FDA/AAMI call for safety in infusion pumps

The Food and Drug Administration (FDA)’s document "Infusion Pump Improvement Initiative, 2010" noted, "From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths." During that same period, 87 infusion pumps were recalled. Those numbers may sound astounding until you consider the thousands upon thousands of infusion pumps that were used without incident each and every year during that 5-year period.

The FDA observed: "These adverse event reports and device recalls have not been isolated to a specific manufacturer, type of infusion pump, or use environment; rather, they have occurred across the board." The document goes on to say that adverse events may be the result of user error, deficiencies in design and engineering, software defects, user interface issues, and mechanical or electrical failures.

The purpose of the FDA’s document is not to point fingers but to support use of this valuable medical device while taking steps to prevent infusion-pump problems. The three steps outlined in the document are (1) establish additional requirements for infusion-pump manufacturers; (2) proactively facilitate device improvements; and (3) increase user awareness.

Industry is taking the matter very seriously. Rich Nevin, vice president, medication management systems, US, Hospira, Lake Forest, IL, noted, "Due to the seriousness of infusion-related errors, providing technology to help hospitals address them is a top priority for Hospira. Infusion pumps were developed to help enhance the safety and accuracy of IV [intravenous] medication delivery. With 56% of medication errors associated with IV drugs, it is key that technology evolve to support clinicians in administering safe and effective IV therapy."

Tim Vanderveen, MD, vice president, Center for Safety and Clinical Excellence, CareFusion, San Diego, CA, added: "IV medication errors are twice as likely to cause harm to patients as medications delivered via other routes of administration and represent 61% of the most serious and costly medication errors. They typically involve the wrong drug, wrong dose, wrong route, or wrong rate of administration."

"The medication process in the OR is unique," continued Vanderveen, "as anesthesiologists are the only medical personnel responsible for prescribing, obtaining, preparing, administering, and documenting all medications. Outside of the OR, it is estimated that two-thirds of serious medication errors involve injections and infusions, but, in the OR, it is closer to 100%, so each step in the process poses potential risk."

Eric Melanson, MS, MBA, director of marketing, infusion systems, B. Braun Medical Inc., Bethlehem, PA, further discussed why infusion pump-related errors can be so serious. "We are delivering medication directly into the vascular system. One operator error or device malfunction can have unacceptable consequences at any scale. As an industry, there have been documented errors in administering the correct medications to patients, using the wrong route for the administration of medication, delays in timely administration of IV medications, and cases of patients getting the wrong dosages."

The Association for the Advancement of Medical Instrumentation (AAMI) and the FDA held an Infusion Device Summit in October 2010 that resulted in a list of priorities that includes the following points: standardize systems and processes for reporting, aggregating, and analyzing infusion device incidents; improve the integration of infusion devices with information systems and drug libraries; mitigate use errors with infusion devices; improve management of multiple infusions; reconcile challenges and differences in the use environments of infusion devices.

Healthcare Purchasing News approached the industry to determine just what kind of an impact the AAMI/FDA Infusion Device Summit of October 2010 has had.

Baxter's SIGMA Spectrum Infusion System features technology intended to help reduce adverse drug events.

Vanderveen, CareFusion, observed: "While it’s still too soon for us to measure the impact on new infusion technology, the Summit set in motion critical efforts to improve infusion therapy. A number of working groups are now focused on establishing and disseminating best practices, including creating standardized models for drug libraries, infusion terminology, and reporting systems. Infusion practices are complex and vary considerably both within and between hospitals, so the adoption of new practices takes time. The real value of the summit, so far, has been to devote much needed focus on the issues and challenges within infusion therapy."

"Many key agencies, including the FDA, are mandating changes that ultimately will benefit the patients and clinicians who depend upon our products," said Melanson, B. Braun Medical. "Every vendor has been impacted in ways that affect how devices are designed, validated, and cleared in the market. In December 2011, we all received new guidance from the Center for Devices and Radiologic Health in what does or does not require a 501k. Most of the developing recommendations and guidelines have not yet been finalized and incorporated into already-cleared devices."

"The AAMI Summit also produced a very good publication that raised awareness of issues and challenges with smart pumps and recommendations for areas to be studied," said Melanson. "One of those was management of multiple infusions. This resulted in a study done by HealthCare Technology Safety team in collaboration with Institute for Safe Medications Practices (ISMP) Canada, which provides specific recommendations to more safely manage multiple infusions."

Industry advice

When looking at infusion pumps, what should purchasers look for, particularly in "smart" pumps? Industry offered some general and specific advice.

Ferguson, Baxter Healthcare, observed: "Today’s infusion systems focus on three core capabilities: reliability of design; robustness of the safety features; and, in many countries, the wireless connectivity that enables data analysis of infusions and EMR [electronic medical record] integration."

"Baxter’s SIGMA Spectrum smart infusion system was designed to help prevent adverse drug events with a sophisticated drug-error—prevention software that helps clinicians avoid programming errors that may result in incorrect administration of life-saving or life-sustaining therapies. This software, embodied in the master drug library, allows a facility to set upper and lower dosing limits on infused medications to ensure that programming errors by a clinician do not erroneously exceed the facility’s therapeutic guidelines. In addition, Spectrum’s intuitive workflow has been designed to place multiple error-prevention systems at the point of care with consideration for the clinician’s environment."

"The SIGMA Spectrum device is popular with customers looking for the next-generation safety software in an infusion system that will take them beyond a merely ‘smart’ system to one that proactively warns them of potential issues to help avoid adverse drug events. The ‘titration limitation’ or ‘titration control’ feature in the software is highly valued by users who recognize that it can help minimize the likelihood of titrating too much medication to a patient by alerting the clinician that a proposed action will exceed the facility’s recommended limits on the therapy being infused. In addition, Baxter has a robust implementation process to safely implement the SIGMA Spectrum pumps within a hospital. This helps ensure that the hospital carefully creates a customized drug library for their facility and that all clinicians are fully trained on the operation of the pump."

B. Braun Space Infusion System including the Infusomat Space, Perfusor Space, and Perfusor Space PCA

Melanson, B. Braun Medical, highlighted the importance of taking into consideration the clinician’s working environment. He explained that ease of use, creation of uniform user interfaces, ‘right sizing’ the solution to the institution, and elimination of unnecessary steps enhances safety.

"Among the most important things is to design safe devices that recognize the working environment of the clinician," said Melanson. "In surgery, there are time limitations. There may be many different activities taking place at once. Often there is limited space. There is intense activity when critical-status patients are being treated. Devices that are designed to fit well in that environment allow patients to be treated with attention directed to the procedure and not to the device. Two key examples of B. Braun’s design approach working well in that environment are the Infusomat Space and the Perfusor Space. Due to the modular and versatile design, both large-volume and syringe delivery can be done effectively in a compact, modular design that fits in a surgical environment."

"Our Perfusor Space syringe pump offers automated syringe-recognition and post-occlusion bolus-reduction features that support use by anesthesia. Our Infusomat Space large-volume pump has the performance and features that easily support the delivery of critical drugs, electrolytes, and blood during surgical procedures. Both can be incorporated into an ergonomically designed Space Station that allows the creation of up to 24 pumps in a single vertical array that conserves precious space with only one power cord connection."

Melanson believes it is important to address the potential for confusion by minimizing "the use of numeric keypads to avoid decimal place and numeric errors in dosing. This has been something emphasized by ISMP. We strive for a user interface design that reduces the number of steps or key presses necessary to change a dose or modify programming while also requiring confirmation of each step." He also recommended "the use of single-channel modular devices, which tend to reduce line confusion and which allow the maximum asset usage of valuable smart pump technology."

Melanson also talked about the importance of having adequate drug libraries. "Smart-pump drug libraries need to have enough capacity to ensure safe administration of IV medications. They should include the provision for hard and soft limits and the use of appropriate clinical advisories for those drugs or solutions that the hospital wants to highlight in clinical practice. The capability to extend safety to all types of therapies, including bolusing, piggyback infusions, and other types, is most desirable. With wireless technology, we gain the ability to interface with bar code medication administration, EMR systems, and the capability to easily collect and review infusion data."

"We stay keenly aware of the success of our customers and have seen some of their published data in our smart pumps’ effectiveness in reducing and mitigating medication errors," said Melanson. "In one case, pump-based dosing errors were reduced to zero. They documented a year of product use."

Hospira's Symbiq infusion pump with built-in MedNet safety software

Nevin, Hospira, suggested considering ergonomics as well as safety. "Our hospital customers evaluate a number of smart-pump design and functionality features to determine how well a device meets their workflow, technology, and safety needs, such as overall user friendliness; ease of infusion-pump programming; wireless capabilities; ability to upgrade devices as technology infrastructure and resource needs change; safety software capabilities; and IV clinical integration capabilities."

"Hospira offers a number of smart infusion-pump options to meet varying functionality and clinical needs. For example, Hospira’s Plum A+ device is a proven, scalable infusion pump designed to meet evolving hospital needs, with options like adding Hospira MedNet safety software and upgrading to IV clinical integration. The advanced Symbiq infusion pump features a large LCD touch-screen display, has Hospira MedNet safety software already built in, and boasts enhanced connectivity features to support IV clinical integration. Hospitals have begun using IV clinical integration technology to connect infusion devices, such as Symbiq and Plum A+ systems with Hospira MedNet safety software, with hospital information systems to achieve near real-time sharing of infusion information between infusion pumps, EHRs, and other hospital systems."

Nevin cited anecdotal evidence supporting use of their system. "One hospital saw a 32% reduction in reported heparin-administration errors following implementation of IV clinical integration. One hospital that implemented IV clinical integration technology experienced a 27% reduction in nursing time to start a new infusion, more than 1,300 nursing hours saved per year in titration and documentation of an existing infusion, and the ability to avoid an average of 30 potential adverse drug events in a 2-month period. Another hospital saw a $6.8 million financial benefit after implementing IV clinical integration."

"We are especially excited about the opportunity that exists right now for Symbiq. The enhanced Symbiq device received FDA clearance in March 2012, becoming the first general infusion pump to receive approval under the rigorous new 510(k) draft guidance for infusion pumps."

Vanderveen talked about CareFusion’s history: "We delivered the industry’s first ‘smart’ infusion pump with dose-error reduction software, which has helped improve the safety of IV medication administration. Our flagship infusion pump is the Alaris System, which is built on a modular platform to help clinicians protect all types of infusions and across all modalities including pump, patient-controlled analgesia and syringe infusions, respiratory monitoring, and bar-coding capabilities."

"CareFusion is uniquely able to equip customers with actionable information that helps bridge the gap between medical devices and a hospital’s health information system. Through our Guardrails Suite MX continuous quality-improvement software, our Infusion Analytics Service, or our Knowledge Portal for Infusion Technologies, healthcare providers can access near real-time and retrospective data and analytics to help improve clinical practice, medication safety, and workflows."

Vanderveen also talked about a recent product development. "This year, CareFusion introduced a series of new intelligent infusion technologies to improve interoperability between devices and health information technology systems. We recently went live in limited commercial release with a new, bi-directional infusion-pump connectivity solution that helps hospitals enhance patient care, improve workflow efficiencies, and reduce medication administration errors by enabling nurses to remotely program IV medication orders from the hospital’s EMR system to the CareFusion Alaris System smart infusion pump through bar-code scanning."

Not every occasion calls for infusion pumps with all the whistles and bells to get the job done. Sometimes the beauty of a product is found in its simplicity. Elastomeric infusion pumps have a stretchable balloon reservoir that holds the fluid. The fluid is delivered by pressure from the elastic walls of the balloon.

I-Flow’s elastomeric ON-Q pumps have no complicated electronics.

Chris Barys, general manager, I-Flow LLC, a Kimberly-Clark Health Care Company, Lake Forest, CA, talked about their elastomeric pump. "I-Flow’s ON-Q Pain Relief System is a cost-effective alternative to electronic pumps that promotes mobility. The ON-Q pump is a disposable and portable elastomeric device filled with a local anesthetic prescribed by the patient’s physician for postoperative pain relief. The ON-Q pump is used for local and regional anesthesia and, in some cases, may be a good alternative to narcotic epidurals, which are typically administered with electronic pumps."

"The ON-Q continuous infusion therapy pump does not have any alarms or complicated electronics, has no batteries or cords, nor does it require maintenance," explained Barys. "ON-Q pumps come in many sizes and configurations: fixed flow rate, Select-A-Flow dial, and the ONDEMAND bolus feature. Some of the ON-Q models also allow for multi-site catheter placement."

"ON-Q pumps provide better pain relief than narcotics alone and significantly reduce the need for narcotics. By reducing narcotic use, continuous infusion therapy with ON-Q can reduce length of stay, help patients feel better faster, and manage their pain locally while reducing narcotic-associated side effects such as nausea, vomiting, grogginess, and constipation."

Resources

There is no better place to start investigation of new products than with the vendors themselves. They have invested much time, money, and research in their products. With purchasers’ input, they can help facilities decide on the type of product that is appropriate for them, as well as how many are needed. Below are a few resources offered by these companies.

B. Braun Medical offers a ‘Smart Pump Selection Guide’ at no charge. The guide outlines selection criteria and identifies who should participate in the infusion-pump selection process. "We use classroom live, on-unit, and online training resources to support the uptake of knowledge on smart pumps," said Melanson.

Vanderveen recommended visiting CareFusion’s infusion clinical documentation site: http://www.carefusion.com/medical-products/infusion/infusion-clinical-documentation.aspx. CareFusion San Diego Patient Safety Council’s working groups have developed several toolkits on infusion safety. Learn more at http://www.carefusion.com/safety-clinical-excellence/medication-safety/patient-safety-council.aspx. "The Center for Safety and Clinical Excellence at CareFusion (www.carefusion.com/centerforsafety) serves as a clinical resource for conferences, educational programs, working groups, and publications to help clinicians and administrators nationwide improve the safety, quality of care, and financial performance of their institutions," explained Vanderveen.

Hospira offers educational resources regarding IV clinical integration of infusion pumps with EHRs at http://www.ivclinicalintegration.com/. Go to http://www.hospira.com/ClinicalResources/continuingeducation.aspx to see continuing-education programs related to infusion technologies and other Hospira products. White papers and journal articles discussing infusion technologies and other Hospira products may be viewed at http://www.hospira.com/Clinical
Resources/whitepapers.aspx.