Essential Characteristics.docx

ESSENTIAL CHARACTERISTICS

Automated TEE Probe Cleaner/Disinfector

NMCP Cardiology requires an automated TEE probe cleaning and high-level disinfection system that meets the following essential characteristics:

· Must be capable of performing fully automated pre-cleaning, cleaning, and high-level disinfection within a single system, without reliance on separate manual pre-cleaning processes or additional handling steps outside of the system.

· Must be FDA-cleared specifically for automated reprocessing of transesophageal echocardiography (TEE) probes.

· Must be fully compatible with Philips TEE probe platforms currently in use and planned for future implementation, including the ability to process all probes using the same system without exclusions.

· Must support a single, standardized reprocessing workflow for all TEE probes, eliminating the need to maintain multiple cleaning methods.

· Must not require parallel manual or semi-automated reprocessing workflows for any subset of probes.

· Must utilize a validated enzymatic cleaning process designed specifically for TEE probe reprocessing as part of the automated cycle.

· Must provide repeatable, validated cleaning and high-level disinfection cycles to ensure consistent compliance with infection prevention standards for semi-critical devices.

· Must minimize direct handling of probes to reduce variability and risk of cross-contamination.

· Must support high-volume clinical operations without introducing workflow delays or inefficiencies.

· Must be a commercially available system with manufacturer-supported installation, service, and consumables as part of a complete and validated reprocessing solution.

Vendor and Support Requirements

· Must include delivery, installation, and system setup performed by the manufacturer or authorized representatives to ensure proper configuration and operation.

· Must include initial on-site training for clinical and support staff to ensure proper use, reprocessing procedures, and compliance with infection control standards.

· Must include system verification and validation upon installation to confirm proper functionality and readiness for clinical use.

· Must provide manufacturer-supported service, maintenance, and technical support for the system and all associated components.

· Must include access to manufacturer-approved consumables, replacement parts, and service to maintain system performance and warranty compliance.

· Must ensure that all installation, service, and maintenance activities are performed in accordance with manufacturer specifications to avoid system malfunction or voiding of warranty.

These essential characteristics collectively require a system capable of fully automated reprocessing of all Philips TEE probes within a single standardized workflow. Systems that lack full probe compatibility or require manual pre-cleaning steps or additional handling outside of the system cannot meet this requirement, as they introduce variability, reduce operational efficiency, and increase infection control risk.