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|Newsletters: Trends in Ambulatory Infusion Pumps|
Trends in Ambulatory Infusion Pumps
In the 1980s, as the home infusion therapy market grew exponentially, manufacturers of ambulatory infusion devices introduced a variety of pumps capable of delivering complex therapies outside of the acute care setting to ambulatory patients. Their response to the evolving needs of a fledgling provider community resulted in product improvements, specialization, and introduction of innovative advances in technology.
By the 1990s, as payers began ratcheting down reimbursement, providers faced considerable pressure to remain profitable and the market underwent a significant consolidation. These financial challenges dissuaded providers from investing in new device technology, and as a result, sales of pumps—and thus the creation of newer models by the manufacturing industry—flattened.
Today, home infusion providers are faced with a variety of challenges--growing patient populations, ongoing reimbursement issues, and national nurse and pharmacist shortages to name a few. However, in the near future they may be more likely to adopt—and invest in--new delivery device technology for a number of reasons.
The Fittest Survived and are Looking Up
First and foremost the providers who survived the fiscal and regulatory challenges of the recent past have a significantly better understanding of their companies than ever before—these are the successful providers operating healthy businesses. Collectively, providers have scored some major victories that should allow them to remain a profitable sector of the health care industry, such as the successful adoption of electronic claiming and specialized coding and the creation of a standardized definition of per diem for use in contracting and billing.
Another potentially promising development is the creation of a Medicare prescription drug benefit under the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). Along with coverage for traditional retail medications, the Part D provisions of the MMA also broaden coverage for home infusion drugs effective January 2006. This could lead to a significant expansion in the patient population for cost-effective home and alternate site infusion therapies. Because this new coverage is not linked to the usage of specific types of durable medical equipment (as it is now under Medicare Part B for the few infusion drugs currently covered in the home) providers may have more freedom to make use of higher-tech delivery devices when indicated, based on the clinical needs of patients as well as cost-effectiveness.
As written, however, the legislation does not specifically discuss the coverage of the professional services, supplies, and equipment needed to make this new infusion drug coverage safe, meaningful, and consistent with professional standards of practice. The per diem reimbursement model used by cost-sensitive managed care plans addresses these issues and provides an ideal model for Medicare coverage that would also help the industry make further strides in streamlining operations. The National Home Infusion Association is actively working with the Centers for Medicare and Medicaid Services to shape this important new benefit in this way.
Focus on Patient Safety
The health care industry’s ongoing focus on patient safety and reducing medication errors is also contributing to a renewed interest in high-tech delivery devices. While the research and development activities of pump manufacturers has always focused on reducing the cost of care and improving patient outcomes, they are now focusing on the development of new features that anticipate patient safety regulations set forth by the U.S. Food and Drug Administration (FDA), accrediting bodies, and the like. As is typical, such changes are appearing in the acute care sector now but will soon begin trickling into the alternate care settings.
As part of its ongoing efforts to encourage health care providers to use information technology to promote higher quality of care, in February 2004, the FDA issued a final rule requiring bar codes on the labels of thousands of human drugs and biological products. The agency estimates that the use of such technology in hospitals can reduce medication error rates by as much as 85 percent.
Pump manufacturers are already selling “smart” devices to hospitals. These pumps incorporate new enhanced medication delivery safety software that includes drug libraries, pre-programmable dosage levels, drug and concentration selections, bar code scanners, new reporting capabilities, and interfaces with the hospital’s pharmacy software system that support error-avoidance and process improvement.
One such example is the Medley™ Medication Safety System by Alaris® Medical Systems. The Medley is a modular point-of-care computer that integrates infusion, patient monitoring, and clinical best practice guidelines in one platform. Currently, a pump module, a syringe module, and two pulse oximetry modules are available. In addition, the pump uses Guardrails® Safety Software to protect against medication errors. In another example, the Colleague® series of pumps, manufactured by Baxter Healthcare Corporation, offer basic programming as well as dose calculation modes, label library, and programmable personalities, which allow for storage of up to eight user-defined parameters.
B.Braun Medical, Inc. also offers a “smart” pump called the Outlook™ Safety Infusion System. Outlook™ is equipped with DoseScan™ and DoseGuard™ technologies, which allow a qualified clinician to automate the programming of the device and notify the clinician when institution-defined dose limits are exceeded. And, Hospira (a spin-off division of Abbott Laboratories) offers the OmniFlow 4000® Plus Medication Management System™, which features dose calculator, programming up to 24 hours in advance, clinician call-back, and history reports.
On the ambulatory side CME, an Israeli-based company, has recently introduced the Body Guard 323 ambulatory multiple therapy infusion pump. Small and portable, weighing just over 11 ounces without the battery charger, this pump is the first ambulatory device in the U.S. to have the capability to connect to a hand held computer that contains a customizable drug library and allows for a specific patient identification code that must match in order for the pump to run. The Body Guard 323 also has a bar code reader accessory and a pulse oximeter attachment that can monitor a patient’s temperature and heart rate while infusing.
Other manufacturers indicate that the next generation of ambulatory infusion pumps will incorporate bar coding software and drug library software, similar to those found in hospital based equipment, to assist in the safer delivery of medications to patients outside the hospital. Several ambulatory pumps on the market today, such as the 4000CMS™ from Curlin Medical, LLC and the CADD® Prism series from Deltec, Inc. (part of the Smiths Medical family of companies), incorporate computerized telecommunications capabilities allowing them to be programmed remotely either over the phone, from an authorized computer, or personal data assistant (PDA). In addition, the Deltec CADD-Sentry™ Medication Delivery Manager allows for the entry of standardized protocols, on a PC, with pump settings and programming limits. The protocols are stored and indexed by patient type, care area, and/or drug for easy reference and selection. Others, such as the GemStar® Infusion System from Hospria, allow for remote data collection via downloadable pump history; the Baxter 6060 downloads history along with a monitoring function. While these capabilities do not specifically address medication errors, they provide the technological groundwork for such features.
Such developments will be timely considering that the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) may require home care providers to develop a plan for implementing bar code technology for patient identification and for matching patients to their medications or other treatments. The requirement is currently being considered as part of JCAHO’s 2005 National Patient Safety Goals; if adopted, providers would need to be compliant by January 1, 2007 as part of their JCAHO accreditation.
Wider Use of Telecommunications
Having a computerized ambulatory pump in a patient’s home offers several advantages beyond the assurance of safe medication delivery. Providers can benefit from receiving electronic reports from pump data on the administration of therapies or from data, such as height, weight, and blood pressure, entered by the patient or caregiver. This allows clinicians to check compliance and infusion profiles from a distance. The extensive history of events can be used for troubleshooting, electronically sharing with other health care providers, and as part of the documented patient record.
Pumps can be programmed remotely and even make use of digital imaging and messaging technologies for patient training or communication with health care professionals, greatly reducing “windshield time”—an added benefit in light of the current nurse and pharmacist shortage.
Ambulatory infusion pump manufacturers have been incorporating telecommunications capabilities into their devices since the early 1990s, however early technology was not reliable, existed in numerous platforms, and was difficult and expensive to implement. Now many of those hurdles are gone and health care providers use similar technology to a wide extent in their day-to-day business activities.
To date, the adoption of new ambulatory electronic infusion technology has been very slow. However, there are clear indications that authorities in the regulatory and accreditation arenas are looking toward computer and telecommunication technology to aid in the significant reduction of medication errors to patients in all health care environments.
For home infusion, widespread adoption of these devices seems inevitable. Yes, initially they may be more cost-intensive and there may not be immediate reimbursement available, but there is no doubt that if regulations are implemented and the technology is available health care providers will respond. One just has to look at the conversion to needleless technology following state and federal mandates to prevent needle stick injuries to see the effect that regulatory authorities have in driving the market and opening the door for the introduction of innovative and new technologies.
Jack Saladow has more than 30 years of experience in health care sales, marketing, and strategic planning with a specialty in drug delivery systems. As president of Laguna Niguel, California-based, Jack Saladow & Associates (949-495-7097), he provides sales, marketing, strategic planning, and technology assessment consulting services to a wide variety of health care companies throughout the United States, Canada, and Europe.
Reprinted with permission of the National Home Infusion Association www.nhianet.org. This article originally appeared in the July/Aug 2004 issue of Infusion (vol.10 No.4).
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