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As of June 2022, the U.S. FDA has recognized ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities as a guidance document “appropriate for meeting requirements for medical devices under the Federal Food, Drug, and Cosmetic Act.” Additionally, five other new or updated AAMI standards were added to the federal regulator’s list.
ANSI/AAMI ST91:2021 was specifically designed to establish a state-of-the-art for cleaning and storing medical devices such as flexible bronchoscopes and various endoscopes. After five years of research and discussion, the new document represents the consensus of clinicians, industry, and sterilization professionals from around the world. The guidance accounts for new technologies and modern insights concerning medical device cleanliness. The revised standard also reflects and expands upon 2021 recommendations issued by the FDA in the interest of helping healthcare providers prevent infections caused by or related to reprocessed urological endoscopes.
And that’s no coincidence. FDA representatives were involved in the development of ST91, working alongside numerous other members of AAMI’s Endoscope Reprocessing Working Group (ST-WG 84). In addition to accounting for regulatory concerns, the new standard comes with extensive appendices citing peer-reviewed research and data to support the requirements and recommendations of the document.
“We wanted to make sure that everybody's voices were heard and that all comments were discussed and resolved properly,” said MaryAnn Drosnock, director of Clinical Affairs at Healthmark Industries and a member ST-WG 84 of since its inception. “There was no question afterwards. This guidance is about patient safety and we have the data baked in to support it.”
The document’s predecessor, ST91:2015, was similarly recognized by the FDA in August 2015, but is now superseded. According to the FDA, it will continue to accept declarations of conformity, in support of premarket submissions, to ST91:2015 until July 9, 2023. After this transition period, declarations of conformity to the 2015 version will no longer be accepted.
Another newly recognized AAMI sterilization standard is ANSI/AAMI/ISO 11737-1:2018, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microrganisms on products. This standard specifies requirements and provides guidance on how to measure and characterize the population of viable microorganisms on or in a health care product, component, raw material, or package — an essential step in ensuring a product will not cause a patient infection.
ANSI/AAMI/ISO 11737-1:2018 is a national adoption of an ISO standard. The ISO standard was also recognized by the FDA and supersedes a version which does not include 2021 amendments.
AAMI TIR101:2021, Fluid delivery performance testing for infusion pumps is a new addition to the list. This document outlines methods for testing the fluid delivery of an infusion pump in order to provide clinically relevant data of how the pump will perform. According to the FDA, “this document is applicable to syringe pumps, container pumps, and volumetric infusion pumps for all indicated delivery modes including enteral, patient controlled analgesia, or epidural and prescribed infusate sources… This document does not establish criteria for the clinical acceptability of infusion pump performance, provide guidance for test method validation, or address uncertainty of measurement.”
ANSI/AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications is also newly recognized. Although LAVs have been incorporated into medical devices for intravascular applications for several decades, a lack of harmonized practices among manufacturers has made aligning terminology and comparing performance claims particularly difficult. This new standard is designed to improve understanding common terminology, minimum requirements, and test methods for LAVs among manufacturers, regulatory agencies, and end users.
The recognition of ANSI/AAMI HA60601-1-11:2015 [Including AMD1:2021], Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)] means that after December 17, 2023, the FDA will only recognize declarations of conformity that account for the general medical electric equipment safety standard with its 2021 amendments, reflecting modern industry consensus. This modified national adoption of an IEC standard ensures the basic safety and performance of electronic medical equipment in the home healthcare environment — an essential standard in this era of telemedicine.
Similarly, the FDA has recognized 2021 amendments for ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]. The main document and amendments provide requirements for the safety and essential performance for all medical electrical equipment, while the newly-recognized second amendment addresses changes to terminology and references since the main document was finalized in 2005 and first amended in 2012. There are additional updates to clauses to keep current with technology as well as to address questions received since the first amendment was published.