D.L.gs 9 aprile 2008, n.81 Segnale di rischio biologico D.L.gs 9 aprile 2008, n.81 TITOLO X Esposizione ad agenti biologici Capo I Art 267. Definizioni. 1. Ai sensi del presente titolo si intende per: a) agente biologico: qualsiasi microorganismo anche se geneticamente modificato, coltura cellulare ed endoparassita umano che potrebbe provocare infezioni, allergie o intossicazioni; b) microorganismo: qualsiasi entità microbiologica, cellulare o meno, in grado di riprodursi o trasferire materiale genetico; c) coltura cellulare: il risultato della crescita in vitro di cellule derivate da organismi pluricellulari. D.L.gs 9 aprile 2008, n.81 75. Classificazione degli agenti biologici. 1. Gli agenti biologici sono ripartiti nei seguenti quattro gruppi a seconda del rischio di infezione: a) agente biologico del gruppo 1: un agente che presenta poche probabilità di causare malattie in soggetti umani; b) agente biologico del gruppo 2: un agente che può causare malattie in soggetti umani e costituire un rischio per i lavoratori; è poco probabile che si propaga nella comunità; sono di norma disponibili efficaci misure profilattiche o terapeutiche; c) agente biologico del gruppo 3: un agente che può causare malattie gravi in soggetti umani e costituisce un serio rischio per i lavoratori; l'agente biologico può propagarsi nella comunità, ma di norma sono disponibili efficaci misure profilattiche o terapeutiche; d) agente biologico del gruppo 4: un agente biologico che può provocare malattie gravi in soggetti umani e costituisce un serio rischio per i lavoratori e può presentare un elevato rischio di propagazione nella comunità; non sono disponibili, di norma, efficaci misure profilattiche o terapeutiche. RISCHIO INFETTIVO NELLE PROFESSIONI SANITARIE • Infezione – nosocomiale – occupazionale – operatore paziente • Stima rischio – % sieropositività – probabilità trasmissione (%sieroconversione) – frequenza infortuni + possibilità immunizzazione + efficacia PEP Prevalenza di infezioni da HBV, HCV e HIV nella popolazione afferente alle strutture sanitarie 8 7 % 6 5 4 3 2 1 0 HBV HCV HIV Linee guida SIMLII-2003 draft Contagio per contatto percutaneo con sangue infetto da HBV, HCV, HIV Stato del paziente Effetto % HbsAg+ HbeAg+ Sieroconversione 37-62% HbsAg+ HbeAg- Sieroconversione 23-37% HCV+ Sieroconversione 1.8% HIV+ Sieroconversione 0.3% Distribuzione infortuni in ambiente ospedaliero (Roma, n = 942) 100 80 60 40 % Infortuni 20 0 Area medica Area chirurgica Servizi Infortuni biologici/totale infortuni aziende sanitarie Emilia Romagna (2003-2006) 40 % infortuni 38 36 34 32 30 2003 2004 2005 2006 Tipologia infortuni biologici in ambiente ospedaliero (Pisa 1993-95) da taglio da punta da schizzo altro Infortuni sul lavoro in strutture sanitarie della Regione Veneto denunciati all’INAIL Modalità di accadimento Anni 1994-2000 Totale n° 9053 Caduta, scivolamento 25% Incidente stradale 23% Urti-contatti con utensili, macchine, arredi... 17% Movimentazione cose o persone 17% Contatti con frammenti, liquidi, polveri 8% Contatti con materiale biologico infetto 5% Aggressioni 5% (Bartolucci et al.; G Ital Med Lav Ergon 2002;24:392-397; www.gimle.fsm.it) RISCHIO INFETTIVO NELLE PROFESSIONI SANITARIE Agenti • HBV, HCV • HIV • Salmonella • HAV • TBC • Influenza • SARS-CoV • (Sarcoptes scabiei, hom.) Tubercolosi • Contagio: TBC polmonare non sospettata • Aumento suscettibilità: – tubercolino negativi – immunodepressione Tubercolosi • Aumento rischio: – – – – TBC polmonare o vie aeree caverne Espettorato BK+ non sufficiente chemioterapia – Tosse ed espirazioni forzate – Espettorato indotto – ambienti piccoli – scarsa ventilazione – ricircolo aria Tubercolosi Prevenzione • Ambienti • Assunzione: – test tubercolina (Quantiferon, Elispot) – (Rx torace) – vaccinazione BCG (non obbligatoria dal 2000) • DPI Severe Acute Respiratory Syndrome OMS (sett. 2003): 8437 casi, 813 decessi, mortalità 9.6% 21% di casi in professioni sanitarie Coronavirus from SARS isolated in FRhK-4 cells. Thin section electron micrograph and negative stained virus particles Department of Microbiology, The University of Hong Kong and the Government Virus Unit, Department of Health, Hong Kong SAR China Severe Acute Respiratory Syndrome www.cdc.gov/ncidod/sars www.who.int/sars/en www.ministerosalute.it scientifico.pneumonet.it/focus/sars CORONA VIRUS MHV: murine hepatitis virus AIBV: avian infectious bronchitis virus HcoV: human coronavirus FACT SHEET Basic Information about SARS SARS Severe acute respiratory syndrome (SARS) is a viral respiratory illness caused by a coronavirus, called SARS-associated coronavirus (SARS-CoV). SARS was first reported in Asia in February 2003. Over the next few months, the illness spread to more than two dozen countries in North America, South America, Europe, and Asia. The SARS global outbreak of 2003 was contained; however, it is possible that the disease could re-emerge. How SARS spreads The main way that SARS seems to spread is by close person-to-person contact. The virus that causes SARS is thought to be transmitted most readily by respiratory droplets (droplet spread) produced when an infected person coughs or sneezes. Droplet spread can happen when droplets from the cough or sneeze of an infected person are propelled a short distance (generally up to 3 feet) through the air and deposited on the mucous membranes of the mouth, nose, or eyes of persons who are nearby. The virus also can spread when a person touches a surface or object contaminated with infectious droplets and then touches his or her mouth, nose, or eye(s). In addition, it is possible that the SARS virus might spread more broadly through the air (airborne spread) or by other ways that are not now known (Rat vector hypothesis, Lancet 2003; 362:570-2). Indice di trasmissibilità: R0 = 2.5-3 (influenza R0 = 7) Symptoms of SARS In general, SARS begins with a high fever (temperature greater than >38.0°C. Other symptoms may include headache, an overall feeling of discomfort, and body aches. Some people also have mild respiratory symptoms at the outset. About 10 percent to 20 percent of patients have diarrhea. After 2 to 7 days, SARS patients may develop a dry cough. Most patients develop pneumonia. Hong Kong: linfopenia (<1000/mm3)(90%) > LDH (71%) Case definitions (WHO, revised may 2003) Suspect case 1. A person presenting after 1 November 20021 with history of: - high fever (>38 °C) AND - cough or breathing difficulty AND one or more of the following exposures during the 10 days prior to onset of symptoms: - close contact with a person who is a suspect or probable case of SARS; - history of travel, to an area with recent local transmission of SARS - residing in an area with recent local transmission of SARS 2. A person with an unexplained acute respiratory illness resulting in death after 1 November 2002, but on whom no autopsy has been performed AND one or more of the following exposures during to 10 days prior to onset of symptoms: - close contact, with a person who is a suspect or probable case of SARS; - history of travel to an area with recent local transmission of SARS - residing in an area with recent local transmission of SARS Probable case 1. A suspect case with radiographic evidence of infiltrates consistent with pneumonia or respiratory distress syndrome (RDS) on chest X-ray (CXR). 2. A suspect case of SARS that is positive for SARS coronavirus by one or more assays. 3. A suspect case with autopsy findings consistent with the pathology of RDS without an identifiable cause. Criteri diagnostici OMS: sensibilità 26% Laboratory Criteria¶ • Confirmed • Detection of antibody to SARS-associated coronavirus (SARS-CoV) in a serum sample, or • Detection of SARS-CoV RNA by RT-PCR confirmed by a second PCR assay, by using a second aliquot of the specimen and a different set of PCR primers, or • Isolation of SARS-CoV. • Negative • Absence of antibody to SARS-CoV in a convalescent–phase serum sample obtained >28 days after symptom onset. • Undetermined • Laboratory testing either not performed or incomplete. Exclusion Criteria A case may be excluded as a suspect or probable SARS case if: • An alternative diagnosis can fully explain the illness. • The case has a convalescent-phase serum sample (i.e., obtained >28 days after symptom onset) for which is negative for antibody to SARSCoV. • The case was reported on the basis of contact with an index case that was subsequently excluded as a case of SARS, provided other possible epidemiologic exposure criteria are not present. SARS: prevenzione in ambiente sanitario Misure organizzative • allertare P.S. • segnalazione ASL e Ministero salute, dopo accertamento di caso sospetto • ventilazione ambienti Operatore • vaccinazione antiinfluenzale • Precauzioni standard: – igiene mani, DPI • Precauzioni per trasmissione da contatto: – cambiare i guanti, DPI e biancheria all’interno della stanza, – disinfezione superfici • Precauzioni per trasmissione per via aerea – maschera FFP2 o FFP3 (nella stanza del paziente) SARS: prevenzione in ambiente sanitario Paziente (da sospetto) • Isolamento – stanza a pressione negativa – stanza singola con bagno separato – stanza con paz. = patologia • Mascherina chirurgica, senza vavola, nel trasporto www.ecdc.eu.int Influenza virus Recommendations for Avian Influenza All patients who present to a health-care setting with fever and respiratory symptoms should be managed according to recommendations for respiratory hygiene and cough etiquette (www.cdc.gov/flu/professionals/infectioncontrol/resphygiene.htm) and questioned regarding their recent travel history. Patients with a history of travel within 10 days to a country with avian influenza activity and are hospitalized with a severe febrile respiratory illness, or are otherwise under evaluation for avian influenza, should be managed using isolation precautions identical to those recommended for patients with known Severe Acute Respiratory Syndrome (SARS). WHO: Influenza A/H5N1 (www.who.int) Rationale for Enhanced Precautions Human influenza is thought to transmit primarily via large respiratory droplets. Standard Precautions plus Droplet Precautions are recommended for the care of patients infected with human influenza. However, given the uncertainty about the exact modes by which avian influenza may first transmit between humans additional precautions for healthcare workers involved in the care of patients with documented or suspected avian influenza may be prudent. The rationale for the use of additional precautions for avian influenza as compared with human influenza include the following: • The risk of serious disease and increased mortality from highly pathogenic avian influenza may be significantly higher than from infection by human influenza viruses. • Each human infection represents an important opportunity for avian influenza to further adapt to humans and gain the ability to transmit more easily among people. • Although rare, human-to-human transmission of avian influenza may be associated with the possible emergence of a pandemic strain. Vaccination of Healthcare Workers against Human Influenza Health-care workers involved in the care of patients with documented or suspected avian influenza should be vaccinated with the most recent seasonal human influenza vaccine. In addition to providing protection against the predominant circulating influenza strain, this measure is intended to reduce the likelihood of a healthcare worker’s being co-infected with human and avian strains, where genetic rearrangement could take place, leading to the emergence of potential pandemic strain. • Standard Precautions • Pay careful attention to hand hygiene before and after all patient contact or contact with items potentially contaminated with respiratory secretions. • Contact Precautions • Use gloves and gown for all patient contact. • Use dedicated equipment such as stethoscopes, disposable blood pressure cuffs, disposable thermometers, etc. • Eye protection (i.e., goggles or face shields) • Wear when within 3 feet of the patient. Airborne Precautions • Place the patient in an airborne isolation room (AIR). Such rooms should have monitored negative air pressure in relation to corridor, with 6 to 12 air changes per hour (ACH), and exhaust air directly outside or have recirculated air filtered by a high efficiency particulate air (HEPA) filter. If an AIR is unavailable, contact the health-care facility engineer to assist or use portable HEPA filters to augment the number of ACH. • Use a fit-tested respirator, at least as protective as a National Institute of Occupational Safety and Health (NIOSH)-approved N-95 filtering face piece (i.e., disposable) respirator, when entering the room. Surveillance and Monitoring of Healthcare Workers Instruct healthcare workers to be vigilant for the development of fever, respiratory symptoms, and/or conjunctivitis (i.e., eye infections) for 1 week after last exposure to avian influenzainfected patients. Healthcare workers who become ill should seek medical care and, prior to arrival, notify their healthcare provider that they may have been exposed to avian influenza. In addition, employees should notify occupational health and infection control personnel at their facility. With the exception of visiting a health-care provider, health-care workers who become ill should be advised to stay home until 24 hours after resolution of fever, unless an alternative diagnosis is established or diagnostic tests are negative for influenza A virus. While at home, ill persons should practice good respiratory hygiene and cough etiquette to lower the risk of transmission of virus to others. RISCHIO INFETTIVO NELLE PROFESSIONI SANITARIE Agenti • HBV, HCV • HIV • Salmonella • HAV • TBC • Influenza • SARS-CoV • (Sarcoptes scabiei, hom.) Contagio per contatto percutaneo con sangue infetto da HBV, HCV, HIV Stato del paziente Effetto % HbsAg+ HbeAg+ Epatite Sieroconversione 22-31% 37-62% HbsAg+ HbeAg- Epatite Sieroconversione 1-6% 23-37% HCV+ Sieroconversione 1.8% HIV+ Sieroconversione 0.3% Sangue HIV+ contatto mucose: 0.09% contatto cute: <0.09% Precauzioni universali • Guanti monouso • Mascherine e occhiali • Camici • Lavaggio mani • Prevenzione incidenti da oggetti taglienti • Minimizzare respirazione bocca a bocca senza precauzioni • No assistenza diretta o manipolazione apparecchiature per portatori di lesioni essudative e dermatiti secernenti • Adozione scrupolosa delle misure preventive in gravidanza Protocollo di profilassi attiva-passiva in caso di incidente biologico • Pulizia della parte contaminata: – cute: acqua e sapone, poi amuchina 5-10% o Betadine – mucose: acqua corrente • Prelievo di sangue all’operatore e al paziente (consenso) per markers HBsAg, anti-HCV, anti-HIV (test rapido) > recapitato dall’infortunato • Se paziente HIV+ o dubbio > accesso a Mal. Infettive entro 4 ore • Se negativo o non identificabile > Mal. Infettive entro 48 ore Morb Mort Wkly Rep 2001; 50 (RR-11):1-42 Updated U.S. Public Health Service Guidelines for the management of occupational exposures to HBV, HCV and HIV and recommendations for postexposure prophylaxis Morb Mort Wkly Rep 2001; 50 (RR-11):1-42 Updated U.S. Public Health Service Guidelines for the management of occupational exposures to HBV, HCV and HIV and recommendations for postexposure prophylaxis Morb Mort Wkly Rep 2001; 50 (RR-11):1-42 Profilassi post-esposizione (PPE) per HIV (Linee guida SIMLII-2003 draft)