2004 National Patient Safety Goals FAQs, excerpt from page 18 …
Questions about goal #5 (Infusion pumps):
Does this safety goal also apply to syringe pumps, ambulatory pumps
or enteral pumps?
It applies to ambulatory pumps, but not to syringe pumps or enteral pumps. [Revised,
5/30/03]
Do ambulatory pumps used for applications other than patient controlled
analgesia (PCA) fall within the scope of goal #5? If so, what issues should be
considered?
Many ambulatory pumps (for example, certain models of CADD brand pumps) can be
used for applications other than PCA. Such applications include, but are not
limited to, chemotherapy, antibiotic, and total parenteral nutrition (TPN) infusion.
Although a PCA medication reservoir should be secured within the pump, reservoirs
for other applications are frequently external containers and are hung above
the pumps. Because the latter configuration creates a greater opportunity for
inadvertent free-flow, Joint Commission has determined that goal #5 applies to
all ambulatory pumps. [New 5/30/03]
Some pumps with their administration sets do not have "built
in" free-flow protection. Instead, the manufacturers provide "add-on" antisiphon
valves to achieve free-flow protection. Are these acceptable?
Beginning January 1, 2004, add-on devices to achieve free-flow protection are
no longer acceptable for compliance with this requirement. For systems that do
not have built-in free-flow protection, some pump manufacturers include an anti-siphon
valve in the package with its administration set, along with instructions for
use of this add-on device. These add-on devices were permitted in 2003 as an
interim measure pending availability of administration sets with intrinsic free-flow
protection. Joint Commission has determined that the majority of pump manufacturers
are now providing intrinsic free-flow protection. Any continued use of add-on
devices for this purpose must be submitted to Joint Commission in a "Request
for Review of an Alternative Approach to a 2004 NPSG Requirement." Purchase
and implementation of new equipment without intrinsic free-flow protection is
not in compliance with this goal. [New 1/1/04]
Regarding free-flow "protection," all our devices immediately
shut off when the door is open and the set is removed without closing any tubing
clamps. However a patient or family member might easily figure out how to undo
the free-flow protection mechanism. This would allow for the medication to infuse
so we have no guarantee regarding free flow but we have "protection." Would
these devices meet the intent of this requirement?
As you describe them, your infusion pumps are in compliance with the requirement.
Most safety features can be overridden if there is sufficient determination to
do so. The intent of the requirement is to achieve protection against the more
common misadventures involving these pumps.
I've heard the term "set-based free-flow protection." What
does this mean?
The "protection" is actually an attribute of the administration set
used with the pump rather than with the pump itself. It is important to always
use the administration set that is specified for use with the infusion pump.
The term "set-based free-flow protection" refers to a design in which
the protection is built in (intrinsic) to the administration set.
How can I determine whether our general-purpose infusion pumps have
free-flow protection?
To test for free flow protection, turn the power off with the infusion set primed
and loaded in the device. With all tubing clamps open and the fluid container
as high above the device as the tubing will allow, verify that no fluid flows
out of the set as it hangs straight down from the device. Then remove the set
from the device (tubing clamps still open) and again verify that no fluid flows
out of the set. (Source: ECRI's Health Devices Inspection and Preventive Maintenance
System.) [Revised 5/30/03]
Do we have to test all of our infusion pumps to verify that they have
free-flow protection?
No. The test for free-flow protection described above is for use only when there
is a reasonable question about whether the particular pump/infusion set has adequate
free-flow protection. Configurations that have been tested by ECRI and rated
as "Free-flow protected" or "Free-flow protected with dependencies" do
not need to be tested on-site as long as they are being used in a manner consistent
with manufacturers' instructions and with the "dependencies" specified
by ECRI. [New 5/30/03]
Where can I get more information about specific infusion pumps?
Joint Commision recognizes ECRI as an authoritative source of information about
the safety considerations relating to infusion pumps. As such, information published
by ECRI indicating the adequacy of free-flow protection for specific pump/administration
set configurations will be acceptable as evidence of compliance with goal #5
of the 2004 NPSGs, pending verification by on-site survey of the appropriate
use of such configurations by the specific health care organization in the provision
of health care services. In other words, if ECRI says a particular infusion system
is capable of providing adequate free-flow protection, Joint Commission will
still survey the way in which that equipment is being used.
What about PCA pumps—can you say more about free-flow protection
with these devices?
According to ECRI, most PCA pumps fall under the "Free-flow Protected with
Dependencies" category, which means that the free flow protection of PCA
pumps is dependent on the use of tubing sets with an integral positive pressure
(anti-siphon) valve. These are usually purchased independent of the pump itself,
so the key issue for assessment should be to determine whether the set is protected
rather than whether the model of pump is acceptable. Although these sets may
allow small amounts of solution to flow under conditions of maximum head height,
PCA reservoirs are normally secured to the pump (not hanging above it) so head
height during use is typically much less than that for general-purpose infusion
pumps. [Revised 5/30/03]
What about patients being treated in a hyperbaric chamber? Is free-flow
protection required there?
Yes. This requirement also applies to patient undergoing hyperbaric therapy.
Infusion pumps capable of providing free-flow protection in this environment
are available. [New 1/1/04]
Full text of 2004 National Patient Safety Goals FAQs (PDF, 106KB)