Ihre Browserversion wird nicht unterstützt. Bitte aktualisieren Sie Ihren Browser. Schließen

Contamination During Infusion Therapy & Particle Filtration

The Risks of Particles & The Benefits of IV In-Line Filtration

Explore the Benefits & Solutions of IV Particle Filtration

 

Read more with in the following chapters about the particle burden for patients, the potential harmful effects of particles, and how IV in-line filters can be used as a strategy to reduce the numbers of particles, improve the clinical outcome for patients and increase revenues for hospitals. Read about US guideline makers and their recommendation regarding the use of IV in-line filters and how we can support theimplementation of IV filters on your ward.

 

The Benefits of IV Filtration for Patients & Staff

Mehr lesen

Our IV In-Line Filters Can Retain Particles

 

“Unfortunately, the problem of particles remains largely invisible, although many clinicians may believe they have never seen a patient affected by particles, the truth is they probably have not seen a patient who is not in some way affected by particles.” 

 

(Prof. Patrick Ball (2017), PDA Conference “Particles In Parenteral Injection Solutions” at Berlin, Germany).

 

Intensive care patients usually receive a multitude of IV infusions that, without IV in-line filters, can infuse up to one million particles per day.1–4 Infused particles may lead to a disturbance in the microcirculation and a compromised microvascular flow in vital organs may result in organ dysfunction of ICU patients.5–7  

 

Laboratory and clinical studies have been shown that our IV in-line filters can retain particles in a clinical set up, improve patient outcomes, reduce the length of stay in ICU and could have a positive financial impact on the hospital’s revenues.8–15

benefits-of-implementing-iv-in-line-filters

In 2020 the American Society for Parenteral and Enteral Nutrition states that “The detrimental effects of particulate infusion appear to be more pronounced in neonates, the critically ill, and those with preexisting tissue damage from trauma, surgery, or sepsis. The need for prolonged or intensive intravenous therapy, as is frequently the case for patients receiving Parenteral Nutrition, also increases the risk for adverse events related to particle infusion.”16

 

In 2021 the Infusion Nursing Society states in the 8. Edition of the Infusion Therapy Standards of Practice: “Consider filtration of solutions and medications to reduce particulate matter in critical ill patients that can cause thrombogenesis, impaired microcirculation, and alter immune response.”17

 

 

 

 

     

Referenzen

 

 

 

Speak to a Representative
By clicking the Submit button below and proceeding I confirm that I have reviewed and agree with the Terms of Use and the Privacy Policy.

Particles Trapped in a Pall IV Filter

Mehr lesen

 

 

 

Particle contamination of IV solutions can arise from many sources, including incomplete reconstitution of drugs, drug incompatibility reactions during IV therapy, conglomerates of parenteral nutrition components, glass from containers / ampoules, plastic containers or components of the infusion systems, such as IV tubing, catheters and rubber stoppers.1–8

 

 

Figure 2: Size comparison of a red blood cell with particles that have been found on Pall filters in clinical use (internal Pall images)

 

 

 

 

 

     

Referenzen

  1. Perez M., Maiguy-Foinard A., Barthélémy C., Décaudin B. and Odou P. (2016). Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients. Pharm. Technol. Hosp. Pharm.; 1(2): 91-103

  2. Ball P.A. (2003). Intravenous in-line filters: filtering the evidence. Curr Opin Clin Nutr Metab Care; 6:319-325

  3. Jack T. et al. (2010). Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med; 36:707-711

  4. Langille, S.E. (2013). Particulate Matter in Injectable Drug Products. PDA J Pharm Sci and Tech; 67: 186-200 

  5. Perez M. et al. (2015). In vitro analysis of overall particulate contamination exposure during multidrug IV therapy: impact of infusion sets. Pediatr Blood Cancer; 62(6): 1042-7

  6. Benlabed M. et al. (2018). Clinical implications of intravenous drug incompatibilities in critically ill patients. Anaesth Crit Care Pain Med; 2019 Apr;38(2): 173-180

  7. Lázaro Cebas A. et al. (2018). Precipitation limits in pediatric parenteral nutritions with organic sources of calcium and phosphate. Nutr Hosp 20; 35(5): 1009-1016

  8. Brent B.E., Jack T. and Sasse M. (2007). In-line filtration of intravenous fluids retains ‘spearhead’-shaped particles from the vascular system after open-heart surgery. Eur Heart J; 28 (10):1192 

 

 

 

Particle Infusion & High-Risk ICU Patients

Mehr lesen

 

Patients hospitalized in intensive care units (ICUs) are considered a high-risk group for exposure to particles associated with infusion therapy.

  • ICU patients receive high volumes of drugs and fluids.

  • Drugs and fluids are predominantly administered intravenously in ICUs.

  • ICU patients commonly require the use of multiple drugs through a limited number of venous accesses and therefore have a higher risk of drug incompatibilities leading to particle formation.1–3

 

 

 

 

     

Referenzen

 
  1. Maison O. et al. (2019). Drug incompatibilities in intravenous therapy: evaluation and proposition of preventive tools in intensive care and hematology units. Eur J Clin Pharmacol;75(2): 179-187

  2. Neininger M.P. et al. (2018). Incompatibilities in paediatric intensive care - pitfalls in drug information. Pharmazie; 73(10): 605-608

  3. Perez M. et al. (2018). Effectiveness of in-Line Filters to Completely Remove Particulate Contamination During a Pediatric Multidrug Infusion Protocol. Sci Rep; 8 (7714): 1-8

 

 

 

The Impact Harmful Particles Can Have on Patients

Mehr lesen

 

 

No matter what size particles are, they have the potential to hurt the human body once they are in the circulatory system. The effect of infused particles depends on several factors, such as particle size, shape, number, characteristics and electrical charge.1,2

 

Infused particles may lead to blockages of blood vessels3–5, systemic hypercoagulability effects due to the activation of the coagulation system6, impairment of the microcirculation7–9, immune-modulation effects and inflammatory reactions.10–13 Furthermore, proteinaceous particles from therapeutic proteins, such as monoclonal antibody therapies may lead to immunogenicity and hypersensitivity reactions.14–16

 

five-possible-mechanisms-of-harmful-particle-effects

Figure 3: Five possible mechanisms of harmful particle effects

 

 

 

 

 

     

Referenzen

  1. Perez M., Maiguy-Foinard A., Barthélémy C., Décaudin B. and Odou P. (2016). Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients. Pharm. Technol. Hosp. Pharm.; 1(2): 91-103 

  2. Langille, S.E. (2013). Particulate Matter in Injectable Drug Products. PDA J Pharm Sci and Tech; 67: 186-200 

  3. Ilium L. et al. (1982) et al. Blood clearance and organ deposition of intravenously administered colloidal particles. The effects of particle size, nature and shape. Int J Pharm.; 12(2): 135-46 

  4. Bradley J.S., Wassel R.T., Lee L. and Nambiar S. (2009). Intravenous ceftriaxone and calcium in the neonate: assessing the risk for cardiopulmonary adverse events. Pediatrics; 123(4): e609-13 

  5. Puntis J.W.L. et al. (1992). Hazards of parenteral treatment: do particles count? Archives of Disease in Childhood; 67: 1475-1477 

  6. Boehne M. et al. (2013). In-line filtration minimizes organ dysfunction: New aspects from a prospective, randomized, controlled trial. BMC Pediatrics, 13 (21): 1-8 

  7. Kirkpatrick CJ. et al. (2013). Non-Equivalence of Antibiotic Generic Drugs and Risk for Intensive Care Patients. Pharmaceut Reg Affairs; 2(1): 1-7 

  8. Schaefer SC. et al. (2008). 0.2 µm in-line filters prevent capillary obstruction by particulate contaminants of generic antibiotic preparations in postischemic muscle. Chemother J; 17: 172-8 

  9. Lehr HA., Brunner J., Rangoonwala R. and Kirkpatrick C.J. (2002). Particulate Matter Contamination of Intravenous Antibiotics Aggravates Loss of Functional Capillary Density in Postischemic Striated Muscle. Am J Respir Crit Care Med; 165: 514-520 

  10. Jack T. et al. (2012). In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med, 38, 1008-1016 

  11. Jack T. et al. (2010). Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med; 36:707-711 

  12. Schmitt E. et al. (2019). In-line filtration of intravenous infusion may reduce organ dysfunction of adult critical patients. Critical Care; 23 (373): 1-11 

  13. Chisholm C.F., Behnke W., Pokhilchuk Y., Frazer-Abel A.A. and Randolph T.W. (2020). Subvisible Particles in IVIg Formulations Activate Complement in Human Serum. J Pharm Sci.; 109(1): 558-565 

  14. Berger M. (2013). Adverse effects of IgG therapy. Journal of Allergy and Clinical Immunology: In Practice; 1(6): 558-566. 

  15. Kessler M., Goldsmith D. and Schellekens H. (2006). Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant; 21 [Suppl 5]: v9–v12 

  16. Rosenberg A.S. (2006). Effects of protein aggregates: An immunologic perspective. The AAPS Journal; 8: E501–E507

 

 

 

The Burden Harmful Particles Cause to Patients

Mehr lesen

 

How many particles are infused into patients? The numbers vary, depending on the set-up of the ICU infusion regime, the drugs tested, the frequency of drug incompatibilities and the sizes of particles counted. Research projects over the last years counted the number of particles potentially infused into patients. Particles up to 100 microns are classified as subvisible.1 Particles detected from infusion regimes, single drugs, parenteral nutrition solutions and drug containers fall mainly into the subvisible range. The rule of thumb is that the smaller the particle size, the higher the number.

 

studies-evaluating-number-of-particles-potentially-infused-to-a-patient
Table2 : Overview of studies evaluating the number of particles potentially infused to a patient

Table: Overview of studies evaluating the number of particles potentially infused to a patient

 

 

 

 

 

     

Referenzen

  1. Melchore JA. (2011). Sound practices for consistent human visual inspection. AAPS Pharm Sci Tech;12 (1): 215-221
  2. Perez M. et al. (2018). Effectiveness of in-Line Filters to Completely Remove Particulate Contamination During a Pediatric Multidrug Infusion Protocol. Sci Rep; 8 (7714): 1-8
  3. Benlabed M. et al. (2018). Analysis of particulate exposure during continuous drug infusion in critically ill adult patients: a preliminary proof-of concept in vitro study. Intensive Care Medicine Experimental; 6 (38): 1-9
  4. Perez M. et al. (2017). Dynamic Image Analysis To Evaluate Subvisible Particles During Continuous Drug Infusion In a Neonatal Intensive Care Unit. Scientific Reports; 7 (9404): 1-8
  5. Joo G.E., Sohng K.Y. and Park M.Y. (2016). The effect of different methods of intravenous injection on glass particle contamination from ampules. SpringerPlus; 5 (15): 1-8
  6. Perez M. et al. (2015). In vitro analysis of overall particulate contamination exposure during multidrug IV therapy: impact of infusion sets. Pediatr Blood Cancer; 62(6):1042-7
  7. Ernst C, Keller M. and Eckstein J. (2012). Micro-Infusion Filters and Particulate Matter in Injections. Pharm. Ind; 74 (12): 2009-2020 (German Language)
  8. Oie S. and Kamiya A. (2005). Particulate and microbial contamination in in-use admixed parenteral nutrition solutions. Biol Pharm Bull; 28 (12): 2268-2270.
  9. Puntis J.W., Wilkins K.M., Ball P.A., Rushton D.I. and Booth I.W. (1992). Hazards of parenteral treatment: do particles count? Arch Dis Child;67 (12):1475-1477

 

 

 

Our IV Filters Reduce The Particle Burden for ICU Patients

Mehr lesen

Two studies mimicking real hospital scenarios have proven that IV in-line filters can retain particles.

 

Perez et al. demonstrated that the introduction of in-line filters in multidrug infusion lines typical for pediatric intensive care unit patients led to a significant reduction in overall particulate matter. The total number of particles was assessed after a 24–hour multidrug administration. The data in the table below shows a particle retention  between 99,9% and 98,2% depending on counted particle sizes. This study was conducted with a Pall AEF1NTE filter.

 

number-of-particles-before-and-after-filtration-in-a-pediatric-multidrug-infusion-regime

 

Table: Number of particles before and after filtration in a pediatric multidrug infusion regime

 

 

 

     

Referenzen

  1. Perez M. et al. (2018). Effectiveness of in-Line Filters to Completely Remove Particulate Contamination During a Pediatric Multidrug Infusion Protocol. Sci Rep; 8 (7714): 1-8

 

 

 

The IV Filter Clinical Benefits for ICU Patients

Mehr lesen

 

The impact of particles, or the impact of IV in-line filters retaining particles, on ICU patients has been in the spotlight of researchers and clinicians since 2008. Our IV filters have been and continue to be a driving force in this regard. Several studies have demonstrated the clinical benefits of using IV in-line filters.1–8

 

Already in 2008 Schaefer et al. demonstrated in an animal model that infusion of particles poses a major threat to critical tissue perfusion and that IV in-line filters prevent further a reduction of the postischemic functional capillary density. The results of the animal studies suggest that “in-line filters have potentially enormous relevance for patients with prior microvascular compromise of vital organs (i. e. post trauma, major surgery, sepsis).

 

Over the last 10 years several human clinical studies suggest that IV in-line filters have a positive impact on ICU patients by preserving organ functions and reducing the incidence of the systemic inflammatory response syndrome (SIRS) and reducing postoperative phlebitis rates in surgical patients.2–8 

clinical-benefits-of-iv-in-line-filters

 

Figure 5: Clinical Benefits of IV In-Line Filters 

 

studies-demonstrating-clinical-benefits-of-iv-in-line-filters

Table: Overview of studies demonstrating the clinical benefits of IV in-line filters (2012–2013)

studies-demonstrating-clinical-benefits of-iv-in-line-filters

 

Table: Overview of studies demonstrating the clinical benefits of IV in-line filters (2019)

 

Table: Overview of studies demonstrating the clinical benefits of IV in-line filters

 

Table: Overview of studies demonstrating the clinical benefits of IV in-line filters (2008)

 

studies-demonstrating-the-clinical-benefits of-iv-in-line filters

Table: Overview of studies demonstrating the clinical benefits of IV in-line filters (2015–2016)

Table: Overview of studies demonstrating the clinical benefits of IV in-line filters

 

Table: Overview of studies demonstrating the clinical benefits of IV in-line filters (2020)

 

 

 

 

     

Referenzen

  1. Schaefer SC. et al. (2008). 0.2 µm in-line filters prevent capillary obstruction by particulate contaminants of generic antibiotic preparations in postischemic muscle. Chemother J; 17: 172-8

  2. Jack T. et al. (2012). In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med; 38: 1008-1016 

  3. Boehne M. et al. (2013). In-line filtration minimizes organ dysfunction: New aspects from a prospective, randomized, controlled trial. BMC Pediatrics; 13 (21): 1-8

  4. Sasse M. et al. (2015). In-line Filtration Decreases Systemic Inflammatory Response Syndrome, Renal and Hematologic Dysfunction in Pediatric Cardiac Intensive Care Patients. Pediatr Cardiol; 36: 1270-1278 

  5. Villa G. et al. (2018). In-Line Filtration Reduces Postoperative Venous Peripheral Phlebitis Associated With Cannulation: A Randomized Clinical Trial. Anesth Analg; 127(6): 1367-1374

  6. Schmitt E. et al. (2019). In-line filtration of intravenous infusion may reduce organ dysfunction of adult critical patients. Critical Care; 23 (373): 1-11 

  7. Virlouvet A.L. et al. (2020). In-line filtration in very preterm neonates: a randomized controlled trial. Scientific Reports; 10 (5003): 1-8

 

 

 

The Economic Impact of IV Filters

Mehr lesen

IV in-line filters reduce the length of stay in ICUs and hospitals

 

Two clinical studies evaluated length of stay (LOS) in the ICU and the total length of hospital stay.1,2

 

The table below shows a summary of the data from a study by Jack et al. which included 807 pediatric patients. Pediatric ICU patients with IV in-line filters were able to leave the ICU significantly earlier than patients without IV in-line filters.1

 

The table below shows a summary of the data from a study by Schmitt et al. which included 3215 adult patients. Adult ICU patients with IV in-line filters were able to leave the ICU and the hospital significantly earlier than patients without IV in-line filters.2

 

 

Table: Impact of IV in-line filters on the LOS in the PICU and total stay in the hospital

 

Table: Impact of IV in-line filters on the LOS in the PICU and total stay in the hospital

 

Table: Impact of IV in-line filters on the LOS in the adult ICU and total stay in the hospital

 

Table: Impact of IV in-line filters on the LOS in the adult ICU and total stay in the hospital

 

 

Return of investment of IV in-line filters

 

An analysis evaluating the economic value of in-line filters in a German PICU revealed that an investment of 50K € in in-line filters led to a return of investment for the hospital of 1,6 million €.3

 

Dr Michael Sasse, leading senior physician of the PICU at Hannover Medical School (MHH), added additional economic aspects at the EAHM (European Association of Hospital Managers) congress in Portugal 2018: 

 

Less severe complications result in fewer drugs such as antibiotics, reduction of organ replacement, medical staff workload and also a decrease in costs for diagnostic procedures. Being able to release patients sooner also increases the flexibility of ICU allocation and the capacity for surgeries.”3


Moreover, the Van Lingen’s study evaluated the costs in treating sick newborn infants during a standard 8–tägig stay. Besides a significant decrease in major clinical complications, substantial cost savings were also observed.4

Figure 6: An economic analysis of IV in-line filter in a German PICU at the Hannover Medical School, Germany

Figure 6: An economic analysis of IV in-line filter in a German PICU at the Hannover Medical School, Germany

 

 

 

 

     

Referenzen

  1. Jack T. et al. (2012). In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med; 38: 1008-1016

  2. Schmitt E. et al. (2019). In-line filtration of intravenous infusion may reduce organ dysfunction of adult critical patients. Critical Care; 23 (373): 1-11

  3. Unger-Hunt L. (2019). Reducing Risks and Generating Economic Benefits. Health Management; 19(4): 286-287

  4. Van Lingen R.A., Baerts W., Marquering A.C. and Ruijs G.J. (2004). The use of in-line intravenous filters in sick newborn infants. Acta Paediatr; 93: 658-662 

 

 

 

The US Guideline Recommendations for IV Filtration

Mehr lesen

 

In light of laboratory and clinical trial results demonstrating the benefits of IV in-line filters on intensive care patients, the Infusion Nurses Society (INS) and the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) are recommending in-line filtration.1,2,3 

 

Regarding the use of IV filters ASPEN stated in a position paper in 2020 that “healthcare organizations that do not filter parenteral nutrition (PN) admixtures or Intravenous Lipid Emulsions (ILE) reevaluate these decisions and consider the small price of filters in comparison to increased morbidity and mortality that may result from not filtering ILE or PN.”2

 

Table: Recommendations of A.S.P.E.N and INS guidelines regarding the use of IV in-line filters
Table: Recommendations of A.S.P.E.N and INS guidelines regarding the use of IV in-line filters
Table: Recommendations of A.S.P.E.N and INS guidelines regarding the use of IV in-line filters
Table: Recommendations of A.S.P.E.N and INS guidelines regarding the use of IV in-line filters
Table: Recommendations of A.S.P.E.N and INS guidelines regarding the use of IV in-line filters
Table: Recommendations of A.S.P.E.N and INS guidelines regarding the use of IV in-line filters

 

 

 

 

 

     

Referenzen

  1. Gorski L.A. et al. (2021). Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs; 01(44): S1-S224

  2. Worthington P. et al. (2020). Update on the Use of Filters for Parenteral Nutrition: An ASPEN Position Paper. Nutrition in Clinical Practice; 0(0): 1-11

  3. Ayers P. et al. (2014) A.S.P.E.N. Parenteral Nutrition Safety Consensus Recommendations. Journal of Parenteral and Enteral Nutrition; 38 (3): 296-333

 

 

 

Our IV Filtration Team is Here to Help You

Mehr lesen

Our highly skilled technical experts in our “Scientific Laboratory Services” (SLS) are here to support you and offer advice on optimal intravenous filtration and infusion solutions or to perform drug compatibility studies. 

 

Our Clinical Specialists support customers who wish to implement Pall intravenous, breathing and gas filtration devices. They implement and evaluate our products in hospitals at the patient’s bedside and advise on any problems that might arise.

 

 

 

 

 

     

Watch Webinars

Medical Blog

Online Shopping with Medical

Wissenschafts- und Laborservice