AAMI News November 2018

Standards Spotlight: 'Mega Standard' in the Works for Electrocardiographic Equipment

Help Wanted

Interested in shaping 80601-2-86? The AAMI ECG Committee is looking to add members to comment and vote on the draft standard, which is due for circulation this fall. The committee is particularly interested in members with user perspective as well as small- and medium-size industry perspective. To learn more, contact Hae Choe at hchoe@aami.org.

 

Six standards that cover electrocardiographic (ECG) equipment are undergoing revisions that will result in one consolidated, “mega” standard by late 2020.

The International Electrotechnical Commission (IEC) standard under development, which AAMI plans to adopt as an American National Standards Institute (ANSI) standard, will be ANSI/AAMI/IEC 80601-2-86: Medical electrical equipment—Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables and leadwires.

“The intended audience for this standard is the manufacturers of ECG devices, although anyone who works with ECG devices may have interest, especially if they are doing their own testing or verifications using this standard,” said Hae Choe, director of standards at AAMI.

The decision to develop a consolidated standard came about when three ANSI/AAMI/IEC standards were due for revision:

  • 60601-2-25:2011: Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
  • 60601-2-27:2011, Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
  • 60601-2-47:2012, Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

Joint Working Group 22, which comprises IEC Subcommittee 62D, Electromedical equipment, and ISO Technical Committee 121/Subcommittee 3, Respiratory devices and related equipment used for patient care, are responsible for the revisions. Working group members agreed that it made sense to incorporate information from three other “gold” ANSI/AAMI standards that cover parts of ECG devices, Choe said:

  • EC12:2000, Disposable ECG electrodes
  • EC53:2013, ECG trunk cables and patient leadwires
  • EC57:2012, Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

Rationale for the Consolidation

Brian Young, principal engineer for diagnostic cardiology at GE Healthcare Systems, project lead, and co-chair of the AAMI ECG Standards Committee, laid out the rationale for revising and consolidating the six ECG standards:

  • Global harmonization. AAMI and IEC standards, developed beginning in the 1980s, cover aspects of ECG equipment. Because many manufacturers now produce products for global markets, they must comply with both sets of standards.
  • Consistency. Maintaining consistency across six separate standards has been very challenging—and discrepancies have crept in. “Combining these standards into a single standard allows us to create a common set of safety and performance requirements with a single set of testing methods that would be much easier to maintain,” Young said. “The particular requirements for different clinical applications or specific technologies will still have separate clauses in the single standard, and manufacturers will still have the responsibility and ability to determine which clauses apply or do not apply based on the claimed clinical use.”
  • Recognition of state-of-the-art technology. “ECG technology has evolved significantly,” Young said. “I believe we have the responsibility to update these standards so that they are current with the clinical uses of ECG devices, as well as the current state of art in ECG device technology.”
  • Clarity on patient safety, essential performance, and testing. The consolidation and simplification of ECG standards will update requirements for patient safety and essential performance so that the requirements and testing match current clinical use and ECG device technology. On the testing front, there has been ambiguity and lack of guidance on how to apply the standards, particularly for newer technology.

The new standard will address these issues.


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