Needleless Connectors

Design Matters

Nadine Nakazawa, RN, BS,

OCN, VA-BC
Learning objectives

1. Review history of “needleless” access

devices
2. Discuss important sources of contamination
3. Clarify confusing terms
4. Understand connector design features and
their relevance to clinical practice
5. Discuss guideline limitations to practice
recommendations
6. Identify key considerations for aligning
products with practice protocol strategies
2
This Program is supported by CareFusion
Disclosures

4
The Problem:
Needle sticks
 The needle

• Fluid filled
• Solid sealed access surface
• Clear housing

6
Eliminating needle-sticks

7
How we eliminated the needle

• The purpose of these devices was to eliminate the

needle
• First needleless connector was the needle optional,
split-septum Interlink – long on the market, many
studies
• Key design features were not included in subsequent
needle free connector designs

8
Replacing Needle with External Cannula

Pro’s Con’s
• Reduces needle-sticks • Additional devices
• No longer needed to tape needed (cannula, etc)
needles in place • Reflux because the
• Solid Laser pre-split cannula is larger than the
surface needle
• Fluid filled
• Clear

9
Then came luer access

• Great for eliminating needle-

sticks but created other
problems:
» Complex design
• Not fluid filled like needle access
cannula: air space within housing
where bacteria can grow
• Opaque housing hides inadequate
flushing and visual confirmation of
flushing
• Since 1992 this piercing pin design
style with empty space within
connector has seen little change
10
What Created the Confusion?

• The original studies discussed design features of

needleless connectors which made disinfection
ineffective.
• Reflux/displacement was not mentioned as a factor.
• The interaction of product, practice and protocol causes
confusion about clinical relevance of needleless
connector design features
• With the marked differences in design, is there a more
clinically relevant method of evaluating connectors?
11
Nationwide Statistics of Interest
1990 1999 2006 2011

12
Contribution of design to contamination

13
Did early needleless connector
design create a bigger problem?

Relevant categories of
needleless connectors
How do contaminants enter the line?

Connector related Contaminated

catheter hub
contamination:
•Contamination of
male luer on tubing
set
•Frequency of Skin organisms

cap/tubing change Skin

•Needleless Vein
connector design

Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central
venous catheters. Int Care Med. 2004;30:62-67.1 15
 Needle and split septum similarities

Needle Split Septum

• Completely fluid filled • Completely fluid filled
• Visible fluid path • Visible fluid path
• Solid silicone access • Solid silicone access
surface surface
• Small needle size does • Difference: Size of
not create reflux cannula creates reflux

16
Progression to luer activation

• Early luer activated designs eliminated

fluid filled design and visible fluid path
• More attention given to solving reflux
» Can be corrected by clamping and heparin
locking
» Movement of fluid does not create
contamination or contaminate the line or
connector

17
Luer maintenance during intermittent
therapy

2011 INS Standards of Practice2

A new, sterile, compatible covering

device should be aseptically attached to
the end of the administration set after
each intermittent use. S55

2009 APIC Guide3

Sterile end caps to protect the male luer

end of the tubing between uses if using
a luer accessed technology.

18
Choosing which needleless connector
is right for your patients and nurses
Current needleless connector issues

• Confusing terms
• Key opinion leader interpretations of
terms, studies and related topics
• Visual perceptions without accounting
for clinical relevance
• Lack of clinical prioritization of design
features

20
Clarifying confusing terms

• Split septum
• Priming volume
• Dead space
• Interstitial space
• Displacement (positive/negative/neutral)

21
What is split septum?

The first type of

needleless system
consisted of a split
septum connector which
is accessed with an
external blunt cannula
instead of a needle.

This type of connector

could also be accessed
with a needle.

Reference: CDC/HICPAC 22
What is priming volume?

Priming volume is
the amount of fluid
required to fill the
fluid path to
eliminate all air.

23
 What is dead space?

Dead space is space within

the fluid path that is difficult
to flush.

Dead space is created by

moving parts blocking flush
access to space or sharp
corners within the fluid
path.

Medication can remain

trapped in dead space
making accurate dosage
delivery difficult. 24
What is interstitial space?

Interstitial space is air filled space

that is inside the connector
housing but outside the fluid path.

Fluid and bacteria can collect in

interstitial space and serve as
media for bacterial growth.

Connectors of this design type

have two areas of interstitial
space; between the housing and
flexible “cover” and between the
cover and post.
25
 Complex designs are more mechanical

Non-fluid filled designs have

empty, air filled (interstitial) space
within the housing.
Bacteria can enter these spaces
and cannot be flushed or
disinfected.
Bacteria trapped may then be
transferred to the male luer and
subsequently to the fluid path with Male Luer

repeated access. Interstitial

Space

26
Dramatization of bacterial risk of air space

27
 What is displacement/reflux?
Displacement is fluid movement in the catheter upon
disconnection of the syringe. It’s just plain physics!
• Negative displacement causes reflux at disconnect
» Positive pressure flushing and clamping is required for negative
displacement connectors and those “neutral” connectors that cause
“minimal reflux” at disconnect
• Positive displacement prevents reflux at disconnect
» No special practice is required
• Neutral displacement
» Is the connector truly “neutral”? Most likely slightly negative!
» How does that affect occlusions if you don’t clamp before
disconnection?
» Truly neutral connectors contain a valve, an even more complex
design, causing the requirement for added pressure to open the valve 28
What does displacement do?

• Displacement of fluid does not

contaminate the line
• Displacement is only relevant to blood
reflux into the catheter thus only relevant
to practice

29
Design Matters: Back to Basics
The Surface

31
Solid surface

Split-septum external Solid surface luer

cannula activation access
(access surface basically
solid silicone)
Interlink® MaxPlus clear®,
MaxPlus®, MaxGuard®

32
 Non-solid surface

Non-solid surface luer access

Clave®, MicroClave®, Neutron®, MicroClave clear, OneLink®,
ClearLink®, V-Link®, Invision Plus®, Nexus®, CareSite®,
NP Medical®, Covidien®, UltraSite®, Q-Syte®…

33
 What is a “non-solid” access surface?
Interstitial space may cause cross
contamination to the male luer.
Repeated access with same male
Gaps luer may lead to fluid path
around contamination
access
surface may Interstitial
harbor space may Fluid must flow
bacteria allow through small
and allow contaminants Slits and holes in access hole(s) on
bacteria to to fall between surfaces may open wider with piercing
enter housing and repeated accesses pin/column – may
housing access surface cause hemolysis

Internal
corrugations may
harbor bacteria 34
“Non-solid” surface

• Slits, gaps or holes in access surface to allow flexible

sleeve to compress around center pin/column to
expose holes for fluid flow. These openings can
weaken with multiple accesses.

35
Summary of access surfaces

Split-septum Solid surface for Non-solid surface for

surface for needle luer access luer access
or cannula access
Interlink MaxPlus clear, Clave, MicroClave,
MaxPlus, Invision , Nexus,
MaxGuard OneLink, UltraSite,
SmartSite, CareSite…

36
Internal Structure
 Internal structure: fluid filled

Fluid filled, solid surface Fluid filled, non-solid surface

Needle or Luer access: solid Luer access: non-solid surface
cannula surface
access: split
septum

Cannula enters Luer enters Luer enters

fluid filled space fluid filled space fluid filled space

Interlink MaxPlus, MaxPlus Q-Syte, CareSite, UltraSite

clear, MaxGuard

38
Internal structure: non-fluid filled

Non-fluid filled
Luer access: non-solid surface

Luer depresses silicon sleeve and accesses a pin or column inside

a dry space
Clave, MicroClave, Neutron, OneLink, Nexus/Smith’s, Invision-
Plus, ClearLink, SmartSite, NP Medical, Covidien…

39
What does “non-fluid filled” look like?

• Center pin, post or column

• Flexible sleeve which is compressed
upon luer insertion.
• Access surface is created by flexible Mechanical interactive
sleeve which must have a slit, hole or pieces sit inside a housing
gap to allow sleeve to be compressed
around center pin

40
 Complexity of non-fluid filled

• Non-fluid filled designs have

dry (interstitial) space within
the housing.
• Bacteria can enter these
spaces and cannot be
flushed or disinfected.
• Bacteria trapped may then
be transferred to the male Male Luer
luer and subsequently to Dry Space

the fluid path with repeated

access. 41
 Evaluate and use Needleless connectors
based on DESIGN
Fluid filled Non-fluid filled
Needle/ Luer access Luer Luer access non-solid surface
cannula solid surface access
access split non-solid
septum surface
Cannula Luer enters Luer enters Luer depresses silicon sleeve to
enters fluid fluid filled fluid filled access pin or column inside
filled space space space empty air-filled space
Interlink MaxPlus, Q-Syte, Clave, MicroClave, Neutron,
MaxPlus CareSite, OneLink, Nexus, Invision-Plus,
clear, UltraSite ClearLink…
MaxGuard

42
How do thought leaders and clinical
organizations support “design matters”?
Guidelines:
A look in the rearview mirror

Research time ends well before guidelines are

finalized
• 2008 SHEA Recommendations: evidence to 20078
• 2009 APIC Guidelines based on SHEA 2007 evidence3
• 2010 FDA 522 Request for Post-market Surveillance
based on SHEA evidence dated 2007 and older9
• 2011 CDC needleless connector guidelines included
SHEA 2007 evidence with one cited publication from
20087
44
Original connector studies

Field: “difficulty in sterilizing the

Common Theme? gap between the valve and the
hub”4

Maragakis: “intricate access

surfaces that are more difficult
to disinfect”5
Device deficits
are related to: Salgado: “mechanical valve
1.Access Surface could be more difficult to
2.Internal Design disinfect because of the
complicated nature of the multi-
not displacement part device”6
45
Guidelines and Standards of Practice

• CDC • INS
» Change no more » Disinfection-scrub with
frequently than 72 time and friction
hours » Time not determined
» Frequency not » Refer to device
determined manufacturers’
» Refer to device recommendations for
manufacturers’ use
recommendations for
use

46
What do the guidelines really tell us?

• No “one size fits all”

• Knowing attributes and limitations of the
devices is critical in making decisions for
protocols and care practices
• Reviewing manufacturer’s testing, indications
and instructions for use is critical

© 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. 47

CDC Guidelines define true “split septum”

“The first type of needleless system connectors

consisted of a split septum connector, which is
accessed with a blunt cannula instead of a
needle (external cannulae activated split
septum)”7

48
CDC 2011- Where we are today

6. When needleless systems

are used, a split septum
valve may be preferred
over some mechanical
valves …
[197–200]. Category II7

Does everyone agree on the definition of split-septum?

© 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. 49
What testing requirements were in place
when the connector came to market?

50
FDA 2005

• Microbial risk was recognized

» “The testing should demonstrate that
disinfection procedures you use are
effective for removing microorganisms from
the device.”10

FDA 2005 Microbial Ingress Testing Guidelines 51

FDA 2008

The 2008 FDA Guideline revision removed some

of the more stringent test parameters.
Changed to:
“the testing should demonstrate that disinfection
procedures you use are effective.”11

…“for removing microorganisms from the

device”10
was eliminated.
52
Testing for effective removal of bacteria

Connectors FDA
510(k) cleared for
market:

• before 2005
• and after 2008

may not have been

tested the same way

53
 Simple design-back to basics

Solid, sealed access surface

• Can be effectively disinfected
• No slits, crevices or gaps that can trap or
allow contaminants to enter the connector

Fluid filled
• The entire interior of a fluid filled connector
is active space.
• There is no empty space within the
connector housing, outside of the fluid
pathway, where contaminants can enter and
not be flushed or disinfected. 54
Remember

In this era of “Do more with Less”,

needleless connector technology should
support protocols that reduce financial
burden and most importantly improve
patient care.

55
 Additional Material

Design-based Product Usage

Clinical Relevance and Connector Design:
Effect of Surface and Structure

Standards of practice, products

and protocols
Protocols and practice vary significantly from
one luer activated design to another

• Solid surface - fluid filled/no “air” space

• Non-solid surface - fluid filled/no air
space
• Non-solid surface – interstitial space
empty with “air” space

58
How do they compare to split septum?

Why externally activated is significant:

• Laser pre-cut split creates SOLID
surface
• Fluid filled
• Clear housing

59
Major difference in contamination risk

60
Solid surface, fluid filled

Fluid filled designs offer a

sterile luer environment.
The entire interior of a fluid
filled connector design is
active space.
There is no space within the
connector housing that is
outside of the fluid pathway.

61
Major similarity

62
Visible fluid path

A visible fluid path is only beneficial

when the visibility:
• Provides for productive flushing of the
line
• Encourages closed line
practice/protocol
• Confirms that the catheter is clear
» If the connector clears before the catheter
is clear, is that a benefit?
• Reinforces best practices 63
 How design affects line maintenance

• What is relevant to clinical protocol?

• What features support maintaining a
closed line for the longest period?
1. Ease of disinfection process
2. Fluid filled design
3. Visible fluid path
4. Supports clinically relevant practices

64
 Disinfection process varies with design

• Solid surface is quickly, easily and effectively disinfected

• Solid surface eliminates places bacteria can be missed
by the disinfection process
• No crevices, gaps or open areas that allow bacteria to
enter the connector and cannot be disinfection.
• The surface determines disinfection methods: time,
pressure, friction…

65
Alcohol pad versus “capping” the NC

66
Supports clinically-relevant practice

• No clamping sequence should be required

» Connector should prevent reflux at disconnection
• Surface should be solid and sealed
» To prevents entry of bacteria and allow effective
removal of bacteria before each access
• Connector should be fluid filled
» To eliminate dry space within the housing that can
harbor bacteria
• Connector should have a visible fluid path
» To promote productive flushing of the catheter, not
just the connector
67
Degree of bacterial risk affects protocols,
practice and cost per use

• Change out interval time?

» The longer the better to keep the line closed

• Specific disinfection time?

» The shorter the better, easier practice

• Is access surface sealed when not in use?

» If not, additional measures and expense are
required to maintain a closed system

68
Remember

In this era of “Do more with Less”,

needleless connector technology
should support protocols that
reduce financial burden and most
importantly improve patient care

Thank you 69
 References
1. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with non-cuffed short-term
central venous catheters. Int Care Med. 2004;30:62-67.1
2. Infusion Nurses Society. Infusion nursing standards of practice. J Infus Nurs 2011;34(1S):S1–S110.
3. APIC Guide 2009; Guide to the Elimination of Catheter-Related Bloodstream Infections
4. Field K, McFarlane C, Cheng AC, et al. Incidence of Catheter-Related Bloodstream Infection Among Patients with
a Needleless, Mechanical Valve–Based Intravenous Connector in an Australian Hematology-Oncology Unit.
Infection Control and Hospital Epidemiology 2007; 28:610-613.
5. Maragakis LL, Bradley KL, Song X, et al. Increased catheter related bloodstream infection rates after the
introduction a new mechanical valve intravenous access port. Infect Control Hosp Epidemiology 2006;27:67–70.
6. Salgado CD, Chinnes L, Paczesny TH, Cantey JR. Increased Rate of Catheter-Related Bloodstream Infection
Associated with Use of a Needleless Mechanical Valve Device at a Long-Term Acute Care Hospital. Infection
Control and Hospital Epidemiology 2007; 28:684-688.
7. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related
infections. Clin Infect Dis 2011;52:1087–1099.
8. Marschall J., MD; Mermel, L.A., DO, ScM et al; Strategies to Prevent Central Line–Associated Bloodstream
Infections in Acute Care Hospitals Infect Control Hosp Epidemiology 2008; 29:S22–S30
9. United States Food and Drug Administration. Letter to infection control practitioners regarding positive
displacement needleless connectors .http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices
/ucm220459.htm#a. Accessed December 15, 2011.
10. Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions
[510(k)] issued on: April 15, 2005 by the U.S. Department of Health and Human Services Food and Drug
Administration Center for Devices and Radiological Health
11. Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions
[510(k)] issued on: July 11, 2008 by the U.S. Department of Health and Human Services Food and Drug
Administration Center for Devices and Radiological Health
70