1. health and fitness
2. disease
3. incontinence

Peripheral IV and PICC Safety
in Pediatric and Neonatal Patients
Agenda

Welcome and Overview

Medical Device Adverse Event Reporting Through
MedSun and KidNet

The Influence of Human Factors

Peripheral IV and PICC Catheter Safety
Considerations in Pediatric and Neonatal Patients

Case Studies

The Importance of Reporting Medical Device
Adverse Events
MedSun
800-859-9821
medsun@s-3.com
Nursing Continuing
Education
One contact hour of nursing continuing education
credit is available
Speakers
Suzanne Rich, RN, MA, CT (moderator)
Senior Project Manager, KidNet
Office of Surveillance and Biometrics (OSB)
Division of Patient Safety Partnerships (PSP)
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration (FDA)
Angela James, RN, RRT, BS
Nurse Consultant
OSB, PSP
CDRH, FDA
Speakers (continued)
Dana Etzel-Hardman, RN, MSN, MBA, CPN
Training and Education Specialist
Children’s Hospital of Pittsburgh
University of Pittsburgh Medical Center
Jacqueline Francis, MD, MPH
Medical Officer
Plastic Surgery and Reconstruction Branch
Office of Device Evaluation (ODE)
CDRH, FDA
MedSun
800-859-9821
medsun@s-3.com
Speaker
Angela James, RN, RRT, BS
Nurse Consultant
OSB, PSP
CDRH, FDA
Organization of FDA
FDA is comprised of several Centers

Three Centers deal with medical products:

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Center for Devices and Radiological Health (CDRH)

MedSun

KidNet
Center for Devices and
Radiological Health
Center for Devices and Radiological Health (CDRH)
CDRH promotes and protects the health of the public by
ensuring the safety and effectiveness of medical devices
and the safety of radiological products.
MedSun

An adverse event reporting program

Over 350 health facilities participate

The primary goal of MedSun is to work
collaboratively with the clinical community to
identify, understand, and solve problems with the
use of medical devices.
KidNet

Focuses on identifying, understanding, and solving
problems with medical devices used in neonatal and
pediatric intensive care units (NICUs and PICUs)

Launched in June 2007

40 participating MedSun hospitals
“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.”
Lucian L. Leape, M.D.
A leading patient safety expert
from Harvard University
Reported Adverse Events

IV products (e.g. infusion pumps, pump tubing,
PICCs and peripheral IV catheters) are the most
frequently reported devices in MedSun reports
involving pediatric/neonatal patients

The top reported problems with both PICCs and
peripheral IV catheters are associated with

removal or replacement

leaks

breaks; cracks
Examples of MedSun
IV Device Adverse Events

Packaging, product defects, product not performing as
intended




contaminants in the catheter packaging
burr noted on needle prior to insertion
guidewire became unraveled during insertion
Problems that occurred during clinical use



otoscope and transilluminator looked the same but had
different light intensities; otoscope mistakenly used to
illuminate vein for IV catheterization resulting in a patient
burn
inability to flush a PICC due to obstructed lumen resulted
in embolization of a catheter fragment.
PICC Luer hub cracked and leaked
15
“Swiss Cheese” Model of System
Failure that Can Lead to Injury
Device Maintenance
Device Problem Reporting
Culture of Low Expectations
FAILURE 1
PICC Luer
hubs cracking
during clinical
use. First leak
occurs.
Departmental Communication
FAILURE 2
New PICC
catheter
inserted. Luer
hub cracking
problem not
reported.
FAILURE 3
Luer hub
cracking
problems
continue
to go
unreported.
FAILURE 4
Others not alerted
to PICC Luer hub
cracking problems
Another PICC Luer
hub crack occurs
resulting in break and
air embolism.
16
Case Study #1
Reported Luer Hub Cracks

Several reports were received from a single MedSun
KidNet site that described events of Luer hub
cracking, leaking, and breaking.

The problem was originally attributed to users over
tightening the Luer hub connections.

FDA follow up with both the KidNet reporting site and
the manufacturer prompted the manufacturer to visit
the site to better understand the reported events as
they occurred during clinical use.

The manufacturer subsequently made materials and
design changes to address the reported events.
17
Human Factors Issues that Contribute
to Medical Device Adverse Events
Human Factors – the science of how humans interact with
technology; focuses on the device-user interface, incorporates
the following:
Device Design Considerations

Device-user interface, including labeling and instructions for use
– auditory, visual, tactile
Situations/Environment in which the Device is Used

Light/noise intensity, time pressures, distractions, high stress
User Characteristics

Skills, training, expectations, familiarity with devices

Policies and procedures for device use, cleaning, maintenance
18
Speaker
Dana Etzel-Hardman, RN, MSN, MBA, CPN
Training and Education Specialist
Children’s Hospital of Pittsburgh
University of Pittsburgh Medical Center
19
Major Complications with
Peripheral Catheters

Infiltration

Extravasation

Nerve injuries

Hematomas

Infection

Phlebitis

Cellulitis

Occlusion

Catheter Fracture

Venous Spasm
20
IV Insertion Challenges


IV insertion challenges with pediatric patients:

Children’s anatomy – small, fragile, difficult to locate veins

Patient pain, fear, anxiety

Practitioner skill in IV insertion
Some facilities have an IV team comprised of staff
certified in IV insertion that assists bedside nurses (team
members receive specialized training in accessing sites
not used in adults, i.e., scalp or foot).
21
IV Insertion Tips

Use age appropriate explanations

Perform insertion outside patient’s room

Allow child to keep comfort item (i.e. blanket)

Encourage parent to be present

Use age appropriate distraction techniques
22
Infant (birth-1 year)

Educate the parent or caregiver on what to expect
about reason for IV insertion and site appearance.

Use comfort measures such as a pacifier if
appropriate and try not to insert IV immediately after
feeding to avoid aspiration.

Utilize age appropriate distractions including games,
songs, nursery rhymes.

If a pedal IV site is chosen, get assistance to hold
the infant’s foot in position.
23
Toddler (1-3 years)

Provide simple, concrete explanations immediately
before the procedure.

Offer transitional objects such as stuffed toys for
comfort.

Distract with songs, games, or counting.

Reward cooperative behavior with stickers or small
toys.

May require more than one person to help with
positioning.
24
Preschool (3-4 years)

Prepare child just before procedure.

Encourage patient handling of, or medical play with
some of the device equipment that may be used,
e.g., placing an IV into a stuffed animal.

Reward good behavior.

Distract with concrete games, songs.
25
School Age (5-12 years)

Explain procedures in simple terms.

Encourage the child to help set up equipment or do
small related tasks.

Respect the child’s choice of whether or not to have
parents present.

Let the child know it’s o.k. if he or she is
apprehensive or afraid.
26
Adolescents (13-20 years)

Maintain privacy and assure confidentiality,
recognizing adolescents may prefer that parents not
be present.

Explain procedure in adult language.

Allow adolescents to participate in care decisions.

Be aware of adolescents’ concern for body image in
choice of vascular access device and care.
27
Parent Care

Offer parents the option to attend the procedure

Explain what to expect to parents

Describe roles available for parents to play

Reassure patient

Observe

Wait outside the room

Assist with comfort measures
28
Peripheral Short-Term
Catheter Selection
From the Infusion Nurses Society (INS) 2006
Practice Guidelines:

Choose the catheter size and type based on therapy

A peripheral short-term catheter should be defined
as one that is less than or equal to 3 inches (7.5 cm)
in length

Peripheral short-term catheters and steel-winged
infusion sets should be equipped with a safety
device with engineered sharps injury protection.
29
Catheter Placement
Precautions

Inspect the catheter for product condition prior to
insertion.

Care should be used when stylets, needles, and
wires are used to facilitate catheter placement.
Don’t reinsert stylets as there is a potential for
severing or puncturing the catheter.

A needle or guidewire should never be withdrawn
through a catheter.
30
Case Study #2
Device Problems Noted Before
Patient Use

CDRH works with manufacturers to address reported
problems and improve the product:

When the package of an IV needle was opened, the
plastic catheter fell off the needle hub. The needle was
noted to be bent and retracted.

Before use on patient, it was noticed that the catheter had
been speared by the needle below the catheter tip.
31
IV Site Selection

Site selection choice based on type and duration of
IV therapy and patient development level


INS guidelines (2006) for peripheral IV insertion
indicates selecting veins in the dorsal and ventral
surfaces of the upper extremities, including the
metacarpal, cephalic, and basilic.


Consider the patient's condition, age and diagnosis, vascular
condition, history of previous access devices.
For neonatal and pediatric patients, additional sites may include
veins of the head and lower extremities.
The vasculature should be able to accommodate the
catheter size and length required for the prescribed
therapy.
32
IV Site Preparation

Clean site thoroughly prior to application of antiseptic
solutions.

Follow manufacturer indications and instructions for use
when applying antiseptic agents

Antiseptic solutions that should be used include:

alcohol

chlorhexidine gluconate (CHG)

povidone-iodine
***Use as single agents or in combination, used individually, or in
series. Formulations containing a combination of alcohol (ethyl
or isopropyl) and either CHG or povidone-iodine are preferred.
33
IV Site Preparation

CDC - category IA recommendation for 2%
chlorhexidine-based preparation preferred over
iodine or alcohol; FDA has not approved CHG
for use in neonates younger than 2 months.
34
IV Site Access and
Catheter Placement

Warm the site

Topical local anesthetic

Tourniquet appropriate for child’s size

Small gauge catheter

INS recommends consideration of visualization
technologies that aid in vein identification and
selection.

Vein viewer/transilluminator – a near infrared device to
view veins

Adverse events have been reported when using devices
not approved for vein illumination
35
Case Study #3
Neonatal Transilluminator

A two-month-old patient in the NICU received a second
degree burn to the right forearm after a transilluminator
was used to locate a vein for intravascular access.

The reporting facility convened an interdisciplinary team
with staff from risk management, engineering, and the
NICU. Temperature testing where the light emitting
diodes (LEDs) at the end of the transilluminator make
contact with the patient’s skin, indicated that the device,
over time, can become hot enough to cause thermal
burns to fragile infant skin.

MedSun/FDA follow up with the manufacturer resulted in
a recall. The recall was for excessive heating due to
incorrect wire assembly process.
36
Securing Catheters

The pediatric patient population is likely to touch and
manipulate catheters

Secure the catheter to prevent occlusion, stress, kinking
or migration.

The highest rates of dislodgement were reported in patients 1 to
5 years old.

Twiddler’s Syndrome – when kids play with the venous access
device causing catheter to dislodge and/or infiltrate the site.

Make sure that site is visible.

Tubular elastic netting applied over a child’s arm may help
prevent dislodgement.
37
Securing Catheters

Although sutures, tape, and surgical strips are used to
secure or stabilize catheters, the INS recommends use
of a manufactured catheter-specific stabilization device
when feasible. Follow the manufacturer's instructions for
use.

Remove the catheter stabilization device at established
intervals to allow visual inspection of the access site and
monitoring of skin integrity.

Apply sterile tape or surgical strips only to the catheter
adapter and don’t place directly on the catheter-skin
junction site.
38
Case Study # 4
Securing Peripheral IVs

A two-year-old was admitted to a local pediatric unit for
dehydration secondary to diarrhea. An IV was started in her foot,
to deliver fluid; potassium chloride was added to the IV solution
once her urinary output was sufficient.

Several hours after admission, a nurse noticed the IV site on the
patient’s foot appeared to be discolored. When the large 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.

She had two additional surgical procedures, and two weeks later
she was discharged home with extensive physical therapy and
39
plastic surgery follow up.
IV Site Care and
Assessment

Assess IV site dressing and the entire IV administration set at
the beginning of each shift and according to your facility’s
policy/procedures.

Assessment should include:

visualizing and inspecting the site,

checking the security and integrity of the dressing

Follow your institution’s protocols for catheter site care.

Use antiseptic solutions according to manufacturer directions.
40
Site Dressings

The CDC recommends the use of either sterile gauze or a
sterile transparent semi-permeable membrane (TSM)
dressing to cover the catheter site.

Advantages and Disadvantages of TSM dressings


Enhances visualization for ongoing assessment and security of the
catheter.

Provides an artificial dermal layer, allows decreased moisture, and
can be used for prolonged periods of time without damaging skin.
However, there is a potential for damage to the stratum corneum and
possible discomfort upon removal.
Advantages and Disadvantages of Gauze Dressings

Provides absorbency when there is moisture present (i.e., oozing at
the insertion site) however they can be bulky and may require more
41
frequent dressing changes due to moisture retention.
Peripheral IV and PICC
Dressing Changes

Pediatric and neonatal patients may experience
some discomfort during removal of dressings.

Minimize stimulation to the neonate using individualized
approach according to gestational age and medical
history

Use age appropriate explanations for pediatric patients

Containment strategy- positioning and/or restraints

Oral sucrose for neonates, distraction for older patients

Focused lighting on the procedure area – subtle lighting
overhead

Adhesive remover

Dressing stretching techniques prior to removal
42
Speaker
Jacqueline Francis, MD, MPH
Medical Officer
Plastic Surgery and Reconstruction Branch
Office of Device Evaluation (ODE)
CDRH, FDA
43
Common Complications
with PICC Catheters

Infection

Infiltration/Extravasation

Hematomas, Phlebitis, Venous Thrombosis

Occlusion, Dislodgement, Air Embolism

Catheter Fractures

Potential complications include migration, perforation,
arrhythmia, and embolization of catheter fragments.
44
PICC Catheter Selection

Central vascular access devices have the distal tip
dwelling in the lower one third of the superior vena cava
to the junction of the superior vena cava and the right
atrium.

Make anatomical measurements to determine the length
of the catheter needed and ensure appropriate catheter
tip placement.

If catheter is modified to a patient-specific length,
document the inserted catheter length.
45
Preparation for PICC
Insertion

Maximal barrier precautions, including sterile
gown, powder-free sterile gloves, cap, mask,
protective eyewear, and large sterile drapes and
towels should be used for midline and
peripherally inserted central catheters, and all
other central catheter insertions.
46
PICC Catheter Placement

Check for adequate blood return prior to infusion of
fluids.

Radiographic confirmation of the central catheter's
tip location needs to be obtained immediately after
device insertion and in the following clinical
situations:

pain or discomfort after catheter placement;

inability to obtain positive aspiration of blood; inability to
flush the catheter easily;

difficulty removing guidewire or it is bent upon removal;

after catheter migration is noted.
47
Case Study #5
PICC Placement Problem

A patient had a PICC line inserted at the bedside.
There were no problems noted at the time of
insertion.

A post-procedure chest X-ray and follow up CT scan
of the patient's chest showed a foreign body in the
right subclavian vein.

Later, it was determined to be a guidewire broken
during placement and located in soft tissue. It could
not be removed; thus it is considered a retained
device fragment.
48
PICC Catheter Site
Assessment and Care

Use aseptic technique, including sterile gloves and a mask to
clean the catheter-skin junction with an appropriate antiseptic
solution, apply a stabilization device and apply a sterile
dressing.

Check insertion site and extremity for erythema or edema
along the vein track.

Document the length of externally lying catheter.

A catheter that has migrated externally should not be readvanced prior to restabilization, regardless of stabilization or
securement method.

Check all tubing connections from the catheter to the infusion
pump and verify correct pump alarm settings.
49
Case Study #6
PICC Catheter Assessment

Reports of device related complications noted
during PICC catheter assessments

A PICC catheter became clotted and was unable to be used
for fluid administration or to draw blood. The catheter was
sluggish to flush and one port was totally occluded. The
catheter was discontinued for use and a peripheral
intravenous catheter was inserted.

A PICC line catheter was leaking at the proximal end of the
catheter. A split in the catheter was noticed at a seam point
where the catheter leg connected to the proximal hub. The
catheter was removed.
50
PICC Catheter Safety Tips

Pounds per square inch (psi) is determined by syringe
diameter and the amount of force applied to the plunger.

Never use <10 cc syringes for flushes and medication
administration

Avoid twisting or kinking the catheter

Do not flush against resistance or use excessive force

Partial or complete catheter occlusions may be caused by
thrombosis, drug precipitates or mechanical factors
51
Case Study #7
Catheter Storage

A PICC was successfully placed in an infant through
the femoral vein. 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 inserted. Within minutes, it also
broke 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.
52
Case Study #7
Catheter Storage
What we learned:

The facility stored the catheters, which come in
transparent wrap, in a carousel inventory control
system with a clear front panel that exposed
them to ultraviolet (UV) light. The catheters were
made of polyethylene, which is susceptible to
degradation by UV light over time. Both
catheters were close to their labels’ expiration
dates.
53
Catheter Storage Safety Tips

Follow manufacturer recommendations for storage

Visually inspect catheter packaging and
catheter/accessories for defects prior to placement

Check expiration dates prior to catheter use

Be familiar with manufacturer device-specific instructions
for catheter maintenance

Certain chemicals, solutions, or antibiotic ointments should not
be used near catheters made of materials susceptible to damage
54
Your Role in Medical Device
Patient Safety
Recognize, report, and
understand medical
device problems

Identify actual and potential
problems, near misses, and potential
for harm events with medical devices

Report the problem or adverse event
to your supervisor, according to
policy and procedure

Make sure your report includes
details

Remove the device and save the
packaging
55
When Do I Report?
When you think a device has, or may have,
caused or contributed to any of the
following outcomes for a patient, staff
member, or visitor:

Death

Serious injury

Minor injury

Close-calls or other potential for harm
56
What Information Is Needed
for a Report?

If there was an injury, what happened to the person(s)
affected?


What were the problems with the device(s)?


air embolism, respiratory arrest
catheter leaking at hub
What, if any, were the follow up medical procedures
required because of the event?


Surgery to remove retained catheter fragment
Include the original procedure for which the device was used

What is the name of the device manufacturer?

What are the manufacturer device identification numbers?

serial, model, lot, catalog, and any other specific information
57
Take Home Message
Why Reporting Medical Device Problems Is
A Model for Patient Safety In Your Hospital:

Helps to prevent future medical device problems within
your facility and protects patients, staff, families, and
visitors by creating a climate of patient safety and also,

Identifies actual or potential public health risks for the
nation’s pediatric patients and their care providers
because medical device adverse event information alerts
FDA, manufacturers, and the clinical community to safety
issues.
58
Questions and Answers

What is the length of time a peripheral IV can be left
in a pediatric patient?
59
Questions and Answers

How do I know if a PICC can be used with a power
injector?
60
Questions and Answers

Where can I find information about FDA recalls
relating to IVs and PICCs?

New product approvals and clearances, recalls and
safety alerts, and patient safety information
http://www.fda.gov/MedicalDevices/default.htm

MedSun monthly newsletter
http://www.fda.gov/MedicalDevices/Safety/MedSun
MedicalProductSafetyNetwork/default.htm
61
Question and Answers
Clinical Practice Related Questions

Infusion Nurses Society
http://www.ins1.org/i4a/pages/index.cfm?pageid=1



Association for Vascular Access
http://www.avainfo.org/website/article.asp?id=4
CDC
http://www.cdc.gov/
The Joint Commission
http://www.jointcommission.org/
62
MedSun
800-859-9821
medsun@s-3.com
63
References

Etzel-Hardman, Dana. (Nov. 2008) Teaching IV Therapy to Pediatric
Nurses. RN. pp 24-28

INS Standards of Practice. (January/February 2006). Journal of Infusion
Nursing. 29(1) Supplement, pp S1 – S62.

MAUDE (Manufacturer and User Facility Device Experience database):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

Rich, Suzanne. (April 2009). KidNet: Get Set for Patient Safety. MedSun
Newsletter # 35. Accessed 8-21-09. Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.
cfm?news=35.

Rosenthal, Kelli. (December 2005). Tips for Venipuncture in Children.
Nursing. p 31.
64
References

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.

Sullivan, Roberta. (Apr 2006). Light can Wreak Havoc on CVCs. MedSun
Newsletter #3. Accessed 8-21-09. Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newslet
ter.cfm?news=3#1

Sullivan, Roberta. (Feb 2006). Preventing PICC Fractures. MedSun
Newsletter #1. Accessed 8-21-09. Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/printer.c
fm?id=644
65