(637 days)
The STERIS Amsco Reliance Family of Washer / Disinfectors are indicated for use in the cleaning and low-level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid instruments such as forceps and clamp, and other similar and related articles found in healthcare facilities.
The Amsco Reliance Family of Washer/Disinfectors are mechanical, computercontrolled Washer/Disinfectors. They are designed with pre-programmed cycles intended specifically for surgical instruments, delicate instrumentation (gentle cycle), utensils, glassware, plastic goods, anesthesia/respiratory goods and equipment decontamination. Additional cycles are available for customized programming to meet specific operating requirements.
Essentially, the Amsco Reliance Family of Washer/Disinfectors operate as follows: the load items are placed in the chamber where they are exposed to pressurized fluids delivered through a circulation system driven by a pump and controlled by a programmable computer. Injection pumps allow the automatic delivery of the selected chemicals in the sump water. Available configurations include steam or electrical heating of the sump water; and the drying option (electrically heated on some models. steam heated on others). The cabinet, chamber, and circulation system (including the pump) are primarily constructed of stainless steel.
The available cycle phases can be summarized as follows:
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- cold tap water pre-wash for the removal of gross soil;
- soaking in an enzymatic solution to break down proteinaceous materials; 2.
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- detergent wash to complete the soil removal:
- sonic cleaning to remove fine debris in crevices:
- hot tap water rinse to remove detergent and soil residues:
- thermal rinse to disinfect the load items;
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- pure water rinse and instrument lubrication:
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- drvina.
Note: Phases 2 and 4 are not offered on all models. Phases 2, 4, 7 and 8 are optional features.
The available accessories include a variety of single and multi-level loading racks, and transfer carts. Some models offer conveyor systems used to automate the loading of racks into the chamber, to initiate the proper cycle by reading a bar code tag located on the loading rack, and to provide queuing capacity.
Here's an analysis of the acceptance criteria and the study presented in the provided text for the Amsco® Reliance® Family of Washer/Disinfectors, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document focuses on performance tests for cleaning, residue removal, thermal low-level disinfection, equipment decontamination, and instrument lubrication. The most detailed acceptance criteria and results are given for residue testing.
| Test Property (Chemical) | Type of Item Tested | Acceptance Criteria (mg/item) | Reported Device Performance (mg/item)¹ |
|---|---|---|---|
| STERIS Liqui-Jet (Residue) | Surgical Instruments | 0.79 | 0.023 |
| Micro Surgery Instruments | 0.79 | 0.069 | |
| Suction Tips | 6.34 | 0.08 | |
| Respiratory Equipment | 12.66 | 4.1 | |
| Enzy Care II (Detergent Fraction) (Residue) | Surgical Instruments | 4.8 | 0.11 |
| Micro Surgery Instruments | 4.8 | 0.4 | |
| Suction Tips | 9.5 | 0.31 | |
| Enzy Care II (Enzyme Fraction) (Residue) | Surgical Instruments | 14.5 |
§ 880.6991 Medical washer.
(a)
Identification. A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.