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new regulations for USAAn organ transplant system is proposed to promote the utilization of “imperfections” organ and introducing enhanced security standards for donor organizations.
The Centers for Medicare and Medicaid Services (CMS) announced Wednesday that the proposed rule will significantly strengthen its supervise An Organ Procurement Organization (OPO) is the entity responsible for procuring organs from deceased donors.
There are currently more than 100,000 people on the transplant waiting list in the United States (the vast majority of whom are seeking a kidney), and thousands of people tragically die each year while waiting for a new organ. The move is part of ongoing reforms to the complex transplant system that began during the previous administration.
The announcement follows a worrying trend: Deceased organ donations fell last year for the first time in more than a decade, raising concerns that public trust in the system is eroding. While the total number of organ transplants did rise to just over 49,000 last year, compared with 48,150 the year before, the year-on-year growth rate has slowed significantly.
PhD Muhammad Oz“Every missed opportunity for organ donation means a life lost,” the CMS administrator said, adding that the proposed rules, expected to be finalized later this year, “increase accountability, clarify expectations, and give us stronger tools to eliminate underperforming organizations, protect patients, and honor the incredible gift of life.”
A key aspect of the proposal is to maximize the use of “medically complex organs”, which often come from older or sicker donors. CMS intends to impose new requirements on OPOs to track the retrieval and use of these organs, and the agency noted that “special or additional considerations” may be required to find suitable recipients.
Many OPOs have increased the search for such organs, particularly the kidneys. For example, a less-than-perfect kidney may not be suitable for a younger recipient, but may be available for an older, sicker recipient patient – who may not receive another offer – precious time during dialysis.
However, many transplant centers currently reject these medically complex organs, even when medical standards indicate they are a good match.
Jeff Tragser, president of the Association of Organ Procurement Organizations, expressed “cautious optimism” Wednesday that he believes clearer definitions of these donors and organs will encourage OPOs and hospitals to use them.
“If we are going to seek to maximize our chances of taking people off the transplant list, we have to make sure that hospitals support donation, help us manage those donors with complex medical conditions, and that transplant centers have mechanisms in place to take advantage of those mechanisms,” he commented. CMS officials did not respond to inquiries about similar requirements for transplant centers or donor hospitals.
The proposed rule also includes new definitions of “unsound medical practices” regarding organ handling and patient safety — the standards CMS uses to regulate and certify organ groups. These measures complement other safeguards being taken by the OPO and being considered by another government agency following rare but alarming reports of patients showing signs of life before their organs were scheduled to be harvested. Although the searches were halted, the incidents severely affected public confidence, prompting thousands of people to remove their names from donor lists last year.