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OPTN board discusses NRP safety notices and policy path; members press for public discussion on paralytic guidance
Summary
Board members pressed for broader discussion of safety notices related to normothermic regional perfusion (NRP), particularly guidance on paralytic use after vessel transection; the work group will draft policy language and the items will go out for public comment with monitoring plans to follow.
Board members used the May 21 meeting to press the OPTN’s NRP work group for more community engagement on safety notices and the transition from guidance to formal policy.
Chair updated the board that a work group, now including input from IRSA, is drafting components of a possible NRP policy; the Chair emphasized the standard policy development process — development by the work group, public comment and then board consideration — and said public comment will be maintained.
Board member Darren raised specific concerns about a recently circulated safety notice that mentions paralytic use after head-vessel transection. He asked where the guidance originated and urged broader community discussion, saying the lack of context and public comment may leave stakeholders without perspective. Darren said it would be “nice to for something like that, it would be great to have more of a community discussion because… there have been a lot of questions about that.”
The Chair and other members said the paralytics recommendation came from a work group of clinical experts, that paralytics are not strictly necessary for the procedure and that their primary rationale was to reduce safety signals such as involuntary movement during recovery. The Chair reiterated that the circulated notes are not yet binding policy and that the work group and public-comment process will determine what moves into enforceable policy.
Board members also asked how procurement practices and related procedures would be audited. The Chair said auditing and monitoring plans will be further specified in the policy document, with oversight by the MPSC and other regulatory components, and that some items may be reported through OPTN data in real time.
Several members urged the organization to balance moving quickly to address safety concerns with giving the community an opportunity to comment and prepare for implementation; the Chair committed to keeping the process open while working to advance the work group’s product.
