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PICC and Umbilical Catheter Safety in Neonatal Patients - October 28, 2010


MedSun Education Webcast Transcript:

PICC and Umbilical Catheter Safety in Neonatal Patients

Thursday, October 28, 2010

2 p.m. – 3 p.m. ET

Slide 1

Coordinator: Welcome and thank you for holding. At this time your lines are in listen only mode. Today's call is being recorded, if you object you may disconnect at this time. I would now like to turn the call over to Angela James. You may begin.

Angela James: Good afternoon everyone. My name is Angela James, and I'm a nurse consultant with KidNet, a MedSun subnetwork within the Office of Surveillance and Biometrics, which is in the division of Patient Safety Partnerships at the Center for Devices and Radiological Health at the Food and Drug Administration.

I will be your moderator today. And I'm happy to welcome you to the 1-hour MedSun KidNet sponsored webcast on PICC and Umbilical Catheter Safety in Neonatal Patients.

Slide 2

Today's webcast on PICC and Umbilical Catheter Safety for Neonatal Patients is co-presented by MedSun and the Iowa Health System.

Slide 3

During today's program experts from the FDA and a MedSun Hospital will discuss medical device safety during insertion and care of PICCs and umbilical catheters in neonatal patients. Case studies with PICCs and umbilical catheters will also be presented.

Slide 4

I also want to mention that the opinions and assertions presented during this webcast by those not from the FDA are the private views of the presenters and are not to be construed as conveying either an official endorsement or criticism by the U.S. Food and Drug Administration. Any discussion during this webcast is not confidential.

In addition, the speakers from Iowa Health System and the clinical practices contained herein are the result of reference research and review. Any practices discussed for patient care do not represent the only medically acceptable approach, but rather are presented with the recognition that other acceptable approaches may exist.

New knowledge, new techniques, clinical research data, clinical experience, clinical or bioethical circumstances may provide sound reasons for alternative approaches even though they are not described in this program.

Slide 5

If you have any questions, or you encounter any difficulty accessing the slides, please call MedSun at 800-859-9821. Again, that number is 800-859-9821.

Slide 6

One nursing continuing education contact hour is available for this program. Certificates of participation with this credit will be available after the webcast by going to the registration Website and completing a brief evaluation. A link to the registration site can be found in your confirmation email.

Slide 7

And now I would like to briefly introduce today's presenters. Again, I'm Angela James. I'm your moderator for today's presentation. My clinical background includes 21 years of combined neonatal intensive care and respiratory therapy experience. And now I'll present the other three presenters.

Our first speaker is Barbara Smith. Barbara is a registered nurse, certified in neonatal intensive care nursing. She is also a unit-based educator at Blank Children's Hospital, which is affiliated with the Iowa Health System. She has over 32 years of neonatal nursing experience and she'll be discussing PICC catheter use in the neonatal population.

Slide 8

Our next speaker is Amanda Wagner. Amanda is a registered nurse, certified in neonatal intensive care nursing. She is also the clinical educator at Allen Memorial Hospital, which is also part of the Iowa Health System. Amanda has seven years of neonatal nursing experience, and she will be discussing umbilical catheters.

And I'd just like to include that the Iowa Health System has been a long time member of the MedSun program.

The last presenter is Crystal Lewis. Crystal has recently joined our MedSun staff as a nurse consultant within the Office of Surveillance and Biometrics at the Center for Devices and Radiological Health at the Food and Drug Administration. Crystal has 16 years of nursing experience that consists of neonatal intensive care and pediatric nursing. Crystal will be presenting case studies on PICC and umbilical catheters.

Slide 9

Following the presenters’ presentations we'll answer a few questions that were submitted by the audience at the time of registration. If you have any additional questions of the speakers, you are welcome to submit them via email to medsun@s-3.com, and we will address them individually.

Again, if you have any questions or if you're encountering any difficulty accessing the slides, please call MedSun at 800-859-9821. Again that number is 800-859-9821.

Slide 10

Our objectives for today's presentation are to describe indications for use, placement (insertion sites) considerations, and catheter care for peripherally inserted central venous catheters, PICCs, and umbilical catheters in neonatal patients.

Our second objective is to recognize complications associated with PICC and umbilical catheter use in neonates.

And our last objective is to identify safety tips and risk reduction strategies that promote neonatal patient safety with PICCs and umbilical catheters.

Slide 11

And now I'll turn the program over to Barbara Smith, who will discuss PICC use in the neonatal population. Barbara?

Barbara Smith: Thank you Angie. Good afternoon everyone.

Slide 12

Peripherally inserted central catheters have been used in neonates since their introduction more than three decades ago. They are used to administer hyperosmolar solutions such as TPN (total parenteral nutrition), or solutions with high dextrose concentrations; medications such as Acyclovir, Ganciclovir and Amphotericin; continuous infusions such as Dopamine, Dobutamine, Fentanyl, Morphine; and PICCs are not recommended for the administration of blood products or to give bolus medications while a continuous drip is infusing.

Slide 13

If you are considering placing a PICC, you first need to determine infusion needs and length of therapy. You need to really know if that patient really needs a PICC, or can you give that therapy with a peripheral IV?

You need to review current laboratory data such as blood cultures and bleeding times. You want to avoid placing the PICC if the baby has a positive blood culture. You need to also acknowledge whether the patient has any sensitivity to tape or antiseptics.

And review the patient history for other central line placements, because sometimes it might be difficult to cannulate a previously used site.

Slide 14

You need to obtain a physician or a nurse practitioner order and make sure to verify informed consent. Please remember that informed consent can be stressful, so give the parents time to ask questions. Document the information you gave to them, and note effectiveness of their understanding by utilizing Teach Back.

Time Out should include at least two patient identifiers such as the date of birth and the medical record number.

Slide 15

Before placing a PICC, consider first the infant's overall medical condition. Will that infant actually tolerate the procedure? Anticipate the length of treatment; once again, if treatment is going to be short-lived, you might be able to utilize only a peripheral IV and not have the need for the PICC.

Assess the need for vascular access device early. With early recognition there will be less sites used for peripheral IVs prior to your PICC placement, which will make PICC insertion much easier because you have more possible sites.

And then note the condition of the peripheral veins. Many sites may have already been used and are not in good condition to support PICC cannulation.

Slide 16

Position and swaddle the baby if you're able, this will provide the baby with containment and comfort. Offer a sucrose pacifier, and any pain meds as needed. By using safe application of warm packs, you can promote vasodilatation and make PICC cannulation easier.

And then cover the patient's eyes if bright lights are used. Generally your larger sterile field will be able to cover the patient's eyes, but if not, you can use a cloth diaper, a blanket or even a cap to cover their eyes.

Slide 17

The most common sites for catheter insertion are the basilic, the cephalic, the saphenous and the temporal veins. But when sites are limited, you can use other sites such as sites in the wrist, the hand and the medial aspect of the knee.

Slide 18

Twenty-four to twenty-eight gauge PICCs are most commonly placed in neonates. These smaller catheters don’t allow for routine blood sampling or blood product transfusions. Select the smallest catheter that will meet your needs. Larger catheters can occlude the vein, resulting in decreased venous return and distal edema.

Slide 19

Prepare the insertion site with an antimicrobial agent such as iodine or Chlorhexidine. Remember that the FDA has not approved the use of Chlorhexidine in patients less than two months of age. You need to follow your product manufacturer’s indications and instructions for use when applying antiseptic agents.

If you want to change insertion preparation practice, it is recommended that you perform a thorough literature search to determine best practices. At Blank Children's Hospital after a thorough literature search, we created a central line bundle using CDC (Centers for Disease Control and Prevention) guidelines and implemented the use of Chlorhexidine for infants greater than 30 weeks. After a year without any adverse affects of using it in infants greater than 30 weeks, we changed the practice to include all infants regardless of gestational age.

Slide 20

There are times when challenges are encountered when attempting to place a PICC. Some of these can include vein cannulation, where you simply cannot access the vein; advancing the catheter to the premeasured distance; and tip malposition where the catheter is not in far enough to be consider central, or

the tip is in the heart.

Slide 21

When using a PICC with a peel-away cannula, once venous access is obtained, advance the catheter slowly to prevent vascular irritation or phlebitis. The catheter should advance easily, so don't force.

Difficulty advancing the catheter can result from valves, bifurcation, venospasm or the cannula isn't inside the vein. Massaging or repositioning the extremity may help advance a catheter.

And another little trick that we have learned through many years of placing PICCs is that if the catheter has a guidewire, you can withdraw the guidewire about one half to one centimeter, and then advance. We have found this to be very successful on those catheters that are difficult to advance.

Flushing the catheter may help advance the catheter past the obstruction. You need to remove the guidewire and try flushing while advancing. This is generally best if the catheter has advanced most of the way and you're needing to advance only the last few centimeters.

Slide 22

Once the catheter has advanced, withdraw the needle until it's outside the skin, and then peel the cannula away according to the manufacturer's instructions. Then you need to advance the catheter to the premeasured distance. When you withdraw the needle, the catheter comes with it, so you need to advance the catheter once the needle is out to where your desired position would be.

Slide 23

Because of the small catheter size you generally won't get a blood return if you aspirate. You cannot use these small catheters for blood sampling or transfusing blood products. Secure the catheter and apply a sterile dressing per hospital policy.

At Blank Children's Hospital our practice is to apply a thin, opaque hydrocolloid dressing to the skin, and secure the hub of the catheter to this dressing with steri-strips. We then cover the hub of the catheter and insertion site with a transparent dressing.

The T-connector is considered an extension of the catheter and is not routinely changed. You need to verify the location of the catheter tip with an X-ray. An X-ray needs to be done after placement and weekly to assess for migration; a chest film for upper extremities and a two- view KUB (kidneys, ureter, bladder x-ray) for lower extremities to include PA and lateral (posterior/anterior - front view and lateral – side view).

To assess for furthest tip placement on an upper extremity, position the patient with the arm extended and bent at a right angle with the arm upward at the elbow. This position advances the catheter to the farthest distance on the X-ray. The catheter tip should be in the SVC (superior vena cava) or the IVC (inferior vena cava) depending on the extremity used.

Slide 24

Insertion complications may include bleeding, arterial cannulation, arterial perforation, arrhythmias -- which generally result when the catheter has entered the heart, infection; and infrequently, complications can include hemothorax and pneumothorax.

Because many of these complications are related to tip placement, it is very important to assess placement routinely per X-ray. Much of the literature recommends weekly X-rays to assess for migration.

Slide 25

Prepare all devices prior to the procedure. You need to measure and then cut the catheter to the desired length.

With the introducer's needle, make certain that the catheter will advance through the needle before inserting it. There are occasions when the hole of the introducer needle is not large enough to hold the catheter. So always double check to make sure that that catheter will advance through the needle prior to using it.

You want to use a maximum sterile barrier such as facemask, cap, sterile gown and gloves. And maintain a large sterile field to prevent contamination on the peripheral surfaces.

Slide 26

Make certain that you know and follow the manufacturer's recommendations for whichever product you use. Avoid force, both with needle insertion and advancing the catheter. Gentle and slow needle insertion decreases the risk of vein injury and helps make cannulation of the vein successful.

Once blood is obtained, insert the catheter and advance slowly. Again, as stated earlier, if there is difficulty advancing the catheter, you can reposition the extremity, massage the area in the path of advancement, and remove the guidewire slightly, or flush while inserting.

Slide 27

Make sure hemostasis is achieved prior to placing the dressing. If bleeding should occur after placing the sterile dressing, apply pressure through the dressing. Avoid changing the dressing at this time because you may dislodge any clot formation and cause more bleeding.

Replace the dressing PRN (as needed) per hospital policy. Evidence based research suggested that dressings on neonates should be changed PRN only. Before changing any dressing change practices conduct a thorough literature search to determine best practices.

Slide 28

Indications for the procedure such as prematurity or poor peripheral access should be documented. Additionally, you should document that you have a verification of informed consent, and make certain that that consent is signed. For Time Out, document the time and the individuals present.

Document if any analgesics, sedatives or local anesthetics are given; document any pain meds that were given prior to the procedure; the date and time of catheter placement; the name of the person placing the catheter and anyone assisting. And then also document which vein you selected.

Slide 29

You need to document the number of attempts and whether you used transillumination or ultrasound. And especially important in the very micro-preemie, you need to document the amount of blood loss.

You need to document skin prep and type of dressing and securement device used; the infant's tolerance to the procedure, complications, and any actions taken to address concerns about the infant during the procedure such as needs for increased oxygen.

Document the catheter length and the insertion distance. It is also helpful to document the amount of catheter left exposed to ensure that the catheter has not migrated in or out. During dressing changes is when you will be able to note whether or not your catheter has moved positions.

If your facility practices routine dressing changes, document when the next dressing change would be due.

Slide 30

In addition, you need to document on the catheter the brand name, the size, the number of lumens, the original catheter length, the model number, the lot number and the catheter length once it was trimmed.

For the introducer you should document the type or style, the brand name, the size, the model number, the lot number and the length. Documentation may vary per hospital protocol.

Slide 31

I just want to show a typical picture of a chest X-ray done for PICC line placement. This is a picture of a 700 gram infant with the tip of the PICC positioned in the superior vena cava.

Note the small size of the catheter which sometimes makes it difficult to determine tip location. This is especially true if the tip lies over a bony prominence. So someone skilled at reading X-rays should be available to assess location of the catheter tip.

Slide 32

Insertion complications can include malposition or migration. And because of the small catheter size, catheter occlusion is one of the main complications.

Others can include thrombosis or mechanical phlebitis, which need to be treated per your hospital policy; catheter leakage, with either internal or external fractures; inadvertent catheter dislodgement; catheter related local or systemic infections; and dermatitis -- which can sometimes be prevented by using sterile saline to wipe off excess skin antiseptic once catheter is placed.

And just like a peripheral IV, infiltrations can occur. Remember that edema will appear at the site of the catheter tip and not the insertion site if the catheter is infiltrated.

Slide 33

Removing or exchanging the catheter may be considered in the following situations:

  • If the catheter is damaged, you may need to remove it. Some catheters do come with a repair kit.
  • A need for a change in size or type of device needed, or if you no longer need a central line, you may need to remove it.
  • Or if the catheter needs to be central because of high dextrose concentration, you may have to replace it if the catheter becomes occluded.

Malposition is when the tip is not in the ideal position. If the tip migrated in, you can withdraw the catheter to the desired position. But if it's too far out it will need to be discontinued because you can't advance a catheter once originally placed. And once again, you may have to remove it if you need high dextrose concentration and the tip is no longer central.

If the catheter becomes dislodged, you need to assess the patient for continued need for a PICC before re-inserting. The patient may be able to get by for the next few days with simply a peripheral IV.

Slide 34

To remove your PICC, first stop your IV fluids. Remove the dressing and then clean the site with an antiseptic solution and then slowly withdraw the catheter. Hold pressure to the site for five minutes. Generally there is very limited bleeding with a PICC; you may need to place a dressing if needed.

Observe the area for one hour for bleeding or for hematoma. And then once the catheter is removed, you need to inspect the catheter to determine that the entire catheter was withdrawn. Check the documented catheter length and double check with the length of catheter removed, and then document that you indeed have removed the entire catheter.

That ends my discussion on PICCs and so it's back to you Angie.

Angela James: Thanks Barbara.

Slide 35

Now we will hear from Amanda, who will be discussing umbilical catheters. Amanda?

Amanda Wagner: Thanks Angela.

Slide 36

Now we're going to talk about umbilical catheters. We've been using umbilical catheters in neonatal practice for quite some time. Early use dates back to 1947 when an umbilical catheter was used in an exchange transfusion to treat severe indirect hyper-bilirubinemia. The first documented use of umbilical catheters for monitoring blood gases was in 1959.

We're going to discuss specifics from each type of catheter in a moment. But in general, umbilical lines are currently used for rapid and reliable vascular access, accurate lab determination, invasive monitoring and administration of fluids, medications, parenteral nutrition and blood products.

Slide 37

Now it's time to get a little more specific. Umbilical arterial catheters are most widely used for monitoring arterial blood gases and sampling blood for laboratory testing. They should not be used to administer blood products, basal pressures, calcium boluses or sodium bicarbonate.

Umbilical Venous Catheters -- or UVCs -- can be used to administer vasopressors and hypertonic solutions. Another very handy use for UVCs includes placing a low venous line during neonatal resuscitation in order to administer medications or blood products. UVCs should not be used to administer platelets.

Slide 38

Umbilical catheters are most often made of polyvinyl chloride, and occasionally made of other substances like silastic -- which is silicon and plastic – or made of plastic or of bonded materials. Umbilical catheters are available in standard sizes of 5 French, 3.5 French and 2.5 French.

Umbilical catheters have a single end hole. Side hole catheters have in the past been associated with increased thromboses.

A single lumen catheter can be used in the umbilical vein or the artery. A double lumen or triple lumen catheter can only be used in the umbilical vein.

The benefit of multiple lumens is to provide the ability to infuse incompatible fluids; it can lead to fewer traumatic needle punctures; it preserves peripheral veins for future use; and multiple lumen catheters can provide the potential for cost containment.

Slide 39

So let's talk a little bit about preparing for umbilical catheter placement. First, we want to make sure that we verify that informed consent has been obtained by the person performing the procedure. As with any procedure we need to perform a Time Out before we start. Then we need to gather our supplies.

Prepackaged umbilical catheter insertion trays now commercially available have been really helpful lately.

Then we need to prepare the catheter. So we need to take the catheter and connect to a Luer lock stop cock and flush with some saline.

Then we're going to move to the umbilical stump. We need to cleanse the stump and the surrounding skin. You can cleanse with Chlorhexidine or Povidone iodine according to your hospital's policy. Make sure you allow this cleansing agent to dry.

Also remember the FDA has not approved Chlorhexidine in use for neonates younger than two months, like Barbara mentioned. So make sure you check with your individual institution for approved cleansing agents.

Once the umbilical stump has been cleansed, it's a good idea to remove the cleansing solution with sterile saline prior to your catheter insertion. Make sure you do this in sterile fashion. Then, we're going to trim the cord to 1 to 1-1/2 centimeters from the skin margin. We need to have an umbilical cord tie there to maintain hemostasis during our procedure.

Once the catheter is placed by the approved personnel, there are two widely accepted methods when it comes to securing the line. You can use the bridging technique that secures the lines as they exit the umbilical stump. The lines will come out perpendicular to your stump, and then you'll bridge over the stump.

The other option involves coiling the line on the abdomen and securing it with a clear occlusive dressing. Always make sure no matter what way you're securing the line that you can see the markings on the catheter all the way down to where it enters the umbilical stump.

It's a good idea to make sure that the patient’s abdomen is free of burrs/nicks and is as dry as possible to enhance adhesion of whatever you're using to secure the line.

Another idea is to consider a layer of protectant like a thin, opaque hydrocolloid dressing next to the infant's skin, below the line in the dressing. Don't cover the umbilical stump with the dressing, only the umbilical catheter. In highly humidified environments, be sure to assess the integrity of this dressing frequently.

Slide 40

Malposition of the UVC -- as we're going to see here on our list of complications with UVCs -- is one of our biggest concerns.

The appropriate position of the UVC is above the diaphragm just below the junction of the right atrium. If there's resistance to insertion or poor blood return, this likely indicates that the back of the catheter might be in the inappropriate position, like the portal or splenic system.

If you're using an umbilical venous catheter for neonatal resuscitation purposes, all you need to do is advance the catheter until you see blood return, which should typically just be two centimeters beneath the skin surface. Remember to add any links of your cord that has not been trimmed to that two centimeter measurement.

Avoid advancing a catheter more than two centimeters below the skin's surface, to prevent infusion of our resuscitation methods into the liver.

Slide 41

So umbilical venous catheter complications include, like we just mentioned, malposition. And the other kinds of complications listed are portal vein thrombosis/hepatic necrosis; sepsis; arrhythmia; perforation or tamponade; thrombotic endocarditis; and hemorrhagic infarction in the lungs. We will discuss some of these complications in depth in the following slides.

Slide 42

Like I mentioned, catheter malposition is the most common complication for UVCs. The tip of the UVC can be placed in or migrate to the liver, which can result in portal vein thrombosis or hepatic necrosis. Another complication is if the tip of the UVC is placed high in the right atrium; that might lead to a cardiac arrhythmia/tamponade.

It is always important for the provider placing the line to obtain an X-ray to assure correct placement. It is especially important to monitor placement of umbilical catheters in extremely low birth weight infants.

Slide 43

The double catheter technique for a malpositioned catheter involves inserting a second catheter of equal or smaller size into the lumen, while the original catheter remains in place. Advance that second catheter gently into position. If you're successful, remove the first catheter, suture and then secure the new indwelling catheter.

Slide 44

Another complication that I mentioned is sepsis and thrombosis. Umbilical line solutions may contain .5 to 1 unit per ml of Heparin to assist in-line patency. However Heparin is a high alert medication, especially in the neonatal population.

As far as sepsis though, sepsis incidence is noted to be increased in infants receiving TPN and intralipids. Both the concerns of sepsis and thrombosis increase when we're talking about prolonged catheter use.

Slide 45

Now we're going to move along to umbilical arterial catheters (UACs). UACs should be placed between the sixth and tenth thoracic vertebrae for high placement and in between the third or fourth lumbar vertebrae for low placement. Radiographic imaging is needed to confirm correct placement.

UACs require constant infusion to prevent clotting. Solutions used include: .25% normal saline; .5% normal saline; or a dextrose 5% and water -- depending on sodium intake concerns with an extremely low birth weight infant.

UACs are used for blood sampling for lab work and arterial blood gas samplings. They also are used for invasive blood pressure monitoring.

Slide 46

The most significant complications related to umbilical arterial catheter use are vasospasm; thrombosis or embolism; perforation of the vessel; urachus catheterization; an intraventricular hemorrhage; necrotizing enterocolitis; sepsis; hematuria; hypertension; hemolysis and hemorrhage. We will discuss these in detail on the following slides.
 

Slide 47

Vasospasm is typically seen in the neonate as a blanching of the buttocks and lower extremities. It's important to differentiate vasospasm from thrombosis or emboli formation, as the latter can cause extensive ischemic injury and limb loss.

In order to help relieve the signs of vasospasm, try warming the unaffected or opposite limb, or repositioning the catheter to a lower position. If blanching or cyanosis are persistent, the catheter should be removed.

Remember that the urachus can unintentionally become catheterized when the UAC is placed. The urachus is the canal that drains the urinary bladder of the fetus that joins and runs within the umbilical cord. Accidental urachus catheterization can lead to urinary ascites.

Slide 48

It is important to remember to slowly withdraw and re-infuse blood at the rate of 1 ml over 30 seconds. Abrupt changes in blood flow can cause a transient increase in blood pressure, which can contribute to intraventricular hemorrhage and or necrotizing enterocolitis.

Always visualize your line as you re-infuse blood and observe for any air emboli.

Slide 49

Sepsis is always a concern in any indwelling line and extremely low birth weight infants are at an increased risk for developing sepsis. Always remember that the longer we utilize the line, the higher risk there is for infection. It's also important to remember that hypertension may result from thrombi or other catheter-related effects.

We will discuss central line bundles in the question and answer portion of today's seminar so stay tuned for some tips related to sepsis prevention.


 

Slide 50

UACs should be removed within or by five days, and UVCs should be removed within or by 14 days. Catheters should be removed one at a time.

So we're going to talk a little bit about the actual catheter removal procedure. First, we usually stop the infusion of fluids. Then we're going to clip the sutures with scissors. Remember not to use knife blades for cutting the sutures because the concern is that we will cut the catheter.

Next we're going to withdraw the catheter to about five centimeters. Slowly withdraw the catheter over five minutes, make sure to monitor for bleeding. And to enhance visualization for a hemorrhage related to these vessels, make sure that babies remain supine for six to eight hours minimum in order to maintain visual monitoring. Some institutions place a pressure dressing over the umbilicus after catheter removal.

No clothing or blankets should cover the umbilical stump after catheter removal. Take caution when covering isolettes with blankets or covering the baby immediately following umbilical catheter use to maintain visualization of the catheter removal site.

Slide 51

In order to control bleeding upon removal of umbilical catheters, if a venous line, apply pressure by lifting and pinching the skin just above the cord. If an arterial line, apply pressure just below the cord. If there is persistent bleeding, consider the use of a hemostat to close the vessel's lumen.

This completes the discussion on umbilical catheters. Angie?

Angela James: Thanks Amanda.

Slide 52

Our last presenter is Crystal. Crystal will be discussing case studies on umbilical and PICC catheters. These case studies actually came from some adverse event reports that we’ve received through our MedSun KidNet subnetwork program. Crystal?

Slide 53

Crystal Lewis: Good afternoon everyone. Since we've just finished our section on umbilical catheters, I'll start with a case study on a UVC and one on a UAC.

An umbilical venous catheter developed a leak at the Luer lock connection. A close examination revealed that the connector had a crack in it that allowed TPN, lipids, fentanyl and blood to leak out.

Fluid loss and inadequate medication contributed to the situation where the, neonate was temporarily very unstable. The reporting hospital had at least eight problems with this catheter over the last two years. Fortunately, the facility reported this event to us for follow-up.

Slide 54

The FDA works with the manufacturers as well as the MedSun hospital to understand reported problems. MedSun encourages the reporting of potential for harm events the first time they occur.

The next case study involves a UAC. A nurse was attempting to discontinue an umbilical artery catheter, and while pulling gently on the line, the catheter separated below the suture, close to the umbilical site. This resulted in a blood loss of approximately 13 mls. of blood, and required a transfusion of 5 mls. of packed red blood cells. This is a case study of what we don't want to happen.

Now I'll present the last two case studies; they're on PICCs.

Slide 55

A PICC line was placed into the right antecubital vein of an extremely low birth weight infant. Multiple X-rays following placement over the next three days were read by many pediatric radiologists as being placed above the right atrium.

However, confirmation through an echo showed that the PICC line had always been in the right ventricle. The baby developed a non-life threatening pericardial effusion.

This event reported through MedSun's KidNet underscores not only the importance of radiographic confirmation of PICC placement, but also the importance of careful assessment and monitoring for changes in patient respiratory and cardiac function.

Here's the last case study that I'll present.

Slide 56

A dual lumen PICC line was placed via the saphenous vein. Seven weeks later during the removal attempt, the catheter would not freely pull back through the vein. Despite warm compresses over the vessel, the catheter could not be pulled. The patient underwent a cut down procedure near the groin to remove the catheter.

I'd like to say how much we appreciate your reports of medical device problems associated with neonates. We at MedSun FDA are able to make a significant impact on patient safety by following up with manufacturers to address reported device problems and safety concerns that may result in improved design and materials and improved instructions for use.

Here's an example of success story where this happened based on a group of reports we received from a single hospital.

Several reports were received from a MedSun KidNet hospital that described events of cracking, leaking, breaks and catheter occlusions related to the cracking of Luer hubs. The manufacturer had indicated that the problem was due to users over-tightening the connection -- a precaution listed in their instructions for use.

FDA followed up with both the reporting site and the manufacturer, which prompted the manufacturer to visit the KidNet hospital to better understand the reported events during clinical use. The manufacturer subsequently considered material and design issues, and has made changes in their product to address the reported event.

Now I'll turn the program back over to Angie. Angie?

Angela James: Thanks Crystal.

Slide 57

During the time of registration, we received many questions. And now we're going to take some time to address three of the questions that we received.

Slide 58

So the first question. We received several comments and questions about the management of central line associated bloodstream infections, which leads us into Question Number 1, "What are the challenges related to the management of central lines -- especially central line associated bloodstream infections?" Barbara, will you take this one?

Barbara Smith: To address central line bloodstream infections you should consider developing a central line bundle. If your practices and protocols are standardized, you are less likely to encounter central line infections.

First you need to identify the components of the central line bundle. At Blank Children’s Hospital, we utilize the CDC's guidelines -- entitled Guidelines for the Prevention of Intravascular Catheter Related Infections 2002.

And that bundle included things such as:

  • Education -- you need to make sure that your staff and all who place PICCs are thoroughly educated on the appropriate care and placement of that line;
  • Hand hygiene;
  • Barrier protections, making certain that we have a very large sterile barrier when we place that PICC -- we use a sterile barrier when we do dressing changes;
  • Skin antiseptics, catheter site prepping and dressing changes; antibiotics and antiseptic ointments that are topical may be used;
  • Whether you want to use anti-coagulants in your line;
  • Central line care and maintenance;
  • Removal of the line.

And line removal included things such as: you really need to assess your patient daily to see if that line is still needed. If the patient is almost at the goal of feeds and you really aren't using the line other than to deliver small quantities of fluid, it's probably time to take that line out to avoid a central line infection.

You need to assess the site of the catheter insertion; the type of catheters that were used previously; whether you want to use inline filters; whether you want to use prophylactic systemic antibiotics.

The bundle also would include maintaining insertion competencies, and standardized central placement.

Those are the areas that were listed by the CDC. You do not have to use all aspects of the bundle to have a good bundle; you can choose what works best for your facility. But just here at Blank Children's Hospital, we do not use prophylactic systemic antibiotics. So in our bundle we addressed it, but we also gave rationale as to why at this time we're choosing not to do utilize prophylactic systemic antibiotics.

This provides an overview of things to consider when developing a central line bundle. Angie, back to you.

Angela James: Thanks Barbara.

Slide 59

Now the second question deals with education and training, and certification with PICCs along with education and training in umbilical catheter insertion and care. I'll ask Barbara to take this question address the training and certification for PICC catheter insertion. And then I'll have Amanda follow to address the training and certification for umbilical catheter insertion.

Barbara, can you take this question again please?

Barbara Smith: You need to know your facility's protocol and who has been deemed competent and certified to place PICCs.

PICC certification requires a formal class for nurses. And after taking that class, the nurse must successfully place three PICCs while being monitored by an already certified PICC nurse. Successful placement means that the nurse has been able to cannulate the vein and advance the catheter to the point where the catheter is able to be sutured in place and an X-ray is needed for confirmation of placement.

And then to maintain certification, evidence-based practice recommends a minimum of five successful PICC placements per year to maintain competency.

Now Amanda will pick up this question as it relates to umbilical catheters.

Amanda Wagner: Thanks Barbara. Currently at Allen Memorial Hospital, physicians are the only practitioners placing umbilical catheters. Some institutions do utilize nurses on transport teams to place catheters, and many use neonatal nurse practitioners for umbilical catheter placement. Just make sure you follow your institution’s and state’s scope of practice guidelines when developing umbilical catheter competencies.

Angela James: Thank you Amanda.

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Our last question is about how FDA handles recalls with medical devices. Crystal, can you answer this one for us please?

Crystal Lewis: Sure Angie. A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company; a recall sometimes means that the medical device needs to be checked, adjusted or fixed.

For example, if an implanted device, such as a pacemaker or an artificial hip is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.

Examples of the type of actions that may be considered recalls are as follows: when a manufacturer inspects the device for problems; repairs the device; adjusts settings on the device; relabels the device; destroys the device; notifies patients of a device problem; and/or if a manufacturer asks users to monitor patients for health issues related to device use.

Sometimes a company may have concerns about a group of products, but it cannot predict which individual devices will be affected. To be on the safe side, the company may recall an entire lot, model or product line.

In most cases a company -- which entails a manufacturer, distributor, or other responsible party -- recalls a medical device on its own or voluntarily when a company learns that it has a product that violates FDA law. The company does two things; it either recalls the device through correction of the problem, or removal of the device from the marketplace and in either case, notifies the FDA.

Legally, FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However in practice, FDA has rarely needed to require a medical device recall.

Now I'll turn it over to Angie. Angie?

Angela James: Thank you Crystal.

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On behalf of the FDA, I'd like to thank you for attending this webcast. Again, let me remind you that certificates of participation with one nursing continuing education contact hour is now available. Please go to the registration website listed on your confirmation e-mail, complete a short evaluation and print a copy of the electronic certificate.

Additionally, if you know of others at your MedSun organization who would like to receive a replay of this presentation, and the associated nursing continuing education contact hour or you would like to participate in KidNet, please call MedSun at 1-800-859-9821. Again that number is 1-800-859-9821. And this concludes today's webcast.

Slide 62

Coordinator: This concludes today's call. Thank you for your attendance. You may disconnect at this time.

References

Centers for Disease Control and Prevention (CDC). Guidelines for the Prevention of Intravascular Catheter-Related Infections. Morbidity and Mortality Weekly Report (MMWR) August 9, 2002; 51(No. RR-10):1-30 Accessed October 2010.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5110a1.htm

Gamulka, B., Mendoza, C., & Connoly, B. (2005). Evaluation of a unique, nurse-inserted, peripherally inserted central catheter program. Pediatrics, 115(6), 1602-1606. Retrieved from CINAHL Plus with Full Text Database May 2010.

Hansen, A., Greene, A., & Puder, M. (2009). ONE: General Considerations: Part 5: Vascular Access (pp. 42-55). People’s Medical Publishing House USA Ltd (PMPH). Retrieved from Academic Search Complete database May 2010.

Infusion Nursing Standards of Practice (2006). Journal of Infusion Nursing, 29(1S), S1-90. Retrieved from CINAHL Plus with Full Text database. Accessed July 2010.

KidNet Webcast: Peripheral IV and PICC Safety in Neonatal and Pediatric Patients (2009). Aired November 18, 2009. Available at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm206357.htm

MAUDE (Manufacturer and User Facility Device Experience Database) (2010) retrieved July 2010. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

Nash, P. (2006). Umbilical catheters, placement, and complication management. Journal of Infusion Nursing, 29(6), 346-352. Retrieved from CINAHL Plus with Full Text database.

Pettit, J. (2007). Beyond the basics. Technological advances for PICC placement and management. Advances in Neonatal Care (Elsevier Science), 7(3), 122-131. Retrieved from CINAHL Plus with Full Text database.

Sharpe, Elizabeth L. (June 2008). Tiny Patients, Tiny Dressings: A Guide to the Neonatal PICC Dressing Change. Advances in Neonatal Care. 8(3), pp 150-162.

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