Hazard [Health Devices Jun 1994;23(6):256-7]
In a Public Health Advisory issued on March 1, 1994 ("Avoiding Injuries from Rapid Drug or
I.V. Fluid Administration Associated with I.V. Pumps and Rate Controller Devices"), the U.S. Food
and Drug Administration (FDA) stated that it had received reports of injuries and
deaths from uncontrolled, rapid infusion of medications and/or fluids associated with IV
pumps and rate-control devices. The Advisory focuses on uncontrolled gravity flow, or what
is commonly referred to as free-flow. However, it does not adequately describe free-flow
protection mechanisms and makes suggestions that are misleading, unwarranted, hazardous,
or expensive to implement. One suggestion places patients at greater risk than the problem
it is intended to prevent.
ECRI recommends against purchasing electronic infusion devices (EIDs) that
do not have infusion set-based free-flow protection, and we provide conditions for use of
EIDs with unprotected infusion sets. We strongly disagree with the FDA's suggestion to
limit drug concentration and see no substantiation for its suggestions to place warning
labels on EIDs, use limited-volume reservoir chambers, or change the regular inspection
and preventive maintenance (IPM) schedule. The FDA Public Health Advisory is intended to
be used only as guidance; it does not have the force of law.
For a comprehensive discussion of free-flow overinfusions associated with
EIDs, see "IV Free-flow—Still a Cause for Alarm" (Health Devices,
21, September 1992). In that article, we describe reports of numerous free-flow
incidents, some resulting in death, as well as how both user error and device design
contributed to these incidents; we also provide recommendations for reducing the
likelihood of free-flow.
Below we discuss the major problems associated with the FDA Advisory.
EID- versus set-based
In its suggestion to use anti-free-flow mechanisms, FDA fails to
distinguish between EID-based and infusion set-based free-flow protection mechanisms,
implying that they are equivalent; they are not.
Free-flow most commonly occurs when an infusion set is removed from an EID
and the infusion set has not been manually closed (e.g., with a roller or slide clamp);
any fluid remaining in an elevated container will flow into the patient under gravity
pressure. Thus, EID-based free-flow protection can protect against free-flow only while
the set is installed in the device; free-flow will occur if the user does not close
the set before it is removed from the EID. Set-based mechanisms, which either close the
infusion set automatically or require that the set be manually closed before it can be
removed from the EID, provide a greater level of protection.
Infusion sets with free-flow protection mechanisms are now available with
many EID models. These sets are clearly preferable for all infusions, but are especially
important when administering potent, fast-acting drugs, such as those that affect the
cardiovascular or central nervous systems or that control labor, or when delivering drugs
to patients who cannot tolerate fluid overload.
Unfortunately, the FDA Advisory does not convey the clear advantage of
infusion set-based free-flow protection. Although it cites the Association for the
Advancement of Medical Instrumentation (AAMI) American National Standard—Infusion
(ANSI/AAMI ID26—1992), the standard does not even mention this level of
protection, simply calling for two distinctive and separate actions to initiate
uncontrolled (free) flow in a device that is infusing or ready to infuse. Few if any EIDs
manufactured in the past 10 years fail to meet this requirement. Since September 1992,
ECRI has recommended against the purchase of EIDs that lack set-based free-flow
Placing warning labels on EIDs, as FDA suggests, has little if any value.
Labels are typically ignored and may interfere with other labels that identify operational
procedures or obscure displays from view.
FDA suggests using "sets that incorporate limited volume reservoir
chambers" when infusing drugs that would be "potentially toxic" if
overinfused. This suggestion assumes that a free-flow infusion would not have adverse
effects if its volume did not exceed 150 mL, the typical volume of a metered chamber. It
also assumes that the clamp between the metered chamber and the source fluid container
will always be closed so that the chamber would not be a conduit. Metered chambers provide
a false sense of protection against free-flow, and we believe that the added cost for this
purpose is unwarranted.
The FDA's suggestion to limit drug concentration may be hazardous in two
respects: 1) It would result in an increased total infusion volume (e.g., for the same
dose, halving concentration doubles the volume), which is unacceptable for
fluid-restricted patients, such as adults with congestive heart failure or neonates. 2)
The practice of altering drug concentrations or of stocking multiple concentrations is
more likely to lead to life-threatening dosage calculation or administration errors than
the free-flow incidents it may mitigate. Many institutions, recognizing that such errors
may occur, have recently standardized on premixed solutions of fixed concentration.
FDA also suggests that users "conduct regular inspection and
maintenance." However, unless an institution's equipment control system demonstrates
otherwise, an inspection interval of one year is generally adequate for hospital-based
EIDs. Also, EIDs typically do not require preventive maintenance, and EID failures are
rarely the cause of overinfusion.
- Purchase only EIDs with infusion set-based free-flow
protection. Assess and compare several set-based free-flow protection
mechanisms for effectiveness and reliability. If set-based free-flow
mechanisms are available as an option, they should be purchased and/or
implemented as soon as possible.
- In institutions where EIDs with infusion set-based
protection are being phased in, use EIDs with unprotected sets only for
noncritical infusions. Use EIDs with set-based protection for critical
infusions—that is, when administering drugs that affect the
cardiovascular or central nervous systems or that control labor or when
delivering drugs to patients who cannot tolerate fluid overload.
- The following conditions of use apply when using
EIDs with unprotected infusion sets:
- Ensure that only fully trained personnel are
authorized to set up, adjust, or remove such infusion sets. Nurses
aides, technicians, and orderlies should not remove the set to
facilitate treatment, patient positioning, or gown changing (or for
any other reason).
- Ensure that all personnel administering IV therapy (including
physicians) receive periodic in-service training on the use of EIDs
and on avoiding potential problems related to
- Regardless of which type of infusion set is used,
ensure that in-service education programs provide periodic training to
authorized users, including instructions to close the manual clamp whenever
removing an infusion set from an EID.
- Retire from use any EID on which a single action
(e.g., opening the door) can result in free-flow.
- Immediately investigate and periodically review
(e.g., every six months) all overinfusion incidents.
- Do not use limited-volume chambers or infusion sets
with these chambers as a means of mitigating the effects of potential
- Do not alter the concentration of IV drugs or stock multiple drug
concentrations as a means of mitigating the effects of potential free-flow
- Infusion Pumps, General-Purpose [13-215]
- Infusion Controllers [11-010]
Cause of Device-Related Incident
Device factors: Design/labeling error; Failure of accessory
User errors: Failure to perform pre-use inspection; Inappropriate reliance on
an automated feature; Incorrect clinical use
External factors: Failure to train and/or credential; Poor prepurchase
Mechanism of Injury or Death