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New Infusion Pump Testing TIR Focuses on Clinically Relevant Metrics

A new AAMI technical information report (TIR) aims to help product designers and developers apply a more robust testing regime to infusion devices – and, ultimately, improve device, medication and patient safety. AAMI TIR101:2021, Fluid delivery performance testing for infusion pumps, provides guidance on:

  • expanded test conditions across the full spectrum of clinical use;
  • performance measurements translated into clinically relevant metrics; and
  • standardized testing and disclosure.

With few exceptions, infusion devices have not fundamentally changed over the past decade or more. But infusion practices have “markedly increased in complexity and sophistication of clinical usage,” according to the TIR’s authors. This can result in clinician uncertainty about how these devices will perform across a broad range of conditions that have not been tested.

The international standard that addresses performance testing is IEC 60601-2-24:2012, Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers. The standard is “already pretty old,” said Ben Powers, vice president of infusion systems at Ivenix and co-chair of the AAMI Infusion Device Committee, “and a revision appears to be at least four years away.”

Thus, TIR101 – which has been in development for more than two years – is the first U.S. guidance to define fluid delivery performance test methods to accurately and efficiently align with the intended use of an infusion pump.

Complicated Use Cases Spur A ‘Big Innovation in Analysis’

The international standard largely relies on laboratory test conditions to evaluate infusion device performance. Real-world use cases are more complicated.

“Medications are getting more and more concentrated and they have more kinds of clinical uses,” Powers said. “There are more drugs that have immediate effects – where flow accuracy and continuity are very important. There are also a lot of new biologicals that have higher viscosities.”

In addition, more high-alert medications are used in patient care today. High-alert medications “bear a heightened risk of causing significant patient harm when they are used in error,” according to the Institute for Safe Medication Practices.

“Clinicians need to rely on these pumps a lot more than they have in the past,” Powers said. “Flow rate, viscosity, head height, back pressure and temperature are all external conditions that affect the pump output. Clinicians do not need to understand the science of infusion devices. They do need to know how different clinical conditions affect the output of the pumps.”

Unfortunately, not all instructions for use (IFU) disclose this useful information.

“A lot of the people on the committee have spent a lot of time in labs playing around with this challenge themselves,” Powers said. “It’s a big collaboration of creative ideas from a lot of really talented individuals across the industry.”

TIR101 now provides a standardized approach to disclosure about infusion pump performance in IFU, which will enable a more straightforward understand of which device is suited for which job.

Acute Dialysis Survey Readiness Handbook Gets ‘Tremendous’ Update

The Acute Dialysis Survey Readiness Handbook, a valuable resource for anyone responsible for patient safety and outcomes in acute dialysis settings, has undergone significant changes – in-part inspired by the COVID-19 pandemic – with the publication of its second edition.

‘A Tremendous Amount of Updating’

Glenda Payne, chief compliance officer and co-founder of the National Dialysis Accreditation Commission, wrote the original handbook with the late Jo-Ann Maltais, who served as co-chair for the AAMI’s Renal Disease and Detoxification Committee.

“The first edition was really the only source of information on how to prepare for a state or accreditation survey of an acute hemodialysis unit, where patients can be at risk,” Payne said. “Jo-Ann really pushed me to do this handbook in the first place, and we were both disappointed when it had to be retired as ‘out of date.’ We were determined to get this revision done; Jean and I found the revision required a tremendous amount of updating.”

The overhaul was necessary because “the regulations are ever-evolving towards higher standards of care for our patients to decrease their morbidities and mortality,” said Jean Colaneri, nurse practitioner, clinician, and educator at Albany Medical Center, who co-authored the new edition.

The handbook has been expanded and now includes:

  • The various accreditation survey processes.
  • Updated step-by-step guidance to prepare for a survey, guidelines on risk reduction and examples of auditing tools useful for acute dialysis programs.
  • Best practice audit information and case studies for additional assistance for ensuring patient safety, survey preparedness, continued improvement and long-term compliance.
  • Frequently asked questions.
  • Definitions and abbreviations.
  • Additional emphasis on emergency preparedness.

The primary audiences for this handbook are the nurse and physician leaders and staff who provide acute dialysis services, along with clinician educators. Many others will find it useful as well, including companies that develop dialysis products and the accrediting organizations.

“There are lots of clues in the handbook for how to do a survey, as well as from the point of view of the nurses who provide the services, medical directors, and quality improvement, regulatory, and compliance staff,” Payne said.

“I hope the update will make the regulations more understandable and easier to implement for acute dialysis units,” Colaneri added. “I also hope it will be a practical and readable resource for survey readiness, which really means that we all know how to do things the right way and we do them correctly 100% of the time.”



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