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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.

 

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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 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

 

Comparing Options for Clearing Clogged Feeding Tubes

No one wants a clogged feeding tube.  They impact the patient’s ability to receive adequate nutrition and keep medication on schedule.[1]  If the clog cannot be cleared, the tube is replaced. Tube replacement can be a painful, risky, and costly procedure that can include x-rays, surgery, and emergency transportation.  Plus, it takes hours or even days before the patient receives a new tube. The lack of medication, nutrition, and hydration increases the patient’s cost of care.

Because of this, nurses and caregivers have tried several different strategies for clearing and preventing clogs.  From flushing with soda to using products designed for clogged feeding tubes, below are some of the most common solutions.

 

Water

The current standard practice, health care facilities and feeding tube manufacturers alike recommend flushing tubes with water regularly to treat and prevent clogs.  In spite of this, clogs still occur as often as 15% of the time.[2] An internal bench study at Actuated Medical, Inc. showed feeding formula still left on the interior tube walls after flushing with water.[4] Power flushing, a technique in which the syringe depressed with extra force, may cause the water to come back out of the entry port, or worse – rupture the tube.[2,3]

When clogged, water flushing restored feeding tube flow just 20% of the time and took nearly two hours.[5]

Soft Drinks

When water fails, clinicians and care givers turn to soda or juice to dissolve clogs.  This is a myth.[4] In fact, literature suggests that the opposite is true: soft drinks make existing clogs worse. The acidic fluid mixed with feeding formula causes a reaction that forms a new clog.[6] In addition, cola and orange juice can damage the interior lining of feeding tubes.[7] In general, studies suggest lack of efficacy with these remedies,[3,8] with more recent literature discouraging the practice altogether.[9]

Enzyme Mixtures

Another common solution involves crushing enzymes and mixing with baking soda to dissolve the clog.  Early studies showed this to be effective.[2] However, the compound used in these studies was discontinued when the Food and Drug Administration (FDA) started regulating enzymes.[2] Some alternatives have enteric coating, making it difficult to crush and more likely to create clogs.  Other enzymes tested for removing clogs were less than 50% effective.[10]

Enzyme-Based Clog Removing Products

While a clogged feeding tube is a common problem, few products have been developed to treat them.  One such product, Clog Zapper (Avanos Medical, Inc., Alpharetta, GA), is a pre-mixed food-based enzyme that includes a stylet for improved access to the clog.  A recent bench study found limited effectiveness against clogs at just 33%. It also takes a long time – in the same study, Clog Zapper required two hours or more to work (if it did at all).[5] The product is designed for formula clogs and is ineffective in clogs containing medication.  In addition, Clog Zapper’s label states that it Contains Tree Nuts (Coconuts).  Therefore, clinicians must ensure that their patients do not have a food allergy to Coconuts prior to use.

A comparison of each solution’s effectiveness against clogs.[5]

Manual Clog Removing Devices

When fluids and enzymes don’t work, clinicians turn to mechanical tools designed for clogged feeding tubes. One advantage of these types of devices: the clog contents don’t matter.

Declogger (Bionix Development Corporation, Toledo, OH) is a plastic screw-like device for large-diameter feeding tubes. There is limited information available about its effectiveness. A few adverse events have been reported in which the tip of the device broke off inside the feeding tube.

Powered Clog Clearing Devices

Another mechanical product, the TubeClear system, uses a motor to move a flexible Clearing Stem backward and forward to break up clogs in most types and sizes of feeding tubes.[11] A recent study found the TubeClear system at least four times as effective as flushing with water, and 13 times faster.[11] In fact, clinical use found that the TubeClear system cleared clogs in an average of 14 minutes.[12] Designed specifically for feeding tubes, the TubeClear system did not cause damage during use in bench studies.

Download the White Paper

The downside? Limited published clinical data and minimal reimbursement. But that’s a defining characteristic of innovation; early adopters are beginning to see its benefits to patient care and nursing experience.

What are your experiences with clogged feeding tubes?  Have you used any of the solutions mentioned in this article, or perhaps something entirely different?

References:

  1. 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.
  2. Dandeles LM, Lodolce AE. Efficacy of agents to prevent and treat enteral feeding tube clogs. Ann Pharmacother. 2011;45(5):676-680.
  3. Fisher C, Blalock B. Clogged Feeding Tubes: A Clinician’s Thorn. Practical Gastroenterology. 2014:16-22.
  4. Hayes KD, Hayes DD. Best practices for unclogging feeding tubes in adults. Nursing2019. 2018;48:1.
  5. Garrison CM. Enteral Feeding Tube Clogging: What Are the Causes and What Are the Answers? A Bench Top Analysis. Nutr Clin Pract. 2018;33(1):147-150.
  6. Boullata JI, Carrera AL, Harvey L, et al. ASPEN Safe Practices for Enteral Nutrition Therapy. JPEN J Parenter Enteral Nutr. 2017;41(1):15-103.
  7. Rucart PA, Boyer-Grand A, Sautou-Miranda V, Bouteloup C, Chopineau J. Influence of unclogging agents on the surface state of enteral feeding tubes. JPEN J Parenter Enteral Nutr. 2011;35(2):255-263.
  8. Metheny N, Eisenberg P, McSweeney M. Effect of feeding tube properties and three irrigants on clogging rates. Nurs Res. 1988;37(3):165-169.
  9. Zoeller, S., Bechtold, M.L., Burns, B., Cattell, T., Grenda, B., Haffke, L., Larimer, C., Powers, J., Reuning, F., Tweel, L., Guenter, P. Dispelling Myths and Unfounded Practices About Enteral Nutrition. Nutrition in Clinical Practice. 2020. 1-9.
  10. Stumpf JL, Kurian RM, Vuong J, Dang K, Kraft MD. Efficacy of a Creon delayed-release pancreatic enzyme protocol for clearing occluded enteral feeding tubes. Ann Pharmacother. 2014;48(4):483-487.
  11. TubeClear | Occlusion Clearing System. Actuated Medical Inc. https://www.tubeclear.com/. Published 2012. Accessed.
  12. Belcher, M. “An Active Device for Restoring Patency in Clogged Small Bore Feeding and Decompression Tubes, Case Report Series.” 2016. https://www.tubeclear.com/white-paper-download.

    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.

    Methods

    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.

    Results

    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.

    Conclusions

    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.

    References:

    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.

    TubeClear System More Effective at Clearing Clogged Feeding Tubes

    TubeClear System More Effective at Clearing Clogged Feeding Tubes

    In a recent study published in Nutrition in Clinical Practice by Christopher M. Garrison, Ph.D., RN, CNE, the TubeClear system was found to be significantly more effective at removing clogs from feeding tubes than water or enzyme-based clog-clearing treatments.[1] While water flushes and Clog Zapper seemed to work sometimes, the TubeClear system worked nearly every time regardless of clog type (see Figure 1). In addition, the TubeClear system required less Active Nursing Time and Total Nursing Time than the water or Clog Zapper.

    Based on this study, clinicians may save time by clearing clogs with the TubeClear system first.

    Figure 1: The TubeClear System restored patency to feeding tubes 93% of the time during the study, compared to 33% and 20% for Clog Zapper and water treatments, respectively.

    See TubeClear For Yourself!

    12 + 13 =

    References:

    1. 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.

    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.

     

    i

    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.

    A

    B

    C

    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.

    How often do you notice a change in the required force during routine flushes? Let us know! Find us on Twitter and Facebook or send us an email at info@tubeclear.com.

    References:

    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.