The home healthcare market is growing rapidly and is forecasted to continue to grow at a CAGR of eight to nine percent over the next five years. There are several factors driving this growth including an aging population, increases in chronic diseases, increasing healthcare costs, and patient preference to receive care in a familiar setting. The delivery of fluids to and from the patient in applications such as infusion, drainage, and dialysis are increasingly being done at home. The need to make these procedures safe and easy for the home care setting can be a challenge with respect to infection control and exposure to hazardous fluids (drugs and bodily fluids). The introduction of easy to use closed fluid delivery systems will help to reduce and eliminate some of these hazards.

Fig. 1 – Fluid delivery bag with integrated female valve.

In the hospital setting, the issues are similar with an emphasis on reducing infection rates, and minimizing exposure to hazardous drugs and bodily fluids. There is also a work load component that can be addressed with making these fluid delivery systems more convenient and easier to use.

The integration of a female luer valve system into the fluid delivery devices, such as IV bags, and a male luer valve in fluid sets can help to eliminate accidental spills and enhance ease-of-use for both the clinician and home care patient or caregiver. (See Figure 1)

Bag ‘Spiking’

“Spiking” a bag—attaching tubing to an IV bag’s access port—can be a challenge for clinicians as well as home care patients. There are guidelines for the maximum force required to spike a bag which can be as high as eight pounds force. Nurses may have to spike several bags per day. This can lead to fatigue and, in the long run, to carpal tunnel injury as well. Now, imagine an elderly home care patient trying to spike this same bag and the problems it may cause. Many home care patients will have limited dexterity along with a limited amount of muscle power to push a spike into a bag.

Spiking and unspiking a bag also requires using the proper technique. It has been reported that drug leaking during spiking of IV bags occurs up to 25 percent of the time and during unspiking 100 percent of the time. Overspiking can make it very difficult to pull the spike out of the bag when changing to a new bag and under-spiking can cause fluid leakage. This can expose patients and caregivers to hazardous drugs as well as the expense of spilling potentially expensive drugs such as chemo/antibiotics or blood. Having a luer activated valve built into the bag will allow the bag to be disconnected from the fluid delivery set without any risk of leakage. (See Figure 2)

Fig. 2 – Connection/disconnection from fluid delivery bag showing no leakage.

In a home infusion application, there are instances where an infusion is given intermittently over several hours, so the bag and IV set are disconnected from the catheter and placed in a refrigerator for later use. Having a male luer valve on the catheter side of the tubing set would be a beneficial feature as the set could be disconnected and no fluid would leak out. The set would be discarded and a new IV set would be used. This would help to minimize the possibility of set contamination leading to a bloodstream infection.

Fluid Drainage and Flushing

There are several drainage applications that are ideal for this technology. Fluid drainage from the pleural or peritoneal space is currently using this technology as more of these procedures are being done in the home setting.

The drainage catheter can be disconnected from the collection bag/bottle using the closed system connection which eliminates exposure to the biohazardous fluids. A new drainage waste container can then be connected for further drainage. The advantage of having this type of system is no clamping is required. Oftentimes, these products use a delivery line that requires a clamp to shut off the flow and they get disconnected before clamping, which can cause a biohazardous fluid spill. The advantage of the closed system is the elimination of such a spill.

Endoscopic procedures often involve using saline for flushing and irrigation. This is another fluid management application where a closed system would be beneficial. The process must be monitored carefully for the amount of fluid being used and, of course, there is a drain/waste bag that must be connected and disposed of multiple times and the sterile fluid bag that must be spiked. Eliminating the spike and replacing it with a closed valve system will prevent spills.

Accidental Disconnections/Infection Control

Fig. 3 – Male luer valve connected to catheter preventing leakage on disconnection.

Preventing fluid leakage has both safety and monetary consequences. Reducing exposure to biohazardous fluids and chemotherapeutic drugs is a huge safety concern but there is also a cost to these events such as clean up, exposure to patients/clinicians, and regulatory reporting such as OSHA, etc. Another cost component is the expense of the drug/medication itself. Chemo drugs and antibiotics can cost several hundred to several thousand dollars per infusion. Having a leakage problem due to spiking issues or tubing set failure can lead to sterility issues that can cause infections. Having to discard several thousand dollars of drug can be a real issue that can be minimized by using a closed valve delivery system. Accidental disconnections can happen as patients can be up walking around during the infusion or have to visit the restroom and accidentally disconnect their infusion line from their catheter. (See Figure 3)


With the push for more medical care to be performed outside of the hospital, there is a need to simplify these procedures and make them easy to use for the care givers and patients. The use of a closed fluid delivery system allows for ease of use and the enhancement of safety while helping to reduce the cost of these procedures. These products will not only help in the home care environment but are easily adopted into the hospital setting as well.

This technology can be applied to any open-fluid delivery connections where you want to prevent leakage/spilling while making the product easy to use. The applications are limitless.

This article was written by Steve Bello, Business Development Director, Halkey-Roberts Corporation, St. Petersburg, FL. For more information, Click Here .

Medical Design Briefs Magazine

This article first appeared in the May, 2016 issue of Medical Design Briefs Magazine.

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