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ICU Medical, Inc. is a
San Clemente, California San Clemente (; Spanish for " St. Clement") is a city in Orange County, California. Located in the Orange Coast region of the South Coast of California, San Clemente's population was 64,293 in at the 2020 census. Situated roughly midway betwee ...
-based company with global operations that develops, manufactures, and sells medical technologies used in vascular therapy,
oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...
, and critical care applications. ICU Medical's products are designed to prevent bloodstream infections and protect healthcare workers from exposure to
infectious diseases An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dise ...
or
hazardous drugs In pharmacology, hazardous drugs are drugs that are known to cause harm, which may or may not include ''genotoxicity'' (the ability to cause a change or mutation in genetic material). Genotoxicity might involve ''carcinogenicity'', the ability to ...
. ICU Medical's product line includes
intravenous therapy Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutri ...
(IV) products, pumps, needle-free vascular access devices, custom infusion sets,
closed system A closed system is a natural physical system that does not allow transfer of matter in or out of the system, although — in contexts such as physics, chemistry or engineering — the transfer of energy (''e.g.'' as work or heat) is allowed. In ...
hazardous drug handling devices and systems, sensor
catheter In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Cath ...
s, needle-free closed blood sampling systems, and
hemodynamic Hemodynamics or haemodynamics are the dynamics of blood flow. The circulatory system is controlled by homeostatic mechanisms of autoregulation, just as hydraulic circuits are controlled by control systems. The hemodynamic response continuously mo ...
monitoring systems. ICU Medical's products are designed to prevent bloodstream infections and protecting healthcare workers from exposure to
infectious diseases An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dise ...
or
hazardous drugs In pharmacology, hazardous drugs are drugs that are known to cause harm, which may or may not include ''genotoxicity'' (the ability to cause a change or mutation in genetic material). Genotoxicity might involve ''carcinogenicity'', the ability to ...
. In addition, the company's IV medication compounding and delivery products are designed to improve medication and dosing accuracy and improve clinical workflows. ICU Medical has been named one of the 100 Most Trustworthy Companies in America by ''Forbes Magazine''.


History

The company was founded in 1984 by George "Doc" Lopez, MD who developed a product known as the ClickLock to better secure IV lines after he lost a patient due to an accidental disconnect. The ClickLock consisted of a protected needle and locking housing that prevented health care workers from being accidentally stuck by the I.V. needles. In 2006, ICU Medical introduced its first products for
oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...
. The ChemoClave system from ICU Medical is a closed system transfer device (CSTD) that allows pharmacists and nurses to safely mix and administer hazardous drugs used to treat cancer patients without exposing themselves to these drugs. ICU Medical acquired the former
Abbott Laboratories Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known dr ...
Critical Care business from
Hospira Hospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois. It had approximately 19,000 employees. Before its acquisition by Pfizer, Hospira was the world's largest producer of generic inj ...
in 2009 following a four-year business arrangement in which ICU acted as the manufacturer of the Hospira critical care product line. The acquisition allowed ICU to obtain new manufacturing space in
Salt Lake City, Utah Salt Lake City (often shortened to Salt Lake and abbreviated as SLC) is the Capital (political), capital and List of cities and towns in Utah, most populous city of Utah, United States. It is the county seat, seat of Salt Lake County, Utah, Sal ...
, while it also broadened the company's footprint in the hospital marketplace with products designed for use in high acuity clinical settings like the operating room and intensive care unit. With the February 2017 acquisition of the
Hospira Hospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois. It had approximately 19,000 employees. Before its acquisition by Pfizer, Hospira was the world's largest producer of generic inj ...
Infusion Systems business from
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
, ICU Medical became one of the leading pure-play infusion companies.


Products


Infusion therapy

Over 90% of hospitalized patients receive some form of
IV therapy Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutri ...
during their stay. As a result, infusion devices must be safe, reliable, and cost-effective. ICU Medical's
infusion therapy In medicine, infusion therapy deals with all aspects of fluid and medication infusion, via intravenous or subcutaneous application. A special infusion pump can be used for this purpose. A fenestrated catheter is most frequently inserted into the lo ...
products include a line of needle-free IV connectors that provide significant clinical advantage over other devices, along with a range of custom and stock infusion sets and kits for adult, pediatric, and neonatal applications. ICU Medical's line of needle-free connectors are mechanically and microbiologically closed systems protecting the patient's catheter from contamination that can otherwise lead to bloodstream infections. They feature a unique passive technology that cannot accept a needle, ensuring compliance with needle-free policies. These connectors can be used on all peripheral, arterial, and central venous catheters for the administration of IV fluids or medication, and can be used with blood products. No additional components or adapters are required to access the device, and no end caps are required for sterility. Featuring a dedicated internal fluid path, at no time does the internal fluid path come into contact with the exterior or outer housing of the devices. In addition, the devices' unique design features may help reduce the risk of bacterial contamination: The company launched the Neutron catheter patency device, a needle-free infusion access device that is the first and only device the U.S.
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) cleared to claim the ability to eliminate all types of reflux into a catheter. Blood reflux, or blood backing up into the catheter, has been shown to cause catheter occlusion. Blood reflux can lead to an intraluminal thrombus, which may result in an inability to infuse IV fluids/medications, an inability to withdraw blood, and an increased risk of infection The Neutron device eliminates reflux caused by external factors such as connecting and disconnecting a luer, and is the only device that can eliminate reflux caused by changes to a patients vascular pressure changes caused by coughing, sneezing, crying or vomiting. In clinical use, Neutron has been shown to reduce the instance of catheter occlusion by 50%. In 2015, ICU Medical acquired Excelsior Medical Corporation, a manufacturer of healthcare devices used to disinfect and protect access into a patient's bloodstream. Acquired products included the SwabCap and SwabFlush, as well as pre-filled saline and heparin flush syringes. The total purchase price for Excelsior was $59.5 million, however ICU immediately sold the operating assets of SwabFlush and pre-filled syringe businesses to Medline Industries, Inc. for $27 million.


Oncology

Cancer claimed the lives of an estimated 7.9 million people in 2007 alone. Experts expect this number to double before 2030. The unsafe handling of hazardous drugs used to treat many forms of cancer has been recognized since the 1970s as a significant health hazard to workers. Studies have shown that workers can be at risk of exposure to these drugs throughout their lifecycle—from manufacture to distribution to use in the clinical or home care environment and all the way through to waste disposal. Healthcare workers who handle these drugs may be exposed by inhaling aerosols or dust generated during pharmacy preparation and nursing administration, or by direct contact with the skin during accidental needlesticks, spills, or spill cleanup. ICU Medical's oncology product line is designed specifically to keep healthcare workers and patients safe from exposure to hazardous drugs. The line includes the ChemoClave closed system transfer device (CSTD) that allows for the safe mixing and administration of hazardous drugs. Recent studies found that the ChemoClave system protects clinicians from exposure to hazardous drugs, increases clinician satisfaction rates, costs less and generates less biohazardous waste than other commercially available CSTDs. In 2012, the company introduced the Diana Hazardous drug compounding system, a user-controlled automated system that helps protect clinicians from exposure to hazardous drugs and accidental needlesticks while protecting the patient preparation from exposure to environmental contaminants.


Critical care

ICU Medical's line of critical care products provides real-time hemodynamic monitoring, blood conservation
solution Solution may refer to: * Solution (chemistry), a mixture where one substance is dissolved in another * Solution (equation), in mathematics ** Numerical solution, in numerical analysis, approximate solutions within specified error bounds * Soluti ...
s, oximetry catheter technology that helps optimize oxygen supply and demand, critical care catheters with no natural rubber latex components, and accurate and reliable hemodynamic transducer kits. The critical care portfolio provides clinicians with accurate, reliable, and real-time access to their patients’ cardiovascular and hemodynamic status in surgical and intensive care settings. In addition, ICU Medical's line of advanced sensor catheters, having no natural rubber latex components, helps keep patients safe from potentially lethal allergic reactions. Formerly the Abbott critical care business unit, ICU Medical acquired the Critical Care business from Hospira (itself a spin-off from Abbott) in 2009. Since then, the company has been focusing on streamlining and modernizing the manufacturing processes for these products and actively developing new solutions to bring to market. In 2016, ICU Medical Critical Care received United States Food and Drug Administration (
FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
) 510(k) clearance for its new Cogent 2-in-1 hemodynamic monitoring system, the first and only hemodynamic monitoring system to accept both minimally invasive and invasive inputs, letting clinicians use a single monitor regardless of fluctuations in patient acuity and monitoring requirements.


References

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External links


Corporate Website
Companies listed on the Nasdaq 1984 establishments in California American companies established in 1984 Health care companies established in 1984 Medical technology companies of the United States Health care companies based in California Companies based in San Clemente, California Medical device manufacturers