AAMI TIR99 2024
$40.63
AAMI TIR99:2024 Processing of dilators, transesophageal and ultrasound probes in health care facilities
| Published By | Publication Date | Number of Pages |
| AAMI | 2024 | 53 |
Provides guidance for the proper processing of dilators and ultrasound probes in health care facilities to assist in making them safe and effective for use in patient care. Includes the information on selection and use of cleaning, disinfection and sterilization systems that have been cleared for marketing by the FDA for use in hospitals and other health care facilities.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR99:2024; Processing of dilators, transesophageal and ultrasound probes in health care facilities |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 12 | Foreword |
| 13 | 1 Scope 1.1 General 1.2 Inclusions |
| 14 | 1.3 Exclusions 2 Normative references 3 Terms and definitions |
| 19 | 4 Information to be provided to users by the reusable device manufacturer 4.1 Labeling of reusable devices, including processing validation |
| 20 | 5 Assigning Spaulding classification 5.1 General |
| 21 | 5.2 Application to dilators and ultrasound probes 5.2.1 Critical devices (Table 1 and Sect. 5.1) 5.2.2 Risk assessment Table 1—Spaulding classification applied to example ultrasound procedures and dilator use |
| 22 | 5.3 Integrating decision-making about Spaulding classification with clinical workflow 6 Use of probe covers |
| 23 | 7 Use of ultrasound gel and accessories 7.1 Ultrasound transmission gel (USTG) 7.2 Accessories 7.2.1 Needle guides 7.2.2 Bite guards 7.2.3 Dilator guidewires 8 Design of processing area |
| 25 | 9 Personnel education, training and competency 9.1 Personal protective equipment |
| 26 | 10 Cleaning 10.1 General considerations 10.2 Point of use treatment |
| 27 | 10.3 Containment and transport of contaminated devices 10.3.1 Containment of contaminated items for transport to the decontamination area 10.3.2 External transport of contaminated devices |
| 28 | 10.4 Electrical leak testing 10.5 Manual and mechanical cleaning |
| 29 | 10.6 Rinsing and drying 10.7 Inspection |
| 30 | 10.7.1 Cleaning verification 11 Disinfection 11.1 General considerations 11.2 Low-level disinfection and intermediate-level disinfection |
| 31 | 11.3 High-level disinfection 11.3.1 Liquid chemical sterilants (LCSs) and high-level disinfectants (HLDs) |
| 32 | 11.3.2 High-level disinfection methodologies 11.3.2.1 Automated/mechanical disinfection process 11.3.2.2 Manual high-level disinfection |
| 33 | 11.4 Cycle verification 11.5 Drying after high-level disinfection 12 Sterilization 12.1 General 12.2 Types of sterilization processes |
| 34 | 12.3 Sterilization packaging 12.4 Cycle verification for sterilization |
| 35 | 13 Transport of high-level disinfected and sterile items 14 Storage |
| 36 | 14.1 TEE probes |
| 37 | 14.2 Storage duration 15 Documentation and traceability |
| 38 | 16 Quality control 16.1 General criteria 16.2 Quality process improvement Table 2—Continuous quality improvement matrix |
| 39 | 16.3 Risk analysis Table 3—Example risk assessment matrix |
| 41 | Table 4—Algorithm for suggested workflow for transrectal, transvaginal & surface ultrasound device point of use processing |
| 42 | 16.4 Policies and procedures |
| 43 | 16.5 Product recalls |
| 44 | Annex A (informative) Literature and Studies for Probe Use and Processing |
| 47 | Annex B (informative) Supplementary Information |
| 49 | Bibliography |
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