The Alaris Infusion
System from CareFusion

Infusion pumps get smarter

September 15, 2010

This report originally appeared in the September 2010 issue of DOTmed Business News

Incorrectly programming IV pumps has been one of the most common types of medication error, and when mistakes happen concerning critical drugs, it can result in serious adverse drug events.

“IV pumps have come a long way since the 1950s when they were developed,” says Gale White, vice president of the infusion systems division for B. Braun Medical Inc. “Technology has been developed [to] control the fluids much better. Smart systems within the pump make the pump do a lot of basic thinking and some of the calculations that nursing professionals at the bedside used to have to do.”

Infusion pumps with dose calculation software are known as “smart pumps,” and offer the capability for a hospital to pre-program its standard concentrations and to program upper and lower dose limits, which reduce possible adverse drug events involving intravenous medications.

“When implemented correctly, the pump will alert the nurse if the pump has been programmed outside of safe limits and are designed to prevent administration of doses that are considered by the hospital to be extremely unsafe,” White says. “One of the things we have done is to try to make them simpler so the user doesn’t have to make as many decisions and isn’t distracted by the alarms or indications given to them.”

It is believed that more than 50 percent of all hospitals have already made the switch to smart pumps and that in the next decade the number will be closer to 80 percent.

“Integrating with hospital IT systems is one aspect of innovation that will be critical in the years ahead,” says Gordon LaFortune, senior vice president and general manager for infusion systems for CareFusion.

Industry buzz
In April, the U.S. Food and Drug Administration issued the draft guidance, “Total Product Life Cycle: Infusion Pumps—Premarket Notification [510(k)] Submissions,” focusing on infusion manufacturing companies.

“The action of the FDA over the last few months with the pump guidelines and their approach to how they regulate the industry is what people in the industry are talking about,” says LaFortune. “In some ways, it’s too early to tell what this will mean, as we digest the guidelines and understand what it is we have to do to comply, but the broad implications is that innovation will still happen, but the timeframe to get approvals will be longer, more expensive and we’re going to have to get approvals more often than we have in the past.”

B. Braun Space
Infusion System

The initiative will address safety problems associated with infusion pumps by requiring manufacturers to collect more information about the level of data in pre-market infusion pump products, including providing additional information on design and engineering and conducting additional testing and analytics that need to be done.

“To any company, the bar to enter has been raised considerably,” says Nelson Patterson, senior director of Baxter's global infusion systems business. “If you have a new product, or you make a change to an existing product, even if it’s considered minor, it will require clinical evidence that you are improving the safety and the capability of the product. That’s a time delay and a huge barrier to bringing new products to the market.”

Advancements abound
Newer automated tools have emerged and are beginning to play a role in infusion pumps as some pumps have the capability of integrating patient monitoring and additional parameters such as the patient’s age or clinical condition.

“What we are seeing in the infusion pump market is a lot of conversations surrounding meaningful use,” says Symeria Hudson, vice president, medication management systems for Hospira in the U.S. “The Obama administration launched a big campaign in 2009 focused on the adoption of electronic health records and there are opportunities for pump companies, like Hospira, to really be inclusive in the definition of meaningful use.”

In its goal to shape the parameters of meaningful use in the industry, Hospira has focused its efforts on developing pumps with more interoperability and auto-programming functions.

“We look at how our devices can be integrated within a hospital’s electronic medical records and bar code point-of-care administration systems, which allows for auto-programming for specific patient orders back to IV devices,” Hudson says. “We understand the importance of having a solution that provides customers with these capabilities.”

B. Braun has recently introduced its Outlook Safety infusion system, which has a barcode scanner built into it and has the option for a handheld scanner to be attached.

“This helps automate the administration of fluid from the programming. The pump can scan the bar code and implement all the information the pharmacist sent—patient’s name, drug and rate at how it should be delivered—and it can be programmed into the pump, which eliminates 30 to 40 button pushes,” B. Braun’s White says. “Ordinarily, you would program using buttons and if the nurse noticed there was a change needed to the medication, you would need to put the pump on hold. But with this technology, you can take a prescription bag with a barcode scanner and press a button and the pump will run.”

The information that is stored inside the pump can also be transmitted wirelessly to hospital information management systems, which allows all involved parties throughout the hospital to see what is happening.

Infusion pump manufacturers understand that nurses are busy and have a lot of patients to take care of, so a great deal of thought is put into designing new equipment to help streamline their workflow.

“The smart pump technology with programmable limits and the ability to incorporate bar code identification of the drug, patient and RN can really help close the loop on medication safety,” says Judy Bethe, manager of nursing education for Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., which uses Carefusion’s Alaris pump. “This pump provides the ability to have different profile levels, for example, critical care, medical surgical, anesthesia, etc. Within each of these profiles the limits for dose, rate, and volume can be different and thus help protect the patient from receiving a drug at too fast a rate, or too high a concentration.”

Hospitals are experiencing a number of positive results by having these interoperability systems available by their bedside.

“Working with one of the hospitals, we found we could reduce nursing time by 25 percent by using the auto-programming system,” Hudson says. “We also found that we can streamline the workflow by reducing infusion pump programming steps from 17 to seven and reduce manual bedside errors by greater than 90 percent.”

Recall issues
According to FDA statistics, thousands of serious injuries and more than 500 deaths have occurred in the past few years because of pump problems on the manufacturing level. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns.

In July, the FDA posted a Class I recall of the Symbiq One-Channel Infuser (Model 16026) and Symbiq Two-Channel Infuser (Model 16027), manufactured by Hospira because of their potential for the devices to fail to detect air in the line at the end of an infusion.

On April 30, the FDA sent a letter to Baxter ordering the company to recall and destroy all of its Colleague Volumetric infusion pumps, citing its “long-standing failure to correct many serious problems with the pumps.” Baxter has worked cooperatively with the FDA and is providing refunds or replacing the pumps at no cost to customers.

Sigma Spectrum Infusion
System, exclusively distributed
by Baxter.

Under the FDA’s order, Baxter is responsible for recalling as many as 200,000 CVIP currently in use in the United States and must complete the process by July 14, 2012.

“Baxter’s goal is to support a seamless transition by providing options that best address the needs of our hospital customers and minimize disruption to the delivery of patient care,” Patterson says. “The 24-month timeframe allows customers to continue using the Colleague pump while transitioning to either the Spectrum pump or other FDA-cleared devices. Baxter is working with Sigma to increase production capacity of the Spectrum pump in order to meet the anticipated demand for this device.”

In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the CVIP until it fixed manufacturing deficiencies and brought the pumps into compliance with the law.

Patterson says that the company is excited about resolving its issues and getting out of the consent decree it has had with the FDA as it feels companies such as Hospira, CareFusion and B. Braun have expanded their role in the sector at Baxter’s expense.

“Finally, with the resolution that was announced, I think we will be close to having an end to this oversight we have had for five years,” he says. “It’s an incredible relief to Baxter employees to see the end, so-to-speak, of the legal issues. The hard work they have put in, the incredible talent and improvements in quality systems that will now be evidenced in the products that they have worked on is exciting to Baxter.”

Decision time
Many hospitals are looking to move over to smart pumps now, but making a change to that technology is a major undertaking and requires coordinated preparation.

“It is important that when making an assessment for pump selection that front line staff is involved in hands-on time with the pumps,” Bethe says. “Guidance from the company in making the switch to different tubing is also vital. Equally or possibly more important is to ensure that there is strong company support for the preparation phase involving pharmacy and nursing to define the profiles and then RN training staff who utilize a tested model with enough personnel to effectively train large numbers of nurses in a short amount of time.”

Today, hospitals are spending a lot of money on their information systems and will spend a lot of money on their smart pumps, and they want to make sure these two big investments are going to work well together.

“I think these are big decisions that you are making as a customer; you’re essentially making a bed you will lie in for five to 10 years,” LaFortune says. “You want to understand how this decision will enhance your clinical effectiveness and improve your ability to deliver therapy in a safe and more cost-effective way and make your workers more productive.”

Old faithful?
Philip Stuemke is the vice president of Novatek Medical. The company sells, rents and refurbishes infusion pumps. He says he has had a number of his customers ask about the newer technology, but they’ve been reluctant to make a move on it.

“We have a lot of people talking about going to smart pumps, but their concern is that the ones with wireless could cost a couple of hundred thousand to buy and another hundred thousand in costs a year,” he says. “With the economy the way it is, we have seen a lot of people buying old stuff and trying to maintain what they’ve got.”

John McMahon, owner of Quality Medical South, believes that there is still a market for older brands of infusion pumps.

“Infusion pumps are getting much more complicated and therefore have a greater tendency to fail because there are more things that can malfunction,” he says. “We promote older equipment because of its reliability and durability compared to newer devices.”

Other factors to consider
While the Baxa Corporation does not manufacture or design smart pumps, it provides medical devices and systems that automate pharmacy operations in the delivery of liquids to patients from the IV bag.

“Twelve years ago the smart pump market [was] born with rate control systems and now you have these really brilliant pumps that are the centerpiece of the marketplace,” says Dennis Schneider, senior VP of marketing and business for the company. “We impact about 450,000 doses a day in 3,000 hospitals worldwide, so we have a lot of experience on the liquid side.”

This year, the company launched a new simple infusion pump called the InFuse T-10 Syringe Infuser, designed to be the antithesis of a smart pump to use when a smart pump isn’t warranted.

“This non-programmable pump is ideal for infusions where smart pumps are not necessary,” Schneider says. “This will help health care systems address the constraints that have been placed on them by the recall of the smart pumps by deploying their smart pumps more effectively.”

Schneider explains that about 40 percent of all IVs in the hospitals are used to distribute intermittent antibiotics and for these and other less important doses, there’s no need for all the bells and whistles a smart pump offers.

“I don’t want to spend a $3,000 smart pump on that problem, I want to put in a syringe and click and walk away,” he says. “A $150 pump can do that same job and my smart pump money can be used for more critical applications [that provide] nurses with more time to focus on patient care.”

Looking ahead
When industry experts look to the future, they expect infusion pumps to continue advancing in the areas of safety software, wireless systems and integrated management care.

“We will continue to focus on interoperability, that’s really a big push for us,” Hudson says. “We still find a lot of hospitals are looking for that because as their systems are starting to talk to one another, their expectations are that our pumps are able to do the same thing. Another area that will be really important is the area of decision support, about providing the right information at the right time by the bedside.”

LaFortune says that CareFusion will look more globally in the future and see a lot of opportunities to grow around the world.

CareFusion’s activity on the global stage and Baxter making a big move back into the field should provide an infusion of interest to the sector, setting up some interesting developments for the coming years.