IEC TC62/SC62D/MT23 Report

SoftwareCPR’s partner Dr. Peter Rech convened the IEC TC62/SC62D/MT23 Infusion Pumps working group meeting held from April 22nd to 26th at the AAMI headquarters in Arlington, VA. The attendants included international experts and guests joining from governmental agencies, infusion pump manufacturers, test houses, and clinical research institutions.

Progress was made on a variety topics:

  • Pump classification will be simplified.
  • The requirements on the system configurations for delivery accuracy tests were clarified.
    It was decided that the “trumpet” curve and associated testing will be removed from the 3rd edition document.
  • Alarms information will be refactored after identifying issues with the existing documentation approach which requires alarms that may not be applicable to a specific pump.

The discussions around reliability and robustness started with a pareto of causes from the MAUDE (FDA Maude Database) basis. It must be noted that the current 60601 series of standards focuses on the evaluation and testing of basic safety and essential performance of medical devices. Reliability is not pursued in the current form. It was observed that the 60601 series of standards does not sufficiently define the expected stresses and constraints of general pump use environments. The series provides additional information limited to home health care (-1-11) and emergency transportation (-1-12) settings. The working group intends to establish requirements for general use environments and expected stresses within the scope of the standard.

Fruitful discussions occurred around secondary infusion. This type of infusion is broadly used across medical fields and supported or automated by some pumps today but lacking recognition in the -2-24 standard. Typically two infusion bags are used for this type of infusion and both bags are upstream of a single infusion pump. Various intricacies of secondary infusion could lead to under- or over-delivery. While it may be desirable to automate manual processes around the secondary infusion it is foreseeable that secondary infusion will continue to be used without such provisions. The working group intends to define basic safety requirements, a suitable test method, and requirements for disclosure.

Many infusion pumps offer remote interoperability today. Functionalities leveraging interoperability include dose error reduction, digital communication of prescription information to the pump, remote infusion monitoring and alarming, health record integration, pump firmware updates and others. While other standards and standardization activities may tackle various aspects of remote interaction and communication with the pump, an inspection of the standards revealed a lack of specificity to the infusion pump uses. The group intends to integrate a minimum consensus of basic safety and essential performance requirements around remote control into the -2-24 standard.

While work has started for the 60601 series 4th edition, the working group will continue to focus its efforts to the edition 3.2 of the 60601 series. The group received training during the meeting in ISO and IEC standard documentation practices.

An upcoming challenge to the group poses a new IEC policy which may require a reconstitution of the group in the future. It is not expected that this would have an impact on ongoing work.

To conclude this abbreviated summary I would like to thank all those experts, guests, and parties who made this face to face working group meeting possible and successful. I want to thank all of the participants for the open discussions and unbiased inputs. Thank you to AAMI for hosting us. Thank you to SoftwareCPR for supporting me in my role as convenor of the group.

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