Are you putting patients in danger? Heed warning on infusion pumps

Surveyors want to see evidence of safety measures and education

An adult patient comes to the ED with dangerously low potassium levels, requiring potassium via IV pump. The total volume of potassium is reversed with the rate of infusion, due to a user error. Instead of receiving 20 milliequivalents/hour (mEq/hour), the patient received 60 mEq/hour in 20 minutes. After receiving three times the intended amount of potassium in a shorter length of time, the patient dies. 

In response to tragic situations like this one, surveyors will be asking questions about the use of infusion pumps, says Kathleen Catalano, RN, JD, director of administrative projects at Children’s Medical Center of Dallas and a former consultant specializing in regulatory compliance. Last year the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, issued a Sentinel Event Alert warning about the dangers of infusion pumps. (See "Resources," at end of this article, to learn how to obtain the Sentinel Event Alert.) 

Infusion pumps are potentially dangerous because the wrong drug concentration can be given, the wrong rate can be set, and there is a possibility of decreased respiratory rate with continuous narcotic infusion, warns Cindy Bruns, RN, BSN, CEN, quality management coordinator for the Emergency Center at Tallahassee (FL) Memorial Hospital. Red flags for surveyors include the use of pumps without free-flow protection, multiple types of pumps in use, and lack of coordinated education including a multidisciplinary team to evaluate infusion pumps, says Catalano. If an incident does occur, the ED is at higher risk for an adverse outcome than other departments because critical care drugs are given more frequently, she adds. "Also, ED staff are under pressure of time constraints, so there is a higher risk of error," says Catalano. (See suggested actions from U.S. Pharmacopeia, below.)

5 actions you must take now
You should do the following five things regarding the use of free-flow infusion pumps:
1. Identify all pumps with potential for free-flow errors, including those with confusing labeling.
2. Sequester/quarantine/phase out the use of unprotected devices.
3. Petition the Food and Drug Administration to withhold/withdraw approval of IV pumps that permit free-flow.
4. Petition manufacturers to stop production and sale of free-flow pumps.
5. Continue to report errors associated with the use of IV pumps that do not protect against free-flow so that accurate frequency and severity of these errors can be assessed.
Source: Reprinted with permission from the U.S. Pharmacopeia, Practitioners’ Reporting News, "Free-Flow IV Pumps," 7/99, www.usp.org/reporting. Copyright 2001. All rights reserved. 

Actions you can take now to avoid problems include:

Do not use pumps without protection. The Sentinel Event Alert warns against using pumps that don’t provide protection from the free-flow of intravenous fluid/medication into the patient, says Ann Kobs, president and CEO of Type 1 Solutions, a Fort Meyers, FL-based compliance consulting firm specializing in preparation for Joint Commission surveys. "Check what kind of pumps your organization uses," she advises. "If they do not have a lock-up mechanism, do not use them." Free-flow pumps have no safety valve for the amount of fluid that will flow into a patient, Catalano says. "It’s like a run-away IV left at wide-open," she explains.

Pumps not always user-friendly

Many infusion pumps on the market are not user-friendly, says Catalano. "Some are so busy’ with instrumentation you can’t tell what buttons to push to set the pump," she explains.

Make sure staff read the Sentinel Event Alert. Kobs suggests placing the Sentinel Event Alert into paycheck envelopes. "You should definitely post it in the break room. One surefire way to get staff to read it is to post it on the door inside the toilet stalls."

Have staff train others to ensure competence. Kobs points to "peer pressure" as an effective tool to ensure competence. "As a manager, I would observe and critique two of my weak links’ until they had it perfect," she says. "Then I would charge them each with observing and critiquing two folks apiece. Then those four can each do two more until all staff are signed off’ by their preceptor."

Educate staff. Even if appropriate pumps are used, infusion pumps can be dangerous, warns Kobs. "Problems can occur when the wrong drug concentration is given or the wrong rate is set," she says. Kobs stresses that training and education are not foolproof. Even if inservicing is done appropriately, a patient, family member, or visitor might still handle a pump incorrectly, she notes.

Inservice all appropriate staff

Most EDs provide inservice education on the pumps for nurses, but not for other staff who might handle the pumps, she says. These individuals include orderlies, radiology technicians, and nurse assistants who transport patients. "At a minimum, they should know when to call for the professional person managing the pump," says Kobs. 

If an individual has not been trained thoroughly on the use of the particular infusion pump used, do not have that person use the pump, urges Catalano. Every individual must have a competency for the particular infusion pump being used, she says. "Ensure that each person has been instructed on the differences in the amount of fluid and medication doses for various-age patients, including infant, child, adolescent, adult, and geriatric patients," she adds. There should be competency-based, age-specific, and unit-specific education, says Catalano. "Education should be dependent on the most frequent fluids and medications given in your ED via an infusion pump," she adds. 

At Tallahassee Memorial, mandatory staff inservices for use of infusion pumps are held, including hands-on instruction. "Each nurse has to demonstrate her ability to set up a PCA pump," says Bruns.

Use the buddy system. Catalano suggests having infusion pumps set on a buddy system. "Two individuals check the pump to be sure the right amount of fluid and medication will be infused," she explains. At Tallahassee Memorial, the ED’s policies require all PCA pump medication set-ups to be verified and co-signed on the Emergency Center chart by a second RN, says Bruns. (To see "Policies for the Use of the PCA Plus II for Analgesia," click here. For a copy of "Medication Administration," click here.) "Two nurses verify the medication vial and the pump settings with the physician’s order," she says. "This verification/co-signature requirement is also true for heparin drips and insulin drips."

Consult with risk management

Learn from previous incidents. Check with your hospital’s risk management department to find out if there have been any reports of infusion pump-related errors, Catalano advises. "If so, find out if a root-cause analysis was done and what was learned," she suggests.

Implement policies to increase safety. New policies involving medication administration have been instituted at Tallahassee Memorial Hospital within the past year, says Bruns. The policies include standardized order forms or order sets, a two-nurse verification system, and a lower "lock-out" setting to possibly prevent respiratory depression. "These policies have had a direct bearing on the care and safety of patients," she says.

Be involved in product evaluation. When your facility is examining a change in infusion pumps, make sure the ED is represented on the new product evaluation team, advises Catalano. "Everyone should be comfortable with the choice made. Learn all you can about the infusion pump your facility uses." 

Sources

For more information on infusion pumps, contact:

Cindy Bruns, RN, BSN, CEN, Emergency Center, Tallahassee Memorial Hospital, 1300 Miccosukee Road, Tallahassee, FL 32308. Telephone: (850) 431-5079. Fax: (850) 431-6537. E-mail: BRUNS-C@mail.tmh.org.

Kathleen Catalano, RN, JD, Children’s Medical Center of Dallas, 1935 Motor St., Dallas, TX 75235. Telephone: (214) 456-8722. Fax: (214) 456-6081.  E-mail: kcatal@childmed.dallas.tx.us.

Ann Kobs, President/CEO, Type 1 Solutions, 166 SE 18th Terrace, Suite A, Cape Coral, FL 33990. Telephone: (941) 574-8318. Fax: (941) 574-8814. E-mail: aejbbk@aol.com.

Resources

The Joint Commission’s Sentinel Event Alert, "Infusion Pumps: Preventing Future Adverse Events," identifies the most common human and mechanical errors associated with infusion pumps and provides recommended steps to avoid such errors. It can be found on-line at www.jcaho.org. (Click on "Patient Safety/Sentinel Events," "Sentinel Event Alert," and then "Sentinel Event Alert" again. Scroll down to the Nov. 30, 2000, issue.) You can sign up to receive Sentinel Event Alert via e-mail by going to the Sentinel Event Alert home page. To get the latest copy of Sentinel Event Alert by fax, call the Joint Commission’s fax-on-demand line at (630) 792-3885, and press 4.

The U.S. Pharmacopeia has published an alert on free-flow IV pumps that can be accessed free of charge on the organization’s web site (www.usp.org). Click on "Practitioner Reporting," "Practitioners’ Reporting News," and then "Med Error Reports." Scroll down and click on "Alert! Free-Flow IV Pumps." MedMARx is an Internet-accessible national database for hospitals to report medication errors, available through the U.S. Pharmacopeia. For more information, contact: 

• U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852. Telephone: (800) 227-8772 ext. 8546 or (301) 881-0666. Fax: (301) 816-8532. E-mail: smw@usp.org. Web: www.usp.org.

The Institute for Healthcare Improvement (IHI) has published a guide titled Breakthrough Series: Reducing Adverse Drug Events. The guide includes strategies for improving ordering systems, the dispensing process, administration of medications, and basic prevention strategies. The guide costs $49.95, plus $7 shipping and handling. To order, contact:  Institute for Healthcare Improvement, 375 Longwood Ave., Fourth Floor, Boston, MA 02215. Telephone: (617) 754-4800. Fax: (617) 754-4848. E-mail: info@ihi.org. Web: www.ihi.org.

The Institute for Safe Medication Practices (ISMP) provides education about adverse drug events and their prevention through the ISMP Medication Safety Alert, a biweekly resource sent by fax or e-mail for a $135 annual subscription fee. A previous issue focusing on infusion pumps is available free of charge on the web site, www.ismp.org. (Click on "ISMP Medication Safety Alert!" the April 22, 1998, issue; and then on "IV pump set free-flow: When is enough enough?") To order a subscription, contact:

• ISMP, 1800 Byberry Road, Suite 810, Huntingdon Valley, PA 19006. Telephone: (215) 947-7797. Fax: (215) 914-1492. E-mail: ismpinfo@ismp.org. Web: www.ismp.org

ECRI, a nonprofit health services research agency, publishes Health Devices, which gives evaluations and brand name ratings. The May 2001 issue contains evaluations of patient-controlled analgesic (PCA) infusion pumps. A single issue costs $75 for member of ECRI’s Health Devices System and $275 for nonmembers. The April-May 1998 issue of Health Devices contains evaluations of infusion pump analyzers and general-purpose infusion pumps. The cost of this double issue is $95 for members and $335 for nonmembers. There is no shipping charge for single-issue orders. Healthcare Product Comparison System is a purchasing guide without ratings. The December 2000 issue includes reports on ambulatory and general-purpose infusion pumps, and the January 2001 issue covers PCA infusion pumps. Each report costs $175, with no shipping charge. To order any of these products, contact:

• Brian Duffin, Membership Services, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462. Telephone: (610) 825-6000, ext. 5414. Fax: (610) 834-1275. E-mail: bduffin@ecri.org. Web: www.ecri.org.