curso seguridad paciente m7 diapo 21 release of foreign bodies by clini. use intravenous infusion...

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ELSEVIER

Biomateriols 17 (1996) 663-666

i[l199fj Elsevier Science Lim ited

Pnnl"d in Crnat Brita in. All r ights reserved

0142-9612/961£15.00

Release of foreign bodies (particles) by

clinical use of intravenous infusionsets

Henrik Madsen and Ole Windingtnst ttute of Hygiene, UnlvEifs/('! 01 Copenhagen, Oenmark

in clinical practice, stripping the plastic tubes of intravenous (iv.) intusron sets 'Nlth a scissor blade IS

a commonly used method for re-establishing tlow in malfunctioning i.v. sets. The present Investigation

concludes that this procedure results In release of plastic particles from the luminal wall of the tube.

Particles are subsequently flushed into the patient. The average amount of particles released

exclusively from the i.v . infusion sets under these circumstances may exceed the standards for

acceptable particle content per millilitre in large volume i.v. injectable fluids. according to the British

Pharmacopoeia (1960) and the United Slates Pharmacopoeia (1990).

Keywords: Inrravenous .ntu ston sets. Siripping, oeructes , contsminetioo

Received 21 ;-.Jovember1994: accepted 25 ,'.~ay1985

-•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 v e 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questionnaire (unpublished) of 144 nurses in four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.

B y stripping an i.v. infusion tube, high pressure is

applied to the luminal fluid, thus flushing the tube,

This is done b y ' 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

i1

CDrrespondence to Dr H. Madsen, Lanojergparken J, OK 4000

Roskilde. Denmark.

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 13mrn 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 of parenteral solutions (no. 01

particles allowed In 1ml\

British Pharmacopoeia (1980) 10eD 100

United Slates PharmacDpoela

XXII (1990)

50

66 3 Biomatenals \9%. Vol. 17 ~o. 7

5



A n:

VG S tuttgart-H r. W olfsch rn ittVan:

KM /C -H r. D ittm arZeichen:

KM/DIT /FR

ZUT Kenntni~ (Verbleib):

Telefan

46 51Datum

08.05.96

B!BRAUNInterne Mi tteilunq

S d 1!~ g ee in ter H err W o lfsch rn itt,

anliegerul erhalten S ie, w ie versprochen , eine aktuelle V er6ffen tlichung zurn Problem des

Partikelabriebs bei m echan ischer M altratierung des In fusionsschlauches, beispielsw else

m it H ilf'e einer S chere, w ie in dieser Un tersuchung dargestellt.

Ich denke, dan sich diese Un tersuchung in etwa auch Falle ubertragen la13t, wo m it H ilfe

der geschlossen en R o llen klern me versucht w ird, ein halbw egs leergelaufenes ln fusiorisge-

rat w ieder luftfrei zu bekornmen , u rn so eine Neuverwendurig des B esteckes zu errnogli-

chen .

L eider ist die A rbeit in E nglisch, daher nachfolgend eine kurze Uhersetzung d er Z usarn -

rnenfassung un ter der Uberschrift auf S eite 663:

"In del' k lin ischen R outine ist das S trippen des Plastikschlauches eines in travenosen In fu-

sionssets mit einer S chere eine haufig verw endet M ethode, um den Fluf bei einern

schlecht funktio n ierenden In fusi 0 nsgera t w ieder herzustellen . D ie vo rliegende Un tersu-chung korn rn t zu dern S chluf}, daB dieses V erfahren zu einer Frellassung von Kunststoff-

partikeln aus der in neren W and des S chlauches fuhrt. Die Partikel werden in der Folge in

d en P atie nte n eingespult. Die durchschnittliche Partikelm enge, die un ter diesen Urnstan-den aus den lnfusiorissets freigesetzt wird, kann die von der B ritish Pharm acopoeia (1980)

und der U nited S tates P harm acopoeia (1990) festgesetzten S tandards fur akzeptable Parti-kelm engen pro M illiliter in grof3volum igen I nfu sio nslo su ng en u bersteig en ".

lch hoffe, d a1 3 I hn en d iese V e r6 ffen tlic hu ng ein wenig weiterhilft und verbleibe

m it freundlichen G rii13en

Anlage



66 4 Particle production from i.v. sets: H. Madsen and O. Winding

Figure 1 The stripping procedure. Left hand bending the

Iruusron 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.

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 infusionsets 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 fewerparticles, 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 X-

rays. which enables the detection of inorganic

Bandular fibre

100 urn r---I 100)(

20!-1m r---I 500 "

Figure 2 Example at bandular fibre. length approximately

BOO.um. from the third flushing. set no. 4. Prooably plastic

t ibr e.

Biornater iais 1996. Vol. 17 No.7



Particle orooucuon tram i.v. sets: H. . '.1adsen and O. Winding 66 5

Table 2 . Particle counts accordinq to size for each flushing

separately (particles/100 rnl) Median values and range are

Dresented

First flushing Second flushing Third tlusning

5-IO.um

10--25 pm

25-S0!1m

50-75 pm

75--I00 pm

> 100ur n

2~60 (880--1 I 100)

1793 (610-6810)

685 (130-3070)

226 (20-78'0)

61 (0-120)52 (0-120)

2698 (650-<\060)

1856 (570-5400)

855 (120-2710)

293 (30- 1150)

112 (0-330)111 (10-220)

898 (300-2860)

616 (200-1300)

226 (30--480)

58 (10-140)

12 (0-40)28 ((hq0)

280 um particle

50 urn t-----1 200 x

20 ~ r------t 500:<

Figure:] Example of particle from tile firs: flushmg, set no.

2. ,\"ay be glass or metal.

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. asthese are normally siliconized. while the i..I. sets are

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.

Plaques showing

Silicium content

2000 x

500 x lSl250 urn

Figure 4 Plaques showing silicon con ten! compatible 'Nilh

silicone.

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 beenmade for in-line filtration of i.v.-infusion sets l. 10.11

,,\voiding the stripping procedure rnay 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



66 6 Particle production from i.v, sets: H. Madsen and O. 'Nind/fJg

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

subsequently deliver thrombi as well as particles to thepatient's venous system

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 Sc i Edn 1978: 6: 93-108.

Winding 0 Particle release from angiographic utensils .

Eut: I Radio! 198 l: 11-1-116.

Cooper OF. Baret: CW o Particulate matter from giv:ng

sets. Pharm r 1970: 205: 186-187.

fi

7

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.

Franke RP. Ouanrifizierung Psrtikularer Bestandt.eile in

der Mlkrozirkulation der Lunge. Beitr Elektronetutu-

kroskop Direktabb Obert] 1986: 19: 429--434.

Carvan ) 1 v 1 . Gunnar BW. The harmful effects of

particles in intravenous solutions. Meii f ;-\.ust 1964:

2: 1-6.

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 T N . Petersen RV. Surface characteristics of plastic

intravenous catheters. Am I Hasp Piiartti 1979: 36:

1707-1711.

11

Biornatenals lY96. Vol. 17 No. 7

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