Medication errors continue to represent one of the leading inadvertent causes of complications in patient management. According to the Institute of Medicine, more than 7,000 people die each year in the United States as a result of medication error.¹ As a leading provider of perioperative products and services, Abbott is committed to and continually searches for improvements in anesthetic drugs and pain management techniques and is directly addressing the issue of medication errors.

Patient controlled analgesia (PCA), introduced 17 years ago, inaugurated a new standard for effective pain management by simplifying the administration of opioids and other potent pain medications. Today, PCA devices continue to play an important role in decreasing the risk of over-medication and other medication errors, while providing timely and effective post-operative pain relief.

The Abbott Lifecare PCA Plus II, an advanced design of our first PCA device, is the market leader. In fact, since its introduction in 1988, it has been used safely in more than 22 million patients.² According to the FDA safety database, the incidence of serious injury or death reported with the Abbott PCA system remains low.³

However, no technique for delivering medication is completely risk free. The administration of narcotics through PCA, or by any other route, has the potential to create adverse clinical outcomes, especially if opioids are administered in combination with other medications or to compromised patients. Compounding this issue is the trend toward more aggressive pain management in a health care delivery system stressed by cost containment, labor shortages and “fast-tracking” of patients. Nevertheless, Abbott is concerned about and individually examines each and every serious patient complication that involves our PCA device. Following a recent incident with our PCA device in Florida, Abbott immediately contacted the FDA to report the event. Independently, Abbott convened a group of practicing anesthesia and pain management experts from the academic and private practice settings to objectively review the potential for human error in operation of the device and to solicit their advice for future improvements.

More globally, Abbott is attempting to further reduce the incidence of PCA-related errors by providing continuing education programs and updates on safe pain management. Using Abbott’s own clinical nurse consultants and through partnerships with independent third parties, Abbott’s support has made it possible for hundreds of health care professionals to complete continuing medical education programs Abbott developed in cooperation with the Institute for Safe Medication Practices. Abbott offers grants and awards annually to hospitals and health care systems that have made outstanding quality improvements, especially in the area of medication error reduction, and has awarded the American Society of Health System Pharmacists a multi-year grant to further investigate this issue.

In concert with this strategy, over the years, Abbott has made numerous improvements in its PCA device (and medications used in conjunction with the device) to make PCA use safer. These include the addition of prominent labels on drug syringe vials and cartons, and distinctive color-coding and stick-on warning labels. Abbott also pioneered the availability of prefilled syringes to minimize mixing and handling errors.

Combining knowledge gained from the anesthesia community with its own pain management experience, in 1996 Abbott initiated the development of a next generation PCA device, and plans to introduce the device in 2001. The new LifeCare PCA Pump (known as PCA III) will feature numerous design and safety improvements, the most noteworthy of which is sophisticated, integral bar code technology. Once an Abbott prefilled syringe is inserted into the pump, a bar code imprinted on the syringe is recognized by the device, automatically loading information regarding the drug and drug concentration contained within the prefilled syringe into the device software. In the past, inaccurate programming, of either the type of drug or drug concentration contained in the syringe, has been a critical source of medication error. By eliminating the need for clinicians to program this information into the pump, the state-of-the-art integral bar code technology offers a substantive advance in reducing the risk for medication error. This new PCA device has also integrated the principles of human factors engineering into its design, while incorporating FDA guidelines issued in the reports: “Do it by Design: An Introduction to Human Factors in Medical Devices,” and “Medical Device Use—Safety: Incorporating Human Factors Engineering into Risk Management.” ^4,5

Recently, the safety of our current PCA device has been questioned. In fact, some may ask why Abbott decided in 1996 to undertake the design of completely new pump architecture, including bar code technology, rather than making substantial feature modifications to its current PCA device. The answer lies, in part, again with human factors engineering. The current PCA device is in wide use, in fact it represents approximately 75 percent of all PCA use in the U.S. and its safety record has been excellent. In practical application, simple fixes to software may not only fail to reduce the potential for user error, but may potentially increase the possibility of error.⁶ Since so many people safely use the current PCA device without incident, any decision to modify the device is made only after serious evaluation and careful consideration. Integral bar code technology, a substantial advance in PCA design, eliminates a key programming step which will potentially further reduce the incidence of medication errors.

The pending introduction of our latest PCA device will not end Abbott’s quest to further reduce medication error. In fact, Abbott is currently exploring innovative ways to advance the frontier of pain management safety. This represents part of our ongoing commitment, working with the anesthesia community to provide safe and effective solutions to the future challenges faced by health care providers and our patient public.

Dr. McLeskey is Senior Director, Clinical Development, Abbott Laboratories – Hospital Products Division, Abbott Park, IL.

References

1. Preventing Death and Injury from Medical Errors Requires Dramatic, System-Wide Changes. Institute of Medicine of the National Academies Press Release, November 29, 1999.
2. Data on file, Abbott Laboratories Inc.
3. Abbott/FDA MedWatch System, July 1997-June 2000.
4. Do it by Design, An Introduction to Human Factors in Medical Device. United States Food and Drug Administration.
5. Sawyer, D. Guidance for Industry and FDA Premarket and Design Control Reviewers, Medical Device Use–Safety: Incorporating Human Factors Engineering into Risk Management. United States Food and Drug Administration, July 2000.
6. Wickens, CD. Engineering psychology and human performance. New York: Harper Collins, 1992.