| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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14-572
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| Standard | |
ANSI AAMI ST91:2021
Flexible and semi-rigid endoscope processing in health care facilities |
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Scope/Abstract| Provides guidelines for point of use treatment, transporting, leak testing (where indicated), cleaning, packaging (where indicated), high-level disinfecting and/or sterilizing, storage, and quality control procedures of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, flexible ear, nose, and throat endoscopes, flexible urology endoscopes, and other types of reusable flexible endoscopes used in procedural and surgical settings, and semi-rigid operative endoscopes (e.g., choledochoscopes) used in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these reusable devices and accessories to render them safe for patient use. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 8.2.5 Endoscope drying (Sections referencing drying verification and methods for assessing drying in endoscopes in Annex K)
Clause 13.5.3 Cleaning verification tests for users (Sections referencing cleaning verification tests for endoscopes in Annex F) |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized in part because:
Clause 8.2.5 (Sections referencing drying verification and methods for assessing drying in endoscopes in Annex K) is not recognized because legally marketed drying verification tests for use with endoscopes in health care facilities are not currently available. See Potential for Monitoring Reprocessing Effectiveness in the FDA Safety Communication, reference #2 listed below.
Clause 13.5.3 (Sections referencing cleaning verification tests for endoscopes in Annex F) is not recognized because legally marketed cleaning verification tests for use with endoscopes in health care facilities are not currently available. See Potential for Monitoring Reprocessing Effectiveness in the FDA Safety Communication, reference #2 listed below. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| 801 Labeling |
| 820.3 Definitions |
|
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Issued June 2017.
2. The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication, April 10, 2020. https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication#potential
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
