based assessment regardless of sexual orientation...There is more work to be done, and we will continue to provide date to the FDA in support of further progress.

The draft would eliminate time-based deferrals for men who have sex with men, the current donor history questionnaire would be revised, and a prospective donor who doesn't report having new or multiple sexual partners may be eligible to donate - among other details.

The process involves a public comment period [which the FDA is currently in], final guidance, revised donor questionnaires and an update on operational procedures, information systems and staff training.

To give comments of any kind please follow this link.

To read the release from the FDA click here.

Blood donor eligibility would be based on individual assessment under new guidelines

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