Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; CSR / Materials Management; Nursing; Pharmacy / IV therapy

Device Factors
Design / labeling error; Failure of accessory

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Overdose

Support System Failures
Failure to train and / or credential; Poor prepurchase evaluation

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection; Inappropriate reliance on an automated feature; Incorrect clinical use

UMDNS
Infusion Pumps, General-Purpose [13-215]; Infusion Controllers [11-010]

ECRI Responds to FDA Public Health Advisory on IV Free-Flow



Hazard [Health Devices Jun 1994;23(6):256-7]

Problem

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.

Conclusions

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.

Discussion

For a comprehensive discussion of free-flow overinfusions associated with EIDs, see "IV Free-flow—Still a Cause for Alarm" (Health Devices, 21[9], 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 protection

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 Devices (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 protection.

Warning labels

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.

Limited-volume chambers

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.

Drug concentration

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.

IPM

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.

Recommendations

  1. 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.
  2. 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.
  3. 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 infusions.
  4. 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.
  5. Retire from use any EID on which a single action (e.g., opening the door) can result in free-flow.
  6. Immediately investigate and periodically review (e.g., every six months) all overinfusion incidents.
  7. Do not use limited-volume chambers or infusion sets with these chambers as a means of mitigating the effects of potential free-flow infusions.
  8. Do not alter the concentration of IV drugs or stock multiple drug concentrations as a means of mitigating the effects of potential free-flow infusions.

UMDNS Terms

  • 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 evaluation

Mechanism of Injury or Death

Overdose


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