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Biomateriols 17 (1996) 663-666 i[l199fj Elsevier Science Lim ited Pnnl"d in Crnat Britain.

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Release of foreign bodies (particles) by clinical use of intravenous infusion sets
Henrik Madsen and Ole Winding
tnstttute of Hygiene, UnlvEifs/('! 01 Copenhagen, Oenmark

, ,

in clinical a commonly concludes Particles exclusively acceptable

practice,
that

stripping

the plastic results

tubes of intravenous of plastic

(iv.) intusron particles

sets 'Nlth a scissor

blade

IS

used method

for re-establishing flushed

tlow in malfunctioning The average

i.v. sets. The present from the luminal of particles may exceed fluids. amount

Investigation

this procedure

In release

wall of the tube. released for to the British

are subsequently particle content

into the patient.

from the i. v . infusion

sets under these circumstances in large volume Slates Pharmacopoeia

the standards according

per millilitre

i.v. injectable (1990).

Pharmacopoeia Keywords:

(1960) and the United

Inrravenous

.ntu ston sets. Siripping,
25 ,'.~ay 1985

oeructes , contsminetioo

Received 21 ;-.Jovember 1994: accepted

1 ,

-

i 1

It has been known for decades that intravenous (i.v.l infusion therapy is a source of i.v. particle contamination, Particles are partly contained in the infusion fluid itself, and partly derived from the inside of the utensiis used, /\11 parts of the infusion system (bottle". 'I, set, cannula) ha ve been shown to produce particles ~-4. Considerable efforts have been made to minimize particle contamination of infusion fluids, Thus, empirical limits for maximum particle content In parenteral solutions are given in the British Pharmacopoeias and American Pharmacopoeia" (Table 1), No limits are set for the contribution of particles from devices and handling connected with the administration of parenteral fluids. As regards i,v. infusion sets. some particulate matter is released, even from new sterile infusion sets 2---l , The influence of clinical use and handling is included in this investigation. In clinical practice, flow malfunction in i.v. infusion sets is often seen, even when correctlv installed and changed within recommended intervals. I conducted a questionnaire (unpublished) of 144 nurses in four Danish and one Swedish hospitals, which showed that more than 70% of the personnel stripped the infusion sets-with a pair of scissors as first choice procedure for re-establishing a normal flow under such circumstances. By stripping an i.v. infusion tube, high pressure is applied to the luminal fluid, thus flushing the tube, This is done by' initially bending the tuoe proximally near to the drop chamber to prevent fluid escaping backwards, The tube is then compressed between a finger and a scissor blade and stripped downwards
CDrrespondence to Dr H. Madsen, Lanojergparken Roskilde. Denmark.
J, OK 4000

towards the cannula, so that the fluid cleans the distal part of the set by the pressure obtained, The high prevalence of this rather violent method prompted the present in vestigation. the purpose of which was to examine the possible additional particle release by stripping i.v, infusion sets. MATERIALS

A_.'\rD

~1ETHODS

r\ total of nine polyvinylchloride

(PVC) i.v. infusion sets of three different commercially available brands were stud led. Each set was flushed three times with 100 ml membrane-filtered (0.2 pm pore size) distilled water. The water was filtered separately for each tlushing through a 13 mrn diameter, 5.um pore size Nucleopore filter, mounted on a stainless steel funnel filter holder (total volume 40 rnll, thus collecting what was shed from the inside of the set. Between the second and the third flushings. the infusion tube was stripped three times at a length of approximately 50 cm. by compressing the tube between the thumb and a scissor blade. as shown in Figure 1. Each of the total of 27 samples was labelled first, second or third and also with the set number. The entire filtering procedure was performed in a
Table 1 Hygienic standard particles allowed In 1 ml\
of

parenteral

solutions

(no.

01

British Pharmacopoeia

(1980)

10eD

100 50 5

United Slates PharmacDpoela XXII (1990)

663

Biomatenals

\9%.

Vol. 17 ~o. 7

B!BRAUN
An:

Interne Mi tteilunq

Van:

VG Stuttgart-Hr.

Wolfschrnitt

KM/C -Hr. Dittmar
Zeichen:
Telefan Datum

KM/DIT/FR
ZUT

46 51

08.05.96

Kenntni~ (Verbleib):

Sd1!~ geeinter

Herr Wolfschrnitt, zurn Problem des beispielswelse

anliegerul erhalten Sie, wie versprochen, eine aktuelle Ver6ffentlichung Partikelabriebs bei mechanischer Maltratierung des Infusionsschlauches, mit Hilf'e einer Schere, wie in dieser Untersuchung dargestellt.

Ich denke, dan sich diese Untersuchung in etwa auch Falle ubertragen la13t, wo mit Hilfe der geschlossenen Rollenklernme versucht wird, ein halbwegs leergelaufenes lnfusiorisgerat wieder luftfrei zu bekornmen, urn so eine Neuverwendurig des Besteckes zu errnoglichen. Leider ist die Arbeit in Englisch, daher nachfolgend rnenfassung unter der Uberschrift auf Seite 663:
sionssets

eine kurze Uhersetzung

der Zusarn-

"In del' klinischen Routine ist das Strippen des Plastikschlauches eines intravenosen In fumit einer Schere eine haufig verwendet Methode, um den Fluf bei einern schlecht funktio n ierenden In fusi 0 nsgerat wieder herzustellen. Die vo rliegende Untersuchung kornrnt zu dern Schluf}, daB dieses Verfahren zu einer Frellassung von Kunststoffpartikeln aus der inneren Wand des Schlauches fuhrt. Die Partikel werden in der Folge in den Patienten eingespult. Die durchschnittliche Partikelmenge, die unter diesen Urnstanden aus den lnfusiorissets freigesetzt wird, kann die von der British Pharmacopoeia (1980) und der United States Pharmacopoeia (1990) festgesetzten Standards fur akzeptable Partikelmengen pro Milliliter in grof3volumigen Infusionslosungen ubersteigen".
lch hoffe, da13 Ihnen

diese Ver6ffentlichung

ein wenig weiterhilft

und verbleibe

mit freundlichen

Grii13en

Anlage

664

Particle

production

from i.v. sets: H. Madsen

and O. Winding

Subsequently. particles were counted in a scanning electron microscope at x 500 magnification. tilt 45'. using the equipment and the method described by Windin~:( From each sample. particles were counted in 100' randoml v chosen counting fields. Energy dispersive X-ray equipment was used for further investigation. All utensils that came into contact with the infusion sets were cleaned in an ultrasound bath and flushed with membrane-filtered distilled water to avoid external contamination.

RESULTS
Handling by stripping the i.v. infusion sets produced particles of various size and shape. Table 2 presents the numbers and sizes 0 f particles counted after the three flushings. (See Figures 2 and 3.) As expected and reported previously':", some particles were flushed from new sterile sets (i.e, first flushing). Second flushing reveals considerably fewer particles, probably because most of the loose particles from the lumen have already been flushed out. Third flushing snows a significant increase in particle number. compatible 'with the effect 0[ the stripping procedure, Median particle counts and range are presented in Table 2. Numerous plaques were found covering the filter surface as a thin film. Energy dispersive analysis of Xrays. which enables the detection of inorganic

Bandular

fibre

100 urn

r---I

100)(

I

Figure 1 The stripping procedure. Left hand bending the ruusron tube. right hand stripping downwards using scissor blade

horizontal laminar air flow bench in a clean room. as descnbed by Winding7, in order to avoid airborne contamination of the sampling procedure from the env ironment.
Biornater iais 1996. Vol. 17 No.7

20!-1m

r---I 500 " fibre. length approximately set no. 4. Prooably plastic

Figure 2 Example at bandular BOO.um. from the third flushing. tibr e.

Particle orooucuon

tram i.v. sets: H .. '.1adsen and O. Winding

665

Table 2. Particle counts accordinq to size for each flushing separately (particles/100 rnl) Median values and range are Dresented First flushing 5-IO.um 10--25 pm 25-S0!1m 50-75 pm 75-- I 00 pm > 100 urn 2~60 1793 685 226 61 52 (880--1 I 100) (610-6810) (130-3070) (20-78'0) (0-120) (0-120) Second flushing 898 616 226 58 12 28 (300-2860) (200-1300) (30--480) (10-140)
(0-40)

Third tlusning 2698 1856 855 293 112 111 (650-<\060) (570-5400) (120-2710) (30- 1150) (0-330) (10-220) Plaques showing

Silicium content

((hq0)

2000

x

280 um particle

50

urn

t-----1

200

x

20 ~
Figure:] Example of particle 2. ,\"ay be glass or metal.

r------t

500:< 500
x

lSl 250 urn
silicon con ten! compatible
'Nilh

from tile firs: flushmg,

set no.

Figure 4 silicone.

Plaques

showing

chemica] elements (between nine and 92). showed a silicon content in these plaques compatible with silicon.e (see Fizure 4). There was no oarticular . ~ lncrease in production of these plaques following strip pi.ng, and we did not find their source. They may derive from the i.v. sets or from the utensils (syringe. cannula) used to feed the sets. Most likely, the silicon detected could come from the syringe and cannula. as these are normally siliconized. while the i.. sets are <I.

.

ce inside the venous system. particles can reach the act as emboli and form granulomas or '8.9. Particles may even be shunted into the system via non-obliterated canals or shunt vessels, probably causing thromboembolic llcations in other organs like brain and eyes.

Lung granulomas created around intravascular particles will probably have a larger diameter than the particle itself. In critically ill patients this may have an effect, especially considering the vast amount of relatively large particles created by the stripping procedure. Even the parncte contribution without stripping should be considered. Previously, calls have been made for in-line filtration of i. v. -infusion sets l. 10.11 ,,\voiding the stripping procedure rna y have an equal effective role in reducing particle production in i, v . infusion therapy. From the counts found in this investigation, particle release exclusively from i.v. infusion sets may exceed the limits (particles per millilitre) given for large volume injectable l1uids bv the British Pharmacopoeias and the United Stotes Pnatmocoooeio". It is not~d that the reason for a now malfunction in an
Biomateriais
)ggl). Vo!. 17 :-':0.7

666
I.V. infusion set may well be luminal thrombus forma.tion at the tip of the catbetert2. Re-establishing now by stripping the i.v. infusion tube will

Particle

production

from i.v, sets: H. Madsen

and O. 'Nind/fJg

fi 7

subsequently
patient's

venous

deliver thrombi as well as particles system

to the

The British Pharmacopoeia 1980. London: The Pharmaceutical Press, 1980. The United States Pharmacopoeia 1990. Winding O. A method for determination and element analysis of particulate contamination in injectable solutions. Am ! Hosp Pharm 1976: 33:
1154-1159.

REFERENCES
Ahnfeld FW, Klaus E. Quantitative Analysen uoer den Partikelhalt von Infusicnslosungen. Zubehor und Medikamenten. Anaestesist 1977: 26: 476-4801. IlIum L. Character-ization of particulate contamination released by application of parenteral solutions. r. Particulate matter from administration sets, "rch Pbarm. Chern Sci Edn 1978: 6: 93-108. Winding 0 Particle release from angiographic utensils . Eut: I Radio! 198 l: 11-1-116. Cooper OF. Baret: CWo Particulate matter from giv:ng sets. Pharm r 1970: 205: 186-187.

Franke RP. Ouanrifizierung Psrtikularer Bestandt.eile in der Mlkrozirkulation der Lunge. Beitr Elektronetutukroskop Direktabb Obert] 1986: 19: 429--434. Carvan )1v1. Gunnar BW. The harmful effects of particles in intravenous solutions. Meii f ;-\.ust 1964:
2: 1-6.

11

. l

Rvan PB. In-line final fihration=-A method of minimizing contamination in intravenous therapy. Bull Parent Drug Assoc 1973: 27: 1-14. Faichuk KH et al. Microparticulate induced phlebitis. New Eng!! Med 1985: 312: 78-82. Bait TN. Petersen RV. Surface characteristics of plastic intravenous catheters. Am I Hasp Piiartti 1979: 36: 1707-1711.

Biornatenals

lY96. Vol. 17 No. 7