Proactive Use of the TubeClear System Assists Optimum Therapy Delivery

Enteral access devices (EADs;  feeding tubes) provide vital nutrition, medication, and hydration to more than seven million patients annually [1].  Interruptions to the delivery of enteral therapy has been found to increase the patient’s caloric deficit and their hospital length of stay[2], greatly increasing the overall cost of care.

The TubeClear System, a device developed to clear clogged or sluggish feeding tubes to restore or maintain their patency, could help prevent interruptions to delivery of enteral therapy when used proactively.  A recent bench test found promising results.[3]

Bench studies suggest that, when used correctly and proactively (i.e. before a feeding tube becomes completed clogged), the TubeClear System is 145.6% more effective at removing built-up material along the walls of the feeding tube than the standard practice of flushing a tube with water. As material builds up along the inside walls of the feeding tube, it can gradually restrict the flow of nutrition. 

Feeding tubes before and after being cleared by different methods

Actuated Medical, Inc. (AMI) tested the use of the TubeClear System on partially clogged feeding tubes.  For this test, 22 feeding tubes were used; the patency of 11 tubes was maintained with the standard practice of water flushing, and the patency of the other 11 tubes was maintained with the TubeClear system.  A weight was recorded for each empty feeding tube before it was clogged.  The clog contents included a combination of feeding formula and fiber supplements, to simulate types of clogs observed in a clinical setting, and clogged feeding tubes were then dried to ensure consistency between the tubes. Each clogged tube was weighed and received a water flush. 

For the first 11 feeding tubes, only water was used for clearing the tube.  After treatment, they were weighed again.  On average, flushing the partial clog with water increased the weight of the feeding tube by 68.5%, indicating that the moisture may have been absorbed by the build-up.

The second 11 feeding tubes were treated with the TubeClear System after the initial water flush.  On average, those feeding tubes decreased in weight by 77.1%, suggesting more of the occlusion material was removed than the tubes treated with water alone. 

These results suggest that the TubeClear System is more effective at clearing partial clogs than the standard practice of flushing with water alone.  AMI recommends using the TubeClear System at least once per week for optimum therapy delivery.  If the flow within the feeding tube is sluggish in the meantime, indicated by a feeding pump alarm or when it’s difficult to flush with water or administer medication, it is appropriate to use the TubeClear System more frequently, as needed.

[1] Botoman VA, Kirtland SH, Moss RL. “A randomized study of a pH sensor feeding tube vs a standard feeding tube in patients requiring enteral nutrition”, JPEN J Parenter Enteral Nutr. 1994;18(2):154-158.

[2] Peev, M. P., Yeh, D. D., Quraishi, S. A., Osler, P. , Chang, Y. , Gillis, E. , Albano, C. E., Darak, S. and Velmahos, G. C. (2015), Causes and Consequences of Interrupted Enteral Nutrition. Journal of Parenteral and Enteral Nutrition, 39: 21-27. doi:10.1177/0148607114526887

[3] Source: Actuated Medical, Inc. Internal Test Report Doc. No. 1100791569-000.

New Website for the TubeClear System Features Improved Usability and Additional Clearing Stem Models

For more information:
Maureen L. Mulvihill, Ph.D./814-355-0003

New Website for the TubeClear System Features Improved Usability and Additional Clearing Stem Models

BELLEFONTE, PA – Actuated Medical, Inc. (AMI) announced the launch of its updated website for the TubeClear system, www.TubeClear.com.  This is the first overhaul of the site since its original launch in 2012. The update optimizes lead generation tools while providing updated information about the TubeClear system for visitors.

“We’re excited to unveil this new website to our customers,” said Maureen L. Mulvihill, Ph.D., president and CEO of AMI.  “We believe this update will help bring greater awareness to a common problem in feeding tubes – clogs that disrupt a patient’s vital nutrition and medication needs.”

The TubeClear system is a powered mechanical device for keeping enteral access devices (e.g., feeding tubes) clear of buildup that can eventually clog.  The new website places additional focus on presenting the problem that clogs create.  Approximately 25% of feeding tubes clog, and if they cannot be cleared, they must be replaced.  Replacement risks include misplacement into the lungs, which can lead to pneumothorax and even death.  By keeping feeding tubes clear with the TubeClear system, there is a reduced need to replace feeding tubes, thus reducing these misplacement risks.  In addition, interruptions to a patient’s enteral nutrition have been found to increase the patient’s hospital length of stay, adding to their cost of care.

In 2016, the TubeClear system received additional FDA 510(k) clearance for three new Clearing Stem models.  These Clearing Stems allow facilities additional flexibility for inventory options as well as serve feeding tubes as small as 6 French (2.33 mm) in diameter. The new models recently became commercially available and more information about them is included on the updated website.  

The TubeClear system is the only device of its kind on the market, and is designated as an Innovative Technology Product by Vizient, Inc.

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About Actuated Medical, Inc.

Actuated Medical develops medical devices that integrate electronically controlled motion technologies that improve patient outcomes and reduce healthcare costs.  Their development process focuses on intellectual property, regulatory, and reimbursement strategies to decrease commercialization risk and attract medical device technology acquisition partnerships.  Their devices solve unmet clinical needs in target markets e.g., GI, critical care and pediatrics.  Actuated Medical a certified women-owned business located in Bellefonte, PA and is ISO 13485 certified.

For more information, please visit http://www.actuatedmedical.com

Originally published on PRLog.