Werfen today announced they have been named the Silver Winner of the prestigious Edison Award, in the Emergency and On-Site Health Solutions category, for their GEM Premier 7000 with Intelligent Quality Management 3 (iQM3) blood gas testing system. This honor reinforces the breakthrough represented by this first-of-its-kind innovation, offering hemolysis detection at the point of care.

The Edison Awards are widely regarded as one of the most prestigious in the world for excellence in innovation, new product and service development, and human-centered design. Finalists are selected by a voting body of renowned academics and global innovation leaders.

“We are incredibly proud to receive the Edison Award, a direct result of our passion for innovation in Specialized Diagnostics,” said Remo Tazzi, Vice President Worldwide Marketing and Service at Werfen. “Because hemolysis in blood samples can impact potassium results, detecting it at the point of care was a crucial, unsolved challenge. Our brilliant scientists cracked the code with the patented technology in our new GEM Premier 7000 with iQM3 system, and its potential to positively impact patient care is tremendous.”

The GEM Premier 7000 with iQM3 system, commercially introduced in the US in July 2024, features integrated hemolysis detection at the point of care, addressing the #1 preanalytical error (up to 70% of all such errors).¹ Hemolysis is not visible in whole blood and can go unrecognized.

Hemolysis occurs when red blood cell membranes rupture, causing cellular contents to leak into the surrounding fluid, which can elevate potassium results up to 152%.² In samples impacted by hemolysis, low potassium levels can appear normal and normal potassium levels can appear high. Consequences of in vitro hemolysis include inappropriate patient management, longer lengths of stay and increased costs, among others.^3-8  

In just 45 seconds, the GEM Premier 7000 system detects hemolysis, while delivering a complete menu of results (pH, pCO₂, pO₂, sodium, potassium, ionized calcium, chloride, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry [tHb, O₂Hb, COHb, MetHb, HHb, sO₂]). Hemolysis detection in the system is based upon  Werfen’s patented blood separation and detection technology.

iQM3, a real-time, automated, quality management system, continuously ensures sample quality across the most common preanalytical errors, including hemolysis, micro-clots, bubbles and benzalkonium. It automatically checks sample integrity before, during, and after every analysis, and corrects and documents errors. This helps assure quality results and compliance, 24/7, and supports expedited decision-making.

The all-in-one GEM PAK™ cartridge automates labor- and skill-intensive processes and offers a variety of menu and test-volume configurations, tailored to the clinical setting. GEMweb^® Plus 500 Custom Connectivity simplifies control and compliance, enabling comprehensive management of all systems, operators, and data oversight. Its Sample-Handling Report helps identify operator competency gaps and training needs, for continuous quality improvement.

The GEM Premier 7000 with iQM3 system is the latest innovation in Werfen’s long line of GEM Premier blood gas testing systems. The most recent, previously introduced model is the GEM Premier 5000 with iQM2, which introduced IntraSpect™, performing continuous quality checks during sampling, in addition to before and after every sample.     

The GEM Premier 7000 with iQM3 system is not available in all countries.

About Werfen’s Acute Care Diagnostics Portfolio

The GEM Premier 7000 with iQM3 system is part of Werfen’s integrated and comprehensive ACD product portfolio—helping clinicians and laboratorians achieve better patient outcomes, lower total cost of care, assure accreditation compliance and improve operational efficiency in hospital acute care settings. For Whole Blood Hemostasis testing, ROTEM^® viscoelastic testing systems, the GEM Hemochron™ 100 system, and the VerifyNow™ platelet-reactivity testing system help inform key clinical decisions regarding transfusion, bleeding risk and heparin dose adjustment during surgical and interventional procedures. For Blood Gas testing, the GEM Premier systems, including GEM Premier 7000, 5000 and 3500 systems, and the Avoximeter™ 1000 portable CO-Oximeter, simplify POC operations by automating key labor- and skill-intensive tasks, including quality management and system maintenance. From Cardiovascular Operating Rooms and Catheterization Labs, to Intensive Care Units and Emergency Departments, whole-blood, cartridge-based systems with Werfen’s integrated data management solutions, help hospitals improve efficiency and enhance patient care.

References

1. Lippi G, Salvagno GL, Favaloro EJ, Guidi GC. Survey on the prevalence of hemolytic specimens in an academic hospital according to collection facility: opportunities for quality improvement. Clin Chem Lab Med. 2009;47(5):616–618. doi:10.1515/CCLM.2009.132.
2. Lippi G, Plebani M, Di Somma S, Cervellin G. Hemolyzed specimens: a major challenge for emergency departments and clinical laboratories. Crit Rev Clin Lab Sci. 2011;48(3):143–153. doi:10.3109/10408363.2011.600228.
3. O’Hara M, Wheatley EG, Kazmierczak SC. The impact of undetected in vitro hemolysis or sample contamination on patient care and outcomes in point-of-care testing: a retrospective study. J Appl Lab Med. 2020;5(2):332-341. doi:10.1093/jalm/jfz020.
4. Phelan MP, Ramos C, Walker LE, et al. The hidden cost of hemolyzed blood samples in the emergency department. J Appl Lab Med. 2021;6(6):1607–1610. doi:10.1093/jalm/jfab035.
5. Phelan MP, Hustey FM, Good DM, Reineks EZ. Seeing red: blood sample hemolysis is associated with prolonged emergency department throughput. J Appl Lab Med. 2020;5(4):732–737. doi:10.1093/jalm/jfaa073.
6. Wilson M, Adelman S, Maitre JB, et al. Accuracy of hemolyzed potassium levels in the emergency department. West J Emerg Med. 2020;21(6):272–275. doi:10.5811/westjem.2020.8.46812.
7. Milutinović D, Andrijević I, Ličina M, Andrijević L. Confidence level in venipuncture and knowledge on causes of in vitro hemolysis among healthcare professionals. Biochem Med. 2015;25(3):401–409. doi:10.11613/BM.2015.040.
8. Nichols JH, Apple FS. Prevalence of hemolyzed results in acute care settings. J Appl Lab Med. 2023;8:431-434. doi:10.1093/jalm/jfac141.

Werfen (www.werfen.com), founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s clinical areas of focus include Hemostasis, Acute Care, Transfusion, Autoimmunity, and Transplant. Werfen’s Acute Care portfolio includes the new GEM Premier 7000 with iQM3, the GEM^® Premier™ 5000 with iQM^®2, GEM Premier 3500 system with iQM, GEM Premier ChemSTAT™ system, ROTEM^® viscoelastic testing systems, Hemochron™ systems, VerifyNow™ platelet function testing system, and Avoximeter™1000 CO-Oximeter, GEMweb^® Plus 500 Custom Connectivity and GEMweb Live.

The Hemostasis portfolio includes ACL TOP^® Family 50 Series and ACL TOP Family Hemostasis Testing Systems, ACL AcuStar^® system, ACL Elite^® systems, HemoCell™ Specialized Lab Automation, HemoHub™ Intelligent Data Manager, along with the comprehensive line of HemosIL^® assays.

The Werfen logo is a trademark of Werfen. HemosIL, ACL, ACL TOP, ACL Elite, ACL AcuStar, ReadiPlasTin, RecombiPlasTin, SynthASil, SynthAFax are trademarks of Instrumentation Laboratory Company, d.b.a Werfen, and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners. 

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