Tuesday, September 24, 2013

What Frequency Should You Change IV Administration Sets

The CDC 2011 Guidelines for the Prevention of Intravascular Catheter-Related Infections


CDC Recommendations

  1. In patients not receiving blood, blood products or fat emulsions, replace administration sets that are continuously used, including secondary sets and add-on devices, no more frequently than at 96-hour intervals, [177] but at least every 7 days [178–181]. Category IA
  2. No recommendation can be made regarding the frequency for replacing intermittently used administration sets. Unresolved issue
  3. No recommendation can be made regarding the frequency for replacing needles to access implantable ports. Unresolved issue
  4. Replace tubing used to administer blood, blood products, or fat emulsions (those combined with amino acids and glucose in a 3-in-1 admixture or infused separately) within 24 hours of initiating the infusion [182–185]. Category IB
  5. Replace tubing used to administer propofol infusions every 6 or 12 hours, when the vial is changed, per the manufacturer’s recommendation (FDA website MedwatchExternal Web Site Icon) [186]. Category IA
  6. No recommendation can be made regarding the length of time a needle used to access implanted ports can remain in place. Unresolved issue

Background

The optimal interval for routine replacement of IV administration sets has been examined in a number of well-controlled studies and meta-analyses. Data from these studies reveal that replacing administration sets no more frequently than 72–96 hours after initiation of use is safe and cost-effective [141177, 179–181]. More recent studies suggest that administration sets may be used safely for up to 7 days if used in conjunction with antiseptic catheters or if fluids that enhance microbial growth (e.g., parenteral nutrition or blood) have not been used [216345]. When a fluid that enhances microbial growth is infused (e.g., fat emulsions and blood products), more frequent changes of administration sets are indicated as these products have been identified as independent risk factors for CRBSI [182216346–350]. Little data exist regarding the length of time a needle used to access implanted ports can remain in place and the risk of CRBSI. While some centers have left them in place for several weeks without CRBSI, [351], this practice has not been adequately studied.

Needle-less Intravascular Catheter Systems



Recommendations

  1. Change the needleless components at least as frequently as the administration set. There is no benefit to changing these more frequently than every 72 hours. [39187–193]. Category II
  2. Change needleless connectors no more frequently than every 72 hours or according to manufacturers’ recommendations for the purpose of reducing infection rates [187, 189, 192, 193]. Category II
  3. Ensure that all components of the system are compatible to minimize leaks and breaks in the system [194]. Category II
  4. Minimize contamination risk by scrubbing the access port with an appropriate antiseptic (chlorhexidine, povidone iodine, an iodophor, or 70% alcohol) and accessing the port only with sterile devices [189, 192, 194–196]. Category IA
  5. Use a needleless system to access IV tubing. Category IC
  6. When needleless systems are used, a split septum valve may be preferred over some mechanical valves due to increased risk of infection with the mechanical valves [197–200]. Category II

Background

Stopcocks used for injection of medications, administration of IV infusions, and collection of blood samples represent a potential portal of entry for microorganisms into vascular access catheters and IV fluids. Whether such contamination is a substantial entry point of microorganisms that cause CRBSI has not been demonstrated. Nonetheless, stopcocks should be capped when not being used. In general, closed catheter access systems are associated with fewer CRBSIs than open systems and should be used preferentially [352].
"Piggyback" systems (secondary intermittent infusions delivered through a port on a primary infusion set) are used as an alternative to stopcocks. However, they also pose a risk for contamination of the intravascular fluid if the device entering the rubber membrane of an injection port is exposed to air or if it comes into direct contact with nonsterile tape used to fix the needle to the port. Modified piggyback systems have the potential to prevent contamination at these sites [353].
Attempts to reduce the incidence of sharps injuries and the resultant risk for transmission of bloodborne infections to healthcare personnel have led to the introduction and mandating of needleless infusion systems. There are several types of needleless connectors on the market.
The first type of needleless system connectors consisted of a split septum connector, which is accessed with a blunt cannula instead of a needle (external cannulae activated split septums). Because of the large amount of space in the connector to accommodate the cannula, when the cannula is removed it may result in the creation of negative pressure which may cause blood to be aspirated into the distal lumen, possibly increasing the risk of catheter occlusion or thrombosis. A luer-activated device, which incorporates a valve preventing the outflow of fluid through the connector, was designed to eliminate this problem. Some luer devices require a cap to be attached to the valve when not in use, which can be difficult to maintain aseptically, and therefore they may be prone to contamination.

Another type of second-generation needleless system addressed the occlusion issue by incorporating positive or neutral fluid displacement to either flush out aspirated blood or prevent its aspiration into infusion catheters.
Use of needleless connectors or mechanical valves appear to be effective in reducing connector colonization in some [196354, 355], but not all studies [356] when compared with stopcocks and caps. In one study [354], the incidence of CRBSI was reduced when the needleless connector was compared with standard stopcocks. Appropriate disinfectants must be used to prevent transmission of microbes through connectors [357]. Some studies have shown that disinfection of the devices with chlorhexidine/alcohol solutions appears to be most effective in reducing colonization [195, 196]. In addition, the time spent applying the disinfectant may be important. One study found that swiping the luer-activated device with 70% alcohol for only 3 to 5 seconds did not adequately disinfect the septal surface [358]. However, a number of outbreak investigations have reported increases in CRBSIs associated with a switch from external cannulae activated split septum needleless devices to mechanical valve devices [197, 198, 200359]. The reasons for these associations are not known and it is also not known if this is a device-specific or class association, particularly as physical and mechanical properties of needleless connectors vary from device to device. In addition, one investigation found CRBSIs increased with the switch from a luer-activated negative displacement mechanical valve to a luer-activated positive fluid displacement mechanical valve [199]. However in an observational study, a switch from a luer-activated negative displacement mechanical valve to a different luer-activated positive displacement mechanical valve as part of a bundled intervention resulted in a significant decrease in CRBSIs [201]. Potential explanations for outbreaks associated with these devices include difficulty encountered in adequate disinfection of the surface of the connector due to physical characteristics of the plastic housing diaphragm interface, fluid flow properties (laminar vs. turbulent), internal surface area, potential fluid dead space, inadequate flushing of the device due to poor visualization of the fluid flow pathway in opaque devices, and the presence of internal corrugations that could harbor organisms, particularly if the catheters are used to withdraw blood [199]. Some studies have shown that the increase in CRBSIs with the change to lueractivated devices may be related to improper cleaning and infection control practices such as infrequently changing the devices [192, 194]. Additionally, silver-coated connector valves have been FDA approved; however, there are no published randomized trials with this device and no recommendation can be made regarding its use. Likewise, an antiseptic-barrier cap for needleless connectors has been studied in a laboratory setting and appears to be effective in preventing the entry of microorganisms [360], but has not yet been studied in a clinical trial.

Monday, September 16, 2013

Crystalloids versus Colloids

Retraction Notice--It was brought to our attention that this article had been published with an error and as such we have retracted the original article and replaced it with this article that has the current and up to date information.  If you would like a copy of the previous article with the errors to compare, please contact us at info@central-valley-med.com

Infusion Therapy is an awesome wonder when it comes to saving a patient’s life.  Is it really necessary to give a patient a Colloid versus a Crystalloid?

Trauma burns or surgery can cause people to lose large amounts of blood. Fluid replacement, giving fluids intravenously (into a vein) to replace lost blood, is used to try to maintain blood pressure and reduce the risk of dying. Blood products, non-blood products or combinations are used, including colloid or crystalloid solutions. Colloids are increasingly used but they are more expensive than crystalloids and there are many scientific studies that show no evidence colloids reduce the risk of dying compared with crystalloids.

 B A C K G R O U N D

Fluid resuscitation for hypovolemia and other medical issues is common practice in the medical management of critically ill patients, whether as a result of trauma, burns, major surgery, dehydration, or sepsis.  

Colloids have been widely used all over the country for quite some time and volume replacement with colloids is considerably more expensive than with crystalloids. 

In the early 1860's, it was the investigation by Thomas Graham’s that led him to classify substances as crystalloids or colloids based on their ability to diffuse through a parchment membrane. Crystalloids passed readily through the membrane, whereas colloids did not. Intravenous fluids are similarly classified based on their ability to pass through barriers separating body fluid compartments, particularly the one between intravascular and extravascular (interstitial) fluid compartments.

Crystalloids


According to the Tabers Medical Dictionary, a Crystalloid is a solution in which crystals can or may form; but is able to diffuse across cellular membranes. Crystalloids are the most common fluids used in the healthcare setting. The following are some examples of the most common solutions in the crystalloid category.

  •  Normal Saline
  • Lactate Ringers
  • Dextrose 5%

Normal Saline


Normal Saline is composed of 154 milliequivalents (mEq/L) of Sodium and 154 milliequivalents of Chloride. The ph is 6.0 and the osmolarity is approximately 308. Normal saline is the main solution of choice when administering a blood product. (Raoof, George, Saleh, & Sung, 2008)

Lactate Ringers


Lactated Ringers is composed of 130 milliequivalents of Sodium, 4mEq of Potassium, 109 mEq’s of Chloride, and 28mEq’s of Lactate. The ph is approximately 5.1 and the osmolarity is approximately 273. (Raoof, George, Saleh, & Sung, 2008)

Dextrose 5%


Dextrose 5% is consists of 278 mmoL/L of dextrose. The pH is 4.0 and the osmolarity is around 272. D5W is considered an isotonic solution in the bag, but once administered the glucose is metabolized and the tonicity of the infused solution decreases in proportion to the osmolarity or tonicity of the non-dextrose components (electrolytes) within the water. 

Colloids




Again, according to Tabers Medical Dictionary a colloid is a “glue-like substance, such as a protein or starch… or a substance used as a plasma expander in place of blood.” (Wilbur, 2009) The following are some examples of colloid solutions.

  •  Albumin
  • Hetastarch
  • Dextran

Albumin


Albumin is produced in a couple of varieties; typically 5% and 25%. Albumin “is made from pooled human plasma, which undergoes ethanol fractionation, ultra filtration, and pasteurization.” 20

Albumin 5% contains no preservative and is a clear, slightly viscous liquid; it is almost colorless or slightly yellow tint. 7It is mainly used to expand the intravascular volume whereas Albumin 25% is typically used for hypoproteinemia. Albumin 5% is composed of 154 mEq’s of Sodium and 50 grams of Albumin and has a ph level of 6.6 as well as an osmolarity of 290.

Hetastarch (Hespan)


Hetastarch is another type of plasma expander and is similar in properties to Albumin. If given; it can sometimes cause an increase in the serum Amylase; which may throw healthcare professionals for a loop into thinking the patient may be suffering from pancreatitis. Hetastarch is composed of 154 mEq’s of Sodium with a ph level of 5.5 as well as an osmolarity of 310.

Dextran


Dextran is also a plasma expander; however, it is higher in molecular weight than Hespan. The amount of expansion it provides to the vascular system depends on the amount and rate of infusion. Just like with Albumin; Dextran is provided in a couple strengths; typically 40 or 70. Dextran 40 is composed of 154 mEq’s Sodium, a ph level of 6.7, as well as an osmolarity of 320. Whereas Dextran 70 is composed of 154 mEq’s Sodium, a ph level of 6.3, and an osmolarity of 310.

 

Crystalloids versus Colloids


So, what is the best choice for fluid resuscitation?  The problem is it takes a larger amount of crystalloids to resuscitate a patient fully; on the other hand it only takes a small amount of colloids. Colloids however are more expensive and can expand the intravascular space fairly rapidly. Depending on what the patient’s medical condition is and the end goal of the fluid resuscitation will depend on whether the healthcare provider administers a crystalloid or colloid. For example if a patient arrives to the emergency room or ICU and as in hypovolemic shock; the goal of fluid replacement would most likely be attained by administering a crystalloid. On the other hand if the patient is septic and has been diagnosed with septic shock the provider may give a colloid or crystalloid.

Final Thought

There is no evidence from randomized controlled trials that resuscitation with colloids reduces the risk of patient death, compared to the resuscitation with crystalloids, in patients with trauma, burns or following surgery. So this could help us conclude that the use of colloids may not only increase mortality; but they are also not associated with an improvement in survival and are considerably more expensive than crystalloids, it is hard to see how their continued use in clinical practice can be justified.



PF Vehicle

Sunday, March 10, 2013

Needleless Connectors-What’s the Real Story?



 

Needleless devices are used for connecting to IV catheters, administration sets, and/or syringes.  They were introduced in the 1990s for the purpose of reducing the risk of needlestick injuries among health care providers.   However, in 2000 the Needlestick Safety and Prevention Act mandated that all employers provider these devices as they have shown to reduce needlestick injuries significantly.  On the other hand; their use has been associated with an increase in complications such as catheter-related bloodstream infection (CRBSI) and catheter lumen occlusion. The reason for these complications are not totally understand and efforts to study their design, user knowledge, poor clinical practices have gotten underway to help reduce or eliminate these complications.

The Food and Drug Administration is requiring nine companies to conduct a post market study on positive displacement needleless connectors to determine whether they may be associated with a higher rate of device-associated bloodstream infections (BSI) than other types of needleless connectors, and to assess the factors that may contribute to a possible increased risk.  "As of today, there have been five companies to recall their products leaving four left to decide to remake or stop production on their products."4

FDA has become aware of information that raises concerns about the safety of positive displacement needleless connectors. These devices are intended for use as an accessory to an intravascular administration set to allow delivery of a wide range of fluids to a patient's vascular system through a cannula inserted into a vein or artery. Needleless connectors are known in the nursing worlds as “injection ports” or “claves.” “Positive displacement” refers to the positive pressure of fluid movement from a reservoir into the lumen of the catheter upon disconnection of an administration set or syringe.
FDA has received three reports of death associated with BSI and positive displacement needleless connectors. Infection control authorities are also concerned about positive displacement connectors and the device’s association with BSI.
There have been several clinical reports since 2006showing the association between the introduction of positive displacement needleless connectors into a hospital or unit and an increased rate of BSI, followed by a reduction in BSI after changing to another type of needleless connector. However, because there is insufficient information to determine if positive displacement connectors increase the risk of BSI compared with other needleless connectors, FDA is requiring the companies to conduct post market studies to provide an assessment of the risk associated with positive displacement needleless connectors.

“In 2011 a survey sent to 4,000 health care workers in clinical practice found that 132 (25.4%) of the 554 respondents did not know the specific type of needleless connector they used with short peripheral catheters and 114 (21.9%) did not know the type they used with central venous catheters, and nearly half of respondents didn't understand the correct way to flush and clamp a catheter with a needleless connector attached, even though it's essential to device performance. Self-reported practices are not the best methods by which to assess clinical practices, but no other data regarding these practices exist.”
While we cannot determine what the level of risk associated with each type of needleless connector based on available evidence, we know we can significantly reduce the known complications of infection and catheter lumen occlusion by educating our nursing staff and developing competencies that will increase our skills to use these needless connectors safely. Healthcare facilities need to establish policies and procedures that will educate and guide nursing staff on the risk, of not using these devices correctly and how it may affect patient outcomes.


References


1.   Gardner, S. (2012, November 20). Letter to infection control practitioners regarding positive displacement needleless connectors. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm220459.htm
2.    Delahanty KM, Myers FE III. Nursing2007 infection control survey report Nursing. 2007;37(6):28-36
3.    Delahanty KM, Myers FE III. Nursing2009 I.V. infection control survey report Nursing. 2009;39(12):24-30
4.    Hadaway L, Richardson D. Needleless connectors: a primer on terminology J Infus Nurs. 2010;33(1):22-31