We are pleased to announce our SoftwareCPR® Partner, Dr. Peter Rech, will lead the international working group meeting of IEC TC62/SC62D/MT23 Infusion Pumps as its Convenor. The meeting will be hosted by AAMI at the AAMI headquarters from April 22nd to 25th, 2024, in Arlington, VA.
The meeting will be dedicated to the maintenance of standard IEC 60601-2-24:2012 Particular requirements for the basic safety and essential performance of infusion pumps and controllers. This standard, while internationally recognized, has not been recognized by FDA, in its current released version, as a consensus standard. The next release of the standard intends to address observed gaps and will see significant updates in the areas of performance testing and alarms. The new version will align with the edition 3.2 of the IEC 60601 series of medical device safety standards.
The agenda of the meeting will include four topic areas:
- Updated performance testing is intended to align with FDA recognized consensus standard AAMI TIR 101. This includes changing away from the “trumpet curve” to a pharmacokinetic approach which more realistically informs how the body interacts with administered substances. A set of performance tests and metrics will be introduced. The meeting will determine the transition from current to future testing in context of a safety standard for the type approval for infusion pumps.
- Updates to alarms related content will encompass additional alarm conditions, updates to and new alarms testing, and updates to alarm sounds.
- Topic area three will be reliability and robustness of design. Infusion pumps are almost omnipresent in the delivery of modern critical care. This is why field performance, robust design, and manufacturing are of utmost importance. Still existing and recently approved infusion pumps are associated with a significant number of safety incidents, recalls, and agency warning letters. Observed causes include original device software and updated software.
- A special topics area will include labeling, and air-in-line alarms related discussions.
Dr. Peter Rech has more than 30 years of experience in systems, software, cybersecurity, and safety engineering including regulated industries. He was responsible, both in individual contributor and management roles, for the development of Class II and III medical devices including implantable pacemakers, infusion pumps, remote monitoring solutions, and mobile apps.
