Infusion Therapy Standards of Practice

A summary of 2021 recommendations including the use of filtration to reduce the incidence of phlebitis associated with peripheral venous catheters and the importance of choosing an appropriate pore size in-line filter.

As of January 2021, the Journal of Infusion Nursing published the 8th edition of the Infusion Therapy Standards of Practice. (1)

Recognized as the global authority in infusion therapy, the Infusion Nurses Society (INS) is an international nonprofit organization representing infusion nurses and other clinicians engaged in the specialty practice of infusion therapy. Every five years, the Standards of Practice Committee, a group of professional nurses with a wealth of clinical knowledge and expertise in all domains of infusion therapy, provides the ‘Infusion Therapy Standards of Practice’. 

These standards are based on evidence with the aim of guiding safe practice and ensuring the best patient outcomes. The "Infusion Therapy Standards of Practice" is an invaluable guide for all clinicians responsible for their patients’ infusion care.

While some practice criteria recommendations have been expanded in the filtration chapter 35, such as the filtration of solutions and medications to reduce particulate matter in critically ill patients, two new practice criteria have been added to the 8th edition of the ‘Infusion Therapy Standards of Practice’.

First new INS recommendation for 2021

"Consider filtration of solutions and medications to reduce the incidence of phlebitis associated with peripheral venous catheters." (1)

Background information regarding the incidence of phlebitis

Peripheral venous cannulation is the most common procedure performed among hospitalized patients worldwide, and phlebitis represents a common and painful complication of peripheral IV cannulation. (2) A meta-analysis in 2020 evaluating the incidence and risk of infusion phlebitis with peripheral intravenous catheters describes a 31% incidence of phlebitis during infusion and a 4% development of severe phlebitis. (3) Patients without peripheral intravenous complications, including phlebitis, have been shown to be discharged earlier from hospital, ultimately reducing hospitalization costs. (4)

Justification for recommendation

The ‘Infusion Therapy Standards of Practice’ cites a 2018 study conducted by Villa et al. on 268 surgical patients. (5,6) The study demonstrated that "in-line filtration with a 0.2-micron filter in surgical patients resulted in a significant reduction in phlebitis rates at 48 hours, lower visual infusion phlebitis (VIP) scores, and longer dwell times than the nonfilter group in a randomized con- trolled trial (RCT). Six months after the original study, the researchers reported high rates of patient satisfaction from a qualitative patient survey. The cost of filters was offset by reducing the need for unplanned removal and insertion of a new peripheral catheter."(5,6) This study was conducted with three of our IV in-line filter portfolios.

Second new INS recommendation for 2021

"Use the appropriate pore size in-line filter as required by the specific solution or medication to be infused. Consult with pharmacy for specific medication information." (1)

• "Some medications may require a specific pore size due to the molecular size of the medication (e.g., amphotericin B) and/or the concentration for infusion (e.g., mannitol)." (1)
• "Recommendations for filtration of protein-based medications (e.g., immunoglobulin, monoclonal antibodies, enzymes) vary greatly, including many drugs with no filtration instructions and many variations in filter pore size recommended. Many protein-based medications indicate the need for ‘low protein binding filters’, which includes filters made of polyethersulfone, polyvinylidene fluoride, and cellulose acetate." (1)

Background information regarding the filtration recommendation of specific drugs

To filter or not to filter? The answer to that question is not trivial and the recommendation of the pore size of a filter may dependent if the filter is used for drug administration or preparation or even on the drug concentration. According to Ipema et al. in the latest review "Drugs to Be Used With a Filter for Preparation and/or Administration – 2019" readers "are urged to review national standards of practice for information about clinical situations that warrant the use of a filter for medication preparation or administration" (6) and "should consult the prescribing information for the most up-to-date information." (6)

Example: Amphotericin B

Amphotericin B is an antifungal medication used for serious fungal infections and leishmaniasis. For Amphotericin B liposomal (Ambisome), a 5 µm filter is recommended for the preparation and a 1 µm or larger filter for administration. (8)

Example: Mannitol

Mannitol is a diuretic used to force urine production in people with acute (sudden) kidney failure. In the case of mannitol, the manufacturer does not provide a filter size recommendation, but a 0.2 to 5 µm has been suggested for administration. Further, the use of a filter may depend on the concentration of the drug. "Administer with an in-line filter when infusing concentrated mannitol (20% or more) due to the potential for crystal formation. One resource states to administer with an in-line filter for concentrations of 15% or more." (8)

Background information regarding the filtration recommendation of protein-based medications

Protein-based drugs (e.g. monoclonal antibody therapies) play a crucial role in the treatment of severe diseases. However, due to the instability of these complex molecules, protein particles may lead to negative immune reactions. (9,10) IV in-line filters may help here. An analysis of more than 300 marketed protein drug products revealed that already around 16% of all protein-based drugs products are filtered during preparation or administration, (11) including the monoclonal antibody therapies (bamlanivimab and casirivimab/imdevimab) that recently received emergency use authorization in the United States to combat COVID-19. (12,13)

How to choose the right IV in-line filter? Ask our Clinical Specialist or Scientific and Laboratory Services teams

Not all drugs or patients (neonates, pediatric or adult ICU patients) require the same filter. Some drugs may require a filter with a specific pore size membrane (0.2 µm. 1.2 µm, 5 µm or even higher than 5µm). Some filters are designed for lipid formulations or clear fluid formulations and others for protein formulations. Some filters are indicated for clinical usage, others only for laboratory usage, and not all filters apply to the required infusion protocol. Ultimately, the treating staff must choose the right in-line filters for their intravenous application.

At the end of the day, the primary goal in infusion management remains to ensure that an accurate drug dosage is delivered to the patient. Selecting the wrong filter means risking that the correct drug dosage may not reach the patient.

Our Clinical Specialist team supports in the selection of the proper IV-line filters

The implementation of an infusion regime with IV in-line filters is not easy. The devil is in the details, and it requires knowledge, training and skills. Our Clinical Specialist team gives hands-on care before, during and after the installation of IV in-line filters.

Customers can reach our Clinical Specialist team either via the local sales rep or through Cytiva customer services.

Our Scientific and Laboratory Services team are also here to support in the selection of the proper IV-line filters.

Over the last 10 years, our Scientific and Laboratory Services (SLS) team has conducted internal studies on our filtration devices and their impact on drug dosage delivery.

So far, our SLS team has investigated over 100 drugs as well as the impact of our filtration devices on potential drug loss.

Our report, "Clinical update: Drugs and Filtration in Infusion Management", is a summary of information on drug binding and drugs that have been tested with our IV in-line filters. (14)

Explore our solutions

References

1. Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, et al. Infusion Therapy Standards of Practice, 8th Edition. J InfusNurs. 2021;44(1S Suppl 1):S1-S224. doi:10.1097/NAN.0000000000000396.
2. Ray-Barruel G, Polit DF, Murfield JE, Rickard CM. Infusion phlebitis assessment measures: a systematic review. J Eval Clin Pract. 2014; 20(2):191-202. doi:10.1111/jep.12107.
3. Lv L, Zhang J. The incidence and risk of infusion phlebitis with peripheral intravenous catheters: A meta-analysis. J Vasc Access. 2020;21(3):342-349. doi:10.1177/1129729819877323.
4. Lim S, Gangoli G, Adams E, Hyde R, Broder MS, Chang E, et al. Increased Clinical and Economic Burden Associated With Peripheral Intravenous Catheter-Related Complications: Analysis of a US Hospital Discharge Database. Inquiry. 2019;56:46958019875562. doi:10.1177/0046958019875562.
5. Villa G, Chelazzi C, Giua R, Tofani L, Zagli G, Boninsegni P, et al. In-Line Filtration Reduces Postoperative Venous Peripheral Phlebitis Associated With Cannulation: A Randomized Clinical Trial. Anesth Analg. 2018;127(6):1367-1374. doi:10.1213/ANE.0000000000003393.
6. Villa G, Chelazzi C, Giua R, Tofani L, Zagli G, Boninsegni P, et al. In-line filtration reduced phlebitis associated with peripheral venous cannulation: Focus on cost-effectiveness and patients’ perspectives. J Vasc Access. 2018;21(2):154-160. doi:10.1213/ANE.0000000000003393.
7. Hirakawa M, Makino K, Nakashima K, Kataoka Y, Oishi R. Evaluation of the in-line filters for the intravenous infusion of amphotericin B fluid. J Clin Pharm Ther. 1999;24(5):387-392. doi:10.1046/j.1365-2710.1999.00242.x.
8. Ipema HJ, Zacher JM, Galka E, Nazari J, Varabyeva A, Yu M, et al. Drugs to Be Used With a Filter for Preparation and/or Administration-2019. Hosp Pharm. 2021;56(2):81-87. doi:10.1177/0018578719867660.
9. Nabhan M, Pallardy M, Turbica I. Immunogenicity of Bioproducts: Cellular Models to Evaluate the Impact of Therapeutic Antibody Aggregates. Front Immunol. 2020;11:275). Published 2020 May 5. doi:10.3389/fimmu.2020.00725.
10. Werner BP, Winter G. Expanding Bedside Filtration - A Powerful Tool to Protect Patients From Protein Aggregates. J Pharm Sci. 2018;107(11): 2775-2788. doi:10.1016/j.xphs.2018.07.022.
11. Werner BP, Winter G. Particle contamination of parenteralia and in-line filtration of proteinaceous drugs. Int J Pharm. 2015;496(2):250-267. doi:10.1016/j.ijpharm.2015.10.082.
12. United State Food and Drug Administration (U. S. FDA). Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) of Bamlanivimab. Eli Lily and Company. B3.01-BAM-0006-EUA HCP-20210318. [Online]. https://www.fda.gov/media/143603/download. Updated [2021 Mar 18]. Accessed [2021 April 6].
13. United State Food and Drug Administration (U.S. FDA). Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) of Casirivimab and Imdevimab. [Online]. https://www.fda.gov/media/145611/download. Accessed [2023 FEB 2].
14. Orbaneja MA, Capewell A, Spiers S, Nomura H, Stenning M. Drugs and Filtration in Infusion Management. Pall Clinical Update. #171010.1EUa. 2017.

Author bio

Dr. Volker Luibl, MBA

Dr. Luibl is a Demand Generation Marketing Manager with knowledge in medical device and clinical science.