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IV pump set free-flow: When is enough enough?

From the April 22, 1998 issue

PROBLEM: On April 15, 1998 the St. Petersburg (FL) Times reported that a woman, who had undergone surgery to repair an abdominal aortic aneurysm, died soon after an overdose of Nipride® (nitroprusside sodium). Only a few mL of the nitroprusside infusion were needed during surgery and the patient's blood pressure was also stable in the recovery room. Immediately after transfer to ICU, the patient was in shock. The nitroprusside tubing had at some point been removed from its pump without its gravity clamp engaged. The bag was completely empty with its tubing still connected to the central IV line. Between 45 and 49 mg of nitroprusside had accidentally infused.

Accidental, uncontrolled free-flow of IV fluids and drugs after removal of IV administration sets from infusion pumps is a well known, preventable occurrence which may have a tragic outcome. Most incidents occur upon removal of an IV set from a pump without manually closing the IV set slide or roller clamp1. As long as the removed tubing remains connected to a patent IV line, gravity can force remaining IV fluid to flow, uncontrolled, into the patient. We refer to this as "disposable-based free-flow" to call attention to the fact that some manufacturers have confused customers by stating that their devices are "free-flow protected" referring to a pump clamping mechanism that works only while the set remains within the device.

Accidental free-flow was reported as early as 1984,2 and well documented cases have been coming to light ever since.1, 3 Although most pumps sold today require the use of sets with a fail-safe clamping mechanism, many hospitals continue to use older unprotected devices, purchase cheaper instruments that function without free-flow protection, or choose to bypass options that would otherwise provide protection against free-flow. It is estimated that as many as 216,000 of the currently installed base of 600,000 IV pumps in hospitals are capable of free-flow.4 The tragedy is that, in spite of all of this knowledge, preventable incidents continue to occur.

SAFE PRACTICE RECOMMENDATION: We believe that the time has come for hospitals to stop using unprotected equipment. Many of the free-flow incidents reported to us have involved excellent nurses who were temporarily distracted and forgot to clamp the IV set. Also, patients, family members, radiology technicians, transport personnel, etc. may not realize that manual clamping is required before removing unprotected sets from pumps. Begin a process now to actively and systematically phase out these devices, starting immediately with critical care areas and oncology. All new purchases must demonstrate disposable-based free-flow protection. We are also calling upon FDA to withhold approval of devices that lack this feature. ECRI (610 825 6000), a non-profit organization well known in the medical industry for its objective evaluation of the safety of medical equipment, has determined that infusion pumps that lack set-based anti-free-flow mechanisms are unacceptable.3 They emphasize that such devices should no longer be purchased or rented and they will no longer even evaluate them. If you are unsure if free-flow is possible with currently used equipment, start an infusion with the disposable set properly inserted into the device housing. Turn the pump off and remove the set without engaging any manual flow control clamps. Then, if you must take an action to stop flow, rather than take an action to begin flow, the pump is free-flow capable and potentially dangerous.

References: 1. Cohen MR, Davis NM. Free flow associated with electronic infusion devices: an underestimated danger. Hosp Pharm 1992;27:384-390; 2. ECRI. Infusion pumps. Health Devices Dec 1983, Jan 84 13:31-62; 3. ECRI. General purpose infusion pump purchasing guide. Health Devices 1997;26:36-50; 4. Vanderveen T. Alaris Corp. April 15, 1998, Personal communication.

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