/ en Thu, 01 May 2025 03:50:39 -0500 Mon, 19 Aug 24 16:02:09 -0500 /news/headline/2024-08-19-organ-donation-and-transplant-alliance-launches-new-educational-guide-workshop <p>The Organ Donation and Transplantation Alliance has created new resources for health care providers to encourage more organ donation and transplants. It has launched an <a href="https://www.organdonationalliance.org/resources/donation-after-circulatory-death-educational-guide/">educational guide </a>to enhance collaboration between organ procurement organizations, transplant centers and hospitals. The Alliance last week <a href="https://www.organdonationalliance.org/events/2024-dcd-workshop/">hosted a workshop</a> complementing the guide launch. An on-demand learning pathway video and other supporting materials will be available in September.</p> Mon, 19 Aug 2024 16:02:09 -0500 Organ/Tissue/Blood Donation /news/headline/2024-08-08-aha-issues-bulletin-national-blood-shortage <p>The AHA yesterday sent a <a href="/special-bulletin/2024-08-07-red-cross-americas-blood-centers-aabb-say-us-faces-critical-blood-and-platelet-shortages">Special Bulletin</a> to members notifying them of concerns by the American Red Cross, America’s Blood Centers and the Association for the Advancement of Blood and Biotherapies about the nation's low supply of blood levels. Each of those organizations is urging individuals to donate to boost supplies. The blood groups said this summer’s record heat, as well as recent disruptions in blood collections in the Southeast United States — including a <a href="/news/headline/2024-08-01-southeast-hospitals-impacted-cyberattack-oneblood-aha-health-isac-post-updated-advisory-cyberattacks">cyberattack on OneBlood</a> and the Tropical Storm Debby — have created additional challenges for blood collection. The AHA is urging its members to ask their communities to donate blood.</p> Thu, 08 Aug 2024 15:03:53 -0500 Organ/Tissue/Blood Donation /special-bulletin/2024-08-07-red-cross-americas-blood-centers-aabb-say-us-faces-critical-blood-and-platelet-shortages <div class="container"><div class="row"><div class="col-md-8"><p>The <a href="https://www.redcross.org/about-us/news-and-events/press-release/2024/red-cross-national-blood-inventory-plummets-in-july-declares-emergency-blood-shortage.html">American Red Cross</a>, <a href="https://americasblood.org/press-release/eligible-individuals-encouraged-to-donate-blood-to-help-boost-blood-supply/">America’s Blood Centers</a> and the <a href="https://www.aabb.org/about-aabb/organization/press/release/2024/08/05/eligible-individuals-urged-to-donate-blood-to-boost-blood-supply">Association for the Advancement of Blood and Biotherapies</a> (AABB) in separate messages this week expressed concerns about the nation’s low blood supply levels and urged individuals to donate to boost supplies.</p><p>The American Red Cross said it faces an emergency blood shortage after its national blood inventory plummeted more than 25% in July. The blood groups said the summer’s record heat, as well as recent disruptions in blood collections in the Southeast United States, including a <a href="/advisories">cyberattack on OneBlood</a> and Tropical Storm Debby, have created additional challenges for blood collection. The most needed blood products are platelets, O-positive blood and O-negative blood.</p><p>AABB’s Interorganizational Disaster Taskforce, of which the AHA is a member, has been meeting regularly on the situation and is working closely with the federal government and blood centers.</p><h2>CALL TO ACTION</h2><p>Hospitals and health systems are encouraged to urge eligible individuals in their communities to make an appointment to donate blood or platelets at their nearest blood collection location. Regular blood donations are a critical resource for hospitals and health systems to provide lifesaving care for their communities. The public understands the lifesaving importance of blood and blood products and often steps forward to donate when made aware of a supply shortage.</p><h2>RESOURCES</h2><ul><li>AAAB, <a href="http://www.WhereToDonateBlood.org">www.WhereToDonateBlood.org</a></li><li>America’s Blood Centers, <a href="http://www.americasblood.org">www.americasblood.org</a></li><li>American Red Cross, <a href="http://www.RedCrossBlood.org">www.RedCrossBlood.org</a></li></ul><h2>FURTHER QUESTIONS</h2><p>If you have questions, please contact Nancy Foster, AHA vice president of quality and patient safety policy, at <a href="mailto:nfoster@aha.org">nfoster@aha.org</a>, or Roslyne Schulman, AHA’s director of policy, at <a href="mailto:rschulman@aha.org">rschulman@aha.org</a>. </p></div><div class="col-md-4"><p><a href="/system/files/media/file/2024/08/red-cross-americas-blood-centers-aabb-say-us-faces-critical-blood-and-platelet-shortages-bulletin-8-7-24-.pdf" target="_blank" title="Click here to download the Special Bulletin: Red Cross, America’s Blood Centers, AABB Say U.S. Faces Critical Blood and Platelet Shortages"><img src="/sites/default/files/2024-08/red-cross-americas-blood-centers-aabb-say-us-faces-critical-blood-and-platelet-shortages-bulletin-8-7-24.png" data-entity-uuid data-entity-type="file" alt="Special Bulletin: Red Cross, America’s Blood Centers, AABB Say U.S. Faces Critical Blood and Platelet Shortages cover." width="NaN" height="NaN"></a></p></div></div></div> Wed, 07 Aug 2024 12:28:19 -0500 Organ/Tissue/Blood Donation /role-hospitals-penn-state-health-goes-blue-and-green-each-april <div class="container"><div class="row"><div class="col-md-9"><div class="row"><div class="col-md-5"><p><img src="/sites/default/files/2024-04/ths-organ-donation-flag-700x532.jpg" data-entity-uuid data-entity-type="file" alt="Penn State Health. Donate Life flag is unfurled at the flag raising ceremony." width="700" height="532"></p></div><p>Every organ donor can save eight lives and enhance more than 75, according to the <a href="https://www.organdonor.gov/learn/organ-donation-statistics#:~:text=Every%20donor%20can%20save%208,YOU%20can%20help." title="organdonor.gov">federal government</a>. However, with more than 103,000 men, women and children on the national transplant waiting list, even the ripple effect of a single donation can go only so far.</p><p>Seventeen people die each day as they wait for the potentially lifesaving gift. Another person is added to the transplant list every eight minutes.</p><p>That’s why visitors and patients of Penn State Health are seeing a lot of similar colors around the medical campus today, as employees, College of Medicine faculty, staff and students were asked to show their support for organ donation on National Donate Life Blue & Green Day Friday by wearing blue and green.</p><p>Observed in April each year as part of <a href="https://donatelife.net/how-you-can-help/national-observances-celebrations/ndlm/" title="National Donate Life Month">Donate Life America’s National Donate Life Month</a>, the event promotes the importance of registering as an organ, eye and tissue donor.</p><p>Penn State Health is a strong supporter of the effort each year. Fittingly, early in the month, the health system’s Transplant team leads a Donate Life flag-raising ceremony on medical center grounds, featuring area patients. In 2024, those patient included one who received a Christmas Day lifesaving liver transplant just four months prior, on Christmas Day 2023, along with a mother and daughter, each of whom underwent heart transplants.</p><p>Penn State Health also offers a convenient registration process for potential organ donors.</p><p><a class="btn btn-primary" href="https://pennstatehealthnews.org/2024/04/penn-state-health-celebrates-donate-life-month-with-flag-raising-blue-green-day/">LEARN MORE</a></p></div></div><div class="col-md-3"><div><h4>Resources on the Role of Hospitals</h4><ul><li><a href="/community-benefit">Benefiting Communities</a></li><li><a href="/roleofhospitals">All Case Studies</a></li></ul></div></div></div></div> Fri, 12 Apr 2024 11:22:57 -0500 Organ/Tissue/Blood Donation /news/headline/2024-01-29-groups-release-updated-statistics-us-blood-donation-use <p>America’s Blood Centers and ADRP, the Association of Blood Donor Professionals, last week released a <a href="https://americasblood.org/statistics_guide/">guide</a> highlighting changes in U.S. blood donation and use between 2019 and 2021, including donor and recipient demographics. For example, donations from 16-18 year olds and adults under 25 declined 61% and 32%, respectively, due to limits on blood drives at school campuses, while donations from adults age 25-64 and 65 or older increased 14% and 41%, respectively. The percentage of first-time donors fell from 31% to 26%. Only about 3% of the eligible U.S. population donates blood each year. About 90 hospital-based blood centers and 53 community blood centers are registered with the Food and Drug Administration.<br><br>“This new edition sheds light on the long-term impact of the COVID-19 pandemic on the blood supply and the need for ongoing donations from younger and diverse populations to ensure the resilience of the nation’s blood supply,” <a href="https://americasblood.org/press-release/americas-blood-centers-and-adrp-release-updated-u-s-blood-donation-statistics-and-public-messaging-guide/">said</a> ABC CEO Kate Fry.</p> Mon, 29 Jan 2024 16:03:00 -0600 Organ/Tissue/Blood Donation /news/headline/2024-01-10-red-cross-declares-emergency-blood-shortage-urges-donations <p>The American Red Cross this week <a href="https://www.redcross.org/about-us/news-and-events/press-release/2024/red-cross-declares-emergency-blood-shortage-calls-for-donations-during-national-blood-donor-month.html" target="_blank">announced</a> an emergency blood shortage, urging Americans to donate blood or platelets to alleviate the shortage and ensure lifesaving medical procedures proceed without delay. With blood donations to the Red Cross down 40% in the past 20 years, the nearly 7,000-unit shortfall experienced between Christmas and New Year’s Day can have dramatic consequences for those in need, the organization said. To encourage donations this January during National Blood Donor Month, the Red Cross and National Football League have <a href="https://www.redcrossblood.org/local-homepage/events/super_bowl.html" target="_blank">partnered</a> to offer donors a chance to win a trip for two to the Super Bowl.</p> Wed, 10 Jan 2024 13:59:42 -0600 Organ/Tissue/Blood Donation /news/headline/2023-05-11-fda-finalizes-recommendations-assessing-blood-donor-eligibility <p>The Food and Drug Administration May 11 finalized revised <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human">recommendations</a> for assessing blood donor eligibility, which use the same risk-based questions for every donor regardless of sexual orientation, sex or gender. To reduce the likelihood of donations by individuals with new or recent HIV infection, the recommendations defer all prospective donors who report having a new sexual partner or more than one sexual partner and anal sex in the past three months; and those taking medications to treat or prevent HIV infection, the agency said.<br />  <br /> “The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place,” <a href="https://www.fda.gov/news-events/press-announcements/fda-finalizes-move-recommend-individual-risk-assessment-determine-eligibility-blood-donations">said</a> Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research.<br />  <br /> AHA had <a href="/lettercomment/2023-03-29-aha-support-fda-blood-donation-eligibility-proposed-regulation">urged</a> the agency to finalize the proposal and develop public messaging with the health care provider and LGBTQ+ communities to communicate the new policy and raise awareness about the importance of blood donation.</p> Thu, 11 May 2023 15:04:35 -0500 Organ/Tissue/Blood Donation /news/headline/2023-03-29-aha-urges-fda-finalize-new-blood-donor-eligibility-guidance <p>AHA today <a href="/lettercomment/2023-03-29-aha-support-fda-blood-donation-eligibility-proposed-regulation">applauded</a> and urged the Food and Drug Administration to finalize its draft guidance proposing that blood donor eligibility be determined based on individual risk assessment, regardless of gender or sexual orientation. AHA said the changes would increase the blood supply essential to hospital and health system care and bolster the field’s efforts to encourage blood donation.<br />  <br /> “In addition, we urge the FDA and the Department of Health and Human Services to develop public-facing messaging related to this significant policy change, in coordination with health care provider and LGBTQ+ communities, to raise awareness of the importance of blood donation and provide education about the new policy.” </p> Wed, 29 Mar 2023 16:03:00 -0500 Organ/Tissue/Blood Donation /lettercomment/2023-03-29-aha-support-fda-blood-donation-eligibility-proposed-regulation <p>March 29, 2023</p> <p>The Honorable Robert M. Califf, M.D.<br /> Commissioner<br /> Division of Dockets Management (HFA-305)<br /> Docket No. FDA-2015-D-1211<br /> Food and Drug Administration<br /> 5630 Fishers Lane, Rm 1061<br /> Rockville, MD 20852</p> <p><em><strong>Re: Docket No. FDA-2015-D-1211, “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products”</strong></em></p> <p>Dear Dr. Califf:</p> <p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, and our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the ���������� Association (AHA) appreciates the opportunity to comment on the Food and Drug Administration’s (FDA) draft guidance proposing that blood donor eligibility be determined based on individual risk assessment, regardless of gender or sexual orientation. <strong>The AHA applauds and supports this life-saving and science-based decision by the FDA to eliminate the current time-based blood donor deferral for men who have sex with men (MSM) while preserving the safety of blood as an essential product for the care hospitals and health systems provide to their patients.</strong></p> <p>Hospitals and health systems depend on a steady and robust supply of blood and blood products to treat and save the lives of our patients. The FDA’s current blood donor deferral rules have for many years prevented blood donations from MSM and women who have sex with MSM. Therefore, we are heartened that the FDA has taken into consideration our previous advocacy for changes in federal blood donation policy in this proposal. <strong>For this reason, the AHA strongly encourages the new draft guidelines to be finalized, as they would increase the blood supply, including by bolstering the <a href="/press-releases/2022-01-27-aha-ama-ana-joint-statement-blood-shortages" target="_blank">health care field’s efforts</a> to urge everyone who can to donate blood. This change would also correct this historic inequity between different donor populations.</strong></p> <p><strong>In addition, we urge the FDA and the Department of Health and Human Services to develop public-facing messaging related to this significant policy change, in coordination with health care provider and LGBTQ+ communities, to raise awareness of the importance of blood donation and provide education about the new policy.</strong> As you know, there will always be a need for blood in health care, and meeting that need will benefit from consistent and sustained messaging from all involved stakeholders.</p> <p>The AHA is committed to advancing the safety and availability of the blood supply, and we look forward to working with the FDA to ensure that this guidance is appropriately implemented and to jointly advocate for the importance of blood donation.</p> <p>We appreciate your consideration of these issues. Please contact me if you have questions or feel free to have a member of your team contact Roslyne Schulman, AHA’s director for policy, at <a href="mailto:mailto:rschulman@aha.org">rschulman@aha.org</a>.</p> <p>Sincerely,<br /> <br /> /s/</p> <p>Stacey Hughes</p> <p>Executive Vice President</p> Wed, 29 Mar 2023 10:04:09 -0500 Organ/Tissue/Blood Donation /special-bulletin/2023-01-31-fda-issues-draft-guidance-updating-blood-donation-policy <div class="container"> <div class="row"> <div class="col-md-8"> <p>The Food and Drug Administration (FDA) Jan. 27 issued <a href="https://www.fda.gov/media/164829/download" target="_blank">draft guidance</a> proposing a shift in federal policy on who may donate blood. The policy would eliminate the existing time-based blood donation deferrals for men who have sex with men (MSM) and women who have sex with MSM. The FDA is instead proposing that blood donor eligibility would be assessed using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted Human Immunodeficiency Virus (HIV).</p> <p>Comments on the draft guidance are due within 60 days of the proposal’s publication in the Federal Register.</p> <div class="panel module-typeC"> <h2>Key Highlights</h2> <p>FDA’s draft guidance would:</p> <ul> <li>Eliminate time-based blood donation deferrals for MSM and women who have sex with MSM<br>  </li> <li>Use a revised donor history questionnaire that would defer prospective donors who report that in the past three months they had a new sexual partner or more than one sexual partner and had engaged in certain higher-risk sexual acts<br>  </li> <li>Would allow other prospective donors not reporting these activities to be eligible to donate, provided all other eligibility criteria were met<br>  </li> <li>Not change the donor deferral time periods for other HIV risk factors, such as for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use<br>  </li> <li>Continue to permanently defer any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection<br>  </li> <li>Continue to defer for various time periods those taking oral or injectable medications to prevent HIV infection</li> </ul> </div> <h2>AHA TAKE</h2> <p>Hospital and health systems must have a steady and robust supply of blood and blood products to treat and save the lives of our patients. The FDA’s restrictive blood donor deferral rules have for many years unfairly prevented blood donations from MSM and women who have sex with MSM. The AHA previously has advocated for changes in federal blood donation policy consistent with this proposal, in part due to the significant strain on the nation’s blood supply in the post-COVID-19 pandemic landscape. For this reason, we are pleased that the new draft guidelines, if finalized, would not only increase the blood supply but correct this historical inequity.</p> <p>This change in policy would build on the <a href="/press-releases/2022-01-27-aha-ama-ana-joint-statement-blood-shortages" target="_blank">field’s efforts</a> to increase the blood supply, including working with our members and other national health care and blood advocacy groups to urge everyone who can to donate blood. </p> <p>The AHA will carefully review the draft guidance and submit comments to the FDA.</p> <p>Highlights of the draft guidance follow.</p> <h2>FDA’S DRAFT GUIDANCE FOR EVALUATING DONOR ELIGIBILITY USING INDIVIDUAL RISK-BASED QUESTIONS</h2> <p>The FDA on Jan. 27 published draft guidance that would eliminate its current three-month deferral period for blood donations from MSM and women having sex with MSM. The agency based its draft policy on a review of available information, including data from other countries with similar HIV epidemiology, including Canada and the United Kingdom, that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply. The FDA indicates that the proposed changes represent an attempt to move toward a gender-inclusive, individual risk-based approach to assessing blood donor eligibility.</p> <p>The draft guidance would accomplish this by proposing revisions to the donor history questionnaire to include questions for all prospective donors about new or multiple sexual partners in the last three months. Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the blood supply’s safety or availability.</p> <p>Specifically, FDA’s draft guidance would revise its current donor history questionnaire to ask all prospective donors whether they have had a new or multiple sexual partners in the past three months. Prospective donors replying affirmatively to this question would then be asked about their history of anal sex in the previous three months, according to the proposed guidance. It would also defer prospective donors reporting that, within the past three months, they had a new sexual partner or more than one sexual partner and had anal sex.</p> <p>All other prospective donors could be considered as possibly eligible to donate, provided all other eligibility criteria are met.</p> <p>Other provisions in the draft guidance remain unchanged from existing FDA policy, including:</p> <ul> <li>no changes in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs, or have a history of non-prescription injection drug use;</li> <li>continuing to permanently defer any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection; and</li> <li>continuing to require blood establishments to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.</li> </ul> <p>FDA also notes that available data demonstrate that the use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) may delay detection of HIV in licensed screening tests for blood donations, potentially resulting in false negative results. The agency notes that some blood establishments currently have deferral policies related to the use of such medications to prevent HIV infections. As a result, FDA’s proposed guidance would also defer for three months individuals taking oral medications to prevent HIV infection, such as PrEP or PEP, and defer for two years from their most recent injection individuals taking injectable PrEP to prevent HIV infection.</p> <p>The FDA notes that although these draft recommendations, when finalized, will potentially increase the number of individuals eligible to donate blood, some individuals will still be deferred from donating blood. Nevertheless, the agency stresses that that individuals taking PrEP should not stop taking these medications in order to potentially be eligible to donate blood. Instead, the FDA says it will continue to track the latest data relevant to PrEP and blood donation and propose future updates to their guidance, as appropriate.</p> <h2>FURTHER QUESTIONS</h2> <p>If you have further questions, contact Roslyne Schulman, AHA’s director of outpatient payment policy, at <a href="mailto:mailto:rschulman@aha.org">rschulman@aha.org</a>.</p> </div> <div class="col-md-4"> <p><a href="/system/files/media/file/2023/01/fda-issues-draft-guidance-updating-blood-donation-policy-bulletin-1-31-2023.pdf" target="_blank"><img alt="Image Special Bulletin FDA Issues Draft Guidance Updating Blood Donation Policy" data-entity-type="file" data-entity-uuid src="/sites/default/files/2023-01/cover-image-fda-issues-draft-guidance-updating-blood-donation-policy-bulletin-1-31-2023.png"></a></p> </div> </div> </div> Tue, 31 Jan 2023 14:38:54 -0600 Organ/Tissue/Blood Donation