A CLABSI is a Central Line Associated Bloodstream Infection
CLABSIs are the most-common healthcare infection passed along to pediatric patients.
Aside from pediatric patients, CLABSI rates are highest among females and patients with underlying medical conditions.
5.42 Days
CLABSI Rate Per 1000 Hospital-wide central line days.
Simply put, products are designed to solve a problem. If you look a little deeper, products are designed to communicate a company's philosophy; meet the customers' needs and provide a return on investment for the company and their shareholders. Unlike most products, medical devices have a more complicated development process because they must adhere to strict guidelines and testing requirements provided by the Food and Drug Administration.
The ECAD system is meant to be used anytime an IV or a central line is used on a patient, no matter the application or the length of time it will be used. The ECAD system can be easily installed by any medical professional or a patient themselves at home. The ECAD system's primary goal is to prevent foreign matter from accumulating close to the connection points on a central line so bacterial growth, and, by extension, CLABSI infections can be prevented.
Central Venous Line Applications:
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Administer intravenous fluid and blood products.
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Administer medications.
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Administer hypertonic solution (total parental nutrition), vesicants (chemotherapy), irritants (cloxacillin), and solutions with extreme pH values.
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Venous blood samples.
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Provide long-term intravenous therapy.
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Provide hemodialysis.
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Administer large volumes of intravenous fluid quickly.
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Administer vasopressor or vasodilator therapy (dopamine).
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Monitor central venous pressure (CVP).
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Provides access for a transvenous pacemaker or pulmonary artery catheters.
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Access venous circulation when a patient has difficult or impossible peripheral access.
The Client: Institute for Pediatric Innovation and Donald Lombardi
Putting Patients First:
Medical device manufacturers cannot justify the cost of developing purpose-built devices for children because the window for using the product is too small to be profitable.
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Mission Statement:
Any Device designed to prevent CLABSIs needs to be simple, sanitary, and mass-producible with potential applications that extend beyond the initial intended function.
ECAD System Overview
The ECAD system is designed to isolate injection points and connectors from potentially harmful contaminants using a series of protective layers.
The ECAD system uses a layered defense system to protect everything connected to the end of a CVC's lumen. The hard-outer shell fully encloses the injection point at the end of the CVC and at the head of the end of the lumen. Inside the outer-shell is a stem. The stem slides up and down along a track so it can attach to the needless connector's Luer connection at the bottom of the stem. The top of this stem has a small needle that extends up to the top of the outer shell thus creating two different openings for injecting fluids. The proper injection adapter attached to the end of a syringe allows for fluids to either be injected into the CVC or into the hard shell surrounding the end of the lumen.
The ECAD system can be installed by following three basic steps:
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Connect
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Inject
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Protect
1: Safe-Touch Barrier
2: Hard Outer Shell
3: Antimicrobial Gel
Total Parenteral Nutrition (TPN) Injections:
The ECAD system offers a wide-bore filtered-stem option as part of the filtered line of ECAD products. This allows patients to get the nutrition they need while maintaining piece of mind that their access point will remain sterile and free of clogs.
Blood Products:
Blood products can be injected using the blood-specific stem for the ECAD System. This stem differs from a standard access stem because it has the largest bore of all the different stems the ECAD system offers. This stem comes with its own injection adapter. This adapter has a silicone valve built in which prevents blood from backing up into the anti-microbial gel inside the cover contaminating it. The stem also supports blood draws using vacuum vials.
Power Injection and Rapid Infusion:
To support power injection and rapid infusion, the ECAD system has a stem option that begins with a wide bore while gradually narrowing to the same diameter as the lumen. An optional buffer at the end helps the fluid flow smoothly and reduce strain to help the injection adapter maintain the strong seal.
Patient Safety: Central Line Insertion Checklist
The ECAD System's central line checklist combines the best parts of existing central line installation checklists with solutions designed to fix many of the processes shortcomings. All while providing an elevated level of oversight throughout the entire process.
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The front cover contains basic instructions about how the procedure should be set up and space for a barcode that linked the checklist to the patient's medical record. The back cover of the checklist is populated by information about the hospital, the patient, the central line kit used, the ECAD kit used, and the names of the doctors and nurses involved in the procedure.
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The left side of the complete installation process is broken down into a series of simplified steps. These are intended to jog the medical professional's memory about the process while ensuring the most critical steps are completed properly. The right side of the checklist is a detailed list of the steps required to install a central line in a patient. One of the surgical nurses assisting the doctor will check off each step as it is completed or provide a comment explaining why the step was not completed. The checklist is designed to fold in a way that leaves these marks visible at a quick glance. Each checklist is assigned a unique case number linking it to the patient and the products used in the procedure.
Home Care: Adapters and Kits
Injection Adapters:
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While there are several different variations of both the IV and Gel adapters ordering more is the same for all. Patients who care for their own post can enter their prescription number into the ECAD Systems web portal to automatically add the necessary products they need to care for their port into their cart ensuring they have all the proper supplies.
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They can then choose to order each time or set up their supplies to be delivered at regular intervals before the previous order runs out.
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Hospitals can order products as part of kits or individually, individuals can only order the kits their doctor prescribed. Patient insurance is accepted.
Product Development: Prototypes and Challenges
Next Steps: Working Out the Kinks
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Improve the gel adapter's seal.
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Reduce the number of parts.
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Explore product integrations.
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Create a working prototype.