373
LOW -TEMPERATURE STERI LI ZATI ON AND NEW TECHNOLOGI ES
Van ia Regin a Gov eia1 Silm a Mar ia Cunha Pinheir o1 Kazu k o Uch ik aw a Gr azian o2
Gov eia VR, Pin h eir o SMC, Gr azian o KU. Low - t em per at u r e st er ilizat ion an d n ew t ech n ologies. Rev Lat in o- am Enfer m agem 2 0 0 7 m aio- j unho; 1 5 ( 3 ) : 3 7 3 - 6 .
Th e n ew low - t em p er at u r e st er ilizat ion t ech n olog ies ar e p r esen t ed as an alt er n at iv e t o t h e u se of
et hylene oxide. This r eview w as per for m ed in or der t o ident ify evidences of t he ant im icr obial act ivit y, t oxicit y, adv er se ev en t s an d t h e applicabilit y of t h ese t ech n ologies. Th e r esear ch w as car r ied t h r ou gh t h e elect r on ic dat abases MEDLI NE and LI LACS up t o 2005. The aut hors analyzed 10 art icles in t his survey. The st udies about t he efficacy of t hese st er ilizat ion m et hods const it ut e ex per im ent al and com par at iv e r esear ch t hat show ed t he
influence of t he ext ension and diam et er of t he lum en, besides t he presence of cryst al salt s. Thus, choosing t he correct equipm ent is essent ial, as well as t he assurance of t he cleansing of t he devices, which int erfere wit h t he effect iveness of t he low- t em perat ure st erilizat ion. These t echnologies present lim it at ions regarding t he st erilizat ion of gr aft bone and affect t he m at er ials pr oper t ies.
DESCRI PTORS: st er ilizat ion; et hy lene ox ide; hy dr ogen per ox ide
MÉTODOS DE ESTERI LI ZACI ÓN POR BAJA TEMPERATURA Y NUEVAS TECNOLOGÍ AS
Nuevos m ét odos de est erilización a baj a t em perat ura son una alt ernat iva frent e al óxido de et ileno. El ar t ículo t iene por obj et iv o ident ificar ev idencias de act iv idad ant im icr obiana, t ox icidad, efect os colat er ales y la ap licación d e t ecn ologías p or b aj as t em p er at u r as. La in v est igación f u e r ealizad a m ed ian t e con su lt a en los
bancos de dat os MEDLI NE y LI LACS hast a 2005. Fueron analizados en su t ot alidad 10 art ículos, cuyos result ados dem ost raron que: a) los est udios sobre la eficacia de la est erilización se const it uyen en invest igaciones básicas y com par at iv as que m uest r an la influencia de la ex t ensión y diám et r o del lum en y la pr esencia de sales de cr ist al, b) la selección del equ ipo es t an fu n dam en t al com o el gar an t izar la lim pieza de los m at er iales qu e
in f lu y en en la ef icacia de los pr ocesos y en la t ox icidad, c) la est er ilización a baj as t em per at u r as m u est r a lim it aciones para el caso de est erilización de inj ert o óseo, así com o det eriora las propiedades de los m at eriales.
DESCRI PTORES: est er ilización; óx ido de et ileno; per óx ido de hidr ógeno
MÉTODOS DE ESTERI LI ZAÇÃO POR BAI XA-TEMPERATURA E NOVAS TECNOLOGI AS
Nov os m ét odos de est er ilização à baix a t em per at ur a são apr esent ados com o alt er nat iv a ao óx ido de
et ileno. Est e ar t igo t em com o obj et iv o ident ificar ev idências da at iv idade ant im icr obiana, t ox icidade, ev ent os adv er sos e aplicabilidade das t ecn ologias de baix a t em per at u r a. A pesqu isa foi r ealizada m edian t e con su lt a nas bases de dados MEDLI NE e LI LACS at é 2005. Foram analisados 10 art igos na ínt egra, nesse levant am ent o, cuj o r esult ado dem ost r ou que: a) os est udos sobr e a eficácia da est er ilização const it uem pesquisas básicas e
com parat ivas que dem onst ram a influência da ext ensão e diâm et ro do lúm en e a presença de crist ais de sais, b) a seleção do equipam ent o é fundam ent al, assim com o a garant ia da lim peza dos m at eriais, que int erfere na eficácia dos processos e na t oxicidade, c) a est erilização à baixa t em perat ura apresent a lim it ação para est erilizar osso par a enx er t o e efeit os delet ér ios sobr e as pr opr iedades dos m at er iais.
DESCRI TORES: est er ilização; óx ido de et ileno; per óx ido de hidr ogênio
1
RN, Doct oral st udent ; 2 RN, Professor, e- m ail: rw [email protected] .br, [email protected]. Universit y of São Paulo, College of Nursing, Brazil
Disponible en castellano/ Disponível em língua portuguesa SciELO Brasil w w w .scielo.br/ rlae
Art igo Original Rev Lat ino- am Enferm agem 2007 m aio- j unho; 15( 3) : 373- 6
374
I NTRODUCTI ON
E
t hylene oxide is t he eldest low t em perat ure st erilizat ion m et hod and has been used since t he 1950’st o r e p r o c e s s h e a t - s e n s i t i v e m e d i c a l - h o s p i t a l
m a t e r i a l s . D i f f e r e n t f a c t o r s h a v e i n f l u e n c e d
pr ofessionals and healt h inst it ut ions t o look for new
st er ilizat ion t echnologies. Rut ala and Weber ident ify
t he reasons for t his search am ong healt h professionals
i n t h e Un i t e d S t a t e s , s u c h a s c o m p l y i n g w i t h
e n v i r o n m e n t a l l e g i s l a t i o n t h a t e s t a b l i s h e s t h e
el i m i n at i o n o f CFC ( ch l o r o f l u o r o car b o n s) g as u se,
w hich is a bet t er t hinner t han et hy lene ox ide, w hich
af f ect s t h e ozon e lay er, an d r eg u lat in g accep t ab le
exposure levels t o et hylene oxide, est ablished by t he
public occupat ional healt h body( 1- 2).
I n o u r c o n t e x t , t h e s e a r c h f o r n e w l o w
t em per at ur e st er ilizat ion t echnologies is j ust ified by
t he sam e m ot ives as in t he USA, besides t he need for
fast er r epr ocessing t han w hen using et hy lene ox ide.
The challenge for hospit al infect ion cont rol and m at erial
cent er professionals in healt h inst it ut ions is t o assess
available new t echnologies in t erm s of m icrobiological
safet y, cost - effect iv eness and t he absence of adverse
effect s for pat ient s and professionals. Thus, t he user’s
choice should be based on scient ific ev idence.
This bibliographic r ev iew aim s t o ident ify, in
scient ific lit erat ure, evidences of ant im icrobial act ivit y,
t ox i ci t y, a d v e r se e f f e ct s a n d a p p l i ca b i l i t y o f l o w
t em per at u r e st er ilizat ion t ech n ologies.
METHODOLOGY
Th e b ib liog r ap h ic r esear ch w as car r ied ou t
by consult ing t he elect r onic dat abases MEDLI NE and
LI LACS unt il 2005, on t he port als of BI REME and t he
US Nat ional Libr ar y of Medicine. Fr ee and cont r olled
k ey w or d s w er e u sed in Por t u g u ese an d En g lish , in
co m b i n a t i o n w i t h t h e Bo o l e a n o p e r a t o r AND f o r
sp eci f i ci t y. I n i t i al l y, t h e co n t r o l l ed k ey w o r d s w er e
def in ed in Por t u gu ese by m ean s of t h e Descr it or es
em Ciências da Saúde - DeCS on t he Bir em e por t al
( www.birem e.br) , and in English by using t he Medical
Su b j ect Head i n g - MeSH o n t h e p o r t al o f t h e US
N a t i o n a l Li b r a r y o f M e d i c i n e - N LM
( w w w . pu bm ed. com ) . Nex t , t h e bibliogr aph ic su r v ey
w as car r ied out .
Th e f o l l o w i n g d e s c r i p t o r s w e r e l o c a t e d :
est er ilização/ st er ilizat ion ; óx ido de et ilen o/ et h y len e
oxide and peróxido de hidrogênio/ hydrogen peroxide.
How ev er, n o con t r olled k ey w or ds w er e locat ed f or :
e st e r i l i za çã o b a i x a t e m p e r a t u r a/ l o w t e m p e r a t u r e
st e r i l i za t i o n ; p l a sm a d e p e r ó x i d o d e h i d r o g ê n i o/
h y dr ogen per ox ide plasm a, w h ich w er e u sed in t h e
sear ch as fr ee k ey w or ds.
RESULTS
Table 1 present s t he result s obt ained t hrough
t he applicat ion of t he descr ibed sear ch st rat egy.
Table 1 - Result s of t he bibliographic search unt il 2005,
carried out in t he BI REME and NLM port als, According
t o t he cont r olled or fr ee k ey w or ds used. São Paulo,
2 0 0 6
s d r o w y e
K BIREME PUBMED
d e ll o r t n o
C Free MedilneLliacs Medilne
* n o it a z il i r e t
S X - 9792 774 17.796
* * O T E d n a n o it a z il i r e t S * * * P H d n a
X - 29 2 18
e r u t a r e p m e t w o L n o it a z il i r e t s
- X 124 1 344
e r u t a r e p m e t w o L n o it a z il i r e t S d n a n o it a z il i r e t s * * * P H d n a * * O T E d n a
X X 11 0 4
* The result s of t he search wit h t he cont rolled keyword st erilizat ion were not accessed
* * Et hylene oxide = ETO * * * Hydrogen peroxide = HP
The abst ract s of all publicat ions locat ed in t he
dat abases w er e r ead, ex cept f or t h e r esu lt s of t h e
exclusive sear ch w it h t he descr ipt or st er ilizat ion, due
t o t h e lar g e n u m b er of p u b licat ion s f ou n d an d t h e
lack of specificit y. Th e abst ract s w er e an aly zed an d
t hose t hat addressed at least one of t he following it em s
w ere select ed: ant im icrobial act ivit y, t oxicit y, adverse
e v e n t s a n d a p p l i c a b i l i t y o f l o w t e m p e r a t u r e
st er ilizat ion t echnologies. Only t en publicat ions fr om
t h e r esear ch u n iv er se com p lied w it h t h e in clu sion
cr it er ia.
I n t h e a d o p t e d se a r ch sy st e m , o n l y o n e
Br azilian st udy w as locat ed w hich did not at t end t o
t he inclusion crit erion, as it present ed t he m et hodology
f o r v a l i d a t i n g t h e l o w t e m p e r a t u r e f o r m a l d e h y d e
st er ilizat ion t ech n ology.
Ne x t , w e w i l l p r e se n t a sy n t h e si s o f t h e
p u b l i c a t i o n s , a c c o r d i n g t o t h e t h e m e a n d t h e
chr onological or der of publicat ion.
Ef f i cacy : Co m p ar at i v e st u d i es o f l o w t em p er at u r e
st er ilizat ion m et h ods
Low- t em perat ure st erilizat ion and new... Goveia VR, Pinheiro SMC, Graziano KU.
375
I n 1 9 9 6 , a Ca n a d i a n st u d y a sse sse d t h e
s t e r i l i z a t i o n e f f i c a c y o f f o u r l o w t e m p e r a t u r e
st erilizat ion t echnologies: 100% et hylene oxide ( ETO) ,
12/ 88 m ixt ure of ETO ( 12% of ETO and 88% of CFC) ,
h y d r og en p er ox i d e p l asm a an d h y d r og en p er ox i d e
vapor. All m et hods were effect ive in reducing t he used
t est st rains t o 6log10, except when 10% of serum and
0. 65% of salt w er e pr esent . I n t his condit ion, 12/ 88
ETO showed t he best perform ance, reaching t he secure
st er ilit y lev el( 3).
A n o t h e r s t u d y f r o m 1 9 9 8 a s s e s s t h e
s t e r i l i z a t i o n e f f i c a c y o f f o u r l o w t e m p e r a t u r e
s t e r i l i z a t i o n t e c h n o l o g i e s : ETO, c o n t a i n i n g
h y d r o ch l o r o f l u o r o ca r b o n s ( ETO- H CFC) , STERI S®
sy st e m , co n t a i n i n g p e r a ce t i c a ci d a n d h y d r o g e n
per ox ide, and t he St er r ad 100® and 100S® sy st em ,
cont aining hy dr ogen per ox ide plasm a, 40 cent im et er
-long m at erials and lum ens wit h a diam et er of 1- 3m m .
Nar r ow er l u m en s com p r om i sed t h e ef f i cacy of t h e
st e r i l i za t i o n p r o ce sse s b y t h e St e r r a d 1 0 0 ® a n d
STERI S® syst em s, while t he ot her m et hods displayed
sat isfact or y r esult s( 4 ).
Anot her publicat ion fr om 1 9 9 8 assessed t he
STERI S® sy st e m , 1 0 0 % ETO a n d ETO- HCFC, f o r
m at er ials of 1 2 5 cm an d lu m en s w it h a diam et er of
3m m . Different ly from t he result s of t he above st udy,
t he STERI S® sy st em w as significant ly m or e efficient
in com parison wit h t he ot her processes t o reduce t he
m icr obial load, alt hough it did not achiev e st er ilit y. I t
should be observed t hat , in t his sit uat ion, t he m at erial
was longer, but wit h a less narrow lum en( 5).
The com par at iv e analy sis of t hese st udies is
lim it ed by t he fact t hat each of t hem present s different
c h a l l e n g e s t o a s s e s s t h e p e r f o r m a n c e o f t h e s e
t echnologies in t er m s of st er ilizat ion efficacy.
Adv er se ev ent s: cor nea dest r uct ion epidem ic - 1998
I n 1998, t he Cent ers for Disease Cont rol and
Pr e v e n t i o n ( CD C) i n t e r r u p t e d t h e u s e o f a n e w
st er ilizat ion t ech n olog y in t h e Un it ed St at es, w h ich
st erilizes t hrough peracet ic acid and hydrogen peroxide
v apor, due t o t he occur r ence of a cor nea dest r uct ion
ep i d em i c am o n g p at i en t s su b m i t t ed t o i n t r ao cu l ar
opht halm ological surgery. At t hat t im e, t his t echnology
h a d n o t b e e n a p p r o v e d b y t h e Fo o d a n d D r u g
Adm inist r at ion ( FDA) t o st er ilize sur gical inst r um ent s
wit h lum ens or hinges. Nevert heless, it was int roduced
at t he Hospit al and t he inv est igat ion of t he epidem ic
con clu ded t h at t h e st er ilizat ion m et h od degr ade t h e
m e t a l o f c a n n u l a t e d c o p p e r a n d z i n c s u r g i c a l
inst rum ent s, result ing in t he dest ruct ion of endot helial
cor nea cells( 6- 7).
Cost analy sis of low t em per at ur e st er ilizat ion - 1998
I n g en er al , t h e ch o i ce o f t h e st er i l i zat i o n
t e ch n o l o g y i s b a se d o n co st a n d co m p a r e d w i t h
available t echnologies. A Germ an st udy com pared t he
cost s of hy dr ogen per ox ide plasm a ( St er r ad 100® ) ,
ETO an d f o r m al d eh y d e st er i l i zat i o n s. Th e au t h o r s
included v apor st er ilizat ion and all r elat ed dir ect and
i n d i r e ct co st s. Pl a sm a st e r i l i za t i o n i s f a st e r a n d
cheaper t han ETO and does not require sparging, t hus
n e e d i n g a s m a l l e r i n v e n t o r y o f i n s t r u m e n t s ;
f or m aldeh y de st er ilizat ion t ak es t h r ee t im es lon ger
t han plasm a, but , in com par ison w it h ETO, t he t im e
w as sh or t er, w h ich im plies low er cost s. How ev er, a
lar ger in v en t or y w as n eeded. Vapor w as con sider ed
t he fast est and cheapest m et hod and was chosen for
sm all and m edium - sized inst it ut ions, alt hough it causes
great er dam age t o inst rum ent s in t he long t erm( 8).
Ap p licat ion : r eu se of elect r op h y siolog y cat h et er s
-1 9 9 8
Th e r eu se of h igh ly com plex an d h igh - cost
si n g l e - u se p r o d u ct s h a s b e e n a sse sse d , a n d t h e
r e p r o ce ssi n g o f e l e ct r o p h y si o l o g y ca t h e t e r s h a s
r e v e a l e d t o b e f e a si b l e , f r o m t h e p e r sp e ct i v e o f
secur it y as w ell as efficacy. I n t his Am er ican st udy,
t h e a u t h o r s a sse sse d e l e ct r o p h y si o l o g y ca t h e t e r
( w it h ou t lu m en ) , r ep r ocessed f iv e t im es each , an d
ablat ion cat het ers, reprocessed t went y t im es each and
s t e r i l i z e d i n h y d r o g e n p e r o x i d e p l a s m a , w i t h
sat isfact ory result s. Cost econom y is significant when
each cat het er is used five t im es. The aut hors appoint
t h e f ollow in g st u d y lim it at ion s: ab sen ce of clin ical
r esu l t s i n t er m s of saf et y, al t h ou g h st er i l i t y t est s
revealed t o be sat isfact ory; and t he fact t hat t he t est s
were not realized wit h cat het ers from all com m ercially
av ailable br an ds( 9 ).
Lim it at ions: bone gr aft st er ilizat ion - 2001
B o n e g r a f t s h a v e b e e n w i d e l y u s e d i n
or t hopedic sur ger ies, despit e t he r isk of t r ansm it t ing
infect ious agent s from t he donor, alt hough bone banks
carry out serological t est s. Nowadays, t here does not
ex i st an y st er i l i zat i on t ech n ol og y w i t h ou t ad v er se
Low- t em perat ure st erilizat ion and new... Goveia VR, Pinheiro SMC, Graziano KU. Rev Lat ino- am Enferm agem 2007 m aio- j unho; 15( 3) : 373- 6
376
effect s on t he biological propert ies of t he bone graft .
A t rial st udy assessed t he effect of hydrogen peroxide
plasm a st er ilizat ion on t he ost eoinduct iv e capacit y of
t he dem ineralized hum an bone m at rix, which result ed
in a n egat iv e effect on t h e ost eoin du ct ion capacit y.
Th e r e f o r e , t h i s t e ch n o l o g y ca n n o t b e a p p l i e d t o
st er ilize bone gr aft s( 10).
Lim it at ions: Effect s of st er ilizat ion on t ensile for ce of
single- use pr oduct m at er ials - 2002
The st udy was conduct ed by researchers from
t h e FD A, w h o a ssessed t h e ef f ect o f st er i l i za t i o n
pr ocesses on t h e m at er ials u sed f or m an u f act u r in g
t he art icles: lat ex, silicone, t wo t ypes of polyuret hane,
ny lon, high- densit y poly et hy lene. The sam ples w er e
p r ev iou sly assessed f or t en sile f or ce, su b m it t ed t o
different disinfect ion and low t em perat ure st erilizat ion
t ech n ologies an d t h en r eassessed. Th e f in al r esu lt s
show t hat silicone is t he least affect ed, while t he t ensile
for ce of lat ex , poly et hy lene and ny lon w as r educed.
D e p e n d i n g o n t h e f o r m u l a t i o n , p o l y u r e t h a n e
present ed alt erat ions, st rengt hening or w eakening it s
t en sile f or ce. Th e au t h or s of t h at st u dy h igh ligh t ed
t h at t h er e ex ist s lit t le scien t if ic ev iden ce abou t t h e
effect s of differ ent st er ilizat ion m et hods on m at er ial
pr oper t ies( 1 1 ).
CONCLUSI ONS
Th i s b i b l i o g r a p h i c r e v i e w o n n e w l o w
t em per at ur e st er ilizat ion t echnologies allow ed for t he
follow in g con clu sion s:
- a sm a l l n u m b er o f sci en t i f i c p u b l i ca t i o n s ex i st ,
report ing on basic lab research wit h overdim ensioned
ch a l l e n g e s, w h i ch d o n o t a l w a y s r e f l e ct cl i n i ca l
p r act ice;
- i n so m e ex p er i m en t s, ETO, co n si d er ed t h e g o l d
st andar d as a low t em per at ur e st er ilizat ion m et hod,
did n ot ach iev e t h e desir ed st er ilit y af f ect an d h as
been sur passed by new m et hods;
- p r e se n ce o f se r u m a n d sa l t i n t e st e d m a t e r i a l
pr esen t ed pr ot ect iv e act ion again st m icr oor gan ism s
in t he st er ilizat ion pr ocess;
- w hen using low t em per at ur e st er ilizat ion m et hods,
m at er ials w it h n ar r ow lu m en s ar e m or e ch allen gin g
for successful st er ilizat ion t han long m at er ials;
- cur r ent ly available lit er at ur e is insufficient t o select
t he low t em per at ur e m et hod t o r eplace ETO.
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1 . Ru t a l a WA, We b e r D J. Lo w - Te m p e r a t u r e St e r i l i za t i o n Technologies: Do We Need t o Redefine “ St er ilizat ion” ? I nfect Con t r ol Hosp Ep id em iol 1 9 9 6 ; 1 7 ( 2 ) : 8 7 - 9 1 .
2 . Ru t a l a W A, W e b e r D J. Vl i n a ca l Ef f e ct i v e n e ss o f Lo w Tem perat u r e St er ilizat ion Tech n ologies. I n fect Con t r ol Hosp Ep i d em i o l 1 9 9 8 ; 1 9 ( 1 0 ) : 7 9 8 - 8 0 4 .
3. Alfa MJ, DeGagne P, Olson N, Puchalsk i T. Com par ison of ion plasm a, vaporized hydrogen peroxide and 100% et hylene ox ide st er ilizer s t o t h e 1 2 / 8 8 et hy len e ox ide gas st er ilizer. I n f ect Con t r ol Hosp Ep id em iol 1 9 9 6 ; 1 7 : 9 2 - 1 0 0 .
4. Rutala WA, Gergen MF, Weber DJ. Com parative evaluation of t h e spor icidal act iv it y of n ew low - t em per at u r e st er ilizat ion t echnologies: et hylene oxide, 2 plasm a st erilizat ion syst em s an liquid peracet ic acid. Am J I nfect Cont rol 1998; 26: 393- 8. 5 . Alf a MJ, DeGag n e P, Olson N, Hizon R. Com p ar ison of liquid chem ical st er ilizat ion w it h per acet ic acid and et hy lene oxide st erilizat ion for long narrow lum ens. Am J I nfect Cont rol 1 9 9 8 ; 2 6 : 4 6 9 - 7 7 .
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11. Br ow n SA, Mer r it t K, Woods TO, McNam ee SG, Hit chins VM. Effect s of Different Disinfect ion and St erilizat ion Met hods on Tensile St r engt h of Mat er ials Use for Single- Use Dev ices. Biom ed I n st r u m Tech n ol 2 0 0 2 ; 3 6 ( 1 ) : 2 3 - 7 .
Recebido em : 4.4.2005 Aprovado em : 13.12.2006
Low- t em perat ure st erilizat ion and new... Goveia VR, Pinheiro SMC, Graziano KU.
