Anyone in the medical device industry who has attended a trade show in the past few years is acutely aware of the new standards in performance.

Factors such as interoperability, security and big data application are the new expectations to serve customers and patients.

As a result, the once dowdy infusion pump has emerged smarter, safer and more interactive.

Another factor to consider is that representatives of the OEMs told HealthCare Business News that they have incorporated cybersecurity into their infusion pump platforms.

“That’s the biggest question we get: How secure are you guys?” says Mike Golebiowski, vice president of marketing, automation and infusion systems at B. Braun Medical. The prevailing attitude among the OEMs is that they never assume they have reached a secure state where hacking is not a threat. Constant vigilance to avoid complacency is now the industry standard.

“We ... recognize that there is no such thing as 100 percent secure,” says Nicole Wilson, RN, MSN, CPHIMS, manager of clinical marketing for Alaris Integrated Solutions at BD. “As systems evolve [there are] vulnerabilities that may be identified and we consider you a partner in this process. We support coordinated vulnerability disclosure and incident response.”

Golebiowski echoed this sentiment.

“I don’t think [any OEM] should be completely confident,” he said. “The better question is, how quickly can your organization react when a threat is identified? We’ve already made security enhancements in our [latest] software.”


Wireless connectivity
Alaris has invested heavily in smart, wireless connectivity. “We have 168 hospitals live house-wide with bi-directional connectivity between our infusion pumps and leading EMRs,” says Wilson. “Alaris is the only infusion pump vendor that has customers live with both large-volume pump and syringe module interoperability.”

Bi-directional capability, she added, provides extensive safety of infusion administration and accuracy of documentation. This interoperability provides bedside safety with features that reduce manual programming key presses and inherent errors.

There are other Alaris safety features, including Auto-ID, which captures drug information from medication label bar controls. This, Wilson says, is a good option for hospitals that are not yet ready for interoperability with EMR systems. The platform also offers unauthorized user lock-out and tamper-proof detection. Another feature is minimum and maximum dosing parameters along with a monitoring feature for respiration to reduce risks during opioid infusions.

“Implementation of Alaris integrated solutions results in standardization and reduced variability for both nursing and pharmacy,” said Wilson.

Infusion data analysis
According to Eric Sato, vice president, infusion technologies at Baxter Healthcare, the company’s Sigma Spectrum offers new safety features.



“These features include Baxter’s infusion analytics application, a software solution that provides advanced infusion data analysis and graphical reporting to help identify potential pump programming errors,” he said.


These safety updates join existing Sigma Spectrum features, such as the Master Drug Library — or MDL — and Gateway. According to Sato, MDL allows pharmacists to create and customize a list of medications and fluids within medically appropriate dose ranges to guide safe programming, avoiding mistakes before they reach the patient.

“[The] Sigma Spectrum Infusion System helps clinicians make immediate use of a smart pump’s defining safety feature — the drug library — by automatically defaulting to the drug library at power-on, without requiring clinicians to ’opt in,’ “ says Sato. “Drug library updates can also be delivered wirelessly without interrupting clinical workflow.”

Health systems use the MDL and Infusion Analytics application to gain visibility to clinical workflow at the bedside and to understand drug library compliance metrics.

“These insights can be used to improve patient safety measures, eliminate unnecessary alarms and minimize preventable adverse drug events,” says Sato. “The Safety Management System also includes a suite of remote professional services that offer 24/7 service and technical support, along with regular cybersecurity monitoring and reporting.”

According to Sato, the single IV set technology featured in the platform can yield about 53 percent cost savings in IV tubing and a 30 percent reduction in IV tubing use. Although the system does not deliver alerts to mobile devices, it does offer integrated asset tracking to help optimize system use. The unit is also compact and lightweight for easier handling by nurses and patients.

’Impactful design’
According to Golebiowski, B. Braun Medical’s second generation Space Infusomat LVP infusion pump provides an independent modular design with a wireless, real-time event action alert.

“This is a more impactful design from a customer standpoint because the sooner a clinician gets notification of a problem, the better it is for patients,” said Golebiowski. “You don’t want to bombard nurses with every nuance, but rather have them focus on the more impactful alerts.”



He said there are various reasons for pump alarms, ranging from patient vital signs to sensitivity to a drug. Users can set the pumps to distinguish between high level and other alerts. He also explained that his company’s pumps feature a nonnumeric keypad to avoid decimal medication dosing error if manual programming is necessary.

“We have a nonnumeric feature to help nurses keep from making an error,” Golebiowski said. “The idea is to provide protection for something nurses do less and less of, which is manual programming.”

According to Golebiowski, safety is also enhanced by smarter algorithms, which include the interface to the drug library feature. This, he said, has provided the greatest impact on better patient care. The new government focus to protect wireless devices from being hacked has created a more diligent approval process.

“Approval these days is more difficult. It takes time and effort,” he said. “We have successfully met the latest requirements and rolled out new pumps [at] the end of last year.”

B. Braun pumps provide full electronic medical record integration to avoid transcription errors. They accomplished this through compliance with open EHR standard language. Features include auto integration for both documentation and billing. The pumps also send alerts to remote dedicated cell phones and other mobile devices. Their models include the large volume Infusomat line and the syringe Perfusor model.

ICU Medical
One of the biggest developments in the infusion pump sector in the last year was ICU Medical’s acquisition of the Hospira infusion systems from Pfizer.

“This created a pure play company with focus and scale in the medical device sector, concentrating exclusively on infusion therapy, which is unique,” says Tom McCall, corporate vice president and general manager of ICU Medical.


According to McCall, the company had a 20-year relationship with Hospira, stretching back to its longtime relationship with Abbott Labs through the recent Pfizer acquisition. The acquisition gives ICU Medical an extensive infusion therapy product line, from pharmacy compounding systems and closed system transfer devices (CSTDs), to IV solutions, to smart pumps and safety software, to needle-free connectors and IV sets.

“We now provide the right pumps for any sector of the marketplace, from acute care through to home care,” says McCall. “For example, we have the only PCA [pain pump] that interfaces with the electronic medical record.”

He also cited the company’s PLUM 360 Infusion System, which is used for the administration of oncology drugs. There is, he noted, risk in the use of oncology drugs in that more than one medication is often administered in one treatment session. The closed cassette system in their pumps avoids the risk of air in the line (which can cause an embolism and stroke) and exposure to the liquid or vapors, which can be toxic.

ICU Medical’s Sapphire pump line is versatile, providing service in hospital acute care settings and home health use. All of their pumps feature auto-populate to validate orders from the pharmacy and provide documentation wirelessly.

“Our infusion pump line streamlines the workflow and improves patient safety,” said McCall.

ICU Medical also advocates for evidence-based medicine.

It sponsors extensive studies, which are offered to clinicians and the industry. The most recent study, “Integration of Smart Infusion Pumps with Electronic Medical Record Reduces Potentially Catastrophic Medication Dosing Errors,” found that three hospitals reduced medication dosing errors by 52 percent after the installation of smart pumps.

‘Charting the infusion information’
Smiths Medical is keen on simplifying critical care procedures with bi-directional communication to and from the pump and between the electronic health record, physician order entry system and barcode system.

“Our Medfusion 4000 pump sends all events and periodic updates to the EHR for charting the infusion information in the patient’s record. The order entry and barcode systems send programming parameters to the pumps to automatically enter the infusion parameters on the pump, saving the clinician time and reducing errors,” says Lori Hansen, RN, MBA, the company’s business development manager — informatics.

This auto charting feature reduces the amount of time caregivers need to spend entering data. This allows them to spend more time with the patient.


All Smiths Medical pumps meet IHE technical framework specs to reduce costs, improve efficiency and offer flexibility to health care providers. Hansen said these standards apply to their pumps’ ability to send an alert to a mobile device. Their line also features dose error reduction software, second verification prior to dose administration and weight-based programming.

According to Hansen, these features all support an important goal: clinicians need to spend more time taking care of patients and less time trying to figure out how to use devices.

This is accomplished by ensuring that vulnerabilities are minimized or eliminated. “Safety is everything. Safety for the patient, ensuring the device is smart. Safety for the clinician, reducing the opportunity for human errors. And safety for the hospital, by reducing the risk of vulnerabilities to their systems,” says Hansen.