TubeClear Receives FDA Clearance for New GJ-Specific Clearing Stem Model

TubeClear Receives FDA Clearance for New GJ-Specific Clearing Stem Model

BELLEFONTE, PA – Actuated Medical, Inc. (AMI) recently received its sixth Food and Drug Administration (FDA) 510(k) clearance for the TubeClear® system. Clearance number K200646 introduces a Clearing Stem model that is compatible with select gastro-jejunostomy (GJ) feeding tubes.

These complex dual lumen feeding tubes are often expensive and require surgery to place. When a clogged feeding tube of any type cannot be cleared, it requires replacement. The new TubeClear GJ-1422 Clearing Stem offers a mechanical option for clinicians to keep these expensive GJ tubes clear and avoid an unnecessary procedure to replace the tube. The GJ-1422 Clearing Stem is designed to work with MIC*, MIC-KEY* (Avanos Medical, Inc., Alpharetta, GA) and G-Jet® (Applied Medical Technology (AMT), Brecksville, OH) GJ feeding tubes that are 14-22 French diameter and have a jejunal length of 15-45 centimeters.

“Clogging in GJ tubes is one of the most common complaints we hear from clinicians and patients alike,” said AMI president and chief executive officer Maureen L. Mulvihill, PhD. “Being able to deliver a Clearing Stem that is compatible with our existing TubeClear system as well as GJ feeding tubes is an exciting opportunity for AMI to support vulnerable patients and improve their outcomes.”

The TubeClear system is an FDA cleared medical device that uses patented mechanical motion technology to maintain flow and 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. The new GJ Clearing Stem is slated to be available for sale in clinical settings in early 2021.



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 licensing partnerships. Their devices solve unmet clinical needs in target markets (e.g., GI, oncology, critical care and pediatrics). Actuated Medical a certified women-owned business located in Bellefonte, PA and is ISO 13485:2016 certified.

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


Prophylactic use of the TubeClear system reduces feeding tube material buildup and enables optimal enteral nutrition delivery.

Prophylactic use of the TubeClear system reduces feeding tube material buildup and enables optimal enteral nutrition delivery.

Enteral nutrition (EN) is provided for patients that have a functioning lower gastrointestinal (GI) tract but are unable to orally ingest nutrients and medication and are at risk for malnutrition.[1] Feeding tubes (Tubes) provide these patients essential nutrition, life-sustaining medications and hydration. Numerous conditions may necessitate long-term EN, including GI dysfunction, cancer, cystic fibrosis, neurological disorders, burn patients, congenital heart disease, Alzheimer’s disease, Parkinson’s disease, and congenital metabolic abnormalities.[1,2] Maintaining Tube patency is critical for many, as EN interruptions are often associated with poor clinical outcomes. Tube clogging (see Figure 1) is the most frequently reported mechanical complication associated with feeding tubes, with reported clogging rates ranging from 9-35%.[3-5]  A recent survey of Oley Foundation members (180+ patients with feeding tubes and/or caretakers) indicated that up to 81% of non-acute Tubes become clogged, with 39.4% requiring a tube replacement due to clogs.[6]  Clogs result in the interruption of patient’s nutrition and medication regimens, representing a burden to both caregivers and patients.

Figure 1: Images of actual clogged feeding tubes submitted by three (3) different hospitals to Actuated Medical, Inc.

Common approaches to maintain Tube patency include regular flushing with water, carbonated sodas, and enzymatic solutions immediately after administering nutrition or medication. Some healthcare facilities add procedures for adequately crushing medications to prevent clogs. Current methods for unclogging Tubes are time-consuming and unreliable, often ending in patients having to undergo Tube replacements. Tube replacements are associated with their own set of risks, including the need for patient transport to the hospital, transfer to interventional radiology (IR) for radiological guidance or Tube placement confirmation following placement, exposing patients to radiation exposure, or surgical interventions which can expose patients to anesthesia.[7-10] Moreover, Tube misplacements into the bronchial tree reportedly occur in 2.4-3.2% of all nasogastric (NG) tube insertions,[11] a serious complication which, if unidentified, results in pneumonitis, pneumonia, and/or pneumothorax.[11]

Actuated Medical, Inc. (AMI) aimed to directly compare the prophylactic use of the TubeClear system, an actuated mechanical clearing device, to standard practice water flushes at reducing inner wall Tube material buildup, as a means of reducing subsequent material adherence and Tube clogging in vitro. Establishing protocols that could minimize clog formation would be invaluable for maintaining Tube patency and allowing for nutrition and medication regimens to remain uninterrupted.


Nasogastric (NG) tubes (N=22, 10Fr, 42”) were partially clogged with feeding formula and fiber supplement mixture. Mixture was introduced and blown through with air, coating the Tube inner walls and dried (55°C for 3 hrs.). Tubes were placed in a 3D gastrointestinal model and pump fed (21 mL/hr.) until Tube length was entirely filled with formula (see Figure 2). Half of the Tubes (n=11) were subsequently flushed with 30 mL of water, as directed by clinical practice following feeding formula introduction. The other half of tubes (n=11) underwent a 30 mL water flush in coordination with use of the TubeClear system according to the manufacturer’s instructions. Following clearing procedures, Tubes were dried (55°C for 3 hrs.) to remove moisture introduced by water flushes. Tubes were weighed before and after mixture introduction to quantify the mass within Tubes. As such, the final recorded masses within Tubes were a combination of the initial introduced mixture and added pump fed formula. These mean values did not differ by clearing treatment (0.248 vs 0.250 g, Water vs TubeClear, unpaired T-test, p=0.76) prior to drying. Tubes were weighed following clearing and drying and percent mass increase or decrease from initial mixture mass were calculated (see Figure 3).

Figure 2: Tube in GI model being pumped with formula.

Figure 3: Percent change in mass of NG tubes flushed with with either water alone (Gray Bar) or in conjunction of the TubeClear system (Orange Bar) to  remove buildup residue within Tube inner walls. N=22, 11/treatment; Unpaired T-test for significance, Bars= standard error  of the mean. *p <0.0001.


The TubeClear system in conjunction with water flushes removed 77.1±2.4% of mass while Water flushing alone added 68.5±15.8% (see Figure 3, unpaired T-test p<0.0001).[12]  As added water was removed by post-clearing drying, the added mass, in Water group, was likely formula sticking to the pre-existing Tube material buildup. Images of the partially clogged feeding tubes treated with water or combined with the TubeClear system demonstrated visual differences (see Figure 4), confirmed with mass measurements.

  • All Tubes cleared by TubeClear decreased in mass, while nearly all the Tubes flushed with water alone, increased in mass.
  • The TubeClear system was 145.6% more effective than water alone at removing buildup.

Figure 4: Representative examples of partially clogged feeding tubes treated with water alone (top) or in conjunction with the TubeClear system (Bottom) to  remove buildup residue within Tube inner walls.


This work demonstrates that compared to water flushes alone, proactive use of the TubeClear system prior to Tube occlusions can minimize added material buildup from adhering to Tube inner walls, maintaining full Tube diameter and reducing the risk of future clogging, enabling uninterrupted and optimal EN delivery.


  1. Ireton-Jones C, DeLegge M. Handbook of Home Nutrition Support. Sudburry, MA: Jones and Bartlett; 2007.
  2. Pederson A. Enteral Feeding (Tube Feeding). Gaining and Growing: Assuring Nutritional Care of Preterm Infants. http://depts.washington.edu/growing/Nourish/Tubes.htm. Accessed2000.
  3. Marcuard SP, Stegall KS. Unclogging feeding tubes with pancreatic enzyme. JPEN J Parenter Enteral Nutr. 1990;14(2):198-200.
  4. Bourgault AM, Heyland DK, Drover JW, Keefe L, Newman P, Day AG. Prophylactic pancreatic enzymes to reduce feeding tube occlusions. Nutr Clin Pract. 2003;18(5):398-401.
  5. Shiram K, Jayanth, V., Lakshmi, R., George, V. Prophylactic Locking of Enteral Feeding Tubes With Pancreatic Enzymes. Journal of Parenteral and Enteral Nutrition. 2012;21(6):353-356.
  6. Oley Foundation Member Survey:  Enteral Feeding Tube Clogging and Resolution. In: Actuated Medical, Inc.; 2015.
  7. Mathus-Vliegen L, Koning H. Percutaneous endoscopic gastrostomy and gastrojejunostomy: a critical reappraisal of patient selection, tube function and the feasibility of nutritional support during extended follow-up. Gastrointest Endosc. 1999;50(6):746-754.
  8. Sy K, Dipchand A, Atenafu E, et al. Safety and effectiveness of radiologic percutaneous gastrostomy and gastro jejunostomy in children with cardiac disease. AJR Am J Roentgenol. 2008;191(4):1169-1174.
  9. Towbin R, Ball WJ, Bissett Gr. Percutaneous gastrostomy and percutaneous gastrojejunostomy in children: antegrade approach. Radiology. 1988;168(2):473-476.
  10. Smith R-M, Myers S. 2 devices that unclog feeding tubes. RNWeb. http://rn.modernmedicine.com/rnweb/article/articleDetail.jsp?id=142656#intro. Published 2005. Accessed March 9, 2010.
  11. Stayner JL, Bhatnagar A, McGinn AN, Fang JC. Feeding tube placement: errors and complications. Nutr Clin Pract. 2012;27(6):738-748.
  12. Actuated Medical Inc. TubeClear Prophylactic Test Report: 1100791569, Rev002. 2019.
Syringe Force on Clogged Feeding Tubes

Syringe Force on Clogged Feeding Tubes

Many people think feeding tubes are merely used to deliver nutrition (i.e., feeding formula), however, they deliver life-sustaining medications too – it’s no wonder they tend to clog. At Actuated Medical, Inc., we developed the TubeClear System to keep enteral therapy (medication, nutrition and hydration) being delivered as prescribed.



Article Summary

  • Forces required to do air flushes via enteral syringe in feeding tubes with no clog, 1-layer, and 2-layers of feeding formula mixtures were measured.
  • Feeding tube clogs, or material build-up on the walls (i.e., 1-layer clogs), may begin forming before becoming noticeably difficult to flush.
  • 2-layer clogs required a force that was nearly 5.5 times of the “No Clog” feeding tubes, which was noticeable when flushed by hand.
  • The TubeClear System should be used when caregivers notice higher forces during air or water flushes to maintain full patency of feeding tubes.

We have demonstrated that compared to flushing with water alone, the TubeClear System can remove residue “sludge” from feeding tube interior walls with greater efficacy.[1] However, the question remains – How does one know when material build-up is adhering to the interior feeding tube wall if fluids can still be introduced into the feeding tube?

For patients using feeding pumps, most pump alarms will sound an alert when the flow rate falls below the predesignated flow rate.[2] However, for those using gravity or syringe feedings, clinicians flush the feeding tube with a syringe to confirm patency (open or unobstructed). These water flushes may require increased force if materials are building up on the inner tube walls. In cases of fully clogged feeding tubes, the water may blow backward toward the clinician due to increased syringe resistance. Note that using excessive force on a syringe (often called power flushing) is generally not recommended as it may cause a rupture to the patient’s feeding tube.[3]

Measuring Flushing Force

Our engineers investigated the amount of force (Newtons [N]) required to be applied to a syringe plunger when attempting to introduce air into non-clogged and partially clogged feeding tubes. In vitro produced clogs were created with a mixture of feeding formula and fiber within 14Fr NG feeding tubes (Cardinal Health, Dublin, OH). Three (3) different feeding tube conditions were tested, N=15 trials, with n=5 trials/feeding tube condition: 1) No clog (lacking all material), 2) 1-layer of clog mixture on feeding tube walls, and 3) 2-layers of clog mixture on feeding tube walls (see Figure 2). To create the single layer, the clog mixture was introduced into feeding tubes (N=10) and dried at 55°C for three (3) hours.  To create the two-layer clog buildup, a second clog layer was introduced into a subset of the same feeding tubes (N=5) and dried at 55°C for three (3) hours. To measure the force, a 60-cc syringe was filled with air to the 50-cc mark, and the plunger was depressed to the 10-cc mark using a Shimpo model 100XY force gauge (ELECTROMATIC Equipment Co., Inc., Cedarhurst, NY) (see Figure 1). A n = 5 trials were performed for each feeding tube condition.

Figure 1: Testing set-up.

Figure 2: A rendering of the cross-section of the clog types. The grey circle represents the feeding tube wall, and clog material is represented in shades of orange.

The peak force (measured in Newtons [N]) required to push air via the syringe through a non-clogged feeding tube averaged 7.6±0.1N, compared to 14.3±0.5N and 41.0±1.7N, for the one and two layered partially clogged feeding tubes, respectively (see Figure 3).

While these measurements demonstrate an increasing amount of required force, what does that feel like in practice?

Figure 3: Syringe Force testing summary. 
Blue Bar= No clog, Orange Bar= Single layer of clog mixture, Gray Bar= Double layer of clog mixture. n=5 trials/performed for each feeding tube condition. Error bars= standard error of the mean. Two-way ANOVA, Tukey’s Multiple comparison test, different variables =p<0.01.

Feeling the Force

There are many publications discussing preventative means to feeding tube clog formation and multiple ways to remove clogs;[4-5] however, the question as to how one can determine if a feeding tube is fully patent does not appear to have been addressed.

Some feeding tube clogs appear to form quickly, while others occur gradually over time, leading clinicians and care takers to be uncertain to the state of patency of a feeding tube at any particular time. We aimed to quantify the amount of required force to introduce air into feeding tubes with the various levels of clogging- with the end goal to correlate those values with a subjective “feel,” as such, initial tests were conducted without a force gauge. Videos demonstrate how easily (or not) air could be introduced into feeding tubes of the various conditions.




Figure 4: Syringe resistance against each feeding tube condition. A) No clog. B) 1 layer. C) 2 layers (note: looping GIF animation may look like the plunger “snaps” back, but this is the beginning of the animation).

As expected, the feeding tube without a clog (No Clog) could be flushed with air without experiencing any major resistance. However, the feeding tube with a single layer of clog mixture appears to flush almost as easily as the “No Clog” feeding tube, but the required force as measured by the force gauge was nearly double. This finding suggests that feeding tube clogs, or material build-up on the walls, may begin forming before becoming noticeable to clinicians or caretakers. Further research is required to elucidate this finding.

Attempts to flush air into feeding tubes with a double layer of clog mixture proved the most difficult, requiring additional force as the syringe plunger pushed backwards towards the Operator (see Figure 4c) due to the partial blockage. These simulated clogs required a force that was nearly 5.5 times that of the “No Clog” feeding tubes.

From Bench to Bedside

Using the TubeClear System proactively can remove material build-up from feeding tube inner walls enabling enteral therapy (i.e., medication, nutrition and hydration) to be delivered as prescribed.[1] Based on the results presented here, we recommend using the TubeClear System on a patient’s feeding tube as soon as the clinician notices a change in the required pressure to administer fluid or air during routine syringe flushing, as this may be indicative of material build-up on the inner walls of the tube.


  1. Actuated Medical, Inc. Internal Test Report Doc. No. 1100791569-001.
  2. Cardinal Health, Dublin, OH. https://www.cardinalhealth.com/content/dam/corp/web/documents/patient-recovery/Literature/kangaroo-connect-enteral-feeding-pump-operator-manual.pdf. Accessed 9/27/19.
  3. Richards, S., Walsh, K. (2016), Feeding Tube Irrigation: Performing. Nursing Practice and Skill. https://www.ebscohost.com/assets-sample-content/Feeding_Tube_Irrigation_Performing_-_NSP.pdf. Accessed 9/27/19.
  4. Boullata, J. I., Carrera, A. L., Harvey, L. , Escuro, A. A., Hudson, L. , Mays, A. , McGinnis, C. , Wessel, J. J., Bajpai, S. , Beebe, M. L., Kinn, T. J., Klang, M. G., Lord, L. , Martin, K. , Pompeii‐Wolfe, C. , Sullivan, J. , Wood, A. , Malone, A. , Guenter, P. and , (2017), ASPEN Safe Practices for Enteral Nutrition Therapy. Journal of Parenteral and Enteral Nutrition, 41: 15-103 0148607116673053. doi:1177/0148607116673053.
  5. Lord, L.M. (2018), Enteral Access Devices: Types, Function, Care, and Challenges. Nutrition in Clinical Practice, 33(1): 16-38. doi: 10.1002/ncp.10019.

The Impact of Clogged Feeding Tubes

The Impact of Clogged Feeding Tubes

“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.


[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.

[iii] Unpublished data by Garrison, C.M.

[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.

[viii] American Society for Parenteral and Enteral Nutrition (ASPEN). http://www.nutritioncare.org/NOVEL/. Accessed 25 June 2019.

[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.

[x] Office of Disease Prevention and Health Promotion. https://health.gov/hcq/prevent-hai.asp. Accessed 25 June 2019.

[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.