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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

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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

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 8th 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

 

 

 

 

     

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Particles Trapped in a Pall IV Filter

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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)

 

 

 

 

 

     

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Particle Infusion & High-Risk ICU Patients

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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

 

 

 

 

     

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The Impact Harmful Particles Can Have on Patients

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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

 

Figure 3: Five possible mechanisms of harmful particle effects

 

 

 

 

 

     

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The Burden Harmful Particles Cause to Patients

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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.

 

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

 

 

 

 

 

     

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Our IV Filters Reduce The Particle Burden for ICU Patients

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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.

 

 

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

 

 

 

     

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The IV Filter Clinical Benefits for ICU Patients

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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 

 

Figure 5: Clinical Benefits of IV In-Line Filters 

 

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

 

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 (2008)

 

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 (2020)

 

 

 

 

     

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The Economic Impact of IV Filters

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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 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-day 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

 

 

 

 

     

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The US Guideline Recommendations for IV Filtration

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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

 

 

 

 

 

 

     

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Our IV Filtration Team is Here to Help You

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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.

 

 

 

 

 

     

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