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Radiometer, 1st Automatic/Flexlink (PPID 2013)

Radiometer, 1st Automatic/Flexlink (PPID 2013)

Positive patient identification products, July 2013

Contact Information

810 Sharon Drive
Westlake, OH 44145

Name of positive patient ID product 1st Automatic/Flexlink
Components of positive patient ID product bar-coded blood gas sampler, software
Company is a reseller of this product(s) no
• For whom company is a reseller
Company sells its products through distribution partners no
• Vendors with which company partners
First-ever installation of a positive patient ID product 2009
Most recent installation of current version of positive patient ID product 5/1/2013
Last major product release 2012
No. of contracts for U.S. sites where product is installed and operational
No. of contracts for foreign sites where product is installed and operational
No. of contracts signed since May 1, 2012
No. of facilities where product is installed and operational
Techniques to verify patient ID when creating a wristband on admission or to register outpatient not getting a wristband
Secure techniques to verify patient ID prior to each intervention or specimen collection one-dimensional bar-code wristband, two-dimensional bar-code wristband
• Type of biometric application
Manual entry of ID No. from wristband if bar-coded wristband not available yes
• Manually entered ID Nos. distinguishable in database no
• Facility can elect not to allow manual entry of ID No. no
Product functionality blood gas collection
Techniques for specimen identification at time of specimen collection bar-code label applied to blood gas syringe during manufacturing process
Data elements routinely encoded on specimen label in a machine-readable format
Bedside technology for blood transfusion offered via positive patient ID product
• Techniques for reading labels on blood units
• Manual entry of patient ID permitted for matching blood units for transfusion
Medication tracking offered via positive patient ID product
• Techniques used to read labels on medications
Handheld/point-of-care workstations
• Typical handheld workstation used hospital’s bedside PC with browser access
• Approximate weight of handheld workstation
• How handheld workstation communicates with bedside bar-code printers
• How handheld workstation communicates with host LIS Wi-Fi, local area wireless
• Systems that ID-matching software runs on Windows server
• Other vendors’ positive patient ID products can run on same handheld/ bedside PCs as company’s products without modifying operating system yes
Third-party hospital and/or laboratory information systems interfaced Cerner, Sunquest, SCC Soft Computer, McKesson
Capability for interfacing company’s own LIS with positive patient ID products
FDA 510(k) approval unnecessary
• Applied for, but not yet received, FDA 510(k) approval
• Intend to apply for FDA 510(k) approval
Provide list of client sites to potential customers on request yes (a list of selected reference sites only)
• General license fee per facility
• Hardware cost for single handheld workstation
• Cost of software license per workstation
• Cost of information system interface
• Standard software maintenance fee covers updates to product yes
Distinguishing features (supplied by company)

• dedicated system for blood gases with a collection device (SafePico) that includes a unique bar-coded identifier
• capture of relevant clinical data at the bedside, which is included with final results
• patient results automatically returned to the bedside where sample is registered

Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.