Research has shown that adverse drug events are known to be the single leading cause of medical injuries, according to the National Patient Safety Foundation. The greatest potential for harm lies with medication errors related to intravenous (IV) infusion. Hospitals are faced with the challenge of finding ways to reduce these serious and life-threatening errors.
ALARIS Medical Systems Inc and B. Braun Medical Inc are 2 manufacturers that have developed automated infusion pump systems. Referred to as "smart pumps" by the Institute for Safe Medication Practices, this evolving technology automatically programs infusion pumps with specific information, which differs depending on the system in place, and which ensures that programmed information corresponds with the drug orders.
ALARIS is committed to patient and caregiver safety and to applying technology that can reduce errors and potential harm to patients. Nurses say that administering IV therapy is very different from administering oral medication. "IV therapy is a whole process, but an oral medication is an event, and it is over. With an IV, you program and adjust throughout a shift," said Tim Vanderveen, PharmD, MS, executive clinical director of the ALARIS Center for Medication Safety and Clinical Improvement.
In 2001, the manufacturer introduced the ALARIS Medley Medication Safety System. This system is the next generation of "smart" medication safety technology at the point of care. As a computer-based modular system, it permits the integration of administration and monitoring on a single platform. The pump has the capability of interfacing with up to 4 different modules. The system is equipped with the company's dose-error-reduction system called Guardrails Safety Software. This software is designed to detect IV medication errors at the critical point of infusion delivery to the patient. The Guardrails Continuous Quality Improvement Event Tracker creates a database within the device that allows a hospital to track programming errors that have been averted and could have resulted in patient harm.
"We can take the data over a 3-month period and get a real look at what happened and provide a road map for future IV therapy," Dr. Vanderveen said.
The Signature Gold Infusion System is another product offering from ALARIS. Released 8 years ago, this system is compatible with the Guardrails Safety Software. The Signature Edition Gold Infusion System consists of the single-channel Signature Gold Infusion Model 7130 and the dual-channel Signature Edition Gold Infusion System Model 7230. Both systems support broad clinical applications and IV set performance, and they are designed for maximum reliability and ease of use.
Currently 70 US hospitals are using the Medley system with Guardrails software, and 50 are using the Signature series. More hospitals are in the process of installing systems, Dr. Vanderveen said.
Implementation of the ALARIS system takes about 3 months from the time the hospital purchases the system until it is up and running. "Hospitals have to set up and agree on rules to be programmed into the infusion system," he said. An example of these rules is "Are you a new patient?" If so, the system automatically clears out the old memory. The "Where am I?" option allows the nurse to program in which patient care area of the institution it is being used (eg, pediatrics or the intensive care unit). Another question is "What medication am I about to infuse?" Dr. Vanderveen noted that, depending on the size of the hospital and the number of different departments, the pump has a capacity for 1000 different capabilities.
Once the rules are programmed, ALARIS conducts computer-based training, followed by a 1-on-1 training session with all nurses to ensure that they are comfortable with using the system. The hospital has "superusers" nurses who are trained at a higher level and play an important role in the system's implementation. "In a 700-bed hospital, it only took 3 hours" to have the system running, Dr. Vanderveen pointed out.
ALARIS' job is not finished after implementation of the system. Project managers and a support team help make sure that the system runs smoothly and address any questions or problems. Hospitals using the ALARIS infusion systems will see immediate results. "One hospital had an infusion pump that wasn't picking up an error until ALARIS was in place. The error had been going on for 36 hours," explained Dr. Vanderveen.
St. Joseph/Chandler Health System of Savannah, Ga, has seen results with the ALARIS Medley System with continuous improvement data capabilities. That health system is comprised of >600 beds. Prior to installing the system in October 2002, "we spent some time evaluating our drug-use process and looking at all steps critically involved in the medication-use process. We found that the point of greatest potential for error was at the bedside," said Ray R. Maddox, PharmD, director of clinical pharmacy, research and pulmonary medicine for the hospitals.
The St. Joseph/Chandler Health System, which has >500 pumps installed, had them up and running in about 65 days. Dr. Maddox said that 6 weeks was spent building the drug library and developing the minimum and maximum doses, and several weeks of training was given for the nurses and pharmacists. Within 48 hours of implementation, the system was running smoothly, he noted.
Positive benefits of the system are twofold. The first is intervention, because it stops potential serious errors, using the Guardrails software, from occurring. "In the first 9 months in the hospital, we saw [that] a significant number of errors were prevented," said Dr. Maddox. The second is the continuous quality improvement data, because "we can retool our medication administration."
"In my opinion of the technologies broadly available for health systems, this [infusion pumps] is the most important technology in place because it does have a serious effect on reducing errors," Dr. Maddox concluded.
It is not only the products, but the individuals that are important at B. Braun Medical Inc. "The people component is critical," said Rachel R. Vitoux, RN, MSN, CCRN, manager of clinical and technical support for the company. "Products can only go so far, so by offering information and strategies and looking at ways to close the gap we can avoid errors," she said.
More than half of the serious and life-threatening errors are associated with IV therapy. "Programming is the number-1 error with infusion pumps," Vitoux said.
Therefore, B. Braun has developed the Outlook Safety Infusion System, available in 4 models, to help reduce human errors. The system with doselimits technologies notifies the clinicians if institution-defined dose limits are exceeded. Patient safety is further enhanced with pump-based bar-code technology, featuring automated checks and balances that enhance the manual procedures already in use.
The Outlook 100 alerts clinicians when dose limits are exceeded, reduces titration errors, and provides set-based free-flow protection. "The Outlook 100 is consistent with a lot of infusion systems and ensures [that] the clinician is infusing the medication within the hospital parameters," Vitoux said.
In addition to the DoseGuard error-reduction software, the Outlook 200 has DoseScan software that uses a barcode scanner. Outlook 200 features pump-based bar coding that verifies the right drug, right dose, and right patient and authorized clinician automatic programming to improve safety and reduce manual programming errors. It requires no wireless system to implement bar coding.
"The Outlook 200 has a built-in barcode scanner and closes the loop of the 5 medication rights," said Eric Melanson, product director, infusion systems marketing group, for B. Braun.
Bar-code technology leaves less room for error. "When titrating critical drugs, there is a lot of error ability, and it [the Outlook 200] alerts the clinician to the incorrect rate. The goal is to pick key areas where critical errors are occurring. We're eliminating the steps and allowing the clinicians to use their expertise. The expertise of clinicians enables the industry to develop these technologies," said Vitoux.
The Outlook 300 and 400 models are not currently available. The Outlook 300 will be released late in 2004, and the Outlook 400 will be available in early 2005, according to Melanson. The Outlook 300 has all the technology of the 200 model plus remote access to real-time infusion data and open architecture designed to help reduce time spent on manual charting and to help improve work flow. The most advanced Outlook 400 features all the benefits of the Outlook 300 as well as an interface with existing bedside systems, wirelessly transmits up-to-date IV orders to the infusion pump, and improves management of patient data.
Implementation of any of the 4 models takes about 5 weeks. B. Braun personnel spend 3 weeks with facility personnel discussing which features the facility wants and looking at the product mix to enhance safety. Regarding safety features, Vitoux said, "We sit down with the client [representatives] and talk about which safety features to activate and the level of safety they want."
It takes B. Braun about 2 weeks for the implementation phase. The facility will have support 24 hours a day 7 days a week, with a team of clinical support persons who are experts with the system. Vitoux said that they use a 3- pronged approach for training the clinicians using the systems. B. Braun offers classroom training concurrent with unit-based in-service, which provides a bedside approach and handson training, and a clinical mentoring program. The mentoring program has hospital employees go through specialty training by B. Braun so that they understand all the advanced features of the models and can provide assistance and support for clinicians using the pumps, Vitoux stated.
"We take the ?Sharing Expertise' movement to heart. We come back in for follow-up service as well as advanced feature offerings," she added. B. Braun's "Sharing Expertise" is an ongoing initiative that promotes best practices for continuous improvement of health care products and services by sharing knowledge among its own personnel and other experts.
Another educational program offered by the company is "Ask the B. Braun Safety Expert." Launched in October 2002, the free service is designed to provide clinicians and health care consumers with answers to some of the most pressing safety issues such as medication errors. The panel of experts is comprised of clinicians and nurses with practical expertise in handling patient and clinician safety issues.
Children's Medical Center of Dallas, Tex, is very familiar with B. Braun's Outlook system. In March 2004, the pediatric hospital installed >300 Outlook 200 pumps. Personnel at the 325-bed hospital spent about 6 years from researching to implementation of a product. The hospital also has provided valuable input in helping B. Braun develop its pumps. "B. Braun was the first hospital to ask us about bar coding," said John Tourville, RPh, PharmD, director of pharmacy for the hospital.
During the research process, Dr. Tourville said that, across the board, hospital officials continued to see that "40% of all significant errors had an IV pump attached to them."
The hospital officials decided on the Outlook 200 because "they wanted a system they could control," he added. The Outlook 200 has many benefits. "You can scan the drug and get to the right menu without having to do a lot of inputting or keystrokes. We like the verification because it works with our hospital protocol," explained Dr. Tourville.
The hospital plans to implement the Outlook 400 when it becomes available. As for technology at the hospital, Dr. Tourville said, "Technology has allowed us to be more clinically orientated and allowed us to focus on pharmaceutical care and cut down on the turnover rate of pharmacists."
Experts in the field agree that infusion pump technology will continue to reduce medication errors. As the technology moves forward and more advanced pumps enter the marketplace, hospitals will have more options available to improve patient safety.