R E P R O C E S S E D V A S C U L A R D E V I C E S
ACUNAV ™
DIAGNOSTIC ULTRASOUND CATHETERS
Performance Verification: Material characteristics, electrical profile and
mechanical designs are identified and compared to predicate original
manufacturer devices. Torsion, deflection and tensile strength testing establish
the mechanical functionality and reliability of reprocessed AcuNav™ catheters.
Decontamination and Cleaning: Accepted AcuNav™ catheters undergo
comprehensive cleaning that incorporates prolonged soaking, cleaning and
rinsing in pH-neutral enzymatic cleansers and sanitizers that are compatible
with all device materials. Stryker restores AcuNav™ catheters by removing
bacterial endotoxins and bioburden using a final rinse process to prepare
the catheters for sterilization. Residual levels of organic materials, such as
protein, carbohydrate, hemoglobin and total organic carbon are quantified and
compared with acceptable standards. Stryker’s standards are based on
AAMI TIR30, a series of processes, materials, test methods and acceptance
criteria for cleaning medical devices.
Cleaning Validations: Stryker’s design control process incorporates
independent third-party validation of internal cleaning systems. Numerous
validation tests are performed to evaluate the catheters’ ability to withstand stress
during introduction or withdrawal, bioburden removal and biocompatibility.
During cleaning validations, Stryker utilizes FDA-recognized standards for
soiling devices to worst-case scenarios.
Visual Inspection: All reprocessed AcuNav™ catheters are thoroughly inspected
under magnification to evaluate each device component for cleanliness and
surface defects.
Uses a longitudinal side-fire imaging plane that displays anatomy and deployed devices in standard ultrasound format
Contains a 64-element phased array transducer that provides high resolution 2D imaging
Product Summary:
Comprehensive cleaning of AcuNav™ diagnostic ultrasound catheters
sustainability.stryker.com • 888.888.3433
PRODUCT INFORMATION
Acoustic Performance: During validation, reprocessed catheters were
tested in the M-mode and Doppler Mode and no significant difference was
detected between reprocessed ultrasound catheters and original
catheters. During reprocessing, testing is performed to evaluate the
transducer and acoustic signal strength.
Transducer Integrity: Within each transducer, Stryker evaluates element
sensitivity (volts p-p), Capacitance (pF), Pulse width (ns), Center frequency
(MHz), and Fractional bandwidth (%). Data are carefully interpreted and
evaluated against Stryker’s strict acceptance criteria.
Articulation Integrity: The diameter of the curve created by the tip
deflection is measured against accepted tolerance specifications.
Sterilization: Ethylene oxide sterilization is validated as per ANSI/AAMI/
ISO 11135 to a sterility assurance level of 10-6. Ethylene oxide residuals
do not exceed maximum allowable limits of ANSI/AAMI/ISO 10993-7.
VISUAL INSPECTION
ACOUSTIC PERFORMANCE
TRANSDUCER INTEGRITY
*Savings estimates are based on average annual usage of 75 units at an original manufacturer acquisition cost of $2,500. A hospital’s true savings potential is not realized immediately; rather, savings may increase over time as reprocessing is continuously embraced by staff as a standard best practice.
**These AcuNav and SoundStar 2D part numbers offer equivalent functionality.
The third-party trademarks used herein are trademarks of their respective owners.
Model# French Size Device Type Length Indicator
LabelConsole
Type
08255790** 10F AcuNav™ 90 cm Acuson/ Siemens
10135936 8F AcuNav™ 90 cm Acuson/ Siemens
10135910 8F AcuNav™ 90 cmGE Vivid I
Ultrasound System
10043342** 10F AcuNav™ 90 cmGE Vivid I
Ultrasound System
SNDSTR10-2D** 10F SoundStar 2D 90 cm Acuson/
Siemens
SNDSTR10G** 10F SoundStar 2D 90 cm
GE Vivid I Ultrasound
System10F
10F
10F
8F
10F
8F
75BioSense Webster $2,500 $93,750 50%
Manufacturer Average Annual Usage
Average (OM) Acquisition Cost
Savings Estimate
Savings Percentage*
MKT20141105B
Top Related