Peripheral IV and PICC Safety in Pediatric and Neonatal Patients
Peripheral IV and PICC Safety in Pediatric and Neonatal Patients
November 18, 2009
1:00 p.m. - 2:00 p.m. ET
Coordinator: Welcome and thank you for standing by. I’d like to inform you your lines are on a listen-only for today’s conference call. The call is also being recorded. I’d now like to turn it over to Ms. Suzanne Rich. Ma’am, you may begin.
Suzanne Rich: Good afternoon, everyone. My name is Suzanne Rich and I am the Senior Project Manager for KidNet, a MedSun subnetwork within the Office of Surveillance and Biometrics (OSB) which is in the Division of Patient Safety Partnerships at the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA).
I will be your moderator today and I’m happy to welcome you to the one hour MedSun sponsored Webcast, Peripheral IV and PICC Safety in Pediatric and Neonatal Patients.
During today’s program, experts from the FDA and a MedSun hospital will discuss medical device safety during insertion and care of peripheral intravenous, IV, and peripherally inserted central venous catheters, PICCs, in pediatric and neonatal patients. Examples of medical device adverse events associated with peripherally inserted IVs and PICCs will also be presented.
Additionally, the role human factors plays in medical device related adverse events and the importance of recognizing and reporting medical device problems will be discussed. I’d also like to mention that the opinions and assertions presented during this Webcast by those not from the FDA are the private views of the presenter’s and are not to be construed as conveying either an official endorsement or criticism by the U.S. FDA. Any discussion is not confidential.
If you have any questions or difficulty accessing the slides, please call MedSun at 800-859-9821. Please note that the slides on the registration site were updated as of November 17, yesterday. If you’re following along with a copy of the slides that were printed prior to the 17th, the slide numbers in this live presentation will be slightly different.
One nursing continuing education hour is available for this program. Certificates of participation with this credit will be available after the Webcast by going to the registration Web site and completing a brief evaluation. A link to the registration site can be found in your confirmation email.
And now I would like to briefly introduce today’s presenters. Our first speaker is Angela James. Angie is a Nurse Consultant in OSB within CDRH here at FDA.
Our second speaker today is Dana Etzel-Hardman. Dana is a Training and Education Specialist at Children’s Hospital of Pittsburgh, a participating MedSun and KidNet hospital. And lastly, we will hear from Jacqueline Francis, who is a Medical Officer in the Plastic Surgery and Reconstruction Branch, which is in the Office of Device Evaluation at CDRH/FDA.
Following the speaker’s presentations, we will answer several questions that were submitted by the audience at the time of registration. If you have additional questions of the speakers, you are welcome to submit them via email to email@example.com and we will address them individually.
I would now like to turn the program over to Angie James. As I mentioned, Angie is a Nurse Consultant at FDA. She is both a registered nurse and a registered respiratory therapist with extensive clinical experience in level III neonatal intensive care nurseries. Angie?
Angela James: Thank you, Suzanne. Good afternoon. I would like to start by giving you some background information about FDA, CDRH, MedSun, and KidNet and let you know how they all are related.
Within the FDA, there are three Centers that oversee the safety of medical products: CDER, which is the Center for Drug Evaluation and Research; CBER, which is the Center for Biologics Evaluation and Research; and CDRH, which is the Center for Devices and Radiological Health.
CDRH is the Center within FDA that is responsible for approving the use of medical devices and overseeing the manufacturing, performance, and safety of these devices.
The Medical Product Safety Network, known as MedSun, is a medical device related adverse reporting network within CDRH that is made up of 350 healthcare facilities around the United States. Since you are participating in this Webcast today, it is likely that the healthcare facility you’re associated with participates in MedSun.
KidNet, which was launched in June 2007, is a specialty subnetwork within MedSun that focuses on the collection and sharing of information about potential and actual adverse events associated with medical devices used with pediatric and neonatal patients. Working through MedSun and subnetworks, like KidNet, is one of the ways that CDRH learns about problems and potential problems with medical devices. MedSun uses an Internet-based reporting system that is designed to be an easy and secure way to report adverse events. Our hope is that by providing educational programs such as this, we can increase reporting about medical device problems to the FDA.
Lucian Leape, a physician and patient safety expert from Harvard University, once said that, “Medical errors most often result from a complex interplay of multiple factors. Only rarely are they due to the carelessness or misconduct of single individuals.”
IV products, such as infusion pumps, tubing, PICCs and peripheral IV catheters, are the most frequently reported devices in MedSun that involve the pediatric and neonatal population. Leaks, breaks, and cracks are a few of the top reported problems associated with these devices.
The following are examples of MedSun IV device adverse events. The first three examples are potential for harm adverse events that did not involve an injury, but have the potential to cause an injury. One reported problem consisted of packaging where containments were noted inside the catheter rendering the device unusable. Another reported problem was a burr that was noted on the needle prior to insertion. The last potential for harm example was a reported problem involving a guidewire, a component in the PICC that became unraveled during placement insertion.
The three remaining examples are actual adverse events where there was a patient injury. An otoscope and transilluminator’s physical appearance looked the same, but each device had different light intensity. The otoscope was mistakenly used to illuminate the vein for IV catheterization. This resulted in the patient receiving a burn. The healthcare provider was unable to flush the PICC due to an obstructive lumen. The end result was that the catheter had clotted off. Therefore, the device had to be removed.
The last example in this slide is about a PICC that was leaking, because the hub was cracked. This led to an air embolism.
Now, this slide represents the Swiss cheese model of system failure, which is a popular model used in healthcare to illustrate a sequence in human failures that leads up to an injury. The holes in the cheese slices represent individual weaknesses and individual parts of the system. The system as a whole produces failures when all of the holes in each of the slices momentarily align permitting an accidental opportunity. Think of the holes as an opportunity to allow a problem to pass through a hole in one layer into the next layer.
In this case study, the sequence of failures begins with a PICC leaking because of the cracked hub. This case study is referring back to the previous slide. A PICC is inserted, but the problem of the hub cracking was not reported. The problem continues to go unreported and because others are not aware or alerted that there is a problem, an adverse event takes place where an air embolism occurs.
This problem was actually reported to us by one of our MedSun KidNet hospitals. Originally, the problem was attributed to the users over-tightening the lower hub connector. FDA did some follow up with the KidNet hospital and the manufacturer. This prompted the manufacturer to visit the reporting hospital to try and obtain a clear understanding of what was occurring. So subsequently, the manufacturer made some material and design changes to the product.
Now, we’ll look at human factor issues that may contribute to medical device adverse events. We’ll see how device design, user expectations, and environmental aspects as part of the human factors, all play roles in medical device adverse events.
For example, monitoring alarms, such as a pulse ox alarming for high or low saturations, a ventilator alarming for high pressure or low pressure alarms, inadequate lighting for a procedure; these are all environmental distractions that may impact the safe placement of the PICC or IV catheter.
Are the instructions for use clear to the end user? Is the print on the label bold enough or is the print small and not so easy to read? These are only some of the things to consider as we as humans interact with current and new technology.
Suzanne Rich: Thank you very much, Angie. Our next speaker is Dana Etzel-Hardman. She is a Training and Educational Specialist at Children’s Hospital of Pittsburgh, a participating MedSun and KidNet hospital. Dana is a Registered Nurse and holds master degrees in both nursing and business administration. She has taught IV therapy for eight years, during her 28 years as a pediatric nurse. Dana?
Dana Etzel-Hardman: Thank you, Suzanne. What I’m first going to talk about is some of the major complications that we see with peripheral catheters, especially in pediatrics. The first one is infiltration. Up to about 11% of IV catheter placements that we see in pediatric populations are reported to have an infiltration associated with them.
These infiltrations can cause many other problems and they can cause nerve injuries, one of which is called RSD, which is a reflex sympathetic dystrophy. This can cause severe burning, pain, and pathological changes to the bone and the skin. And also these patients’ extremities become very sensitive. Especially, it’s hard with children that are not able to give you verbal clues that they’re having problems with their IVs.
Another area is extravasation which is a little bit different than infiltration, because with an extravasation you have to look at the pH of the solution and the osmolarity of the solution that you’re using. One such medication, such as Vancomycin, has the same pH as Drano; so you have to be very careful when these medications are given through an IV that if the infiltration occurs, you have to look at what are the outcomes and what can cause pain to these children.
Hematoma, infection, phlebitis, cellulitis, occlusion, and you can even get a fracture of the catheter or venous spasms- are all part of the problems that we have in the pediatric population.
A couple challenges with children, especially the smaller child or those that are very fragile in what they have as far as their diagnosis, especially in children’s anatomy:
They’re small. They’re fragile. And a lot of time it’s very difficult to locate the veins. Especially when you have child that has – I should say a little bit of a “chubbywubel” around them, where you can’t really see where they’re located. Also, children are very fearful and they have a lot of anxiety when you’re trying to start an IV.
Another challenge that we do see is a practitioners’ skill at IV insertions. A lot of times, you’re not seeing nursing schools teaching this skill or those that have been doing IVs, maybe, are a little bit fearful doing it in pediatrics when they’ve been doing it in the adult world.
We at Children’s do have a policy that we allow only two attempts from the first nurse to try to start the IV. If they’re not able to do it, we then allow a second nurse to do it. And then if we still can’t, then we call the physician and see what we’re going to – unless there was an emergency. We also provide training to our new nurses. We do that by reviewing the hospital policy and going over anatomy and physiology and we also have different stations that they’re able to rotate through.
They learn how to do IV pumps; they learn how to do mannequin arms; and we actually have an IV simulator on a computer, in order to try to get them to get more practice. But some facilities do have an IV team which is comprised of staff that are certified in IV insertion. This really can help a lot of the nurses at the bedside.
Also in pediatrics we have to be careful, because we use different areas of the anatomy that most adult IV practitioners do not see. We use scalp and we use the lower extremities, to start IVs.
And that becomes very different when you’re trying to teach that as part of IV insertion techniques for children.
So what do we do for children to make it a little bit easier? First of all we have to use age appropriate explanations to that child, and I’ll go into a little bit more detail. The other things we like to try to do is perform that insertion outside the patient’s room. The room should be an area for a little bit of comfort. You don’t want to do a lot of painful procedures in there. So we do put them in a treatment room.
We also allow that child to keep a comfort item, such as a blanket or a stuffed animal. We do encourage all our parents to be present and we’ll talk about that a little bit, too, and then like I said, we’re going to use some different age appropriate distraction techniques that we can use to help get that IV started.
The first slide you’re seeing here is with an infant and that’s usually birth to about a year. We definitely want to educate the parent or caregiver what to expect about the IV insertion and the site appearance, especially if you’re going to use a scalp vein.
So one, we use comfort measures, such as a pacifier, and we try to bundle them. We try not to cause too much problems with the kids, as far as we try to keep them really calm. We can maybe give them an oral sucrose solution. And especially if it’s an IV site, it’s all in the hold. We want to make sure that the patient is not moving a lot when we’re going to start that IV.
The other thing you have to be careful with in children, especially infants, is that if you unbundle them to start that IV that the room is not cold, because if they have heat loss it’s also difficult to find those veins, especially with a neonatal patient or a young child. We want to make sure that they’re nice and warm.
The toddler goes from one to three years. In this age group, you want to provide simple concrete explanations. As we all know a toddler’s favorite word is “no.” So, if you are going to give them a choice, you want to make sure that you’re still able to provide that task. An example is if you’re giving a medication you can ask the toddler: “Do you want it in a cup or a spoon,” but you’ve got to make sure that you get that medication in.
The other thing we also do is to definitely use our toys and stuffed animals and transition objects, so that they can have comfort. This age group loves to play games or songs or counting. We try to reward behavior with stickers or small toys. Our Child Life department is very good with that and definitely with this age group you’re going to need more than one person to help you with positioning. I was taught about these kids being definitely little Houdinis. They try to get out of everything that you’re doing.
The preschooler is from three to four years of age. Again, you want to prepare this child just before the procedure. You don’t want to give them a long time to think about it, because they won’t understand. We encourage this age group with medical play of handling of device IVs. A lot of times we’ll allow them to put the IV – not with the needle, but a small catheter on their stuffed animal, so that they also have an IV. You can reward good behavior with this and then definitely again, songs and games with them to try to get them to become part of this prior to the procedure.
A lot of times with this age group and also for the younger child, you may want to ask the family before you put a band-aid on them, because these children do not always like to have things on them. So ask the family before you give a band-aid.
The school age is from five to 12 years old. Again, provide simple explanations for what you’re doing. With this age group you can encourage them to help you set up the equipment or they can do small tasks during IV insertion. Respect that child’s choice, whether or not they want to have the parent present. A lot of times they do not like to have them there, or they may, so it’s up to the child. Also let the child know that it’s okay to be afraid or to have a little bit of apprehensiveness before you’re doing the procedure. What you want to do is you want to give a step-by-step explanation and explain to them what they’ll be feeling. Also with this age group, toys, electronics, TVs, actually help.
With adolescents the biggest thing is to maintain their privacy and assure the confidentiality. Again, they may prefer that the parents not be present when you’re doing the procedure. In this age group, you want to explain the procedure in an adult language. Again, adolescents like to participate in their care decisions, but be aware of their concerns for the body image. With this age group, be honest with them. You may want to instruct them in some breathing techniques. This age group works really well with an iPod or any other kind of electronic equipment that takes them out of that bed.
And then with all age groups, you want to make sure that they are aware when you’re done. A lot of times you’ll see them closing their eyes and you already have the IV in and taped and they still think it’s going on.
Last, we talk about parent care. We do offer the parent the option to attend the procedure, but before I do that I like to explain to them what their role is going to be. I tell them that they can either reassure the patient or they can just be the observer or if they don’t feel comfortable, they can wait outside the room. Otherwise, we can use them to help with comfort measures and we call them for comfort positioning. This way we give an explanation to the family. One way is that a parent can be hugging their child with their head to the chest and the arm is behind them, so that the nurse starting the IV is able to start that IV and has a really good patient holder in the parent, but it’s also the parent providing comfort to that child.
Now, we’re going to go ahead and talk about what is a peripheral short-term catheter. The INS recommends that a peripheral short-term catheter should be defined as one that is less than three inches in length. Again in pediatrics, I have never seen less than three inches. You want to choose the catheter size, though, based on the therapy that you’re going to use. Most of the time in pediatrics, we use 24 or 22 gauge. In neonates, they even use a little bit smaller sometimes. So you have to be really careful what you’re choosing.
Peripheral short term catheters and steel-winged should be equipped with a safety device so that it prevents any kind of injury.
When you take that catheter, before you’re going to put it into the patient, you want to make sure that you inspect it. We want to make sure that everything is in place. You don’t see anything sticking out-no stylets, no needles, there are no burrs on the catheter. You should do a very good visual inspection before insertion.
Also you should take care when you’re using stylet needles to make sure they don’t go over the catheter placement. Don’t reinsert stylets back in, because then you can cause a problem with puncturing a hole in the catheter. And then a needle or guidewire should never be withdrawn through the catheter.
This is a case study where the Center for Devices and Radiological Health worked with manufacturers to address reported problems on a product. When the package of the IV needle was opened, the plastic catheter fell off the needle hub and then the needle was known to be bent and retracted. Now before this was used on a patient it was noted that, the catheter had been speared through the needle, so fortunately, they did not put this into a patient. But you do need to make sure that those devices; the packaging, is protected and there aren’t any holes in the device.
IV selection, when you’re looking at a patient – where am I going to put the IV? - you have to consider a couple of things. One, you need to consider the patient’s condition. Have they had multiple IVs in the past? Are they very dehydrated? Things like that, also the age of the patient. I’m not going to put a scalp vein in an older child, so there is an age related factor to choice of insertion sites. Also patient diagnosis, again I talked about vascular history. A lot of times these kids have had multiple IVs inserted, so you need to know what their history is.
Also, if they’ve had previous access devices, they could have had PICC lines placed, central lines placed, that also come into play. The INS guidelines for peripheral IV insertion indicates that most veins should be dorsal and ventral surfaces of the upper extremities, including the metacarpal, the cephalic, and the basilic, but in pediatric patients, as I said before, there are many other sites that we look at.
We look at the head and also the lower extremities. You want to make sure that the vasculature that you have is able to accommodate the catheter’s size and the length required. So you want to look at that vein prior to inserting that catheter. You want to make sure that it’s going to be the right length. A lot of times in kids, you’ll see very small veins and you have to look at whether or not you can get a 3, 4 inch in that area?
Also with our infants, and on neonates, when we do put IVs in the scalp you want to make sure that you’re cutting the hair or using a clipper. You don’t want to use a razor blade, because you can cause micro-abrasions. We also do shave that hair for the parents and give it back to them saying - it’s their baby’s first haircut.
Now, IV site preparation, you want to make sure that you cleanse that site before insertion. And you can use multitudes of different antiseptic solutions. Right now what is accepted is alcohol, chlorhexidine, and providone-iodine. You can use this as a single agent or a combination agent and a lot of times you want to follow that manufacturer’s indications and instructions for use when you’re using these products. Basically though, what you want to do is maintain a good scrub. One that’s at least 10 to 15 seconds and you definitely want to let that area dry.
IV site preparation, according to CDC a category 1A recommendation, is for 2% chlorhexidine based preparation preferred over iodine or alcohol. The FDA at this time does not approve chlorhexidine for the use in neonates younger than two months of age. Although there are some studies that are now coming out that are looking at that. You may see in the future a change in that.
IV site access and catheter placement. The first thing you want to do is, you want to look at the IV site that you’re trying to insert the IV.
If you’re finding that you’re not having good results one thing you may be able to do is warm that site, so that you’re able to cause a vasodilation of those veins. The other thing we do is a topical local anesthetic. There are many on the market and I don’t recommend one more than the other, but it does take a few minutes to work, up to about one half to an hour. There are some ones that are sprayed on; they’re much faster, but they’re very short acting.
You also want to use a tourniquet that’s appropriate for the child’s size. And like I said before you want to use the smallest gauge catheter possible for the prescribed therapy. The INS recommends the consideration of a visualization technology that aid in vein identification and selection. Vein viewers or transilluminators are near infrared devices to view the veins. But there have been adverse events that have been reported with this.
And here’s a case study that we touched on a little bit earlier. There’s a two month old patient within the NICU and received a second degree burn to the right forearm after an illuminator located the vein. The reporting facility convened a multi-disciplinary team with staff from risk management, engineering and the NICU and they did temperature testing where the light emitting diodes were at the end of the transilluminators. What it indicated is that over time that device became hot enough to cause a thermal burn, especially to a fragile infant’s skin.
At MedSun/FDA, they did a follow up with the manufacturer and it resulted in a recall of the device. The recall was due to excessive heating, due to an incorrect wire assembly process.
Now, how do we secure these catheters, especially in children? Children as a population love to play with catheters. In fact, one of the syndromes that I found was Twiddlers Syndrome and this is where children like to play with all kinds of venous access devices and because they like to play, these devices become dislodged or cause an infiltrate to the site. Most of this age group is one to five years old, but you’ve got to understand too that sometimes you have children that are developmentally not in the age group that they really are chronologically.
So you have to look at all age groups when you talk about this. The biggest thing is you want to make sure that the site is visible. You want to be able to assess it at all times. There are other things you can do to help protect it. You can use a tubular plastic netting that’s applied over the arm and that may help with dislodgement, but you want to make sure that you’re able to see the site.
Another way you can do it, is you can use – not as much sutures in pediatrics’ peripheral IVs- but tapes; surgical strips are used to secure that and stabilize the catheters. The INS recommends that a manufacturer catheter-specific stabilization device be used when feasible. And if you do use one of those devices, make sure you follow the manufacturer’s instructions for use.
You want to remove that catheter stabilization device at intervals to allow the visual inspection of the site and usually they allow them stay on the skin. t about seven days. Also, you can apply sterile tape or surgical strips to the catheter adapter, but don’t place them directly on the catheter skin site. Because, like I said, you want to make sure that the site is able to be visualized.
In this Case Study # 4 we have a two-year-old that was admitted to a local pediatric unit for dehydration secondary to diarrhea and an IV was started in her foot to deliver the fluids and then potassium was given after her urinary output was sufficient. Several hours after admission, the nurse noted that the IV site on the patient’s foot appeared to be discolored. When the dressing was removed a very large infiltration with marked circulatory compromise was seen.
Emergency measures were implemented and the patient was transferred to a Tertiary Care Center where she underwent a fasciotomy in an attempt to restore her circulation. After she had two additional surgical procedures and two weeks later, she was discharged home with extensive physical therapy and plastic surgery follow up.
You can see where if you do not have that site visualized, you could have a lot of problems.
When you assess your IV you want to make sure that you’re assessing the dressing and the entire administration set at the beginning of each shift and also according to your facility’s policy and procedures.
Once you assess, you want to make sure you’re looking and inspecting that whole entire site. If it’s an extremity, I like to look at both extremities to see if there’s any differences or any changes in those extremities. Also you want to check the security of the dressing and the integrity of that dressing. A lot of times kids will pick. A lot of times, too, if you start to notice that there’s a little bit of fluid that’s accumulating underneath that plastic dressing, you want to make sure – because that’s a good sign that there’s possibly an infiltration is starting before you even start to see swelling.
Also you want to follow your institution’s protocol of catheter site and care and use aseptic solutions according to the manufacturer’s directions.
Now, we’re talking about site dressings. The CDC recommends that you either use sterile gauze or sterile transparent semi-permeable dressing to cover the catheter site.
Now there’s advantages and disadvantages to both and there’s been a proper review to state there’s really been no difference between tape or gauze. The difference is if you’re using a transparent dressing, it’s much easier to see the site and it’s also a little bit better security. It also provides an artificial dermal layer which allows a decrease of the moisture and can be used for prolonged periods of time without damaging the skin. However, there is some damage though that can happen when – and especially when, you’re trying to take that dressing off.
Advantages of a gauze dressing – it does provide absorbency when the moisture is present, but it can be bulky and you need to change that dressing more frequently than you do the transparent dressing.
In the pediatric patient they may, when you’re trying to change these dressings, have some discomfort. They don’t like to have them taken off. So, we try to minimize the stimulation of a neonate, especially during their care. So you might do some individualized care, especially based on the gestational age and the medical history of that patient, as to how often you’re going to change that dressing.
We use age appropriate, again, explanations for that pediatric patient. We also can use different kinds of positioning and/or, I don’t want to say restraints, but restraint with someone holding the hand or the foot when you’re trying to take that IV out. Oral sucrose for neonates, also any kind of distraction for older type patients.
You want to definitely have good lighting in that procedure, especially if you’re starting it or taking the dressing off. We can use adhesive removers. A technique that I have found that works really well with transparent dressings isif you try to lift the edges from both sides and you just stretch it, it’ll pop up very easily and come right off the patient. Thank you.
Suzanne Rich: Thank you very much, Dana. Our last speaker today is Jacqueline Francis, a Medical Officer in the Plastic Surgery and Reconstruction Branch,
Jacqueline Francis: I’m going to start talking about some common complications with PICC catheters. Dana has already mentioned some of these, so I’ll quickly review. But they’re infection, infiltration, extravasation, hematomas, phlebitis, venous osmosis, occlusions, either vasospasms or otherwise dislodgement, air embolism and catheter fractures.
Potential complications can also include migration, perforation, arrhythmia, embolization at the catheter fragment.
In PICC catheter selection, we must remember that the central vascular access device has the distal tip in the lower one third of the superior vena cava to the junction of the superior vena cava and to the right atrium.
It may help also to make anatomical measurements and determine the length of the catheter needed to ensure appropriate catheter tip placement. If the catheter is modified to a patient specific length then document the inserted catheter length. When trimming the catheter also make sure that the stylet doesn’t extend beyond the trimmed end of the catheter and that helps to avoid vessel damage or separation of the stylet tip. Also, please be sure to check for the catheter’s instructions for use (or IFU) for recommended catheter size and for blood sampling.
When preparing the PICC catheter for insertion, also, it’s always important to make sure that maximal barrier precautions include sterile gowns, powder-free gloves, sterile gloves, of course, masks, protective eye wear; sterile drapes, towels, and these should all be used for the mid-line peripherally inserted catheter, and all other central catheter insertions. It’s important also to utilize bundles, your protocols, or your SOPs, whatever they may be for insertion, for addressing catheter changes and for catheter care.
When placing the PICC catheter it’s also important to check for adequate blood return of course, prior to infusing any fluids. Radiographic confirmation of the central catheter’s tip location needs to be obtained immediately after the device is inserted in the following clinical situations: if there’s any pain or discomfort after the catheter is in place, if there’s any inability to obtain a positive aspiration of blood or an inability to flush the catheter, if there’s any difficulty in removing the guidewire or if it bends upon removal, and certainly, if there’s any catheter migrations.
So, here’s an example of a PICC placement problem. A patient had a PICC catheter inserted at the bedside. There were no problems noted at the time of the insertion. The post-procedure chest x-ray and a following CT scan of the patient’s chest showed a foreign body in the right subclavian vein. Apparently, the guidewire was broken during the placement and was located in the soft tissue. It could not be removed, thus it was considered a retained device fragment.
PICC catheter assessment and care, as always, be sure to use aseptic technique, including sterile gloves and a mask to clean the catheter-skin junction with appropriate antiseptic solution and apply a stabilizing device as well as a sterile dressing.
Check the insertion site and extremity for erythema, edema, along the vein track. Document the length of the externally lying catheter. With a catheter that’s migrated externally, it should not be readvanced prior to restabilization regardless of the stabilization or the procurement method. Make sure to check all tubings and connections from the catheter to the infusion pump and verify correct pump alarm setting.
We have another case, Case Study # 6, during which we’ll discuss the PICC catheter assessment. A PICC catheter became clotted and couldn’t be used for fluid administration or to draw blood. The catheter was sluggish to flush and at one point, it was totally occluded. The catheter was discontinued for use and a peripheral IV catheter was inserted. And in another case, a PICC catheter was leaking at the proximal end of the catheter. A split at the catheter was noted at the seam point where the catheter leg connected to the proximal hub and that catheter was also removed.
These reports illustrate the importance of regular catheter assessments to identify device-related problems before a more serious patient related issue or complications develop. Reporting these events helps us, the FDA, and device manufacturers to assess problems and address them before they cause any problems. With any of these problems that you experience it’s very important to make sure you report them as well.
PICC catheter safety tips. The pounds per square inch or the PSI is determined by syringe diameter and the amount of force applied to the plunger. So never use anything smaller than a 10cc syringe for flushes and medication administration. The infusion pressure shouldn’t exceed 25 PSI. It’s important to avoid shifting or kinking of the catheter. Don’t flush against resistance or use excessive force. Partial or complete catheter obstructions may be caused by thrombosis, drug precipitates, or mechanical factors.
Remember that generally the larger the diameter of the barrel of the syringe the lower the PSI. So, for example, in the occluded catheter with five pounds of force applied to the plunger of a 3cc syringe will generate a PSI of 55. The same five pounds of force to a 10cc syringe will generate only 20 PSI.
When giving incompatible medications make sure to flush the catheter with at least 10cc’s of saline before and after each medication.
So in another case, which actually we’ll now talk about is catheter storage. A PICC was actually successfully placed in an infant through a femoral vein and less than 24 hours later, the catheter broke with a portion remaining inside the infant’s vascular system. After it was removed, a second PICC was placed. Within minutes, it also broke and it appeared to be broken for no apparent reason. The patient required an additional intervention to retrieve the second catheter segment. Both catheters were discovered to be hard and brittle.
So what we learned was the facility had actually stored the catheters, which came in a transparent wrap, in a carousel inventory system, but the clear front panel exposed the catheters to UV light. And the catheters were made of polyethylene, which is susceptible to degradation by UV light over time. Both of the catheters were close to their labels’ expiration dates as well.
So with regard to catheter storage safety tips, please make sure to follow the manufacturer’s recommendations for storage. Check the expiration dates prior to catheter use. Be familiar with the manufacturer device-specific instructions for catheter maintenance. Certain chemicals, solutions, or antibiotic ointments shouldn’t be used near catheters which are made of materials susceptible to damage. Definitely, visually inspect any catheter packaging, the catheters, and the accessories for any defects prior to placement.
For example, alcohol can actually degrade the polyurethane catheters over time with prolonged exposure. Try to avoid any prolonged or excessive contact when using alcohol or alcohol-containing antiseptics with polyurethane PICC’s.
Now, I’ll turn the program over to Angie and she’ll talk about our take home messages.
Angela James: Thank you, Jacqui. Our role in medical device patient safety, as healthcare providers, is that we all have a responsibility to recognize and report medical device problems by identifying actual and potential problems, near misses, and potential for harm events with medical devices.
When filing a MedWatch report or if you are a MedSun facility submitting a report to the FDA, provide details about what the device is; what the device did or did not do; and what follow-up or action that took place as a result of the reported event. Be sure to remove the device that failed, tag the device as appropriate, and if possible, have the Biomed staff perform an analysis at your hospital. In addition, make sure to save the packaging, which often lists the model, catalog, and lot numbers for the device, which helps, the manufacturer in their evaluation and root cause analysis.
When do I report? Often times, we’re faced with the dilemma of when should I report and what should I report. If there’s a reasonable doubt that the device may have caused or contributed to an adverse event involving a patient, healthcare provider, or visitor, then report.
Under the Safe Medical Device Act of 1976, all adverse events that involve a death or serious injury are required by law to be reported to the FDA. At least 80% of MedSun reports are voluntary reports, meaning that facilities have submitted device-related adverse events that they are not required to report. The added value of MedSun is that we receive these voluntary reports of near misses and close calls, which have led to recalls, changes to the manufacturing process of the device, and changes to the labeling for that device. With that being said, voluntary reports often times provide a signal to what may or may not be happening with that device and play a major part in preventing an actual adverse event from occurring.
What information is needed for a report? When a healthcare provider becomes aware of a need to submit a MedSun report, the following are some of the key points that should be included in that report. The type of device or devices involved in the event; the name of the manufacturer along with device identifiers, such as the serial number, the model, catalog number and lot number. This is why it’s important to save the packaging that the device is supplied in. What problem does the user encounter when using the device? Was an injury involved and what type of injury? Did the patient require additional treatment because of the event?
The final take home message is that reporting medical device problems is a model for patient safety in your hospital. Reporting potential and actual adverse events helps to prevent future medical device problems within your facility and protects patients, staff, family, and visitors by creating a climate of patient safety by identifying medical problems posing an actual or potential public health risk for the nation’s pediatric and neonatal patients and their care providers.
I will now turn the remaining part of the presentation back to Suzanne who will go over a few questions that we have received. Suzanne?
Suzanne Rich: We’re received a lot of great comments and questions. Really, I’m amazed by the level of feedback that we’ve received. Because there were so many responses and due to time constraints, we decided that we ‘all answer a question on peripheral IVs, one on PICCs, and one on FDA medical device information, incorporating several of the specific questions that we’ve received from the registration website.
Let’s start with a peripheral IV question. Dana?
Dana Etzel-Hardman: Okay the question that was given is, what is the length of time a peripheral IV can be left in a pediatric patient? Well, according to the CDC, scheduled replacement of catheters has been posed as a method to prevent phlebitis and also other catheter related infections. So, there’s been studies that have shown that peripheral IVs that are short term have an incidence of thrombosis, phlebitis, and bacterial colonizations if the catheter has been left in place for more than 72 to 96 hours.
However, CDC guidelines for children state that the catheter can stay in place in the child until a therapy is completed or a complication develops. The INS, (the Infusion Nurses Society) standard states that a peripheral short-term catheter in a neonate or pediatric patient shall be removed immediately upon suspicion of contamination or complication, or a discontinuation of therapy, but it is not based on a period of time.
Suzanne Rich: Thanks, Dana. Jacqui will take the question on PICCs. Jacqui?
Jacqueline Francis: We’ve received several questions on how to identify a power PICC and the maximum recommended flow rates and pressures. Although some catheters have a purple lumen that identifies them as power injectable, check your device instructions for use and read the markings on the actual lumen to make sure that the PICC is power injectable. Maximum flow rates for power injections or a maximum pressure for power injectors may vary actually according to the size and the brand of the catheter that’s being used.
A look at the labeling for a few brands of power injectable catheters indicates maximum flow rates of 4 to 7cc’s per second or the maximum pressure of a power injector of 300 to 325 PSI. Check the labeling printed on the power injectable lumen for the rates of the specific catheter that you may be using. Remember that a change in temperature or viscosity of the contrast medium may actually result in the change in your flow rates. Contrast media may need to be warmed to body temperature prior to the power injection to avoid catheter failure, such as rupture. Be familiar with your facility’s policy and procedure on contrast media injections.
Suzanne Rich: Thanks, Jacqui. Our last question relates to where FDA recall and device safety information can be found. Because FDA regulates the medical device industry, the FDA doesn’t recommend specific products and there were a few questions on that. We do post new product approvals, recalls, and patient safety information, including alerts and device safety tips articles, which can be found at the URLs listed on the slide – New Product Approvals and Clearances, Recalls and Safety Alerts, and Patient Safety Information can be accessed at Zhttp://www.fda.gov/MedicalDevices/default.htm and the MedSun monthly newsletter with device safety information can be found at http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm.
Additionally because FDA regulates the medical device industry, we don’t regulate clinical practice. So what we’ve provided for you in response to questions related to clinical practice, are the URLs listed on this slide. These are clinical practice organizations that can be used for resources – Infusion Nurses Society at http://www.ins1.org/i4a/pages/index.cfm?pageid=1, Association for Vascular Access at http://www.avainfo.org/website/article.asp?is=4, CDC at http://www.cdc.gov, and The Joint Commission at http://www.jointcommission.org/
On behalf of the FDA, I’d like to thank you for attending this Webcast. If you have any questions or comments about this program, please feel free to call or email us. And again, let me remind you that certificates of participation with nursing continuing education credit are now available. You may go to the registration Web site listed on your confirmation email, complete a short evaluation and print a copy of the electronic certificate. Medsun@s-3.com
Also, you may be interested in our next education program sponsored by MedSun’s HomeNet subnetwork entitled, Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home. That will also have one nursing CE and that will be airing on Wednesday, December 9, 2009 from 1 to 2 pm Eastern time. You will receive an email announcement with the registration detail and I really encourage you to feel free to share this announcement with health professionals who work in a home setting or who manage home health services.
Thanks again for attending this MedSun KidNet presentation. This will conclude our program today.
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Coordinator: Thank you for participating in today’s conference. At this time you may disconnect.