EVALUATI ON OF CLEANI NG AND DI SI NFECTI ON PERFORMANCE OF
AUTOMATI C W ASHER DI SI NFECTORS MACHI NES I N PROGRAMS
PRESENTI NG DI FFERENT CYCLE TI MES AND TEMPERATURES
1Mar ia do Car m o Nor onha Com inat o Ber go2
Ber go MCNC. Ev aluat ion of cleaning and disinfect ion per for m ance of aut om at ic w asher disinfect or s m achines in pr ogr am s pr esent ing differ ent cy cle t im es and t em per at ur es. Rev Lat in am Enfer m agem 2006 set em br o-out ubr o; 14( 5) : 735- 41.
Th er m al w ash er - disin f ect or s r epr esen t a t ech n ology t h at br ou gh t abou t gr eat adv an t ages su ch as, est ablishm ent of pr ot ocols, st andar d oper at ing pr ocedur es, r educt ion in occupat ional r isk of a biological and env ir onm ent al nat ur e. The efficacy of t he cleaning and disinfect ion obt ained by aut om at ic w asher disinfect or s m achines in running program s wit h different t im es and t em perat ures det erm ined by t he different official agencies w as v alidat ed accor ding t o r ecom m endat ions fr om I SO St andar ds 15883- 1/ 1999 and HTM2030 ( NHS Est at es, 1 9 9 7 ) f or t h e det er m in in g of t h e Min im u m Let h alit y an d DAL bot h t h eor et ically an d t h r ou gh t h e u se w it h t herm ocouples. I n order t o det erm ine t he cleaning efficacy, t he Soil Test , Biot race Pro- t ect and t he Prot ein Test Kit were used. The procedure t o verify t he CFU count of viable m icroorganism s was perform ed before and aft er t he t herm al disinfect ion. This art icle shows t hat t he result s are in com pliance wit h t he I SO and HTM St andards. The validat ion st eps confirm ed t he high efficacy level of t he Medical Washer- Disinfect ors. This prot ocol enabled t he ev aluat ion of t he pr ocedur e based on ev idence suppor t ed by scient ific r esear ch, aim ing at t he suppor t of t he Supply Cent er m ult i- professional personnel wit h inform at ion and t he possibilit y of developing furt her research.
DESCRI PTORS: disinfection, validation studies [ publication type] , colony count, m icrobial, technology/ instrum entation
EVALUACI ÓN DEL DESEMPEÑO DE LA LI MPI EZA Y DESI NFECCI ÓN
DE LAS MÁQUI NAS LAVADORAS DESI NFECTADORAS AUTOMÁTI CAS EN
PROGRAMAS CON DI FERENTES TI EMPOS Y TEMPERATURAS
La l av ad o r a t er m o - d esi n f ect ad o r a es u n a t ecn o l o g ía q u e h a t r aíd o g r an d es v en t aj as, co m o l o s p r ot ocolos, la st an d ar d ización d e p r oced im ien t os, la d ocu m en t ación d el p r oceso, la r ed u cción d el r iesg o ocupacional biológico y am bient al. El desem peño de la lim pieza y desinfección realizado por m áquinas lavadoras desinfect ador as aut om át icas en pr ogr am as con difer ent es t iem pos y t em per at ur as r ecom endados por dist int os ór gan os of iciales h a sido v alidado con f or m e las r ecom en dacion es de las Nor m as I SO 1 5 8 8 3 - 1 / 1 9 9 9 y HTM 2030 ( NHS Est at es, 1997) para el cálculo t eórico y con t erm opares de Let alidad Mínim a y DAL. Para evaluar el r esu lt ado de la lim pieza se u t ilizó Soil Test , t est Biot r ace Pr o- t ect y Test Kit Pr ot ein a. El pr ocedim ien t o de cont abilidad de UFC de m icr oor ganism os v iables ha sido r ealizado ant es y después de la t er m o- desinfección. Est e ar t ícu lo d em u est r a q u e los r esu lt ad os est án en con f or m id ad con las Nor m as I SO y HTM. Las et ap as v al i d ad as co m p r u eb an el ex cel en t e d esem p eñ o d e l as l av ad o r as d esi n f ect ad o r as co m o i n st r u m en t o s d e desinfección de alt o nivel. Est e prot ocolo ha perm it ido evaluar la práct ica basada en la evidencia y fundada en la pesquisa cient ífica, par a que la equipe de pr ofesionales del Cent r o de Mat er iales pueda ser subsidiada con in f or m acion es y desar r ollar n u ev as pesqu isas.
DESCRI PTORES: desin fección ; est u dios de v alidación [ t ipo de pu blicación ] ; r ecu en t o de colon ia m icr obian a; t ecn ología/ in st r u m en t ación
AVALI AÇÃO DO DESEMPENHO DA LI MPEZA E DESI NFECÇÃO
DAS MÁQUI NAS LAVADORAS DESI NFECTADORAS AUTOMÁTI CAS
EM PROGRAMAS COM DI FERENTES TEMPO E TEMPERATURA
A lav ador a t er m odesin f ect ador a é u m a t ecn ologia qu e t r ou x e gr an des v an t agen s com o pr ot ocolos, padr onização dos pr ocedim ent os, docum ent ação do pr ocesso, r edução do r isco ocupacional de or dem biológica e am bient al. O desem penho da lim peza e desinfecção das m áquinas lav ador as desinfect ador as aut om át icas, em pr ogr am as com difer ent es t em pos e t em per at ur as pr econizados por dist int os ór gãos oficiais, foi v alidado, con f or m e as r ecom en dações das Nor m as I SO 1 5 . 8 8 3 - 1 / 1 9 9 9 e HTM2 0 3 0 ( NHS Est at es, 1 9 9 7 ) par a cálcu lo t eórico e com t erm opares da Let alidade Mínim a e DAL. Para avaliação do result ado da lim peza, foram ut ilizados Soil Test , t est e Biot race Pro- t ect e o Test e Kit Prot eína. O procedim ent o de cont agem de UFC de m icrorganism os viáveis foi realizado ant es e após t erm odesinfecção. Est e art igo m ost ra que os result ados est ão em conform idade com a Nor m a I SO e HTM. As et apas v alidadas com pr ov am desem pen h o ex celen t e das Máqu in as Lav ador as Desin f ect ad or as com o d esin f ecção d e alt o n ív el. Est e p r ot ocolo p er m it iu av aliação d a p r át ica b asead a n a ev idência e fu n dam ent ada na pesqu isa cient ífica, par a que a equipe m u lt ipr ofissional do Cent r o de Mat er ial possa ser su bsidiada com in for m ações e desen v olv er n ov as in v est igações.
DESCRI TORES: d esin f ecção; est u d os d e v alid ação [ t ip o d e p u b licação] ; con t ag em d e colôn ia m icr ob ian a; t ecn olog ia/ in st r u m en t ação
1
Art icle ext ract ed from t he Mast er ’s Thesis, Acknowledgem ent s t o Prof. Kazuko Uchikawa Graziano; 2 RN, Doct oral st udent UNI FESP, Facult y, School of Nursing, Paulist a Universit y
I NTRODUCTI ON
C
hanges in healt h care have occurred at anu n p r e c e d e n t e d s p e e d , i n c l u d i n g , f o r e x a m p l e :
e m e r g e n c e o f i n f e c t i o n s b y r e c e n t l y - i d e n t i f i e d
pat hogens, int r oduct ion of m or e com plex equipm ent
a n d t e c h n o l o g i e s a n d c a r e t e n d e n c i e s . A s a
c o n s e q u e n c e o f t h i s c h a n g e , h o s p i t a l c a r e i s
i n cr easi n g l y co n cen t r at ed o n car e f o r ser i o u sl y - i l l
p a t i e n t s a n d , t h e r e f o r e , s u s c e p t i b l e t o h o s p i t a l
in f ect ion s.
I n fect ion pr ev en t ion an d con t r ol is com plex
an d d ep en d s on scien t if ic k n ow led g e an d ev id en ce
and t echnical skills. Each care- relat ed act ion requires
t he applicat ion of relevant knowledge, including specific
t op ics in m icr ob iolog y, im m u n olog y, ep id em iolog y,
engineering and personal and environm ent al hygiene.
D i f f e r e n t h o s p i t a l d e v i c e c l e a n i n g a n d
d isin f ect ion p r oced u r es ar e u sed on a lar g e scale.
This gave rise t o t he opport unit y t o st udy t he efficacy
o f w a sh e r - d i si n f e ct o r m a ch i n e s f o r cl e a n i n g a n d
disinfect ion, due t o concerns about cont am inat ion risks
c a u s e d b y h a n d l i n g a r t i c l e s w i t h o u t t h e u s e o f
p r o t e c t i o n e q u i p m e n t a n d w i t h o u t c o r r e c t
st a n d a r d i za t i o n , a s w e l l a s a b o u t e n v i r o n m e n t a l
cont am inat ion by w ast e aft er cleaning( 1).
Th e c l e a n i n g o f w o r k e n v i r o n m e n t a n d
d e v i ce s i s a f a ct o r o f u t m o st i m p o r t a n ce , a s i t s
i n co r r e ct r e a l i za t i o n e n t a i l s se r i o u s p r o b l e m s i n
su b seq u en t st ep s( 2 - 3 ). I n t h is ar ea, t h er e h as b een co n si d er ab l e t ech n o l o g i cal ev o l u t i o n , w i t h v ar i o u s
t y p e s o f w a sh i n g m a ch i n e s, su ch a s: u l t r a so n i c,
disinfect ing, past eur izing and st er ilizing, besides t he
t echnological developm ent of m at erials like enzym at ic
d et er g en t s, d i r t r esi d u e t est s an d p r ot ei n r esi d u e
d e t e ct i o n t e st s( 4 - 6 ). I n t h e Eu r o p e a n Co m m u n i t y, t h er m al w ash er - d isin f ect or s op er at e w it h d if f er en t
r u n n i n g t i m e s a n d t e m p e r a t u r e s, d e t e r m i n e d b y
official organs in different count ries, causing difficult ies
in our cont ext t o choose t he program select ion( 1- 6). I n Br a zi l , t h er e a r e n ei t h er o p er a t i n g st a n d a r d s n o r
g u i d e l i n e s t o a s s e s s t h e s e w a s h e r - d i s i n f e c t o r s .
Therefore, we use st andards adopt ed in t he count ries
of or igin and m anufact ur er guidelines.
Th i s r esea r ch w a s ca r r i ed o u t t o m a k e i t
easi er f o r Su p p l y Cen t er n u r ses t o saf el y ch o o se
d i f f e r e n t c l e a n i n g a n d d i s i n f e c t i o n p r o g r a m s i n
a u t o m a t i c w a s h e r - d i s i n f e c t o r m a c h i n e s , a s a
fou n dat ion for ev iden ce- based pr act ice.
OBJECTI VES
Th e g en er al st u d y ob j ect iv e w as t o assess
t he efficacy of t he cleaning and disinfect ion obt ained
by aut om at ic w asher - disinfect or m achines in r unning
p r o g r a m s w i t h d i f f er en t t i m es a n d t em p er a t u r es,
d et er m i n ed b y d i f f er en t o f f i ci al ag en ci es. Sp eci f i c
obj ect ives w ere: t o assess t he efficacy of m echanical
cleaning and t herm al disinfect ion by aut om at ic
washer-disinfect or m achines in running program s wit h different
t im es an d t em p er at u r es; t o calcu lat e an d an aly ze
Mi n i m u m Le t h a l i t y - A 0 l e v e l s a n d D i s i n f e c t i o n
Assu r a n ce Le v e l - D AL i n t h e w a sh e r - d i si n f e ct o r
equipm ent in v iew of differ ent disinfect ion pr ogr am s,
com par ing t hem w it h t heor et ical calculat ions.
MATERI AL AND METHOD
We c a r r i e d o u t a q u a n t i t a t i v e a p p l i e d
ev alu at ion st u d y in t w o d if f er en t lab or at or ies. Th e
m e t h o d o l o g i ca l f r a m e w o r k co n si st e d o f t h e I SO
15.883- 1- 4/ 1999 and HTM 2030 ( NHS Est at es, 1997)
st andards( 2,7). The operat ional phase was realized wit h t her m al w asher - disinfect or devices in t he Supply and
St erilizat ion Cent ral of a privat e hospit al in t he cit y of
São Paulo, Br azil.
Microbiological analyses were perform ed at the
Br om at ology and Chem ist r y Division, St er ilit y Cont r ol
Se ct i o n o f t h e Ad o l f o Lu t z I n st i t u t e , u n d e r t h e
responsibilit y of a pharm acist , using a Miele® t herm al w a sh e r d i si n f e ct o r, m o d e l G7 7 3 6 CD MCU
-Microcom puter- controlled Unit. The equipm ent offers 15
pr ogr am s of br oad applicat ion w hich can neit her be
m odified nor delet ed; program s 16 and furt her can be
cr eat ed, inst alled or delet ed by specialized t echnical
assist ance. Befor e st ar t ing t he st udy, t he equipm ent
w as subj ect t o m aint enance by specialized t echnical
assist an ce, an d t h e pr ogr am s t o be assessed w er e
revised. The inserted program s contained three cleaning
pr ogr am s. Mech an ical clean in g t im e w as set at on e
m inute with detergent, followed by a one- m inute rinsing
phase, with disinfection tim e and tem perature according
t o est ablished st andards. I n all program s, t he cleaning
phase was assessed using Endozim e A W Plus detergent,
m anufactured by Ruhof®, dispensing a total of 18 m l in each of t he t hree cleaning process phases.
I n t h e v alidat ion pr ocess, per f or m an ce w as
q u a l i f i e d b y a s p e c i a l i z e d c o m p a n y, u n d e r t h e
by t he r esear cher, in line w it h I SO 1 5 . 8 8 3 - 1 - 2 - 3 - 4 /
1 9 9 9 a n d H TM 2 0 3 0 r e c o m m e n d a t i o n s a n d r eq u ir em en t s.
Three resources were used t o assess cleaning ef f icacy : t h e Residu e Test Soil Test®, Biot race Pr o-t eco-t® Prot ein Residue Test and t he Miele Merck® Prot ein Test Kit ; t he chosen inst rum ent s were used in rout ine
su r g i ca l p r o ced u r es, su ch a s: a cet a b u l a r b r o a ch , fem or al br oach, Cr ile for ceps, Kelly for ceps, Har t m an
for ceps, Debak ey for ceps, Ker r ison , Glov er Vascu lar clam ps and ot hers. St andard HTM 2030 was t aken as
t h e b ase t o ch oose an d d et er m in e t h e q u an t it y of
inst r um ent s for t he t est .
The Cleaning Assessm ent Phase occur r ed in
t he sam e w ay in all program s. The Soil and Biot race Pr o - t e ct Te st s w a s a sse sse d i n t h r e e m e ch a n i ca l
clean in g cy cles. Th e Soil Test w as ap p lied t o 3 1 3 inst rum ent s. Five of t hese present ed Soil Test residues
aft er visual evaluat ion. Due t o t heir com plex st ruct ure, t h ey w er e also su b m it t ed t o t h e Biot r ace Pr o- t ect
p r o t ei n r esi d u e t est . Th i s t est w a s a p p l i ed t o 6 5 in st r u m en t s, assessin g 2 0 in each cy cle. A con t r ol
t est w as used in each assessm ent .
The pr ot ein r esidue t est - Miele Pr ot ein Test
K i t w a s se p a r a t e l y a p p l i e d i n t h r e e co n se cu t i v e
m e c h a n i c a l c l e a n i n g c y c l e s , a s s e s s i n g 1 4 1 inst rum ent s, 47 in each cycle. A cont rol t est was used
in each assessm ent .
To q u a l i f y p er f o r m a n ce, cy cl es h a d t o b e
carried out for t hree consecut ive t im es, in accordance w it h I SO 1 5 . 8 8 3 . Th u s, each cy cle con sist ed of 2 0
cont am inat ed inst r um ent s, subm it t ed t o t hr ee cy cles
i n e a c h a s s e s s e d p r o t o c o l . A f t e r t h e t h e r m a l
disinfect ion pr ocess, t he t est inst r um ent s w er e sent t o t he Br om at ology and Chem ist r y Div ision, St er ilit y
Con t r ol Sect ion of t h e Adolf o Lu t z I n st it u t e f or t h e I d e n t i f i c a t i o n o f I n i t i a l a n d Fi n a l V i a b l e
Micr oor g an ism s.
Fo r t h i s p h a s e , 6 0 i n s t r u m e n t s w e r e
int ent ionally cont am inat ed w it h placent a blood aft er n or m al bir t h , m ain t ain in g con t act w it h t h e placen t a
f or on e h ou r. Th is t im e w as ch osen b ased on r eal dat a about int raoperat ive t im e, t im e t o dism ount t he
su r g ical r oom , t im e t o r eceiv e t h e p u r if icat ion an d
p r e p a r a t i o n o f i n st r u m e n t s f o r t h e cl e a n i n g a n d disin f ect ion pr ocedu r e.
Af t er con t am in at ion , ex cess r esid u es w er e t ak en aw ay w it h a j et of cold w at er under pr essur e
an d p laced b et w een t h e secon d an d t h ir d su p p or t shelv es of t he t her m al washer - disinfect or. The ot her
shelv es w er e filled w it h cont am inat ed m at er ial fr om t he service under st udy. Aft er t he t herm al disinfect ion
cycle, t he inst rum ent s were rem oved wit h t he help of glov es and t w o gam m a- ir r adiat ed poly et hy lene bags.
Th e d ev i ces w er e p l aced i n t h e p ack i n g u si n g an a s e p t i c t e c h n i q u e a n d s e a l e d ; n e x t , t h e y w e r e
i d e n t i f i e d a n d e x t e r n a l l y p a c k e d i n r e s i s t a n t
p oly et h y len e.
RESULTS
Result s of t he Dirt and Prot ein Residue Test s
t o Assess t he Mechanical Cleaning Pr ocess.
d o h t e m n o i t c e t e
D VisualInspection Colorimétrico Colorimétrico
g n i n a e l c l a c i n a h c e M
e c n a m r o f r e
p SoilTest %
t c e t -o r P
e c a r t o i
B %
t i K e t s e T
e l e i M a n í e t o r
P % Total %
t r i d n i e t o r p f o e c n e s e r
P 5 1,6 5 8 0 0 10 1,9
t r i d n i e t o r p f o e c n e s b
A 308 98,4 60 92 141 100 509 98,1
l a t o
T 313 100 65 100 141 100 519 100
Table 1 - Residue Fr equency Dist r ibut ion assessed by Soil Test , Biot race Pr o- t ect and t he Miele® Pr ot ein Test Kit . São Paulo, 2003
According t o dat a in Table 1, Soil Test residues were found in five ( 1.6% ) assessed inst rum ent s. The a b se n ce o f So i l Te st r e si d u e s w a s f o u n d i n 3 0 8 ( 98.4% ) cases, t ot aling 313 inst r um ent s.
The Soil Test r esidues w er e obser ved on t he f o l l o w i n g i n st r u m e n t s: o n e Ru sk i n Ro n g e u r, o n e Leksell Gouge, one Luer St ille Gouge, one St ille List on Rongeur, one Ker r ison. I n som e dev ices, t he cent ral lin k w as dism ou n t ed t o per m it open in g an d access for m echanical cleaning; however, ot her m anufact uring
m odels and br ands did not offer t his possibilit y.
S i x t y i n s t r u m e n t s ( 9 2 . 0 % ) p r e s e n t e d negat ive result s on t he Prot ein Residue t est - Biot race Pro- t ect . The sam e t est was applied t o t he five ( 8.0% ) in st r u m en t s t h at sh ow ed r esidu es on t h e Soil Test , and t he r esult s confir m ed pr ot ein pr esence.
I n t ot al, w e assessed 5 1 9 inst r um ent s, and
found absence of dirt and prot ein in 509 ( 98.1% ) . I n
1 0 ( 1 . 9 % ) i n st r u m en t s, t h e p r esen ce o f d i r t a n d
p r o t ei n r esi d u es co u l d h a v e b een d i f f er en t i f t h e
cr i t i ca l st r u ct u r e o f t h e se i n st r u m e n t s h a d b e e n
rigorously observed, dism ount ed and subm it t ing t hese
dev ices t o m anual or m echanical cleaning befor e t he
t h er m al disin fect ion pr ocess.
Result of t he Therm al Qualificat ion of
Washer-Disin f ect or Mach in es, accor d in g t o t h e BGA, HTM,
RI VM, SI S St a n d a r d s a n d i n r u n n i n g cy cl e s w i t h
Past eu r izat ion Tim e an d Tem per at u r e.
Th i s st e p w a s p e r f o r m e d b y a n e n g i n e e r
r esponsible for a specialized v alidat ion com pany and
t h e r esear ch er. Test s w er e per for m ed in em pt y an d
loaded cycles. According t o t he prot ocol, t he following
r ecom m en d at ion s an d r eq u ir em en t s w er e ad op t ed :
GMP/ FDA 2 1 CFR Par t . I I , GHTF St u d y Gr ou p 3
-Qu a l i t y Sy st e m s - Pr o ce ss Va l i d a t i o n Gu i d e , I SO
15.883: 1999 and HTM 2030.
Table 2 - Result of Therm al Distribution Study in Therm al Disinfector in Em pty and Loaded Cycles, according to BGA,
DHSS/ HTM, RI VM, SPRI / SI S st andards and Cycle wit h Past eurizat ion Tim e and Tem perat ure. São Paulo, 2003
The per for m ance qualificat ion of t he t her m al
w asher - disinfect or w as car r ied out in t he em pt y and
loaded cy cles. Tw elv e t her m ocouples w er e used. All
pr ot ocols pr esent ed a v ar iat ion of < ± 2º C bet w een
sensors and < ± 1º C bet ween t he sam e sensor, below
levels det erm ined by I SO15883- 1/ 1999 and HTM 2030
( N H S Es t a t e s , 1 9 9 7 ) . I n a l l c y c l e s , s e n s o r 7
dem on st r at ed a v ar iat ion super ior t o ± 1 º C, dur ing
ex p osu r e, d u e t o it s p lacem en t close t o t h e w at er
heat ing r eser voir. Ther efor e, it s r esult s w er e ignor ed
in t he final r esult int er pr et at ion. Dist r ibut ion st udies
w e r e r e p e a t e d f o r e a c h t y p e o f p r o t o c o l w e
m ent ioned, w it hout any changes out side est ablished
s t a n d a r d s , s o t h a t a l l c y c l e s w e r e c o n s i d e r e d
ap p r o v ed .
Resu lt of Mean Cou n t of Viab le CFU f ou n d
aft er t he Ther m al Disinfect ion Cy cles, Calculat ion of
required Minim um Let halit y and Disinfect ion Assurance
Le v e l a cco r d i n g t o I SO 1 5 8 8 3 - 1 / 1 9 9 9 , o b t a i n e d
Th eor et ically an d w it h Th er m ocou p les, in lin e w it h
BGA, HTM, RI VM, SI S St andar ds, for r unning cy cles
w it h Past eur izat ion Tim e and Tem perat ur e.
Table 3 - Com par ison bet w een Mean Count of Viable CFU, Calculat ion of r equir ed Let halit y and DAL accor ding
t o I SO st andar d, r esult s obt ained t heor et ically and w it h Ther m ocouples, accor ding t o BGA, HTM, RI VM, SI S
st andar ds and Cy cle w it h Past eur izat ion Tim e and Tem perat ur e. São Paulo, 2003
e l c y C e m i T A G
B Great-Britain Great-Britain Pasteurization Holland Sweden Sweden s e t u n i m 0
1 1second 2minutes 30minutes 5minutes 1minute 3minutes
e r u t a r e p m e T t n i o P -t e
S 95,0ºC 90,0ºC 82,0ºC 70,0ºC 90,0ºC 85,0ºC 85,0ºC . C y t p m E . x a
M 95,7ºC 90,5ºC 83,2ºC 71,6ºC 91,1ºC 86,2ºC 86,0ºC . C y t p m E n a e
M 94,5ºC 89,8ºC 82,8ºC 70,7ºC 90,8ºC 85,9ºC 85,4ºC . C y t p m E . n i
M 92,9ºC 87,6ºC 81,9ºC 69,5ºC 90,3ºC 85,4ºC 84,9ºC . C d a o L . x a
M 95,1ºC 90,3ºC 83,4ºC 72,8ºC 91,5ºC 86,5ºC 86,7ºC . C d a o L n a e
M 94,5ºC 89,9ºC 82,9ºC 71,0ºC 91,1ºC 86,0ºC 86,3ºC . C d a o L . n i
M 93,4ºC 88,5ºC 82,3ºC 70,4ºC 90,5ºC 84,6ºC 85,4ºC r o s n e S e m a
S <±1ºC <±1ºC <±1ºC <±1ºC <±1ºC <±1ºC <±1ºC s r o s n e S n e e w t e
B <±2ºC <±2ºC <±2ºC <±2ºC <±2ºC <±2ºC <±2ºC n o it a u t i
S Approved Approved Approved Approved Approved Approved Approved
d r a d n a t
S BGA Great-Britain Great-Britain Pasteurization Holland Sweden Sweden
e r u t a r e p m e
T 94ºC 90ºC 82ºC 70ºC 90ºC 85ºC 85ºC
e m i T e r u s o p x
E 10.00min 1.00Sec 2.00min 30.00min 5.00min 1.00min 3.00min
L A D d n a y t i l a h t e L m u m i n i M d e r i u q e R y t il a h t e
L 10,00min 10,00min 10,00min 10,00min 10,00min 10,00min 10,00min L
A
D > 01 -2 > 01 -2 > 01 -2 > 01 -2 > 01 -2 > 01 -2 > 01 -2 U F C e l b a i V f o t n u o C n a e M U F C l a it i n
I 108 108 108 108 108 108 108
U F C l a n i
F <102 <102 <102 <102 <102 <102 <102 s e l p u o c o m r e h T h t i w d e n i a t b O L A D d n a y t i l a h t e L m u m i n i M y t il a h t e L m u m i n i
M 318,2min 26,42min 7,76min 3,88min 85,76min 12,09min 20,17min L
A
D 1x10-307 3,8x10-19 1,7x100 1,3x10+4 1,7x10-78 8,1x10-5 6,7x10-13
n o it a u t i
S Approved Approved Rejected Rejected Approved Approved Approved
L A D d n a y t i l a h t e L m u m i n i M l a c i t e r o e h T y t il a h t e L m u m i n i
M 251,00min 0,17min 3,17min 3,00min 50,00min 3,16min 9,48min** L
A
D 1x10-243 6,76x10+7 6,76x10+4 1x10+5 1x10-42 6,92x10+4 3,31x10-2*
n o it a u t i
D a t a i n Ta b l e 3 sh o w t h e i m p o r t a n ce o f
assessing all t heoret ical and t herm ocouple param et ers f or A0, DAL an d in it ial an d f in al CFU. Alt h ou gh t h is st u d y h as d em on st r at ed a r ed u ct ion of CFU b elow < 1 02 in all pr ot ocols, t his does not m ean t hat t hey are approved. I n t he t heoret ical calculat ion of Let halit y a n d D AL, t w o p r o t o co l s w e r e a p p r o v e d a n d f i v e
r ej ect ed , b eca u se t h ey sh o w ed l o w er l ev el s t h a n t hose found dur ing validat ion w it h t her m ocouples. I n
t h e v a l i d a t i o n w i t h t h e r m o co u p l e s, t h e a p p r o v e d p r ot ocols w er e: Ger m an St an d ar d , BGA - t im e 1 0
m inut es and t em perat ure 94º C, Brit ish St andard, HTM
- t i m e 1 s e c o n d a n d t e m p e r a t u r e 9 0 º C, D u t c h St an dar d, RI VM - t im e 5 m in u t es an d t em per at u r e
9 0 º C an d Sw edish St an dar ds, SI S - t im es 1 an d 3 m inut es and t em perat ure 85º C. The rej ect ed prot ocols
w er e: Br it ish St an dar d, HTM - t im e 2 m in u t es an d t e m p e r a t u r e 8 2 º C, c y c l e o f 3 0 m i n u t e s a n d
t em per at ur e 70º C used for past eur izat ion, w hich did not reach t he levels set by I SO 15.883.
DI SCUSSI ON
Th e S u p p l y Ce n t e r i s o n e o f t h e m o s t
im port ant areas in t he hospit al environm ent , including t h e m a n a g e m e n t , t e ch n i ca l a n d h u m a n r e so u r ce
ar eas. I n r ecent y ear s, gr eat changes hav e occur r ed in t h is field, r eflect in g on t h e pr ofession als w or k in g
t h e r e a n d o n n e w c l e a n i n g , d i s i n f e c t i o n a n d st er ilizat ion t ech n olog ies( 2 , 7 - 8 ). Th u s, a cr it ical an d det ailed assessm ent of t he physical area is im port ant
w it h a v iew t o pr om ot in g a saf e w or k en v ir on m en t for pr ofession als an d pr ocedu r es.
Th e d e t a i l e d p l a n n i n g o f e q u i p m e n t , accessor ies, m at er ials and adequat e inst r um ent s and
o t h er d ev i ces i s n eed ed f o r ef f ect i v e p l a n n i n g i n su r g e r y a n d o t h e r h o sp i t a l a r e a s. Cl e a n i n g a n d
disinfect ion pr ocedur es in t his cont ex t should follow t he prot ocols and guidelines of m at erial and equipm ent
m anufact urers( 9- 10). Cleaning agent s need t o be t est ed b ef or e t h eir ap p r ov al. Ad eq u at e r esou r ces h av e t o
be assured for professionals, equipm ent and t he work
env ir onm ent( 9- 11).
Pr o f e s s i o n a l q u a l i f i c a t i o n i n t h i s a r e a i s
im port ant . Therefore, t raining and const ant verificat ion o f p r o ce ss k n o w l e d g e a n d p e r f o r m a n ce a r e b o t h
r el ev an t an d p ar am o u n t . Eq u i p m en t w o r k i n g i n a closed syst em is safer for professionals, as it im pedes
t he dissem inat ion of aerosols in t he area and decrease accident risks. The use of individual and environm ent al
pr ot ect ion equipm ent should be r equir ed. Pur ificat ion
is consider ed a pot ent ially cont am inat ed ar ea in t he h ospit al en v ir on m en t( 9 , 1 1 ). HTM 2 0 3 0 an d I SO1 5 8 8 3 St andards need t o be used t o validat e t herm al washer-disinfect ors. I n order t o guarant ee consist ent result s,
a v a l i d a t i o n p r o j e c t s h o u l d b e e s t a b l i s h e d i n accordance wit h t he st andards, which indicat e t he use
of t h er m ocou ples for per for m an ce qu alificat ion . Th e Resid u e Soil Test an d t h e Pr ot ein Resid u e Test ar e
indicat ed t o assess cleaning effect iv eness in t her m al d isin f ect ion . Viab le m icr oor g an ism cou n t s ar e on e
v alue for nur ses t o calculat e and obt ain A0 and DAL lev els dur ing t he v alidat ion.
Th e co m p ar i so n b et w een t h e m ean i n i t i al
viable m icrobial load in t he assessed inst rum ent s ( 108 CFU ) a n d t h e v i a b l e m i c r o b i a l l o a d d u r i n g t h e
assessm ent , aft er t he t her m al disinfect ion pr ocesses g u i d e d b y d i f f e r e n t t i m e s a n d t e m p e r a t u r e s, i n
accordance wit h BGA, HTM, SI S, RI VM St andards and u sin g r u n n in g cy cles w it h p ast eu r izat ion t im e an d
t em p er at u r e ( < 1 02 CFU) d em on st r at ed n o g r ow t h . Viable CFU count s are also im port ant t o get t o know
a n d a ssess t h e cr i t i ca l i t y o f t h e i n st r u m en t s a n d e s t a b l i s h t h e n e c e s s a r y c l e a n i n g p r o c e s s e s t h e
inst rum ent needs t o be subj ect t o before t he t herm al
disin f ect ion pr ocess.
The per for m ance qualificat ion of t he t her m al
w ash er - disin f ect or w as r ealized on t h e basis of t h e BGA, HTM, RI VM, SI S St andar ds and using t he cycle
w it h Past eu r izat ion t im e an d t em per at u r e, u sin g 1 2 t her m ocouples for t he t her m al dist r ibut ion st udy, in
t he t hr ee em pt y and in t he t hr ee loaded cy cles. All
p r o t o c o l s w e r e c o n s i d e r e d a p p r o v e d . M i n i m u m let h alit y calcu lat ion s w it h t h er m ocou p les p r esen t ed
higher result s t han in t heoret ical calculat ions because, in t he t herm al disinfect ion process, m inim um let halit y
st ar t s t o be accu m u lat ed as t em per at u r e in cr eases, befor e t he st ar t of t he disinfect ion phase.
Th e m easu r em en t s w it h t h er m ocou ples can r ev eal bot h t h e in su f f icien cy an d t h e ex cess of t h e
t im e- t em per at u r e r elat ion . Th er m ocou ples allow f or m easur em ent s w it h high- pr ecision w ir es, and r esult s
are available during and im m ediat ely aft er t he end of
t he v alidat ion. Act ual heat quant it ies can be dir ect ly co m p ar ed b y cal cu l at i n g A - Let h al i t y an d su p p l y
t echnical det ails about t he pr ocedur es. An ex cessiv e t im e- t em perat ure relat ion can be equally det erm ined,
as w ell as t ot ally inadequat e heat ing( 6).
I t n e e d s t o b e c e r t i f i e d w h e t h e r t h e s e
I m port ant variables need t o be t aken int o account in
t his process, such as: t im e, t em perat ure, wat er qualit y and v olum e, t y pes of det er gent s, dosage, lubr icant s
and t he w asher m odel it self( 4- 12). I n or der t o cer t ify t hese v alues, t heor et ical dat a need t o be com par ed
w i t h t h e t h er m o co u p l es an d d at a o b t ai n ed i n t h e m icr oor gan ism cou n t s( 6 ).
I n per f or m an ce qu alif icat ion , t h e r esu lt s of Min im u m Let h alit y an d DAL calcu lat ion s n eed t o be
studied, assessed and applied. According to I SO 15883 an d HTM2 0 3 0 , t h e r ecom m en ded t im e for Min im u m
Lethality - A0 was 10 m inutes. The Disinfection Assurance Level - DAL was calculat ed on t he basis of t he init ial k n ow n popu lat ion 1 08. I n or der t o gu ar an t ee an A0 equaling 10 m inutes, a = 10- 2 reduction is needed( 2,7).
Th e f o l l o w i n g p r o t o c o l s r e a c h e d t h e
est ablished Minim um Let halit y and DAL lev els dur ing t h er m al q u alif icat ion w it h t h er m ocou p les: Ger m an
St andar d, BGA ( 94º C/ 10 m inut es) ; Dut ch St andar d, RI VM ( 9 0 º C/ 5 m i n u t e s) ; Sw e d i sh St a n d a r d , SI S
( 8 5 º C/ 1 m in u t e) ; Sw ed ish St an d ar d , SI S ( 8 5 º C/ 3 m inut es) ; Br it ish St andar d, HTM ( 90º C/ 1 second)
Th e p r o t o co l s t h a t d i d n o t r e a ch t h e
recom m ended Minim um Lethality and DAL during therm al qualification with therm ocouples were: Pasteurization Tim e
and Tem perat ure ( 70º C/ 30 m inut es) ; Brit ish St andard, DHSS/ HTM ( 82º C/ 2 m inut es) .
Th e s t a n d a r d s f r o m d i f f e r e n t c o u n t r i e s v alidat ed in t h er m al disin fect or m ach in es by m ean s
of t h er m ocou ples dem on st r at e t h at it is possible t o achieve a reduct ion of t he m icrobial load of Minim um
Let halit y and DAL super ior t o t heor et ical calculat ions
w h e n p e r f o r m i n g H i g h - Le v e l D i s i n f e c t i o n . Th i s provides foundat ions for our act ions t o follow scient ific
a n d t e ch n o l o g i ca l e v o l u t i o n s a t a Su p p l y Ce n t e r, suppor t ing nur ses w it h infor m at ion. The im por t ance
of m ult ipr ofessional t eam w or k at t he Supply Cent er n eeds t o be dissem in at ed an d applied, so t h at t h e
acquired knowledge can generat e benefit s for nursing car e an d pr of ession als.
CONCLUSI ON
Th i s st u d y a l l o w s u s t o co n cl u d e t h a t a l l
e s t a b l i s h e d o b j e c t i v e s w e r e r e a c h e d . Th e or ganizat ional st r uct ur e of t he Supply Cent er should
ev olv e. A car efu l assessm en t of it s ph y sical ar ea is n e e d e d w i t h a v i e w t o i m p r o v e m e n t s a n d t h e
i n s t a l l a t i o n o f a d e q u a t e r e s o u r c e s t o c a r r y o u t t ech n iqu es in m at er ial t r aceabilit y an d pr of ession al
and env ir onm ent al safet y. Pr ot ocols, pr ocedur es and w r i t t en r ou t i n es n eed t o b e v al i d at ed i n t er m s of
applicabilit y and t o be readily available in each area,
depending on it s specific charact erist ics. Their result s should be crit ically assessed t o t he benefit of pat ient s,
guarant eeing com pet ence wit h account abilit y and high-qualit y pr act ice.
I n l i n e w i t h I S O 1 5 8 8 3 a n d H TM 2 0 3 0 r ecom m en dat ion s f or clean in g ef f icacy assessm en t ,
t h e Soil Test , t h e Biot r ace Pr o- t ect an d t h e Pr ot ein Te st Ki t w e r e u se d . Mi n i m u m Le t h a l i t y a n d D AL
concept s were applied during perform ance qualificat ion t o obt ain result s and com pare t heoret ical calculat ions
w it h r esu lt s ach iev ed t h r ou g h t h er m ocou p les. CFU
co u n t s o f v i ab l e m i cr o o r g an i sm s w er e r eal i zed t o assess t her m al disinfect ion.
I n each prot ocol, all assessm ent s carried out befor e and aft er t her m al disinfect ion indicat e qualit y,
according t o our research result s and lit erat ure report s pr ov ing t hat High- Lev el Disinfect ion is per for m ed by
m e a n s o f t h e r m a l w a s h e r - d i s i n f e c t o r m a c h i n e s . M i n i m u m Le t h a l i t y a n d D A L r e s u l t s a b o v e
r ecom m ended st andar ds guar ant ee t he secur it y and
qualit y of t his pr ocess.
I SO 1 5 8 8 3 - 1 - 2 - 3 - 4 / 1 9 9 9 a n d H TM 2 0 3 0
st an d ar d s p er m it t h e assessm en t of ev id en ce an d s c i e n t i f i c r e s e a r c h - b a s e d p r a c t i c e , a l l o w i n g
m ult iprofessional t eam s at st erilizat ion unit s t o act in infect ion prevent ion, carry out new st udies and apply
t h em in t h eir r ealit y, in accor d an ce w it h av ailab le
r eso u r ces.
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