HSCA Submits Comments to FDA on Using Unique Device Identifiers in Medical Device Safety Communications to Support Accuracy, Quality, and Patient Safety
Washington, DC (January 19, 2021) – The Healthcare Supply Chain Association (HSCA) Committee for Healthcare eStandards (CHeS) today submitted comments to the U.S. Food and Drug Administration (FDA) encouraging the agency to use unique device identifiers (UDI) to improve FDA communications regarding the safety of medical devices.
Patients across the country rely on medical devices in their day-to-day lives, and timely, informative communications in the event of medical device issues are critical to patient care. The FDA solicited feedback from healthcare stakeholders on ways to strengthen the agency’s medical device safety communications to help support patient safety.
“The ability to track and recall medical devices when issues arise is critical to protecting patients, many of whom depend on medical devices,” said Curt Miller, Executive Director of CHeS. “Incorporating UDIs into all FDA data sets, submissions, and communications will enable healthcare stakeholders to quickly identify and withdraw relevant products and improve overall accurate identification and traceability while promoting patient safety.”
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Click here to read the full comments.
Lear MoreHSCA Comments to the U.S. ITC on COVID-19 Related Goods: The U.S. Industry, Market, Trade, and Supply Chain Challenges
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. International Trade Commission (USITC) regarding supply chain challenges related to COVID-19 and critical medical products. HSCA appreciates the Commission’s leadership and efforts to-date to help identify COVID-related materials and goods and increase access to these essential supplies. Through collaboration and efforts to further strengthen supply chain resilience, we can best support our nation’s healthcare providers and overall preparedness. HSCA is committed to supporting patient care and ensuring healthcare providers are equipped to respond to emergencies and public health crises like the COVID-19 pandemic.
Click here to read the full comments.
Lear MoreHSCA Letter to the House Committee on Energy and Commerce
Dear Chairman Pallone and Ranking Member Walden:
On behalf of the Healthcare Supply Chain Association (HSCA), we applaud your continued leadership on,
and commitment to, bipartisan legislation that advances the public health and supports a safe, reliable,
and affordable supply of critical medical products.
HSCA represents the nation’s leading healthcare group purchasing organizations (GPOs), the sourcing
and purchasing partners to virtually all of America’s 7,000+ hospitals, as well as the vast majority of the
68,000+ long-term care facilities, surgery centers, clinics, and other healthcare providers. GPOs work
with healthcare providers to negotiate competitive prices and support a safe and reliable supply of
products. The value and services that GPOs provide allow healthcare providers and physicians to focus
on their core mission: providing first-class patient care.
Click here to read the full letter.
Lear MoreComments of the Healthcare Supply Chain Association on USTR Request for Comments on Additional Tariff Exclusions for COVID-19 Response
Dear Ambassador Lighthizer:
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. Trade Representative (USTR) on additional modifications of actions regarding Chinese exports under Section 301. HSCA is dedicated to supporting patient care and ensuring healthcare providers have access to critical medical supplies needed to support our nation’s healthcare preparedness and response efforts amidst COVID-19 pandemic.
HSCA represents the nation’s leading healthcare group purchasing organizations (GPOs), the sourcing and purchasing partners to virtually all of America’s 7,000+ hospitals, as well as the vast majority of the 68,000+ long-term care facilities, surgery centers, clinics, and other healthcare providers. GPOs work with healthcare providers to negotiate competitive prices and support a safe and reliable supply of products. The value and services that GPOs provide allow healthcare providers and physicians to focus on their core mission: providing first-class patient care. As the United States continues to address the spread of the coronavirus, it is critical that we ensure our nation’s healthcare providers are equipped to treat and prevent the spread of this disease and support patient care.
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Lear MoreComments of the Healthcare Supply Chain Association (HSCA) on FDA Request for Comments on Ensuring a Competitive Marketplace for Biosimilars
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the U.S. Food and Drug Administration’s (FDA) request for comments and holding of workshop on a competitive marketplace for biosimilars. HSCA is committed to increasing competition and promoting innovation in the healthcare system, and we applaud FDA for collaborating with the U.S. Federal Trade Commission (FTC) to ensure a competitive marketplace for biological products, including biosimilars and interchangeable products.
HSCA represents the nation’s leading healthcare group purchasing organizations (GPOs), the sourcing and purchasing partners to virtually all of America’s 7,000+ hospitals, as well as the vast majority of the 68,000+ long-term care facilities, surgery centers, clinics, and other healthcare providers. GPOs work with healthcare providers to negotiate competitive prices and support a safe and reliable supply of healthcare products. We play a critical role in helping to lower costs for patients, providers, payers, Medicare and Medicaid, and taxpayers. One report estimated that GPOs reduce supply-related purchasing costs by 13.1 percent annually and will reduce healthcare spending by up to $456.6 billion between 2017 and 2026. The value that GPOs deliver allows healthcare providers and physicians to focus on their core mission: providing first-class patient care.
Click here to read the full comments.
HSCA Releases Third Annual Report on Value GPOs Deliver to the Healthcare Supply Chain
Washington, DC (March 24, 2020) – The Healthcare Supply Chain Association (HSCA), which represents the nation’s leading healthcare group purchasing organizations (GPOs), today released its third annual report on the value that GPOs deliver to the healthcare system. The report, which was based on existing academic research and on a survey of HSCA member GPOs, found that GPOs deliver up to $34.1 billion annually in critical cost-savings to providers; increase competition and transparency in the marketplace; and help to propel improvements to the overall healthcare system while providing critical support to the health system in the face of public health threats like COVID-19.
“As the United States continues to address the spread of COVID-19, supporting healthcare providers and the patients they serve is more important than ever. GPOs are on the front lines of patient care, working with provider partners to deliver a safe and reliable supply of the best products at the best value,” said HSCA President and CEO Khatereh Calleja. “This year’s HSCA Annual Value Report confirms what hospitals, healthcare providers, suppliers and policymakers see every day: GPOs support emergency response, reduce costs, enhance quality, increase competition, and drive transparency throughout the healthcare system.”
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Lear MoreHSCA Applauds House Committee on Energy and Commerce for Commitment to Supporting Quality and Protecting Patients from Counterfeit Medical Products
Washington, DC (March 11, 2020) – Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja today released the following statement in conjunction with the House Committee on Energy and Commerce’s open mark-up session on the Safeguarding Therapeutics Act and twelve other bills:
“HSCA and its member group purchasing organizations (GPOs) applaud Representatives Engel, Guthrie, and all members of the House Committee on Energy and Commerce for helping to protect the healthcare supply chain by working to advance the Safeguarding Therapeutics Act. As the United States continues to address the spread of the coronavirus, strengthening the healthcare supply chain is more important than ever before. The Safeguarding Therapeutics Act enhances the U.S. Food and Drug Administration’s (FDA) authority to destroy counterfeit drugs and medical devices at American ports of entry, preventing such products from entering the supply chain and helping to ensure a safe and reliable supply of products.
Click here to read the full statement.
Lear MoreHSCA Statement on House Committee on Homeland Security Hearing on the Coronavirus
Washington, DC (March 11, 2020) – Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja today released the following statement in conjunction with “Confronting the Coronavirus: The Federal Response,” a hearing before the U.S. House Committee on Homeland Security:
“HSCA and its member healthcare group purchasing organizations (GPOs) applaud members of the House Committee on Homeland Security for their focus on the United States’ efforts to address the coronavirus.
“Health crises like the coronavirus place enormous stress on the entire healthcare system, including the healthcare supply chain. GPOs play a critical role in supporting emergency response and public health efforts and are deeply committed to ensuring that healthcare providers and physicians are prepared to respond to challenges like the coronavirus. HSCA and its member GPOs are working closely with healthcare stakeholders and state, federal, and local health and emergency management agencies to enable a coordinated, comprehensive response to this public health threat.
Click here to read the full statement.
Lear MoreComments of the Healthcare Supply Chain Association (HSCA) on FDA Request for Comments on the Importation of Prescription Drugs
Dear Commissioner Hahn:
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. Food and Drug Administration (FDA) regarding the importation of prescription drugs from Canada. HSCA is dedicated to ensuring patient access to affordable healthcare, and we applaud FDA for taking steps to reduce prescription drug costs, support greater competition, and ensure patient safety.
HSCA represents the nation’s leading healthcare group purchasing organizations (GPOs), the sourcing and purchasing partners to virtually all of America’s 7,000+ hospitals, as well as the vast majority of the 68,000+ long-term care facilities, surgery centers, clinics, and other healthcare providers. GPOs work with healthcare providers to negotiate competitive prices and support a safe and reliable supply of healthcare products. We play a critical role in helping to lower costs for patients, providers, payers, Medicare and Medicaid, and taxpayers. One report estimated that GPOs reduce supply-related purchasing costs by 13.1 percent annually and will reduce healthcare spending by up to $34.1 billion annually and up to $456.6 billion over the next ten years. The value that GPOs deliver allows healthcare providers and physicians to focus on their core mission: providing first-class patient care.
Click here to read the full comments.
Joint Letter of Support for Swift Action on the MEDS Act
Dear Chairman Alexander and Ranking Member Murray,
As the United States takes steps in response to the outbreak of COVID-19, concerns with the integrity of the drug supply chain and the potential impact on downstream drug shortages have surfaced. While no drug shortages have been reported thus far in direct correlation with COVID-19, past situations such as H1N1, Ebola, and Hurricane Maria have highlighted vulnerabilities in the drug supply chain that require congressional action to ensure a stable supply of critical medications is available for patient care. Furthermore, the World Health Organization (WHO) and the Food and Drug Administration (FDA) have stated the COVID-19 outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the United States.
Therefore, the undersigned organizations are writing in support of S.2723 – The Mitigating Emergency Drug Shortages (MEDS) Act which is a holistic and sustainable approach to eliminating drugs shortages and addressing vulnerabilities in the drug supply chain. We urge the Senate Committee on Health, Education, Labor, and Pensions (HELP) to advance this critical piece of legislation expeditiously.
Click here to read the full letter.