avanos MIC Mode D'emploi page 3

Gastrostomy Feeding Tube
MIC
*
e
Bolus Gastrostomy Feeding Tube
MIC
*
Instructions for Use
Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
Description
The AVANOS* family of MIC* gastrostomy feeding tubes (Fig. 1 & 2) allows for
delivery of enteral nutrition and medication directly into the stomach and/or
gastric decompression.
Indications for Use
The AVANOS* family of MIC* gastrostomy feeding tubes is indicated for use in
patients who require long term feeding, are unable to tolerate oral feeding, who
are at low risk for aspiration, require gastric decompression and/or medication
delivery directly into the stomach.
Contraindications
Contraindications for placement of a gastrostomy feeding tube include, but are
not limited to:
• Colonic interposition
• Ascites
• Portal hypertension
• Peritonitis
• Uncorrected coagulopathy
• Uncertainty as to gastrostomy tract direction and length (abdominal wall
thickness)
• Lack of adherence of the stomach to the abdominal wall (replacement only)
• Lack of established gastrostomy tract (replacement only)
• Evidence of infection around stoma site (replacement only)
• Presence of multiple stoma fistulous tracts (replacement only)
Warning
Do not reuse, reprocess, or resterilize this medical device. Reuse,
reprocessing, or resterilization may 1) adversely affect the known
biocompatibility characteristics of the device, 2) compromise the
structural integrity of the device, 3) lead to the device not performing
as intended, or 4) create a risk of contamination and cause the
transmission of infectious diseases resulting in patient injury, illness,
or death.
Complications
The following complications may be associated with any gastrostomy feeding
tube:
• Nausea, vomiting, abdominal bloating or diarrhea
• Aspiration
• Peristomal pain
• Abscess, wound infection and skin breakdown
• Pressure necrosis
• Hypergranulation tissue
• Intraperitoneal leakage
• Buried bumper syndrome
• Peristomal leakage
• Balloon failure or tube dislodgement
• Tube clog
• Gastrointestinal bleeding and/or ulceration
• Gastric outlet obstruction
• Ileus or gastroparesis
• Bowel and gastric volvulus
Other complications such as abdominal organ injury may be associated with the
procedure to place the feeding tube.
Placement
The AVANOS* family of gastrostomy feeding tubes may be placed in the following
ways:
Surgically
Percutaneously under fluoroscopic (radiologic) guidance
Percutaneously under endoscopic guidance
A replacement to an existing device using an established stoma tract
Warning: A gastropexy must be performed to affix the stomach to
the anterior abdominal wall, the feeding tube insertion site identified
and stoma tract dilated prior to initial tube insertion to ensure patient
safety and comfort.
Warning: Do not use the retention balloon of the feeding tube
as a gastropexy device. The balloon may burst and fail to attach the
stomach to the anterior abdominal wall.
Warning: The insertion site for infants and children should be high
on the greater curvature to prevent occlusion of the pylorus when the
balloon is inflated.
Tube Preparation
Warning: Verify package integrity. Do not use if package is damaged
or sterile barrier compromised.
1. Select the appropriate size MIC* gastrostomy feeding tube, remove from the
package and inspect for damage.
2. Using a male Luer syringe, inflate the balloon (Fig. 1-E & 2-D) with water
through the Balloon Inflation Port (Fig. 1-A & 2-A). Do not use air.
• Inflate the balloon with 2-3 ml of water for 12 Fr low volume tubes
identified by LV following the REF code number.
• Inflate the balloon with 3–5 ml of water for 14 Fr and 16 Fr low volume tubes
identified by LV following the REF code number.
• Inflate the balloon with 7–10 ml of water for standard tubes.
3. Remove the syringe and verify balloon integrity by gently squeezing the
balloon to check for leaks. Visually inspect the balloon to verify symmetry.
Symmetry may be achieved by gently rolling the balloon between the
fingers. Reinsert the syringe and remove all the water from the balloon.
with ENFit® Connectors
with ENFit® Connector
4. Check the external retention bolster (Fig. 1-D & 2-C). The bolster should
slide along the tube with moderate resistance.
5. Inspect the entire length of the tube for any irregularities.
6. Lubricate the tip of the tube with a water soluble lubricant. Do not use
mineral oil. Do not use petroleum jelly.
Suggested Surgical Procedure (Stamm Gastrostomy)
1. Through a midline laparotomy, identify the pylorus and the superior
epigastric artery in the abdominal wall.
2. The gastrostomy site should be 10–15 cm from the pylorus on the greater
curvature of the stomach. The gastrostomy site should also be at least 3 cm
away from the costal margin to prevent damage to the retention balloon by
abrasions during movement.
3. Place two concentric purse string sutures around the site. Leave the purse
string needles in place.
4. On the anterior parietal peritoneum, select an exit site that approximates the
gastrostomy. Avoid the superior epigastric artery, drains, or other stomas.
5. Make a stab wound from the anterior parietal peritoneum to the extra
abdominal surface. Insert the tube from the outside to the inside the
abdominal cavity.
Note: The use of a right angle clamp may be used to facilitate placement.
Caution: Never use a clamp with sharp teeth or tenaculum to pull the
tube into position. This will damage the tube.
6. Using two Babcock clamps on the anterior stomach surface, "tent" the
stomach.
7. Use electrocautery or a scalpel to open the stomach.
8. Dilate the enterotomy with a hemostat.
Suggested Site Preparation
1. Use standard Radiologic or Endoscopic techniques to visualize and prepare
for gastrostomy tube placement.
2. Verify that no abnormalities are present that could pose a contraindication to
placement of the tube and place the patient in the supine position.
3. Select a gastrostomy site that is free of major vessels, viscera, and scar tissue.
The site is usually one third the distance from the umbilicus to the left costal
margin at the midclavicular line.
4. Prep and drape the selected insertion site per facility protocol.
Gastropexy Placement
Warning: A three point gastropexy in a triangle configuration is
recommended to ensure attachment of the gastric wall to the anterior
abdominal wall.
1. Place a skin mark at the tube insertion site. Define the gastropexy pattern
by placing three skin marks equidistant from the tube insertion site and in a
triangle configuration.
Caution: Allow adequate distance between the insertion site and
gastropexy placement to prevent interference of the T-Fastener and inflated
balloon.
2. Localize the puncture sites with 1% lidocaine and administer local anesthesia
to the skin and peritoneum.
3. Place the first T-Fastener and confirm intragastric position. Repeat the
procedure until all three T-Fasteners are inserted at the corners of the
triangle.
4. Secure the stomach to the anterior abdominal wall and complete the
procedure.
Create the Stoma Tract
1. Create the stoma tract with the stomach still insufflated and in apposition to
the abdominal wall. Identify the puncture site at the center of the gastropexy
pattern. With fluoroscopic or endoscopic guidance, confirm that the site
overlies the distal body of the stomach below the costal margin and above
the transverse colon.
Warning: Avoid the epigastric artery that courses at the junction
of the medial two-thirds and lateral one-third of the rectus muscle.
2. Anesthetize the puncture site with local injection of 1% lidocaine down to
the peritoneal surface.
3. Insert a .038" compatible introducer needle at the center of the gastropexy
pattern into the gastric lumen.
Warning: Take care not to advance the puncture needle too
deeply in order to avoid puncturing the posterior gastric wall,
pancreas, left kidney, aorta or spleen.
Note: For gastrostomy tube placement, the best angle of insertion is a true
right angle to the surface of the skin. The needle, however, should be directed
toward the pylorus if conversion to a jejunal feeding tube is anticipated.
4. Use fluoroscopic or endoscopic visualization to verify correct needle
placement. Additionally, to aid in verification, a water filled syringe may be
attached to the needle hub and air aspirated from the gastric lumen.
Note: Contrast may be injected upon return of air to visualize gastric folds
and confirm position.
5. Advance a J tip guidewire, up to .038", through the needle and into stomach.
Confirm position.
6. Remove the introducer needle, keeping the J tip guidewire in place and
dispose of according to facility protocol.
Dilation
1. Use a #11 scalpel blade to create a skin incision that extends alongside the
guidewire, downward through the subcutaneous tissue and fascia of the
abdominal musculature. After the incision is made, dispose of the scalpel
according to facility protocol.
2. Advance a dilator over the guidewire and dilate the stoma tract at least four
French sizes larger than the enteral feeding tube being placed.
3. Remove the dilator over the guidewire, leaving the guidewire in place.
Note: After dilation, a peel-away sheath may be used to facilitate
advancement of the tube through the stoma tract.
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