ICU Medical

Last updated
ICU Medical, Inc.
Company type Public
Founded1984
Headquarters San Clemente, California, United States
ProductsInfusion pumps, solutions, sets, and needlefree connectors; critical care monitoring products and systems; oncology drug delivery systems
Revenue$2.28 billion (2022 est) [1]
Number of employees
Approximately 12,000
Website icumed.com

ICU Medical, Inc. is a San Clemente, California-based company with global operations. ICU Medical products are designed to prevent bloodstream infections and protect healthcare workers from exposure to infectious diseases or hazardous drugs. [2] ICU Medical product line includes intravenous therapy (IV) products, pumps, needle-free vascular access devices, custom infusion sets, closed system hazardous drug handling devices and systems, sensor catheters, needle-free closed blood sampling systems, and hemodynamic monitoring systems. [3]

Contents

ICU Medical products are designed to prevent bloodstream infections and protecting healthcare workers from exposure to infectious diseases or hazardous drugs. [2] In addition, the company's IV medication compounding and delivery products are designed to improve medication and dosing accuracy and improve clinical workflows. [3] ICU Medical has been named one of the 100 Most Trustworthy Companies in America by Forbes Magazine. [4]

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. [5] The ClickLock consisted of a protected needle and locking housing that prevented health care workers from being accidentally stuck by the I.V. needles. [6]

In 2006, ICU Medical introduced its first products for oncology. 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. [7]

ICU Medical acquired the former Abbott Laboratories Critical Care business from Hospira in 2009 following a four-year business arrangement in which ICU acted as the manufacturer of the Hospira critical care product line. [8] The acquisition allowed ICU to obtain new manufacturing space in Salt Lake City, Utah, 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.[ citation needed ]

Infusion Therapy: ICU Medical provides a line of needle-free IV connectors including the Neutron Catheter Patency Device (above) as well as a line of custom and stock IV sets. ICU IV 1.jpg
Infusion Therapy: ICU Medical provides a line of needle-free IV connectors including the Neutron Catheter Patency Device (above) as well as a line of custom and stock IV sets.
Oncology: The Diana Hazardous Drug Compounding System is the latest advance from ICU Medical for the safe handling of hazardous drugs used to treat many forms of cancer. Diana System.jpg
Oncology: The Diana Hazardous Drug Compounding System is the latest advance from ICU Medical for the safe handling of hazardous drugs used to treat many forms of cancer.
Critical Care: The SafeSet Closed Blood Sampling System from ICU Medical helps clinicians conserve blood in the operating room and intensive care unit. ICU Critical Care 1.jpg
Critical Care: The SafeSet Closed Blood Sampling System from ICU Medical helps clinicians conserve blood in the operating room and intensive care unit.

With the February 2017 acquisition of the Hospira Infusion Systems business from Pfizer, ICU Medical became one of the leading pure-play infusion companies. [9]

Products

Infusion therapy

Over 90% of hospitalized patients receive some form of IV therapy during their stay. [10] As a result, infusion devices must be safe, reliable, and cost-effective. ICU Medical's infusion therapy 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. [11] [12]

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: [13]

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 (FDA) cleared to claim the ability to eliminate all types of reflux into a catheter. [14] 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. [15] 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 patient's 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%. [16]

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. [17]

Oncology

Cancer claimed the lives of an estimated 7.9 million people in 2007 alone. [18] Experts expect this number to double before 2030. [18] 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.[ citation needed ]

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. [18] [19] 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. [20]

Critical care

ICU Medical's line of critical care products provides real-time hemodynamic monitoring, blood conservation solutions, 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.[ citation needed ]

In 2016, ICU Medical Critical Care received United States Food and Drug Administration (FDA) 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.[ citation needed ]

Related Research Articles

<span class="mw-page-title-main">Central venous catheter</span> A tubular device placed in a large vein used to administer medicines

A central venous catheter (CVC), also known as a central line (c-line), central venous line, or central venous access catheter, is a catheter placed into a large vein. It is a form of venous access. Placement of larger catheters in more centrally located veins is often needed in critically ill patients, or in those requiring prolonged intravenous therapies, for more reliable vascular access. These catheters are commonly placed in veins in the neck, chest, groin, or through veins in the arms.

<span class="mw-page-title-main">Intravenous therapy</span> Medication administered into a vein

Intravenous 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 nutrients for those who cannot, or will not—due to reduced mental states or otherwise—consume food or water by mouth. It may also be used to administer medications or other medical therapy such as blood products or electrolytes to correct electrolyte imbalances. Attempts at providing intravenous therapy have been recorded as early as the 1400s, but the practice did not become widespread until the 1900s after the development of techniques for safe, effective use.

<span class="mw-page-title-main">Intensive care medicine</span> Medical care subspecialty, treating critically ill

Intensive care medicine, also called critical care medicine, is a medical specialty that deals with seriously or critically ill patients who have, are at risk of, or are recovering from conditions that may be life-threatening. It includes providing life support, invasive monitoring techniques, resuscitation, and end-of-life care. Doctors in this specialty are often called intensive care physicians, critical care physicians, or intensivists.

<span class="mw-page-title-main">Route of administration</span> Path by which a drug, fluid, poison, or other substance is taken into the body

In pharmacology and toxicology, a route of administration is the way by which a drug, fluid, poison, or other substance is taken into the body.

<span class="mw-page-title-main">Subcutaneous administration</span> Insertion of medication under the skin

Subcutaneous administration is the insertion of medications beneath the skin either by injection or infusion.

Bloodstream infections (BSIs) are infections of blood caused by blood-borne pathogens. Blood is normally a sterile environment, so the detection of microbes in the blood is always abnormal. A bloodstream infection is different from sepsis, which is characterized by severe inflammatory or immune responses of the host organism to pathogens.

<span class="mw-page-title-main">Injection (medicine)</span> Method of medication administration

An injection is the act of administering a liquid, especially a drug, into a person's body using a needle and a syringe. An injection is considered a form of parenteral drug administration; it does not involve absorption in the digestive tract. This allows the medication to be absorbed more rapidly and avoid the first pass effect. There are many types of injection, which are generally named after the body tissue the injection is administered into. This includes common injections such as subcutaneous, intramuscular, and intravenous injections, as well as less common injections such as intraperitoneal, intraosseous, intracardiac, intraarticular, and intracavernous injections.

<span class="mw-page-title-main">Pulmonary artery catheter</span> Catheter for insertion into a pulmonary artery

A pulmonary artery catheter (PAC), also known as a Swan-Ganz catheter or right heart catheter, is a balloon-tipped catheter that is inserted into a pulmonary artery in a procedure known as pulmonary artery catheterization or right heart catheterization. Pulmonary artery catheterization is a useful measure of the overall function of the heart particularly in those with complications from heart failure, heart attack, arrythmias or pulmonary embolism. It is also a good measure for those needing intravenous fluid therapy, for instance post heart surgery, shock, and severe burns. The procedure can also be used to measure pressures in the heart chambers.

<span class="mw-page-title-main">Intraosseous infusion</span> Medical procedure of injecting medications into bone marrow

Intraosseous infusion (IO) is the process of injecting medications, fluids, or blood products directly into the marrow of a bone; this provides a non-collapsible entry point into the systemic venous system. The intraosseous infusion technique is used to provide fluids and medication when intravenous access is not available or not feasible. Intraosseous infusions allow for the administered medications and fluids to go directly into the vascular system. The IO route of fluid and medication administration is an alternative to the preferred intravascular route when the latter cannot be established promptly in emergent situations. Intraosseous infusions are used when people have compromised intravenous access and need immediate delivery of life-saving fluids and medications.

A post-anesthesia care unit (PACU) and sometimes referred to as post-anesthesia recovery or PAR, or simply recovery, is a part of hospitals, ambulatory care centers, and other medical facilities. Patients who received general anesthesia, regional anesthesia, or local anesthesia are transferred from the operating room suites to the recovery area. The patients are monitored typically by anesthesiologists, nurse anesthetists, and other medical staff. Providers follow a standardized handoff to the medical PACU staff that includes, which medications were given in the operating room suites, how hemodynamics were during the procedures, and what is expected for their recovery. After initial assessment and stabilization, patients are monitored for any potential complications, until the patient is transferred back to their hospital rooms.

<span class="mw-page-title-main">Hospira</span> American pharmaceutical company

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 injectable pharmaceuticals, manufacturing generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management systems. Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. It was formerly the hospital products division of Abbott Laboratories. On September 3, 2015, Hospira was acquired by Pfizer, who subsequently sold off the medical devices portion of Hospira to ICU Medical.

A vasoactive substance is an endogenous agent or pharmaceutical drug that has the effect of either increasing or decreasing blood pressure and/or heart rate through its vasoactivity, that is, vascular activity. By adjusting vascular compliance and vascular resistance, typically through vasodilation and vasoconstriction, it helps the body's homeostatic mechanisms to keep hemodynamics under control. For example, angiotensin, bradykinin, histamine, nitric oxide, and vasoactive intestinal peptide are important endogenous vasoactive substances. Vasoactive drug therapy is typically used when a patient has the blood pressure and heart rate monitored constantly. The dosage is typically titrated to achieve a desired effect or range of values as determined by competent clinicians.

In pharmacology, hazardous drugs are drugs that are known to cause harm, which may or may not include genotoxicity. Genotoxicity might involve carcinogenicity, the ability to cause cancer in animal models, humans or both; teratogenicity, which is the ability to cause defects on fetal development or fetal malformation; and lastly hazardous drugs are known to have the potential to cause fertility impairment, which is a major concern for most clinicians. These drugs can be classified as antineoplastics, cytotoxic agents, biologic agents, antiviral agents and immunosuppressive agents. This is why safe handling of hazardous drugs is crucial.

<span class="mw-page-title-main">Port (medical)</span> Small completely implantable medical appliance that is installed entirely beneath the skin

In medicine, a port is a small medical appliance that is installed beneath the skin. A catheter connects the port to a vein. Under the skin, the port has a septum through which drugs can be injected and blood samples can be drawn many times, usually with less discomfort for the patient than a more typical "needle stick".

<span class="mw-page-title-main">Bendamustine</span> Chemical compound

Bendamustine, sold under the brand name Treanda among others, is a chemotherapy medication used in the treatment of chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin's lymphoma. It is given by injection into a vein.

<span class="mw-page-title-main">Infusion therapy</span>


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 closed system drug transfer device or "CSTD" is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system. Open versus closed systems are commonly applied in medical devices to maintain the sterility of a fluid pathway. CSTDs work by preventing the uncontrolled inflow and outflow of contaminants and drugs, preserving the quality of solution to be infused into a patient. Theoretically, CSTDs should enable complete protection to healthcare workers in managing hazardous drugs, but possibly due to improper handling or incomplete product design, contaminants can still be detected despite use of CSTDs.

<span class="mw-page-title-main">George "Doc" Lopez</span> Freediver and spearfisherman

George "Doc" Lopez is the founder and former chief executive officer and chairman of the board of ICU Medical, Inc. and a noted freediver and spearfisherman who has held several world and U.S. records in both sports.

<span class="mw-page-title-main">Edwards Lifesciences</span> American biotechnology company

Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore; and is building a new facility due to be completed in 2021 in Limerick, Ireland.

In medicine, vascular access is a means of accessing the bloodstream through the peripheral or central blood vessels in order to obtain blood or deliver medications including chemotherapy. A vascular access procedure involves insertion of a sterile plastic tube called a catheter into a blood vessel. Types of catheters can be either peripherally or centrally located. Peripheral catheters are approximately one inch (25 mm) long and are inserted into the small veins of the forearm. Central catheters are bigger and longer and are inserted into the large veins of the extremities, neck, or chest. Central venous catheters are the primary modality used for delivery of chemotherapeutic agents. The duration of central venous catheterization is dependent on the type of treatment given.

References

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  20. http://Cool-Pharmacy-Technology–Diana-Hazardous-Drug-Compounding-System/jerryfahrni.com/2012/12/cool-pharmacy-technology-diana-hazardous-drug-compounding-system/ . Retrieved 2013-01-11.{{cite web}}: Check |url= value (help); Missing or empty |title= (help)