Where are Welkins products manufactured?
Welkins proudly manufactures its products in the U.S.A.
Are Welkins cooling products safe and reliable?
The core electronics, hardware, and patient-contacting components of all Welkins systems (Medical, Athletic, and HAZMAT) have been rigorously tested by independent laboratories and verified compliant to internationally-recognized standards for quality, safety and performance:
  • Electromagnetic Compatibility (IEC 60601-1)
  • Electrical Safety/Construction (UL-60601-1)
  • Biocompatibility (ISO 10993)
In manufacturing, Welkins Quality Assurance personnel perform thorough inspections and tests to verify each and every product is built to our customers' exacting standards.
What happens if the Welkins Cooling Pad leaks?
Welkins cooling pads are constructed of rugged nylon and polyurethane, so puncturing is unlikely; regardless, Welkins utilizes a non-toxic/anti-bacterial/anti-fungal Coolant mixture, which does not constitute a safety hazard or danger to the environment. Although there is no risk to the user, patient or third parties if Coolant is released, punctures may result in leakage, loss of counter pressure, reduced cooling performance, and slip hazard. In case of leakage, Coolant should be cleaned up with a damp cloth and mild detergent or disinfectant, according to EMT, hospital, or other local protocol.
Has FDA cleared the EMT/ICU Temperature Management System?
Yes. FDA has cleared the Welkins EMT/ICU Temperature Management System with the following indications for use: "The Welkins Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated." Note that the safety and effectiveness of the Head-Neck Cooling Pad has not been demonstrated for treatment of stroke or head trauma, and is not indicated for use in the treatment of stroke and/or head trauma.
What is mild therapeutic hypothermia?
Mild therapeutic hypothermia is a medical treatment that lowers a patient’s body temperature to 32°C – 34°C in order to help reduce the risk of the ischemic injury following a period of insufficient blood flow. Major medical societies recommend temperature management as the standard of care therapy for many critically ill or surgical patients, including those suffering acute hypoxic-ischemic injuries. See Clinical Resources for additional information.
Why is cooling beneficial for some patients?
Temperature is one of the human body’s main vital signs, and temperature management has long been recognized as vital to life. Many patients who have return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest eventually have a poor neurological outcome due to hypoxic-ischemic brain injury. Induced mild hypothermia protects tissue by reducing oxygen metabolism and inflammation, and maintaining cell membrane integrity. In the case of reperfusion injury, cooling reduces neuronal cell damage, free radical production and inflammatory responses, which are destructive to cells that have had blood flow restored after a period of ischemia. The Hypothermia after Cardiac Arrest Study Group found that therapeutic hypothermia increases the chances of survival by 31% and the quality of survival by 41%.
Why start cooling in the pre-hospital setting?
Pre-hospital treatment has unique benefits over exclusively in-hospital cooling. Induction of therapeutic hypothermia immediately after return of spontaneous circulation (ROSC) can be crucial to patient survival. According to the American Heart Association Guidelines 2010, “Hypothermia should be initiated as soon as possible after return of spontaneous circulation with a target temperature of 32°C-34°C.”
How is cooling practicable in the pre-hospital setting?
There are only a handful of portable cooling devices presently on the market that allow for pre-hospital induction of therapeutic hypothermia, including phase change gel pads, invasive endovascular cooling devices, and simple ice packs. With the exception of Welkins’ EMT System, however, these devices have limited cooling performance, are difficult and risky to deploy in the field, or impede mobility and obstruct access to the patient. Welkins EMT System provides a safe and effective method for rapid induction of therapeutic hypothermia in the field, at the point of injury. The Cooling Headliner is integrated with a cervical collar and can deploy in under 60 seconds, following standard trauma care (i.e. stabilizing the head-neck with the aforementioned collar); the pad is non-invasive and biocompatible, and the circulating coolant is a non-toxic mixture with anti-bacterial and anti-fungal additives to prevent contamination. The System has been designed for ease of use in the pre-hospital setting, with intuitive controls and clear audio-visual status indicators. Housed in a rugged heat- and impact-resistant thermoplastic shell, the System is lightweight and requires no external power during the cooling. Coupled with valved, quick-release connectors, the System’s portable design enables cooling therapy to begin at the point of injury and continue through medical evacuation to intensive care.
How can we cool in the hospital?
There are many options for in-hospital treatment of mild therapeutic hypothermia, broadly separated into Invasive and Non-Invasive systems:
  • Invasive Cooling Invasive cooling systems circulate chilled saline intravenously to cool the body’s blood supply directly. Although fast and effective, cold intravenous (IV) infusion devices are expensive, require clinical skill to deploy, introduce risk of infection and bleeding at the insertion site, and are impractical in a pre-hospital setting. In contrast, Welkins’ EMT System is an easy-to-operate, non-invasive, and relatively inexpensive solution designed for deployment in field without supporting infrastructure.
  • Non-Invasive Cooling (e.g. Welkins) Non-invasive cooling techniques, including Welkins Systems, utilize circulating cold water or forced-air blankets to regulate patient temperature. These devices are safe, inexpensive (compared to IV cooling) and relatively easy to use. Many surface cooling devices, however, utilize large blankets, sticky gel pads, or whole body wraps that limit patient access and mobility; WElkins Cooling Headliner, in comparison, has a small footprint (head and neck, i.e. “carotid triangle”) and quick-release connectors that make removal a quick, dry and easy process. Setup and operation of the WElkins ICU System is a breeze, thanks to its intuitive touchscreen interface and simple controls, and precise microprocessor control automates cooling treatments to users’ specific requirements.
Are there any contraindications for using Welkins’ Cooling Systems?
There are no known contraindications for the use of a temperature reduction system. That said, caution should be exercised when using the System with any patient who has a history of skin allergies or sensitivities, or on skin that has signs of ulceration, burns, hives or rash. Users should periodically examine the patient’s skin under the Welkins cooling pads, especially for those at higher risk of skin injury.