“This could change the world!” exclaimed a young man observing a product demonstration. He had been tube fed his whole life and seeing the TubeClear System power through a simulated clog in a clear feeding tube captured his attention.
Exhibiting the TubeClear System at the Oley Foundation’s Annual Conference was a new experience for the Actuated Medical team. While many conferences and trade shows target a specific audience, this one was a little different. A non-profit organization providing support to patients on total parenteral nutrition (TPN) or enteral nutrition (EN) and their families, the Oley Foundation invites everyone associated with these two nutritional health requirements to its Annual Conference. Attendees ranged from gastroenterologists and dietitians to the tube-fed patients themselves, allowing a glimpse at the bigger picture of EN and the impact of clogs. These are patients who rely on TPN or EN for their nutrition, medication, and hydration needs as they battle numerous conditions. For them, that tube is their lifeline – their world.
It was a humbling experience, to say the least. These individuals know feeding tubes, and they know clogs. In literature, clogs occur as often as 35% of the time.[i] It seems like a small problem. But for the individual who experiences one, it’s a problem that can grow and affect many aspects of their lives.
Clogs Take Time
Rather, they steal time. A clogged feeding tube interrupts enteral therapy, preventing nutrition, medication, and hydration from being delivered as scheduled. In the hospital setting, this caloric deficit increases their length of stay by eight days.[ii]
Current recommended solutions for removing clogs take time as well. Flushing with water is generally regarded as the standard of care; however, it takes an average of 110 minutes to work while commercial enzyme declogging products such as Clog Zapper take more than 120.[iii] In addition, water is only 20% effective while enzymes are 33% effective at dissolving the obstruction.[iv]
When a feeding tube occlusion cannot be cleared, it must be replaced. Depending on the type of tube, this can require an invasive procedure performed by a specialist as they are available. Some patients must travel long distances for these procedures, with weekends and holidays affecting availability. The patient may have to wait hours or even days before returning to their enteral therapy routines.
Clogs Add Risks
To restore patency for EN to resume, clinicians and patients alike try many possibilities. One of the most common “solutions” is soda, in spite of lack of evidence to support its efficacy. In fact, the acidic nature of sodas and juices can react with enteral formula to make the occlusion worse or create future clogs.[i]It may also lead to damage of the feeding tube itself.[i]
In desperation, foreign objects may be inserted that are not designed for feeding tubes, creating risk of damaging or perforating the tube.
Replacing a feeding tube due to a clog brings the risks associated with tube placement. Nasal feeding tubes have been misplaced into the lungs[v] and even the brain[vi]. Only between 80 and 85% of Tube insertions are successful on the first try, risking complications and multiple radiographs for re-insertion.[vii] Misplacement is such a large concern for pediatric patients that the American Society for Parenteral and Enteral Nutrition (ASPEN) launched the New Opportunities for Verification of Enteral Tube Location (NOVEL) Project.[viii]
“Keeping the feeding tube clear is important for patient safety,” said Beth Lyman, RN, MSN, CNSC, retired Senior Program Coordinator for the Nutrition Support Team at Children’s Mercy Hospital. “If you have to replace the feeding tube, you get those misplacement risks all over again.”
Misplacement isn’t the only risk associated with replacing a feeding tube. Patient transportation, whether from outside the hospital or within, adds risks to that patient’s health and safety.[ix] Entering a hospital also increases a patient’s risk of infection.[x]
The Cost of Clogs
There are a number of different costs associated with clogged feeding tubes. Replacing a feeding tube includes the cost of the hardware as well as the procedure. These costs can range from $200 to $1,000 depending on the type of feeding tube.[xi] For patients outside the hospital, there might be a transportation cost if they require an ambulance.
Another cost to consider is to the patient’s psychological well-being. If the patient is malnourished and dehydrated as a result of the clogged feeding tube, they may experience feelings of apathy, depression, fatigue, and loss of morale.[xii]
Replacement of a feeding tube can also be scary. “It was a traumatic experience for my son,” said one parent attending the Oley Annual Conference. Another described the experience of a nasogastric placement as “feeling like you’re drowning.”
Clogged feeding tubes are a common problem, and they can occur for several different reasons. Improperly crushed medication, mixing formula and medication, medication interactions, checking gastric fluids, and slow infusion rates are just some of the reasons for clogging.[xiii] Adequate water flushing can help prevent them, but it’s not enough. Feeding tube clogs are often treated as a minor technical issue; however, for the patients relying on these tubes to provide enteral therapy (e.g., medication, nutrition and hydration), reducing the impact of clogs means better outcomes.
References:
[i] Dandeles, Lauren M. and Lodolee, Amy E. “Efficacy of Agents to Prevent and Treat Enteral Feeding Tube Clogs.” The Annals of Pharmacotherapy, 2011; 45:676-680.
[ii] Peev, M. P., Yeh, D. D., Quraishi, S. A., Osler, P., Chang, Y., Gillis, E., Albano, C. E., Darak, S. and Velmahos, G. C. “Causes and Consequences of Interrupted Enteral Nutrition.” Journal of Parenteral and Enteral Nutrition, 2015; 39:21-27.
[iv] Garrison, C. M., “Enteral Feeding Tube Clogging: What Are the Causes and What Are the Answers? A Bench Top Analysis.” Nutrition in Clinical Practice, 2018; 33(1):147-150.
[v] de Aguilar-Nascimento, J.E. and Kudsk, J.A.. “Clinical costs of feeding tube placement.” Journal of Parenteral and Enteral Nutrition, 2007; 31(4):269-273.
[vi] Hassan A. The inadvertent intracranial introduction of nasogastric tube: The lesson learned the hard way. Saudi J Health Sci, 2016;5:145-7
[vii] Gubler, C. et al. “Bedside sonographic control for positioning enteral feeding tubes: a controlled study in intensive care unit patients.” Endoscopy, 2006; 38(2):1256-1260.
[ix] Knight, P. H., Maheshwari, N., Hussain, J., Scholl, M., Hughes, M., Papadimo, T.J., Guo, W.A., Cipolla, J., Stawicki, S.P., Latchana, N. “Complications During Intrahospital Transport of Critically Ill Patients: Focus on risk Identification and Prevention.” International Journal of Critical Illness and Injury Science, 2015; 5(4):256-264.
[xi] Escuro, A., Rath, M., Strauser, C. “Evaluation of a tube declogging system in clearing occluded small bore nasoenteric feeding tubes.” Oral Presentation-Nutrition Science & Practice Conference 2019, Abstract # M8.
Lord, LM. “Maintaining Hydration and Tube Patency in Enteral Tube Feedings.” Safe Practices in Patient Care, 2001.
Cresci, G. and Martindale, R. “Bedside Placement of Small Bowel Feeding Tubes in Hospitalized Patients: A New Role for the Dietitian.” Nutrition, Oct; 19 (10):843-6 (2003).
[xii] Lord, L.M. “Enteral Access Devices: Types, Function, Care, and Challenges.” Nutrition in Clinical Practice, 2016; 33(1): 16-38.
[xiii] Lord, L.M. “Restoring and Maintaining Patency of Enteral Feeding Tubes.” Nutrition in Clinical Practice, 2003; 18(5):422-426.
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.
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
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.
# # #
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.
BELLEFONTE, PA – Actuated Medical, Inc. announced its TubeClear System has received an Innovative Technology contract from Vizient, Inc., the largest member-driven health care performance improvement company in the country. The contract was based on a recommendation of the TubeClear System by hospital experts in this category who serve on one of Vizient’s member-led councils. Innovative Technology contracts are reserved for technologies that demonstrate an ability to enhance clinical care or patient safety, and those that improve an organization’s care delivery and business model.
The TubeClear system is an FDA-cleared medical device that uses patented mechanical motion technology to clear occlusions in most enteral access devices (EADs) while the EAD remains in the patient and works at bedside. Clinical research estimates that 7 million enteral access devices are placed each year.1 With a clogging rate of about 25%,2 that is 1.7 million patients experiencing interruptions to their nutrition and medication due to clogged feeding tubes every year. Replacement risks include misplacement into the lungs, which can lead to pneumothorax and even death.
Keeping these EADs clear prevents interruptions to feeding and medication delivery, allowing clinicians to maintain their focus on improving patient care and reducing healthcare costs associated with tube replacement. The TubeClear system is the only powered mechanical system for clearing EADs on the market. Bench top analysis confirms that it is faster and more effective than current solutions such as flushing with water or using enzyme-based treatments. The system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed, and manufactured by Actuated Medical in Bellefonte, PA.
Maureen L. Mulvihill, Ph.D. is Actuated Medical’s President and CEO, as well as one of the inventors of the TubeClear System. “We’re excited to be recognized as an innovative technology provider that is improving patient outcomes,” said Mulvihill. “Having a Vizient awarded contract, the TubeClear System allows members to have access to increased savings.”
The new multi-year contract for the TubeClear System begins November 1, 2018.
“After a full review of the TubeClear System, Vizient’s member council agreed this solution offers unique and incremental benefit over other products available on the market today, and recommended it for an innovative technology contract. We are pleased to award this new contract to Actuated Medical,” said Debbie Archer, director of procurement and leader of Vizient’s Innovative Technology program for suppliers.
Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents approximately $100 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with member-led councils and task forces to review potentially innovative products. If it is determined that a product is innovative, Vizient may award a contract outside of the competitive bid cycle.
# # #
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.
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.
Smith, R.M. and Myers, S. A. “2 devices that unclog feeding tubes.” RN. Jan; 68(1): 36-41; quiz 42 (2005).
Sriram, K., Jayanth, V., Lakshmi, R., George, V. “Prophylactic locking of enteral feeding tubes with pancreatic enzymes.” Journal of Parenteral and Enteral Nutrition. 21, 353-356 (1997).
Bourgault, A.M., Heyland, D.K., Drover, J.W., Keefe, L., Newman, P. and Day, A.G. “Prophylactic pancreatic enzymes to reduce feeding tube occlusions.” Nutrition in Clinical Practice. Oct; 18(5): 398-401 (2003).
Cogen, R., Weinryb, J., Pomerantz, C. and Fenstemacher, P. “Complications of jejunostomy tube feeding in nursing facility patients.” American Journal Gastroenterology. 86(11): 1610-3 (1991).
Marcuard, SP. and Stegall, KS. “Unclogging feeding tubes with pancreatic enzyme.” Journal of Parenteral and Enteral Nutrition. 14, 198-200 (1990).
For more information: Maureen L. Mulvihill, Ph.D./814-355-0003
www.ActuatedMedical.com
info@actuatedmedical.com
BELLEFONTE, PA – Actuated Medical, Inc. (AMI) recently signed two regional U.S. distributors for the TubeClear system. Alamo Scientific, Inc. distributes the TubeClear system throughout Texas, Oklahoma, Kansas, Nebraska, Missouri, and Iowa. Clinical Technology, Inc. (CTI) distributes the system in Ohio, Western Pennsylvania, Kentucky, Indiana, Michigan, Illinois, Wisconsin, Minnesota, North Dakota and South Dakota.
“Clinical Technology, Inc. is excited to begin representation of the TubeClear system from Actuated Medical,” said Kent Krafft, vice president of CTI. “As the premier specialty distributor in the Midwest, CTI strives to provide our customers with solutions to their challenges, and feel strongly that TubeClear offers a unique and effective solution to the persistent problem of clogged enteral feeding tubes. The system also fits nicely with our enteral feeding product mix, and we look forward to educating our clinicians on the many advantages TubeClear has to offer.”
The TubeClear system is an FDA cleared medical device that uses patented mechanical motion technology to clear clogs in most feeding and decompression tubes while the tube remains in the patient and works at bedside. Keeping these tubes clear prevents interruptions to feeding and medication delivery, allowing clinicians to maintain their focus on improving patient care and reducing healthcare cost associated with tube replacement. The system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed, and manufactured by AMI in Bellefonte, PA.
“At Alamo, we specialize in bringing innovative medical technologies to the market for improving healthcare,” said Todd Endersby, president of Alamo Scientific. “TubeClear is a great fit as an innovative solution to a common problem with feeding tubes. We’re excited to represent the device and partner with Actuated.”
“Partnering with Alamo and CTI expedites access of the TubeClear system to clinicians who need an effective tool to clear partially and fully clogged feeding tubes,” said Maureen L. Mulvihill, Ph.D., president and CEO of AMI. “These partnerships are very well aligned to our corporate goal of improving patient outcomes.”
Please contact Actuated Medical at 1-814-355-0003 x 117 to be connected with the regional distributor in your area.
About Alamo Scientific, Inc.
Alamo Scientific Inc. is one of the few specialty medical distributors located within Texas. We carry a full inventory on the items we sell and shipping times to our major markets are only 1 to 2 days. Founded in 2005, Alamo has quickly built a highly respected reputation with both device manufacturers and leading hospitals within our service geography.
Clinical Technology Inc.(CTI) is a leading specialty distributor of medical products in the mid-western region of the United States. Today, CTI operates directly in thirteen states, is part of a national distribution alliance, and serves as master distributor capable of providing sales and distribution throughout the country. In addition, CTI maintains the infrastructure to facilitate a product from concept through the FDA approval process and into manufacturing and distribution.
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.
