Infusion Delivery Systems and Safety

KEY TERMS

Absorption

Adverse Drug Events (ADEs)

Alarm Fatigue

Bubble point

Elastomeric

Good Manufacturing Process (GMP)

Gravity

Hemorepellant

Hydrophilic

Hydrophobic

Hydrostatic

Hypovolemia

Medical Device Reporting (MDR)

Osmolality

Pressure Pump

Psi

Ramping

Smart Technology

Surveillance

Wetted

FROM IDEA TO INCEPTION

As technology has continued to keep pace with advances in medical science, the delivery of patient care has improved, and more sophisticated devices and innovative equipment have become available for administering infusion therapy. Many of these product concepts have evolved as a result of focus groups or nursing input; those in the field, regardless of the setting in which care is delivered, know what is needed, and nurses are willing to share those concepts. Those who design and manufacture devices do so with outcomes in mind; they are our partners and colleagues.

Nurses, as gatekeepers, play an active role in making product selections that are appropriate for the patient across the continuum of infusion care. Nurses rely on best manufacturing processes, product information, the existing evidence base, and clinical research in making recommendations. As an advocate for patient safety, the nurse responsible for infusion care understands the role of safety and the need to ensure safe use of medical devices and equipment.

Equipment used to deliver infusion therapy is regulated by the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration (FDA). The organization is a huge asset to the process of care delivery. Its roles are outlined in Box 12-1. Simply stated, a medical device is an instrument, apparatus, implement, machine, implant, or other similar article recognized in the official National Formulary of the United States Pharmacopoeia intended for use in diagnosis or treatment.

Government Regulations

Before any device may be sold in the United States, it must have FDA approval. Class I devices have nominal risk and include catheter stabilization devices, tape, pressure infusors, and IV poles. Class II devices have a moderate degree of risk and include solution containers, catheters, vessel dilators, introducers, guidewires, and stylet wires. Class III devices are more invasive and carry the greatest amount of risk. Within this category, we find cardiac pacemakers, replacement heart valves, and other surgical devices.

The classification is consistent with the level of review; for example, class I devices must demonstrate “general controls” including proper labeling, adherence to good manufacturing processes (GMP), and adequate packaging/storage.

INSTITUTE OF MEDICINE AND POSTMARKET SURVEILLANCE

In the hallmark report entitled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” published in July 2011, the Institute of Medicine recommended that the FDA develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze, and act on medical device postmarket performance information. The FDA’s postmarket surveillance system specifications are listed in Box 12-2.

Once the device has been introduced and used in the clinical setting, postmarket surveillance begins. The system, known as medical device reporting (MDR), involves the
manufacturers, institutions, and professionals and is aimed at reducing possible adverse effects. Specifically, medical device postmarket surveillance should

Provide timely, accurate, systematic, and prioritized assessments of the benefits and risks of medical devices throughout their marketed life using high-quality, standardized, structured, electronic health-related data
Identify potential safety signals in near real time from a variety of privacy-protected data sources
Facilitate the clearance and approval of new devices or new uses for existing devices

A companion to the Institute of Medicine’s 1999 Report, To Err is Human, is Keeping Patients Safe: Transforming the Work Environment of Nurses (Institute of Medicine, 2004). This report identifies solutions to problems in hospital, nursing home, and other health care organization work environments that threaten patient safety through their effect on nursing care. The report’s findings and recommendations address the related issues of management practices, workforce capability, work design, and organizational safety culture. Actions needed from the federal and state governments and from coalitions of parties involved in shaping the work environments of nurses also are specified.

Medical Product Safety Network (MedSun)

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the CDRH. MedSun works collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices. Once a problem is identified, MedSun researchers work with each facility’s representatives to clarify and understand the problem. Reports and lessons learned are shared with the clinical
community and the public, without facility and patient identification, so that clinicians nationwide may take necessary preventive actions.

The Safe Medical Devices Act defines “user facilities” as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. By monitoring reports about problems and concerns before a more serious event occurs, the FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death (FDA, 2013).

Nongovernmental Organizations

Nongovernmental agencies play a key role in ensuring safety through oversight and creation of product standards. Appropriate use of devices is critical in ensuring patient safety; the nurse plays an important role in utilizing good technique. Professional nursing societies, such as the Infusion Nurses Society (INS), often provide feedback to manufacturers to initiate change as needed. Nongovernmental organizations (NGOs) and their contact information are listed in Box 12-3.

SAFETY PRINCIPLES AND SELECTION OF EQUIPMENT

General infusion equipment includes durable medical equipment (DME), single-use devices, and reprocessed single-use devices. A working knowledge of the selection and use of these devices is vital for the nurse who must provide infusion therapy and ensure the patient’s safety and comfort. DME is equipment that is used for an extensive period of time; examples include IV poles, electronic infusion devices (EIDs), and ultrasound or infrared devices used to enhance vascular visualization. Single-use devices are discarded after initial use and include solution containers, administration sets, catheters, and dressing materials. Reprocessed single-use devices are those that are labeled for single use but reprocessed for use on multiple patients (e.g., angiography catheters and implantable infusion pumps). The practice is controversial but accepted within the industry (Nelson, 2006).

Although purchasing decisions continue to be made with a group purchasing contract in mind, nurses should be involved in selecting infusion equipment as members of a product evaluation committee, equipment task force, or safety committee. Product decisions
may be made in an effort to solve a patient safety issue or as a cost-containment initiative. Such decisions include the following factors: cost, quality, efficacy, safety, and availability.

The concept of safety will always have a profound impact on practice. Worker safety, in particular, is a top priority for health care institutions today (Pugliese, 2013). Sharps safety is also part of a larger discussion among health care leaders and professionals about what a culture of safety means, and whether it means combining all health care safety efforts, such as employee, environmental, and patient safety. Much of the time, the efforts for improvement are similar across all categories, requiring the same culture in the same care environment. Protecting health care workers from injury is essential, especially in infusion therapy, where injuries resulting from sharp objects and devices are more prevalent than in other areas of nursing practice. Sharps injuries are related not only to needles but also to any sharp objects and devices that have the potential to cause harm by exposing the nurse or others to the blood and body fluid of patients. Box 12-4 lists examples of these objects.

Safety Devices and Programs

Many infusion nurses find that gathering information concerning the availability and use of safety devices in an institution or agency is helpful in implementing safety programs. The Centers for Disease Control and Prevention (CDC) estimates that about 385,000 sharpsrelated injuries occur annually among health care workers in hospitals. More recent data from the EPINet suggest that these injuries can be reduced, as sharps-related injuries in nonsurgical hospital settings decreased 31.6% during 2001 to 2006 (following the Needlestick Safety and Prevention Act of 2000). It has been estimated that about half or more of sharps injuries go unreported. Most reported sharps injuries involve nursing staff, but laboratory staff, physicians/licensed independent practitioners (LIPs), housekeepers, and other health care workers are also injured (CDC, 2011).

Because of the high-risk nature of intravenous medications, the potential for harm is greatly enhanced over oral medications. A systems approach to medical safety is needed to ensure positive outcomes related to patient care.

EVIDENCE FOR PRACTICE

Whittington, J., Cohen, H. (2004). OSF Healthcare’s journey in patient safety. Quality Management in Health Care, 13(1), 53-59.

This article describes OSF Healthcare’s recent journey in patient safety. It discusses the involvement of its six hospitals in collaboration with each other and the Institute for Healthcare Improvement. OSF focused on a strategy for decreasing adverse drug events (ADEs). What has been your institution’s role in ensuring patient safety, and has it been documented in the literature?

Systems Approach to Safety

The literature is replete with articles addressing patient safety related to medication administration. Common barriers to safe medication administration are divided into five categories and presented in Table 12-1 (Burke, 2005). Public awareness has pushed this effort forward, and a mandate for reform has involved clinicians, researchers, manufacturers,
pharmacists, and biomedical engineers in an effort to manage the challenge and develop a system approach to safety. Stakeholders in IV medication-related events are listed in Table 12-2.

TABLE 12-1 COMMON BARRIERS TO SAFE MEDICATION ADMINISTRATION

Research
	Outcomes not easily adapted to practice
	Lack of recognition of impact and limitations of technology
	Lack of funding
Education
	Knowledge deficit
	Insufficient clinical practice
	Lack of training on-site
Policy
	Lack of nurse involvement
	Lack of standardization
	Practice/policy implications
Practice
	Lack of best practices
	Lack of standardization
	Lack of focus on safety and fatigue management
	Excessive nonnursing responsibilities
	Inadequate/inaccurate reporting
	Technology and practice failures
Administration
	Lack of administrative support for safety initiatives
	Integration challenges
	Lack of nursing involvement at all levels
	Inadequate allocation of financial resources
Adapted from Burke, K.G. (2005). The state of the science on safe medication administration symposium. American Journal of Nursing, 105(Suppl.), 4-9.

TABLE 12-2 STAKEHOLDERS IN INTRAVENOUS MEDICATION-RELATED EVENTS

Internal	External
Patients/clients	The Joint Commission
Nurses	Boards of Pharmacy and Nursing
Pharmacists	U.S. Food and Drug Administration
Physicians/LIPs	Government: CMS, AHRQ, state regulations
Other members of multidisciplinary team	Professional advisory groups
Leadership	Patient advocacy groups
Risk management	Pharmaceutical industry
Quality	Infusion device industry
Finance	ISMP and ECRI
Board	Professional health care organizations

The advent of smart technology assists in averting infusion errors at the point of care, thus creating an additional layer of safety for patients (ISMP, 2005). These technologies embed computer chips that gather information and respond within a range of preset parameters. Known as smart technology, because it performs a task we think an intelligent person can do, it includes smart IV pumps, smart beds, and smart cards. Smart beds are able to monitor patients’ vital signs and mobility without using electrodes. Smart beds can interface with information systems to transfer information collected and alert health care providers when a patient is getting out of bed unattended. Smart cards collect and store information about patients that is crucial to providing safe care to that individual patient.

The role of smart technology is to recall whatever rules apply, that is, dosing limits and clinical advisories for a particular clinical area, by incorporating the rules within the software. Nurses believe it is essential to have smart, portable, point-of-care solutions for capturing and transmitting data, as well as routine communication. They want technology to reduce demand on nursing time by eliminating waste in care resulting from inefficient workflows. Reducing the opportunity for error improves patient safety. Technology driving medication administration systems, improved communications, timely acquisition of equipment and supplies, and fool-proof patient identification are just some applications that improve safety (Bolton, Gassert, & Cipriano, 2008). Smart infusion pumps provide substantial safety features during the infusion process. However, nurses need to
understand the requisite education necessary to fully benefit from and improve IV smart pump use and clinical integration. Failure to use IV smart pumps places the nurse and patient at increased risk (Harding, 2013).

FIGURE 12-1 Vacutainer Eclipse blood collection needle, economical needle-based safety device for injection in a variety of sizes. (Adapted from BD Vacutainer Eclipse Blood Collection Needle Quick Reference Card. Courtesy of and © Becton, Dickinson and Company.)

Infusion Safety

Manufacturers have met our demands for safer technology by providing equipment to meet complex clinical needs and to enhance patient outcomes. See Figures 12-1, 12-2, 12-3 for detailed information on how these products are used in the clinical setting. Key features of B-D’s Vacutainer Push Button Collection Set are included in Box 12-5 as an example of the types of features available.

FIGURE 12-2 BD Vacutainer push-button blood collection/in-vein needle activation. (Adapted from BD Vacutainer Push Button Blood Collection Set InService Poster. Courtesy of and © Becton, Dickinson and Company.)

FIGURE 12-3 BD Integra 3-mL syringe, a low-waste space syringe with detachable retracting needle. (Adapted from BD Integra 3 mL Syringe Quick Reference Card. Courtesy of and © Becton, Dickinson and Company.)

SAFETY ASSESSMENT

Safety assessment should include the number of sharps-related injuries and the type of devices involved. The global focus on safety devices continues to proliferate. Again, smart infusion systems may avert high-risk errors and provide previously unavailable data for continuous quality improvement efforts.

NEEDLELESS SYSTEMS

In a study by the CDC, 89% of occupational exposures to HIV were caused by percutaneous injuries; most were needlesticks (CDC, 2011). In today’s practice arena, the needleless system has advanced the practice of infusion therapy. In general, the product consists of a blunt-tipped plastic insertion device and an injection port that opens to reduce the incidence of accidental needlestick injuries and to promote safety in infusion practice. Again, diverse systems are available to meet clinical needs in many settings.

However, no matter how sophisticated and reliable or easy to use infusion devices and accessories are, the infusion nurse first needs a solid understanding of the physical principles that govern flow and other facets of infusion therapy.

Flow Dynamics and the Physiology of Flow

Pressure, a principle of physics underlying infusion therapy, is the force that overcomes the natural resistance to flow created by infusion equipment, such as the IV administration set, in-line filters, and narrow-gauge needles, and by venous or arterial back pressure.
Fortunately, the human body readily adapts to changes in pressure, which enables clinicians to deliver IV therapy safely.

BOX 12-5 B-D’S VACUTAINER PUSH BUTTON COLLECTION SET: KEY FEATURES

Intended for blood collection and short-term infusion
Facilitates the prevention of accidental needlestick injury
Ease-of-use reduces training time while improving activation compliance
Easily activated without patient discomfort
Ideal for use in high-risk environment
Latex-free
Flash visualization confirms venous access prior to collection of specimen
Blood flashback is seen clearly through the translucent body
One-handed safety activation also allows attention to the patient and venipuncture site

PRESSURE

Pressure in the arterial system ranges from 80 mm Hg in the aorta to a low of 5 to 10 mm Hg in the venous return system. Intravenous pressure is created by the weight of a column of fluid in the catheter tubing—the weight is due to gravity—and we refer to it as hydrostatic pressure. Fluid always flows from an area of higher pressure to one of lower pressure. For a fluid to infuse by gravity, it is necessary to create a pressure only slightly more than normal or 40 mm Hg in a peripheral line.

A number of resistance factors may interfere with or inhibit fluid flow. These factors include the patient’s vascular pressure, internal diameter of the tubing, in-line filters, viscosity of the fluid, narrow-gauge needles, and the length of the tubing. Resistance to flow is determined by the smallest component in the IV system; this is usually the catheter. An example of equipment that incorporates principles of pressure for delivery of precise amounts of drugs and fluids is the EID, which is discussed later in this chapter.

GRAVITY

Gravity is the physical force that propels the flow of the infusate, although this flow also depends on head pressure. Roller clamps and screw clamps used to adjust and maintain rates of flow on gravity infusions vary considerably in their efficiency and accuracy. Rate minders or flow-control mechanisms may also be used to regulate and adjust flow. When a rate minder is added to an infusion set, the desired flow rate may be preset. Levels of accuracy vary with the type of device used. Factors such as venous spasm, venous pressure changes, patient movement, manipulations of the clamp, and bent or kinked tubing may cause variations in the flow rate. To monitor consistency of the flow rate, preprinted or selfmade time tapes may be attached to the IV container. The time tape, or pharmacy-provided
monitoring strip, should be attached to the container and hourly increments marked on the tape or strip, beginning with the time the infusion began.

FLOW

To accurately determine the flow rate, the nurse must have knowledge of parenteral solutions, their effect, and the rate of administration. The nurse must also understand other factors that influence the speed of the infusion. These factors include the patient’s body surface area (BSA), condition, age, and tolerance to the infusion. The composition of the fluid is also a factor in the rate of administration.

BODY SURFACE AREA

The BSA is proportionate to many essential physiologic processes (organ size, blood volume, respiration, and heat loss) and, therefore, to total metabolic activity. Knowing the BSA helps the nurse determine fluid and electrolyte amounts and compute infusion rates. The larger the person, the more fluid and nutrients are required and the faster they can be used. The usual infusion rate is 3 mL/m2 BSA/min (see nomograms in Figure 12-4). This rate applies to maintenance and replacement fluids. However, the speed must be adjusted carefully to each individual.

PATIENT’S CLINICAL CONDITION AND AGE

Because the heart and kidneys play a vital role in using infused solutions, the cardiac and renal status of the patient affect the desired rate of administration. Blood volume may expand when rapidly infused fluids overtax an impaired heart and when renal damage causes retention of fluid. Patients with hypovolemia must receive plasma and blood rapidly, but the desired rate of the infusion should be specified by the LIP. Vital signs must be carefully observed and the speed of the infusion decreased as the blood pressure rises.

PATIENT’S TOLERANCE

Tolerance to fluids varies among individuals and influences the rate of infusion. A 5% infusion of alcohol has been administered at the rate of 200 to 300 mL/h to sedate without intoxicating an average adult. However, when such a fluid is to be administered, the rate must be titrated to the individual and prescribed by the LIP. The infusion should be checked frequently to maintain the required rate of flow. Because of certain factors, the rate is subject to change.

COMPOSITION OF SOLUTION

The composition of the fluid may affect the rate of flow. When the solution is used as a vehicle for administering drugs, the speed of the infusion depends on the drug and the desired clinical effect. Because of its deleterious effect on the heart when infused at a rapid rate, potassium should be administered with caution. Approximately 20 to 40 mEq potassium in a liter of fluid infused over an 8-hour period is an average rate for administering potassium parenterally.

Concentration of solutions must be considered because the flow rate may alter the desired effect. When dextrose is administered for caloric benefits, it is infused at a rate that ensures complete utilization. Dextrose has been administered at a maximum rate of 0.5 g/kg body weight/h without producing glycosuria in a normal person. At this rate, it
would take approximately 1.5 hours to administer 1 L of 5% dextrose to a person weighing 70 kg or twice as long for 1 L of 10% dextrose. This maximum rate is faster than usual and is not customarily used except in an emergency.

FIGURE 12-4 A nomogram.

When a diuretic effect is desired, a more rapid infusion is necessary. If the fluid is too rapidly infused for complete metabolism, the glucose accumulates in the bloodstream, increases the osmolality, and acts as a diuretic.

When oliguria or anuria occurs, the status of the kidneys must be determined before fluids containing potassium can be administered. Urinary suppression may be caused by blood volume deficit or kidney damage. An initial hydrating fluid, to test kidney function, is usually administered at a rate of 8 mL/m2 BSA/min for 45 minutes. If urine does not flow, the rate is slowed to approximately 2 mL/m2 BSA/min for another hour. If urine output does not occur after this period, kidney damage is likely to be present (Metheny, 2012).

HEIGHT OF THE INFUSION CONTAINER

Intravenous fluids are propelled by gravity. Any change in gravity induced by raising or lowering the infusion container, relative to the patient’s position, alters the rate of flow. When patients receiving infusions are ambulatory or transported to ancillary departments, the containers should be retained at the same height or the speed of the infusion should be readjusted to maintain the prescribed rate of flow.

CLOT IN THE CATHETER

Any temporary stoppage of the infusion, such as a delay in hanging subsequent fluids, may cause a clot to form in the lumen of the catheter, partially or completely obstructing it. Clot formation may also occur when an increase in venous pressure in the extremity receiving the infusion forces blood back into the catheter. This results from restriction of the venous circulation. In arm infusion sites, this is most commonly caused by the blood pressure cuff on the infusion arm; restraints placed on or above the infusion catheter; and the patient lying on the arm receiving the infusion.

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