FDA Safety Communication on MRI Effects on Implanted Infusion Pumps

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Questions and Answers

What was the response of the FDA to the issue of implanted infusion pumps in MRI scanners?

Permanently banned the use of implantable infusion pumps

Stopped the production of implantable infusion pumps

Issued a special safety communication in 2017 (correct)

Issued a special safety guideline in 2015

What can happen to an implantable infusion pump when exposed to an MRI scanner?

It has no effect on the pump

It can cause permanent device failure due to demagnetization of the pump magnet (correct)

It can only decrease the rate of drug delivery

It can only increase the rate of drug delivery

Where is the catheter tip typically placed in an implantable infusion pump?

Intravenously or intra-arterially

Subcutaneously or intraperitoneally

Intrathecally or epidurally

All of the above (correct)

What type of drug is typically administered via implantable infusion pumps for spasticity?

Baclofen Signup and view all the answers

How long have implantable infusion pumps been used clinically?

30 years Signup and view all the answers

What is the mechanism of fluid propulsion in propellant-driven pumps?

Thermal expansion of a gaseous propellant Signup and view all the answers

Which of the following companies does not manufacture implantable infusion pumps currently used worldwide?

Codman Signup and view all the answers

What is the purpose of the refilling port in an implantable infusion pump?

To refill the drug reservoir Signup and view all the answers

What is the primary function of the flurochlorocarbon propellant in intrathecal infusion pumps?

To compress the titanium bellows and drive drug delivery Signup and view all the answers

What is the common feature among all the pumps listed in the text?

They are all MR Conditional at 1.5 and/or 3.0T Signup and view all the answers

What is the potential risk of RF-heating during scanning?

Increased drug flow Signup and view all the answers

What is the unique limitation of Prometra pumps in an MR environment?

Their drug reservoirs must be emptied before entering the MR environment Signup and view all the answers

What is the primary function of the rollers on the rotating wheel in SynchroMed pumps?

To compress the internal tubing for drug propulsion Signup and view all the answers

Why is palpation of the implanted SynchroMed pump necessary?

To ensure the pump is not rotated to a position perpendicular to the long axis of the body Signup and view all the answers

What may occur when a patient with a SynchroMed pump is placed in the scanner?

The pump may stop operating temporarily Signup and view all the answers

What should be done after a SynchroMed pump is removed from the scanner?

The pump should be interrogated to ensure it is no longer stalled Signup and view all the answers

Study Notes

Implantable Infusion Pumps

At least half a dozen cases of life-threatening effects of magnetic fields on implanted infusion pumps were reported in the USA, prompting the FDA to issue a special safety communication in 2017.

Life-Threatening Effects

Increased rate of drug delivery, including discharge of the entire pump contents as a single lethal dose
Decreased rate of drug delivery or cessation of pump operation while in the scanner
Permanent device failure due to demagnetization of the pump magnet

Implantable Infusion Pumps Characteristics

Internally powered devices surgically placed subcutaneously in the upper chest or abdominal wall
Consist of a titanium-encased pump assembly connected to a small-gauge plastic catheter
Typical drugs administered via implantable infusion pumps include chemotherapeutic agents, opioids, and baclofen

Types of Implantable Infusion Pumps

Propellant-driven pumps: rely on thermal expansion of a gaseous propellant to force drug delivery into the catheter
Motor-driven peristaltic pumps: contain a battery, electric motor, and rollers on a rotating wheel for drug propulsion

Propellant-Driven Pumps

Examples include Codman 3000, Isomed, and Prometra pumps
Have two compartments: a collapsible titanium bellows serving as the drug reservoir and a surrounding chamber containing a flurochlorocarbon propellant
RF-heating of the pump may occur during scanning, increasing drug flow, and high SAR protocols should be avoided

Motor-Driven Peristaltic Pumps

Examples include Medtronic SynchroMed series
Contain microelectronics for precise control over infusion rates, remote programming, and interrogation
May demagnetize the pump motor if not placed correctly, rendering it permanently inoperable

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Description

This quiz discusses the potentially life-threatening effects of MRI magnetic fields on implanted infusion pumps, as addressed by the FDA in a 2017 safety communication. It covers the risks of altered drug delivery rates and pump operation.