Are We Ready for Global Consensus on
Filtration Practice?
PDA Europe
Ton van Boxtel, MSc
Trainer & consultant, Infusion Innovations President: Vascular Infusion Technology (VIT) President: World Congress on Vascular Access
1 Support for travel from PALL Medical
2
•
Penetrate the natural barrier (Skin)
•
Entrance for many fluids
•
Strange materials in a vein
•
Remains for a period of time
•
Activates coagulation and the immunsystem
•
Should be done by well trained professionals
5
Patients with an impaired micro-circulation are at an especially high risk
from particulate contamination both in solutions and the environment
Highest likelihood to profit from the removal of particulate contamination
(solid particles, oversized lipid micelles, air bubbles)
6 ¨
The USP (United States Pharmacopoeia) sets the
acceptable limit of particles for single-dose infusion at
not more than 50 particles/mL that are > 10.0 µm and
not more than 5 particles/mL that are > 25.0 µm in
effective linear dimension.
¨
Over the years, manufacturers have made great efforts
to produce high-quality products,
but these efforts may
be negated by manipulating the products before
8
Illustration courtesy of Heart.org.in
10
1. Drug incompatibility
reactions
2. Incomplete reconstitution
of drugs
3. Particle contamination from
components and systems
4. Lipid macro micelles (ultra-
microscopic units of protoplasm)
5. Entrapped air emboli
Esketamin precipitate in IV line Courtesy of F. Schröder11
Clinical Particle Origin
12
Clinical Particle Origin
•
Incompatibility reactions may
be avoided through review of the
drug regime with clinical
13
Infusion Filtration as a part of clinical practice
INS 2016
Chapter 35: Filtration
Filtration is mentioned under Section 6: Vascular Access Device (VAD) Management
INS Guideline
2016
Infusion Therapy
Standards of Practice
Journal Of Infusion Nursing
14 2. Avoid filters when administering very small drug volumes as drug retention may seriously decrease the volume of medication delivered to the patient.1,2(V)
A. Use filters adhering to manufacturers’ directions for use and
filtration requirements of the infusion therapy solution or
medication.
1(V)
1. Filters are contraindicated for use with certain medications that would be retained on the filter material; consult with pharmacy or published drug resources regarding filtration indications.1(V)INS: Practice Criteria
15 4. Use air eliminating filters during treatment of adults with Eisenmenger’s syndrome (heart defect that causes right-to–left shunting) as exclusion of air bubbles in administration sets is recommended as essential.6(I A/P) Air release Air release
16 B. Replace administration sets used for intravenous fat emulsions (IVFEs) infused
separately every 12 hours. Change the administration set with each new container; the characteristics of IVFE (iso-osmotic, near neutral-alkaline pH, and containing glycerol) are conductive to the growth of microorganisms.11(V)
17 C. Locate add-on bacteria and particulate-retentive and air eliminating membrane filters as close to the Vascular Access Device (VAD) hub as possible.1(V) D Ensure that Electronic Infusion Device (EID) pressure does not exceed the Pounds per Square Inch (PSI) rating of the filter when an EID is used. 1(V)
Type of filter max. working pressure
ELD96, NEO96, AEF2, TNA2E, NLF1, NLF2
1500 mmHg app. 30 psi 2.0 bar
TNA1 1140 mmHg app. 22 psi 1.5 bar
Caution with syringes < 10ml
Select: ELD96 “or” AEF1
18 D. Filter parenteral nutrition solutions without lipids using a 0.2 micron filter and lipid containing emulsions (3-in-1) using a 1.2 micron filter, and change filters every 24 hours. 1. When lipids are infused separately from dextrose/amino acids, use a 0.2 micron filter for the dextrose/amino acid solution and infuse the lipid emulsion below the 0.2 filter (eg, during “piggy-back).
19 H. Use a filter needle or filter straw to withdraw any medication from glass ampoules and replace the filter needle or filter straw with a new sterile needle after the medication is withdrawn from the ampoule; recognize that glass fragments may enter the ampoule when opened (refer to Standard 17, (Compounding and Preparation of Parenteral Solutions and Medications).
20
INS: Practice Criteria
2016
International Nursing Society (INS)
•
Consider fluid and medication filtration in critically ill patients;
filter use was associated with a significant reduction in overall
complications for patients in pediatric intensive care units,
including a significant reduction in systemic inflammatory
response syndrome (SIRS); a 0.2 micron filter was used for lipid
containing admixtures.
•
Filter parenteral nutrition solutions without lipids using a 0.2
micron filter and lipid containing emulsions (3-in-1) using a 1.2
micron filter, and change filters every 24 hours.
USA
2016
Royal College of Nursing – Standards of Infusion Therapy
-
The document provides a UK-wide approach in terms of guidance
and guidelines. It should be read in conjunction with local and
national policies
The guidelines recommend (mainly based on the INS standard,
2016)
• For non-lipid-containing solutions that require filtration, additional filters containing a membrane that is both bacteria/particulate-retentive and air eliminating may be required.
28
