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ORDIN Nr

ORDIN   Nr. 1031 din 18 august 2004

privind modificarea si completarea Ordinului ministrului sanatatii si familiei nr. 185/2003 pentru aprobarea Normelor tehnice privind asigurarea curateniei, dezinfectiei, efectuarea sterilizarii si pastrarea sterilitatii obiectelor si materialelor sanitare in unitatile sanitare de stat si private

ACT EMIS DE: MINISTERUL SANATATII

ACT PUBLICAT IN: MONITORUL OFICIAL  NR. 822 din  7 septembrie 2004




    Vazand Referatul de aprobare al Directiei generale sanatate publica si inspectia sanitara de stat nr. OB 9.421/2004,
    in temeiul prevederilor Hotararii Guvernului nr. 743/2003 privind organizarea si functionarea Ministerului Sanatatii, cu modificarile si completarile ulterioare,

    ministrul sanatatii emite urmatorul ordin:

    Art. 1
    Ordinul ministrului sanatatii si familiei nr. 185/2003 pentru aprobarea Normelor tehnice privind asigurarea curateniei, dezinfectiei, efectuarea sterilizarii si pastrarea sterilitatii obiectelor si materialelor sanitare in unitatile sanitare de stat si private, publicat in Monitorul Oficial al Romaniei, Partea I, nr. 194 si nr. 194 bis din 26 martie 2003, se modifica si va avea urmatorul cuprins:
    1. Articolul 1 din anexa nr. 2 va avea urmatorul cuprins:
    "Sterilizarea este operatiunea prin care sunt eliminate sau omorate microorganismele, inclusiv cele aflate in stare vegetativa, de pe obiectele inerte contaminate, rezultatul acestei operatiuni fiind starea de sterilitate. Probabilitatea teoretica a existentei microorganismelor trebuie sa fie mai mica sau egala cu 10^-6.
    Standardele Normelor tehnice privind asigurarea curateniei, dezinfectiei, efectuarea sterilizarii si pastrarea sterilitatii obiectelor si materialelor sanitare in unitatile sanitare de stat si private sunt mentionate in anexa nr. 3, dar se pot folosi si alte standarde prin care sa se demonstreze respectarea cerintelor prevazute de prezentul ordin.
    Conform normelor in vigoare, <<sterilizarea face parte din categoria procedurilor speciale, ale carei rezultate nu pot fi verificate integral prin controlul final al produsului, efectuat a posteriori, trebuind sa fie supusa validarii, supravegherii bunei functionari, precum si asigurarii unei pastrari corespunzatoare a materialelor sterilizate. Sunt necesare atat controlul permanent al operatiunilor, cat si respectarea permanenta a procedurilor stabilite, pentru asigurarea conformarii la exigentele specificate>>.
    Obtinerea starii de <<sterilitate>>, precum si mentinerea ei (pana in momentul utilizarii) reprezinta obligatii de rezultat, unitatile sanitare fiind obligate sa creeze sistemele de calitate bazate pe normele care se refera la cerintele sistemelor de calitate.
    Unitatile sanitare trebuie sa garanteze acelasi nivel de securitate pentru pacienti atat in cazul utilizarii de dispozitive medicale achizitionate de pe piata, cat si al celor sterilizate in unitatea sanitara.
    Dispozitivele si materialele de unica folosinta nu vor fi niciodata reprocesate in vederea reutilizarii.
    Dispozitivele medicale care, prin modul de proiectare sau prin natura materialului din care sunt construite, nu suporta nici un tip de sterilizare trebuie sa fie supuse unei dezinfectii adecvate, al carei efect sa fie bactericid, fungicid, virulicid si sporicid.
    Termenii produs sterilizant sau sterilizare chimica sunt utilizati pentru o gama restransa de compusi chimici (formaldehida, glutaraldehida) care, in conditii controlate, pot distruge sporii bacterieni.
    Toate dispozitivele medicale si materialele care urmeaza a fi sterilizate trebuie curatate prin metode fizice si dezinfectate chimic inainte de a fi supuse unui proces de sterilizare standardizat.
    Toate instrumentele chirurgicale, materialele textile si alte obiecte sau solutii care patrund in tesuturile sterile sau in sistemul vascular, inclusiv instrumentele stomatologice, trebuie sa fie sterile (instrumente/obiecte critice).
    Organizarea activitatilor propriu-zise de sterilizare, precum si a activitatilor conexe (spalarea, decontaminarea si impachetarea, stocarea si livrarea) va tine cont de necesitatea respectarii circuitelor, a evitarii golurilor de control pe parcursul realizarii lor si a utilizarii altor spatii decat cele anume desemnate, serviciul central de sterilizare trebuind sa aiba un caracter unitar geografic pentru toate etapele mentionate.
    La organizarea activitatii serviciului central de sterilizare vor fi avute in vedere:
    - circuitul de colectare, recipientele si mijloacele de transport ale dispozitivelor murdare, nesterile;
    - diminuarea incarcaturii microbiene si eliminarea incarcaturii organice si a biofilmului*1) de pe dispozitivele medicale;
    - controlul conditiilor de mediu, verificarea starii de functionare a aparaturii;
    - spatiul curat pentru inventarierea si impachetarea dispozitivelor medicale;
    - sterilizarea propriu-zisa si sistemul de control al procesului;
    - procedurile de control si marcare a produselor finite;
    - tratarea neconformitatilor;
    - inregistrarea si arhivarea datelor privind parcursul procesului, in vederea asigurarii trasabilitatii, care este un element de sistem de calitate si este parte componenta a materiovigilentei*2);
    - circuitul de stocare, distributie, transport la utilizatori;
    - instruirea personalului;
    - echipamentul de protectie a personalului, diferentiat pe etape de proces.
    Pentru fiecare etapa SPCIN va elabora protocoale de procedura, continand instructiuni clare si bine definite, iar personalul serviciului central de sterilizare va fi certificat.
    Circuitele vor fi stabilite in asa fel incat sa asigure securitatea personalului, a mediului si integritatea dispozitivelor medicale.
    Controlul mediului este important, intrucat permite:
    - sa se evalueze problemele existente;
    - sa se remedieze defectiunile;
    - sa se supravegheze si sa se corecteze conditiile de desfasurare a procesului de sterilizare si a activitatilor conexe.
    Pentru aceasta vor fi tinute sub observatie si verificate:
    - calitatea aerului, apei si a fluidelor utilizate;
    - starea de igiena a suprafetelor;
    - modul de functionare a echipamentelor de sterilizare;
    - modul de functionare a echipamentelor de control, masura si testare;
    - tinuta si formarea profesionala a personalului.
    In unitatile de asistenta medicala sterilizarea se poate realiza prin: metode fizice - abur sub presiune (sau abur la temperatura si presiune ridicate/scazute), caldura uscata, metode chimice - oxid de etilena, <<sterilizanti>> chimici: formaldehida si abur la temperaturi joase si presiune subatmosferica.
    In stadiul actual al datelor stiintifice, sterilizarea cu vapori de apa saturati sub presiune trebuie sa fie metoda de electie daca dispozitivul medical suporta aceasta procedura."
------------
    *1) Biofilm - ansamblul de produse organice avand incluse microorganisme (bacterii Gram negative) capabile sa secrete produse macromoleculare pe suprafata unor materiale. Acesta se constituie in decurs de 3 ore de la utilizarea dispozitivului intr-un mediu contaminat. Neindepartat, constituie o protectie pentru bacteriile remanente, permitandu-le sa elibereze toxine responsabile de producerea socului septic. Biofilmul permite bacteriilor sa reziste la tratamentele de sterilizare si dezinfectie. Majoritatea procedurilor obisnuite de pretratare nu elimina incarcatura de endotoxine, fiind necesare un pretratament si o curatare riguroase, utilizandu-se detergenti enzimatici inaintea oricarui alt tratament.
    *2) Obligatia de a declara incidentele sau riscurile de producere a unor incidente legate de utilizarea dispozitivelor medicale; incidentele pot fi legate de sterilizarea acestora.

    2. Punctul 2.4.1 al articolului 2 din anexa nr. 2 va avea urmatorul cuprins:
    "2.4.1. Curatarea/Decontaminarea instrumentarului chirurgical/Predezinfectie (in blocul operator, in sectii de spital, cabinete medicale, sali de tratament)
    Se poate realiza: manual sau automat cu ajutorul unor echipamente automate de curatare.
    Metoda: curatare manuala
    Imediat, la sfarsitul interventiei chirurgicale sau efectuarii pansamentului, instrumentarul folosit se imerseaza intr-un produs etichetat si avizat ca detergent, detergent enzimatic sau detergent dezinfectant ori produs de curatare-decontaminare pentru instrumentar, in concentratia recomandata de producator (gama pe care producatorul instrumentului o recomanda, compatibila cu materialul din care este fabricat). Concentratia de lucru a produsului utilizat in aceasta etapa trebuie sa acopere spectrul de actiune virulicid (inactivarea VHB si HIV).
    Este de preferat ca in aceasta etapa sa fie utilizati dezinfectanti etichetati si avizati ca <<dezinfectant pentru instrumentar>> cu proprietati de curatare si avizati de catre Ministerul Sanatatii conform legislatiei in vigoare.
    Prin folosirea in aceasta etapa a unui produs etichetat ca detergent, detergent enzimatic sau detergent dezinfectant ori produs de curatare-decontaminare pentru instrumentar exista pericolul contaminarii personalului care efectueaza aceasta operatie cu agenti patogeni transmisibili. Utilizand in aceasta etapa un dezinfectant cu proprietati de curatare, etichetat ca dezinfectant pentru instrumentar, este eliminat acest risc.
    Atentie la eticheta produsului utilizat!
    Sunt produse chimice etichetate <<Curatare si decontaminare>>, <<Detergent dezinfectant>>, care contin pe langa agenti de spumare cel putin un principiu activ recunoscut cu proprietati bactericide, fungicide, folosite inainte de dezinfectie.
    Pentru dezinfectie se utilizeaza dezinfectante anume destinate dezinfectiei instrumentarului, care sunt avizate de Ministerul Sanatatii si care se folosesc in mod obligatoriu dupa decontaminare (curatare).
    Protocol de lucru:
    - se perie cu grija, insistand asupra articulatiilor si canelurilor, utilizand o perie moale din nailon;
    - instrumentarul se demonteaza complet;
    - se curata canelurile cu o compresa;
    - se curata bine toate partile scobite, jgheaburile, cavitatile, cu ajutorul unei seringi.
    Metoda: curatare automata in masini de curatat automate cu program de dezinfectie/baie cu ultrasunete.
    Se pot folosi masini de spalat automate cu program de dezinfectie inclus pentru instrumente, avizate de Ministerul Sanatatii.
    Dezinfectia in masina de curatat automata cu program de dezinfectie inclus se realizeaza la o temperatura si un timp de expunere care variaza in functie de fabricant:
    - 75 grade C, 20 minute sau 80 grade C, 10 minute (sunt distruse formele vegetative ale bacteriilor, inclusiv Mycobacteriile, dar nu si VHB);
    - 93 grade C, 10 minute (sunt distruse formele vegetative ale bacteriilor, inclusiv Mycobacteriile);
    - 105 grade C, un minut (sunt distruse formele vegetative ale bacteriilor, inclusiv Mycobacteriile) sau 105 grade C, 5 minute sau 105 grade C, 7 minute (sunt distruse formele vegetative ale bacteriilor, inclusiv Mycobacteriile, precum si sporii de Bacillus antracis).
    Utilizarea masinilor automate pentru dezinfectia instrumentelor are avantajul ca reduce expunerea personalului la substantele chimice toxice, iar timpul de contact cu dezinfectantul poate fi standardizat."
    3. Punctul 3.2 al articolului 3 din anexa nr. 2 va avea urmatorul cuprins:
    "3.2. Materialele care se sterilizeaza pot fi impachetate in:
    - cutii metalice (pentru sterilizarea cu aer cald);
    - cutii metalice perforate (pentru sterilizarea cu abur sub presiune);
    - casolete perforate cu colier (pentru sterilizarea cu abur sub presiune);
    - hartie speciala, pentru impachetarea instrumentarului sau materialului textil, fabricata special pentru sterilizarea cu abur sub presiune;
    - pungi/role din hartie sau din plastic fabricate special pentru sterilizarea cu aer cald sau oxid de etilena cu indicatori fizico-chimici de temperatura;
    - pungi/role din hartie sau din plastic fabricate special pentru sterilizarea cu abur sub presiune sau abur si formaldehida la temperaturi joase la presiune subatmosferica, cu indicatori fizico-chimici de temperatura."
    4. Dupa anexa nr. 2 se introduce anexa nr. 3 cu urmatorul cuprins:
    "ANEXA 3

                                STANDARDE

    SR EN 556:2001       Sterilizarea dispozitivelor medicale. Cerinte pentru
                         dispozitive medicale etichetate "Steril"
    SR EN ISO 9001:2001  Sisteme de management al calitatii. Cerinte
    SR EN 46001:2000     Sistemele calitatii. Dispozitive medicale. Cerinte
                         particulare pentru aplicarea EN ISO 9001
    SR EN 46002:2000     Sistemele calitatii. Dispozitive medicale. Cerinte
                         particulare pentru aplicarea EN ISO 9002
    SR EN 1275:2002      Antiseptice si dezinfectante chimice. Activitatea
                         fungicida de baza. Metode de testare si prescriptii
                         (faza 1)
    SR EN 1040:2000      Antiseptice si dezinfectante chimice. Activitatea
                         bactericida de baza. Metoda de testare si prescriptii
                         (faza 1)."
    Art. 2
    Prezentul ordin va fi publicat in Monitorul Oficial al Romaniei, Partea I.

                             Ministrul sanatatii,
                               Ovidiu Brinzan



COMENTARII la Ordinul 1031/2004

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ANONIM a comentat Ordin 173 2014
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ANONIM a comentat Rectificare 244 2017
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Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval
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    DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval
ANONIM a comentat Rectificare 244 2017
    DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval DO YOU WANT A PERSONAL/BUSINESS/INVESTMENT LOAN? LOAN IS HERE FOR YOU We have provided over $1 Billion in business loans to over 15,000 business owners just like you. We use our own designated risk technology to provide you with the right business loan so you can grow your business. Our services are fast and reliable, loans are approved within 72 hours of successful application. We offer loans from a minimum range of $10,000 to a maximum of $20 million. bdsfn.com@gmail.com We Offer: * Business Loan * Personal Loans or Signature Loans * Arrangements to Borrow from $10,000.00 up to $20,000,000 * Choose between 1 to 10 years repayment period. * Choose between monthly and annual repayment plan. * Flexible loan terms and conditions applied. * Interest rates as low as 1%. We are certified and your privacy is 100% safe with us. Worry no more about your loans or finances. Contact us today via: bdsfn.com@gmail.com Get your instant loan approval
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