The power of AAMI standards to keep healthcare facilities operating at their best

Patient Safety

Checks and Balances for AAMI Standards ‘Keep Us All Honest’

“There are a lot of layers and a lot of people looking at the standards. They keep us all honest. They make sure that as the standard is developed that it is within the instructions for use and within FDA regulations.”

Conversations that occur during committee meetings of the Association for the Advancement of Medical Instrumentation (AAMI) convene a variety of viewpoints that can produce powerful insights.

So explained Sue Klacik, who has served on AAMI’s standard committees for many years, in a recent Process This! podcast. That podcast is produced by the Healthcare Sterile Processing Association (HSPA) formerly known as IAHCSMM.

“To the table we bring actual experience and really good expert opinion on how these products are actually used in facilities,” she said.

Manufacturers don’t always know exactly what users are doing with equipment, she shared via an anecdote.

In one meeting, equipment users described transporting equipment between facilities before and after use. Representatives for the manufacturers didn’t know that was being done and explained that the equipment probably was not packaged correctly to prevent shaking and vibrations that would occur during transportation between facilities. That could easily be responsible for an increase in repairs, Klacik quoted the manufacturers as saying.

What Are AAMI Standards?

AAMI standards are the best practices used in healthcare facilities, developed in consultation with users, manufacturers and regulators. They are therefore based on a combination of research and expert opinion.

“There are a lot of layers and a lot of people looking at the standards,” Klacik said. “They keep us all honest. They make sure that as the standard is developed that it is within the instructions for use and within FDA regulations.”

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Related Content: What to Know About ANSI/AAMI ST108

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The check-and-balance system ensures “that the standards say exactly what the best practice should be and that we don’t go swerving off into a corner and put the standard too low,” Klacik said.

It’s not unusual to get 2,000 or 3,000 comments on a proposed standard, she noted, and the volunteers who make up the committees come prepared to discuss all of them.

Finalizing standards is a lengthy process that typically entails multiple reviews, task forces, modifications and revised drafts, Klacik said.

“At the very end of all this there’s a patient who counts on us doing our job properly each and every time, that we are following best practices,” she said.

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