Editor’s note: In this interview, Tim Vanderveen, PharmD, a consultant with ICU Medical, discusses IV therapy and its impact on patient safety. The interview was conducted by J.W. Beard, MD, MBA, medical director for medical affairs at ICU Medical.
Q: Tim, from your position as a pharmacist, you have been an industry leader in infusion pump safety and innovation. What led you to your interest in infusion therapy and technology?
Vanderveen: During my residency, I developed a keen interest in IV therapy. It was 1970, and several events helped shaped my interests and ultimately my career. The first was a recall of the Abbott glass IV solutions due to contamination, which meant a major supplier could no longer supply fluids. The second was preparation of hyperalimentation, now called total parenteral nutrition (TPN). The third was the creation of the National Coordinating Committee on Large Volume Parenterals, in part due to the contaminated IV solutions. Each event had academic interest for me and impacted my clinical practice.
After residency, my first position was at Medical University of South Carolina in a combined college faculty and hospital administration position. During my 12 years in academic practice, I continually observed safety issues that were not being addressed. Many of these were caused by a lack of technology; others were often a result of how technology was used or misused. This was especially true of IV therapy. Use of infusion pumps and controllers in the early ’70s was a novelty, and much of the IV fluid and drug administration was using gravity with a plastic clamp and counting drops to set infusion rates. IV tubing sets were not labelled and rarely changed. Burettes were used to administer intermittent medications. In the early days of TPN, we did not have infusion pumps, and patients receiving the therapy were monitored in the ICU. Attempts to use gravity infusions with plastic rate clamps were fraught with issues such as clotted catheters, over-infusions leading to severe metabolic imbalances, etc. The early-generation infusion devices lacked critical safety features such as prevention of free flow if the tubing was removed without the nurse first closing a clamp. Some of the pumps did not alarm for occlusions until the pressure exceeded the pressure in a car tire. Nurses were also challenged to convert physicians’ orders in doses to rates in mL/hr. Medication errors were common but infrequently reported or investigated.
A pharmacist colleague and I authored the first article focusing on infusion devices, which led to us consulting periodically for several of the infusion device companies. One of the companies had recently sold to a large pharmaceutical company, and I agreed to a two-year trial that ultimately lasted 36 years. When I took that position, I became the first clinician in the infusion pump industry.
Q: As you look back on your industry career, what are the most significant safety advances that you have been a part of?
Vanderveen: My first involvement on a national level and ultimately an international level was working with ISMP to champion infusion device free flow prevention. As I mentioned earlier, most of the early devices required the nurse or physician to manually close a clamp to prevent free flow if the tubing was removed from the device. Dr Michael Cohen, president and founder of the ISMP, and I teamed up to increase awareness, and ultimately disposable-based free flow protection became a standard in the industry in the U.S. and in much of the rest of the world.
Another accomplishment that I am proud of is the identification and championing of combining capnography with PCA therapy. I was at a critical care nursing conference, and a representative from a monitoring company was wearing a device with a small cannula in his nose. Being curious, I asked him what he was monitoring. He replied it was his breath rate and end tidal CO2. A light bulb went off that a combination of capnography and a PCA pump had the potential to improve the safety of PCA therapy. Respiratory monitoring feedback to PCA devices continues to be studied and is now implemented in many locations.
Perhaps the most significant safety enhancement I have been intimately involved with has been the creation of dose error reduction software (DERS), the drug library within smart infusion pumps that has become a standard in the infusion industry. Errors such as a missed decimal point or programming a volume as the rate are examples of programming mistakes that caused morbidity and occasionally mortality and are prevented by DERS in many instances.
Q: The safety advances you have mentioned are all significant, but several infusion pump clinical studies have demonstrated that errors persist even with smart pumps. These same studies have indicated that smart pump–electronic health record (EHR) interoperability would be effective in eliminating many of them—especially those that are highest risk to the patient. What is your view on the contribution of interoperability to patient safety?
Vanderveen: While the DERS advance has been shown to intercept inadvertent programming errors as well as intentional but perhaps unsafe low and high doses, the infusion devices with DERS cannot prevent errors such as the incorrect drug selected, programming of a dose that is in error but within the range DERS allows, etc. The infusion system historically has relied on the nurse to transfer the physician’s order to the infusion device. Bar code medication administration (BCMA) systems worked great for medications such as tablets and injections but did not provide the same safety for infusions.
Today, we have wireless connectivity between the infusion devices and the EHR, such that BCMA linked with pump auto-programming and auto-documentation have closed the loop. Smart pump–EHR interoperability has taken infusion safety and productivity to a new and exciting level with wireless connectivity being the conduit to both “talk” and “listen” to every infusion pump. Programming a pump through interoperability enables a pharmacist-verified physician order to be transmitted directly to the pump for nursing staff verification and infusion. Interoperability nearly ensures that the right patient is getting the right medication at the right dose. This technology eliminates several potential serious errors in each step of the process. Infusion devices and EHR systems were developed independently, so a lot of creative effort, cooperation, and development has gone into taking infusion safety to a new and exciting level.
Q: Interoperability is a powerful technology that has addressed many but not all types of medication errors. What are the gaps that remain in infusion safety technology? What are the next steps to improve patient safety?
Vanderveen: We still have a way to go to further patient safety with infusions. Despite widespread recognition of certain long-standing safety issues, technology solutions have been slow to come to the market. For example, switching from burettes to small bags for intermittent delivery of scheduled medications such as antibiotics and using a gravity-head height dependent piggyback/secondary system has historically resulted in delays due to failure to open a clamp on the intermittent tubing. With one exception, the installed base of devices cannot detect this condition, and delays in therapy frequently result. This and other errors in the secondary delivery will be addressed in the soon-to-be-released ISMP Guidelines for Smart Infusion Pumps.
Another problematic issue, especially in the majority of hospitals that have not yet implemented interoperability, is compliance with the use of the drug library. To account for unforeseen circumstances, infusion devices allow for bypassing the library to ensure an infusion can be started in an emergency without a matching library entry. However, this ability to bypass the library may be misused for convenience or other purposes, resulting in patients being at risk from preventable errors when receiving infusions which are not being protected within the safety limits of the DERS. With these devices, the DERS is analogous to a seat belt, requiring an action by the user to enable the safety feature. Clinicians and industry need to work together to maximize DERS compliance, making it easiest to do the right thing to reduce preventable errors.
The complexity of IV therapy, especially in the ICUs, presents another recognized but unsolved issue. For infusion devices that administer from bags and bottles, the fluid/medication is connected to an infusion tubing that typically is 24–30 inches long above the pumping segment that fits into the device. With multiple infusions, the lines from the medications to the device can be switched, potentially resulting in Drug A being infused through the channel programmed for Drug B and vice versa. The infusion device cannot detect a medication and channel mix-up, the drug library is no longer protective, and serious and fatal errors have resulted. Technology ensuring alignment between the infusion container and pumping channel is needed to avoid this mistake.
The Joint Commission focused hospitals on several issues related to medical device alarms and alerts. While the initial focus was on monitors and ventilators, infusion devices are a major source of noise and patient/family dissatisfaction. Today, infusion device alarms go off at the bedside and require clinician interaction with each device to cancel the alarms. Alarm forwarding to central stations and to individual caregivers’ phones is more established for monitors, however. Wireless connectivity with infusion devices sets the stage for transmitting the alarms, but standards will need to be updated to hopefully allow the initial alarms to be transmitted directly to the clinician rather than alarming at the bedside.
In terms of next steps, I believe the most important development in the near future is the release of the ISMP Guidelines for Smart Infusion Pumps. The guidelines will serve as a guide for best practice in the utilization of current technology and advocate for the expansion of technology to areas of the hospital, such as procedural locations and the operating room, which have unique workflows and requirements. The guidelines also comprehensively describe the quality improvement efforts needed for effective infusion system management over time. Ideally, the guidelines will have a substantial contribution to safety through existing technology and set the stage for technology advances in the future.