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5 Strategies for Safer Pain Pump Practices
Practical tips for improved device purchase and clinical practices.
, Judy RN, BSN, Hedy Cohen
Publish Date: October 10, 2007   |  Tags:   Anesthesia

Programmable patient-controlled analgesia (PCA) pumps work safely for the vast majority of patients, but medication errors can and do happen with these devices. Here are five strategies to help you purchase, prescribe, dispense, program and initiate these devices with patient safety in mind.

Select pumps with care
Programming a PCA requires several steps. Clinicians must separately program the

  • loading dose,
  • the continuous infusion and mini-bolus doses, and
  • the lockout interval (which disables the patient-control button so the patient can't deliver a bolus for a predetermined time after the previous one).

Some pumps lack a user-friendly, intuitive design, which can lead to an error during any of these steps. The most common - and sometimes fatal - programming errors happen when the concentration settings for opioid medications default to 0.1mg/mL or 1mg/ML, but a higher concentration is available and accidentally programmed by the clinician. There are also PCAs that don't require clinicians to review all programmed settings before infusion starts and pumps that program doses in mL, rather than mg, both of which may lead the clinician to overlook the amount of drug actually delivered.

Though quite rare, mechanical errors are possible. Free-flow errors caused by fractured glass syringes, which can entrain air into the body, have been reported. Free flow may also happen when a cassette breaks and detaches from a pump lacking anti-free-flow tubing.

Some common design flaws are related to the patient's use of the pump. First, many devices lack an auditory or visual feedback mechanism; if lockout intervals are set, patients might not be able to tell if their button pushing has had any effect. The result is that some patients press the button more frequently than they would if given proper feedback. Others become frustrated, give up and end up undertreating their pain. Another problem: The control button on some PCAs looks like the nurse-call button. Patients in PACU and hospital inpatient rooms can give themselves a medication spike when they want to call the nurse.

The FDA requires pump manufacturers to perform human-error testing in addition to delivery efficacy testing, but the former is loosely regulated and it's clear front-line practitioners and patients were not deeply involved in pre-market testing of many of these devices.

Before you buy a PCA pump, answer these questions:

  • Can clinicians easily program the pump to deliver the desired drug concentrations? Are the controls ergonomic? Could a decimal point easily be moved and escape notice?
  • Could unsafe administration sets accidentally allow free-flow?
  • Do the drugs, delivery units and strengths appear in a logical sequence?
  • What are the default settings for the opioid concentrations? (Preferably, zero is the default setting.)
  • Does the pump require a double check before it'll work?
  • Is pump operation intuitive?

Standardize pumps
Limit the number of different PCA pumps you use (see "Pain Pump Round Up" on page 56). If possible, obtain consensus on a single model the clinicians trust and stick with that device. This is desirable both from an economic and safety standpoint. Not only will you save time and money dealing with one distributor, using a single device facility-wide promotes programming proficiency, minimizes error potential and expedites the time clinicians need to correctly program the pump.

Establish PCA privileging
Take the time to teach nurses (and, in hospitals, pharmacists) how to program your pain pumps. Require clinicians who prescribe, dispense or initiate PCAs to undergo a privileging process; follow up yearly.

Train staff close to the time they'll actually use the pump. Mandate practice sessions to increase and maintain proficiency. Work with surgeons and anesthetists to design standard order sets to guide drug selection, doses, lockout periods and patient-monitoring protocols. Test personnel on these sets using the pump's programming sequence to reduce error risks.

Run simulations in which a selected clinician purposely writes an incomplete order, selects an incorrect drug or dose, makes a programming error, overlooks double-checking or forgets a critical monitoring point. See if the test-takers spot these. PCA-privileged nurses should also be able to recognize signs of opioid toxicity, assess patients with minimal verbal or tactile stimulation and distinguish between over-sedation and other complications; at minimum, they should evaluate the patient's pain level, alertness and vital signs (including respiration rate and quality).

Develop patient-selection protocols
Exercise caution before entrusting patients to manage pain with a PCA. Patients must have an appropriate level of consciousness and cognitive ability to operate a PCA; pediatric and confused adult (most commonly elderly) patients are contraindicated.

You may limit or heighten your monitoring requirements for patients at heightened respiratory depression risk, including obese patients, those with pre-existing conditions such as asthma or sleep apnea, and patients taking concomitant medications that potentiate opiates. Determine whether you can meet the increased monitoring level, including the availability of capnography or an overnight apnea alarm.

Conduct patient PCA education pre-operatively so you're not dealing with someone too groggy to understand instructions and ask questions. Warn the patient and family members that the devices are intended for the patient's use only. Reinforce this point by placing a "for patient use only" warning label on the pump's activation button. No device can guard against PCA-by-proxy (a third party pushing the button to deliver a mini-bolus), and oversedation and death have resulted from well-meaning family members (or staff) pushing the button for a patient who seems uncomfortable.

Follow medication and clinical best practices
The patient-controlled nature of PCA pumps heightens the imperative to establish good pharmacy and clinical initiation and monitoring standards. Create and adhere to a system of independent double-checks, even if it's for all settings. Follow these best practices:

  • Check patient allergies before selecting a drug, before programming the pump and before initiation.
  • Set maximum dose limits for PCA drugs in the pharmacy computer so an alert appears if an order entry exceeds safe limits.
  • Use pumps that dose in mg or mcg, not only by volume (mL).
  • When setting loading and maintenance doses, consider other meds given to the patient, such as oral analgesics, and medications the patient takes (such as antihistamines).
  • Separate easily confused meds and take appropriate labeling precautions (such as "tall man" lettering differentiating HYDROmorphone from morphine).
  • Use pre-filled syringes, bags or cassettes whenever available commercially. If not, have the pharmacy prepare the PCA medication.
  • Finally, require two clinicians to independently double-check the original order patient ID, drug and concentration, pump settings and line attachment before initiation, program change or refill.

Pain Pump Round Up

Pain pumps come in two varieties: mechanical and electronic. With mechanical pumps, the clinician pre-selects one fixed infusion rate. The rate cannot be changed. With electronic devices, the clinician programs varying infusion rates - ranging from the loading dose, to the continuing infusion rate, to patient-controlled bolus doses. Mechanical pumps deliver the drug with an elastic device, such as a rubber ball, balloon or spring. Electronic devices have a motorized pump. Here's an alphabetical list of the latest in both categories.

- Bill Meltzer


Advanced Infusion
Alpha Pumps (200 mL or 450 mL)
(770) 979-3379
www.advancedinfusion.com
Pump type: Mechanical pump with pressure regulator
Key safety features: Proprietary (Micro-Bore) free-flow restriction; proprietary Micro-Slit provides alternative outlet ports at the end of the catheter without compromising strength
Price: $195 (pump and catheter)


Alaris Medical
Medley PCA
(858) 458-7000
www.alarismed.com
Pump type: Programmable electronic PCA
Key safety features: Single programming platform with common user interface; asks for user location (such as PACU) and whether pump is being programmed new; customizable drug library specific to agents, concentrations and dose limits; provides automated double-checks; collects medication administration data measurable for benchmarking
Price: not provided


Baxter
Syndeo PCA
(800) 933-0303
www.baxter.com
Pump type: Programmable electronic PCA
Key safety features: Intuitive touch-screen programming with built-in safety checks; configurable medication unit, auto restart, dose tone and dose limit options; downloadable medication history reduces transcription error risk
Price: not provided


Breg, Inc.
Paincare3000
(800) 321-0607
www.breg.com
Pump type: Pre-set mechanical pump with optional patient-controlled bolus
Key safety features: Flow-indicator window provides immediate medication flow and unit function feedback; optional patient-controlled 4cc bolus capability incorporates a controlled bolus refill
Price: $165 (wholesale list price)


I-Flow
On-Q Pain Buster
(800) 448-3569
www.i-flowcorp.com
Pump type: Mechanical pre-set continuous infusion pump
Key safety features: Pre-set infusion of local anesthetic requires little patient or clinician intervention or management; flow restrictor ensures pump infuses at labeled rate
Price: not provided



McKinley Medical
Accufuser 275
(800) 578-0555
www.mckinleymed.com
Pump type: Mechanical pre-set pump (optional patient-controlled bolus
Key safety features: Variety of pre-sets customize to case and enhance control of patient-actuated dosing; graduated markings provide intuitive double-checking of proper device operation
Price: not provided


Sgarlato Labs
PainFree Pump
(800) 421-5303
www.sgarlatolabs.com
Pump type: Mechanical continuous infusion pump
Key safety features: Fifteen customizable set-up options (physician chooses medication and flow rate) spring-operated design for regulated continuous infusion; lightweight and easily portable for patient
Price: $195 to $225


Smiths Medical
CADD-Legacy PCA Ambulatory Infusion Pump
(800) 426-2448
www.smithsmedical.com
Pump type: Programmable electronic PCA pump
Key safety features: Patient-specific delivery parameters (continuous, PCA, or both) easy-to-read displays; messages alerting patient of bolus delivery; device can be programmed in mg, mcg or mL; downloadable event data is time- and date-stamped
Price: $4,125 (list)


Sorenson Medical
AmbIT (Ambulatory Infusion Therapy) PCA
(877) 352-1888
www.sorensonmedical.com Pump type: Programmable electronic PCA pump
Key safety features: Anti-free-flow protection, occlusion and audible alarms; bolus lockouts programmable from five minutes to 12 hours; uses include post-op local anesthetic pain management, nerve blocks and narcotic therapies
Price: not provided


Stryker
Pain Pump 2
(800) 800-4236
www.stryker.com
Pump type: Programmable electronic PCA pump
Key safety features: Easy-to-read digital displays; provides patients with non-narcotic bolusing; programming lockout prevents patients from altering dose settings
Price: not provided

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