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1 High Level Isolation Units today: the new high tech lazzarettos Giuseppe Ippolito National Institute for Infectious Diseases L. Spallanzani, Rome, Italy WHO Collaborating Center for clinical care, diagnosis, response and training on Highly Infectious Diseases

2 Thanks to: F. M. Fusco, V. Puro, R. Iacovino, F. N. Lauria National Institute for IDs Lazzaro Spallanzani, Rome. Italy P. Brouqui. CHU Nord AP-HM, Marseille, France B. Bannister. Royal Free Hospital, London, UK, S. Schilling, H-R. Brodt. J W Goethe University, Frankfurt, Germany P. Follin Vastra Gotaland Region, Gothenburg, Sweden B. Jarhall Linko ping University, Sweden H. C. Maltezou, O. Adrami Hellenic Centre for Disease Control and Prevention, Athens, Greece G. Thomson. Health Protection Agency, London, UK

3 Thanks to: M. Borg, St Luke s Hospital, Malta R. Gottschalk, Public Health Office, Frankfurt.Germany R. Hemmer, Centre Hospitalier de Luxembourg, Barble, Luxembourg; A. Horban, Hospital of Infectious Diseases, Warsaw, Poland M. Kojouharova, National Centre of Infectious and Parasitic Diseases, Sofia, Bulgaria C. Perronne, Unite des Maladies Infectieuses Hopital Universitaire Raymond Poincare, Paris, France; J. Lambert, University College of Dublin, Dublin, Ireland H. Siikamaki, Helsinki University Central Hospital, Helsinki, Finland P. Skinhoj, Rigshospitalet, Copenhagen, Denmark F. Strle, University Medical Centre, Ljubljana, Slovenia A. Trilla, University of Barcelona, Barcelona,Spain N. Vetter, Otto Wagner Spital, Vienna, Austria

4

5 Summary EIDs in western countries Highly Infectious Diseases (HIDs), Rational for High Level Isolation Unit (HLIU) HLIUs: current logistic, technical and infection control issues; The EuroNHID data: HLIUs in Europe

6 Emerging Infections in western countries: a rare and unusual event in the XXI century!

7

8 A HID: is transmissible from person-to-person causes life-threatening illness presents a serious hazard in health care settings and in the community requires specific control measures

9 Agents/Diseases fulfilling the definition Viral haemorrhagic fevers: marburgvirus, ebolavirus, Crimean Congo haemorrhagic fever virus, Lassa virus, and South American haemorrhagic fever (Junin, Machupo, Sabia, and Guanarito) viruses; Multi drug- or Extensively drug- resistant M tuberculosis (MDR and XDR-TB) (known or suspected infection) SARS Co-V Emerging highly pathogenic strains of influenza virus Smallpox and other orthopox infections (eg monkeypox) Other emerging highly pathogenic, human-to-human transmitted agents, including agents of deliberate release (pneumonic plague)

10 War and famine, bioterrorism i threats, t possible importation of HIDs, emerging of new contagious pathogens, emerging pandemic threats = Needs for an higher level of protection (HIGH ISOLATION) based on Precaution Principle!

11 You said it was ONLY a virus!

12 Focus on Highly Infectious Diseases (HIDs): why? HIDs requires specific procedures and standardized technical features for safe management in Health Care Settings; HIDs, according to international ti guidelines, should be managed in High Isolation Settings according to Precaution Principle ;

13 HIDs linked with international travels/trades: Increased frequency of imported VHFs in Europe In the recent years, the number of imported cases of VHFs, has increased; Most frequently imported human-to-human transmissible VHFs is Lassa fever; From 1996 up to now: 20 confirmed VHFs imported in Europe, including 12 deaths; and hundreds of suspected cases;

14 Imported cases of VHFs: the experience of INMI with the last 2 suspected cases Two suspected VHFs cases have been managed at Spallanzani Institute recently; One CCHF suspected patient from Nepal and one Lassa fever suspected patient from Senegal; The first one was a fatal case of systemic HSV-1 infection; The second is a Dengue patient, currently improving.

15 Models for answer

16 Main points to be addressed to face EID Surveillance and prevention: Early warning systems (prompt detecting, ti investigating and monitoring of EID events), Systems monitoring the factors influencing EIDs; Research: Integration between basic and translational research; Infrastructures: Isolation units and biocontainement laboratories BSL 3-4; HCW training: Informatic systems, Specific training modules; Response: Elaboration of effective tools for intervention.

17 Early Detection The FASTER We Know What It Is Rapid Response The FASTER We Can Take Appropriate Action

18 What is HIGH ISOLATION? Combined use of transmission based precautions Within facilities with appropriate technical features in order to isolate patients with highly infectious diseases Adopting PPE with higher efficiency

19 Main points to be addressed to face EID Infrastructures t Isolation Units High Level Isolation Units: a healthcare facility specifically designed to provide safe, secure, high quality and appropriate care, with optimal infection containment and infection prevention and control procedures, for a single patient or a small number of patients who have, or who may have, a Highly Infectious Disease. Lancet ID, Jan 2009

20 Main points to be addressed to face EID Infrastructures t Isolation Units High Level Isolation Units: essential for the isolation of sporadic cases of Highly Infectious Diseases (such as imported cases of SARS, Viral Haemorrhagic Fevers ) in order to protect HCWs, other patients, the whole community; essential for the isolation of initial cases of next pandemic flu, in order to delay the establishment of transmission within the country.

21 HIU: mission HIUs are not an asset to increase surge capacity in the community, but rather should be used for giving care to a small numbers of patients with HIDs; HIU needs to provide a spectrum of care from complete basic care to intensive i care unit (ICU) level care;

22 Are our infrastructures t d t t f EID? adequate to face EIDs?

23 Are our infrastructures t adequate to face EIDs? two surveys, in UK and USA: In UK, only 24% of surveyed hospitals had isolation facilities available in the ED. Up to 30% of hospital do not isolate patients with suspect infectious diseases. Conclusion: EDs in the UK are not prepared for emerging g biological threats. With current facilities it is highly likely that an infectious agent will spread to staff and other patients. In USA, more than one-half of surveyed hospitals (278 of 410) expressed concerns about their facilities preparation and capacity for managing SARS cases. Anathallee M et al, J Infect 2007 Srinivasan A et al, CID 2004

24 Preparedness against emerging infections/infectious diseases Facilities for high h level l isolation of patients with high threat pathogens in USA

25 HLIU in USA Different civilian and army facilities; At USAMRIID, in Fort Detrick, a special biocontainment unit with 3 beds is available, mainly for researchers working in BSL-4 lab;

26 HLIU in USA Civilian HLIUs are present at Nebraska University, Omaha, Nebraska (10 beds) and at Emory University Hospital, Atlanta, Georgia (2 beds); Totally very few but highly specialized High Level isolation beds are available!

27 Preparedness against emerging infections/infectious diseases Facilities for high level isolation of patients with high threat pathogens in Europe

28 National Institute of Infectious Diseases IRCCS Lazzaro Spallanzani Via Portuense, Roma C.F. e P.IVA

29 Main aim -to improve preparedness and response within Europe to health threats from Highly Infectious Diseases, whether naturally occurring, newly emergent, or deliberately released.

30 and EuroNHID To improve co-operation and exchange of information on highly infectious diseases (HIDs) among ID clinicians, epidemiologists and public health experts; To create a functioning i network of High hlevel Isolation Units / Referral Centres for the management of HIDs in Europe;

31 2004 Inventory of /Isolation High Isolation Units in participating Countries

32 The European Network for Infectious Diseases EUNID (Jun 2004 Jun 2007) EURONHID (European Network of Highly Infectious Diseases, Jul 2007 Jun 2010) Countries: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Malta, Portugal, Poland, Slovenia, Spain, Sweden, and dthe UK.

33 EUNID project: Main Results Consensus documents on: Procedures for selection and use of PPE; Requirements of HLIUs; Infection Control procedures in HLIUs; Core-curriculum for HCWs working in HLIUs; Archive of national guidelines for management of patients with HID; Inventory of High Isolation Units in participating Countries

34 Consensus panels on HLIUs

35 EUNID project: Main Results Consensus documents on: Core-curriculum for HCWs working in HLIUs;

36 A special issue of Clinical Microbiology and Infections (August 2009) has been completely dedicated to HIDs

37 Centres surveyed during EuroNHID project

38 survey 47 centers selected to be surveyed; Complete data from 46 centers; 44 directly surveyed on-site; 2 centers (London and Newcastle), surveyed by checklists

39 General overview Different kinds of centers surveyed: Isolation units: facilities equipped with special technical features, logistically or functionally separated from the other hospital areas, able to operate independently; d Isolation rooms: rooms with special technical features, but logistically or functionally integrated into other hospital areas, not able to operate independently; Referral centers: facilities without special technical features, but only identified by National authorities for giving care to HIDs patients.

40 60% 50% 40% 30% 20% 10% 0% HLIU (n=16) Isolation Rooms (n=25) Refferal Centres (n=5) (*): based on EUNID and CDC consensus

41 EuroNHID project: HLIUs in Europe

42 General overview: use of units/rooms Different mode of use: For HID patients only (exclusive use unit/room): used in 12 centers, For some patients needing isolation, i.e. TB patients (partially reserved unit/room): used in 16 centers, For all patients (routine use): used in 18 centers.

43 HIU: routine vs. reserved use Because of high-cost, a strategy of multi- functionality should be assessed, integrating: day-by-day use needs for training and exercise

44 60% 50% 40% 30% 20% 10% I. Infrastructure/ general aspects 0% <2001 > 2001 Year of (re-) construction Number of centres (%)

45 Different model of Isolation facilities Negative pressure rooms- Lux Inflatable negative pressure tents Hamburg Trexler Unit (negative pressure bed) London

46 Portable Isolation Chamber Kaplan Medical Centre, Rehovot, Israel

47 Gelman s Isolators manufactured for IDs units in Rome and Brescia in 1980

48 Numbe r of beds Numbe er of beds (n) Beds in total I. Infrastructure/ capacity of beds ICU beds Capacity of beds (all centres) Beds in total ICU beds Population of enrolled member states: ~ Million All centres 1 bed per ~ 0.95 Million people 1 ICU bed per ~ 2.74 Million people HLIUs only 1 bed per ~ 3.32 Million people 0 HLIU Isolation Rooms Referral Centres Capacity of beds by type of centre 1 ICU bed per ~ 6.17 Million people

49 HLIUs: minimal i technical requirements Negative pressure; HEPA filters for exhausting air; Sealed door and windows; Adequate hospital material in the room; Existence of (or access to) an autoclave; Existence of an anteroom.

50

51 HLIUs staff: minimal i requirements A specifically trained Infectious Diseases team should be available on call on 24/7; A specifically trained Intensive Care team should be available on call on 24/7; External consultants should be pre-identified and trained; A specific shift plan should be developed and exercised: Few persons exposed, but with an high turn-over (brief and frequent shifts), Special vaccination policies? Written protocols for HCWs safety.

52 Requirements: HLIUs: staff requirements 100% 1. Specifically trained team (periodical drill) 75% 2. Infectious Disease and Intensive Care specialists availiable 3. Shift and surge capacity 50% 25% Infectious Disease Specialists 0% Intensive Care Specialists HLIU Isolation Referral planning Rooms Centres Common gaps: - Shift planning often absent in non-experienced centres - Other specialist often availiable but not trained - Almost no (financial) compensation for teams

53 HLIUs medical care: requirements Intensive Care should be given into isolation area; Medical equipments should be dedicated or pre- identified ; d Aerosol-generating procedures should be limited; In general, all medical procedures should be carefully evaluated through a risk assessment process

54 HLIUs: Diagnostic capabilities HLIUs should be located near a BSL-3 lab; Procedures of bed-side testing ti should be implemented; For routine tests, also central hospital laboratories could be used, given strict infection control procedures and automatic, closing-type analyzers available.

55 General overview Diagnostic capabilities Only 4 centers have a BSL-4 lab in the same city; A BSL-3 lab is operating in the same structure in 36% of centers, in the same city in 46% centers, in another city in the remaining 18%; For microbiological tests: 34% of centers use the BSL-3 lab, 24% use the central hospital lab, 22% uses both, in 9 centers (mainly in Germany) some microbiological tests are performed in the isolation area; Routine analysis are carried out: in central hospital lab in 58% (2/3 of centres have automatic closing-type systems), in the BSL-3 ambient in 12%, the isolation area in 30%.

56 Key data by country - Austria One hospital identified as referral one, in Vienna; It is a very old hospital Real experiences in the past with XDR-TB. A new isolation facility has been identified in Graz

57 Key data by country - Bulgaria Two referral hospitals surveyed, in Sofia and Varna; No negative pressure rooms are present tin the country; Real experiences with some CCHF cases in the past.

58 Key data by country - Denmark One hospital is identified in Denmark for giving care to HID: Hvidovre Hospital, in Hvidovre, 5-6 km far away from Copenhagen; Two large rooms with double-way anterooms in a completely new ID ward, with possibility of separate entrance;

59 Denmark - Hvidovre Rooms are fully yprepared p for IC, are equipped with all technical requirements (including an autoclave with the dirty lock inside isolation area), and all additional features are present, too. A BSL-3 lab is available in the city, 10 km far away; A trained staff is present, management by ID physicians.

60 Key data by country - Finland Two hospitals identified: Aurora Hospital, Helsinki, TYKS Hospital, Turku; In Helsinki an HLIU is available; In Turku adequate isolation rooms are disseminated in many different wards; The level of technical features, logistic solution and infection control procedures is generally high.

61 HUCH Aurora hospital HUS Finland high isolation ward built 1910, completely l renovated 1998

62 Finland - Helsinki

63 France General features Many hospitals, not uniformly distributed on the field; good dtechnical llevel; l Strong centralization policies: Same monitored programs for hand hygiene for the whole country; Same transport procedures for the whole country; PPE pre-prpared kits for the whole country; Color codex for isolation precaution;

64 Inside of the high-level isolation unit at CHU Nord AP-HM, Marseille, France.

65 8 hospitals visited; Key data by country - Germany 6 equipped with HLIU (Frankfurt, Hamburg, Berlin, Stuttgart, tt t Munchen, Wurzburg); 2 equipped with ih isolation rooms (Liepzig i and Saarbrucken).

66 Key data by country - Germany Hospital not uniformly distributed on the territory; Technical level excellent; Strong attention ti to Infection Control, in particular to decontamination procedures; Special suites always used; Transport procedures mainly standardized and not managed by hospitals; Generally ygood attention to medical aspects of HCWs safety, and strong attention to training;

67 Key data by country - Greece 6 hospital identified, 4 in Athens (one pediatric hospital); One isolation unit, all hospitals with isolation rooms; Isolation units/rooms built/renovated before Olympic Games in 2004; Good technical level; l

68 Key data by country - Ireland Two hospitals, one for adults (isolation unit), and one for children (isolation rooms); Isolation room very well-organized and designed; Different technical, logistic and procedural level between the two hospitals.

69 Key data by country - Luxembourg One identified centre, with isolation rooms; 9 neg pressure rooms in ID, 6 in ICU, 6 in pediatric ward; Technical requirements in place, autoclave available but not used; Additional technical features mostly yp present; BSL-3 lab 3 km far awaytrained staff available, both ID and IC.

70 Key data by country - Malta One centre identified, recently built, with isolation rooms; One large room identified d for isolation; Additional technical features all present; BSL-3 lab in the centre; Trained ID staff available.

71 Key data by country Poland In Poland one hospital with negative pressure rooms in Warszawa; Technically well- equipped; Trained staff available; BSL-3 lab available in the hospital.

72 Two hospitals identified, d in London and in Newcastle; Trexler Units are used. Key data by country - UK

73 Conclusions

74 Isolation facilities in Europe Experiences with confirmed cases of Highly Infectious Diseases Among 46 isolation facilities in Europe, 21 have experiences with Highly Infectious Diseases confirmed cases; Totally 30 cases of HIDs have been managed in these facilities. In particular: a Several cases of MDR- and XDR-TB (exact number not known), 14 cases of SARS, 7 cases of Lassa, 4 cases of CCHF, 4 cases of Hantavirus, 1 case of Ebola.

75 Isolation facilities in Europe Experiences with suspected cases of Highly Infectious Diseases Among 46 isolation facilities in Europe, 35 have experiences with Highly Infectious Diseases suspected cases; Among the isolation facilities surveyed, 7 have no real-life experiences (no confirmed/suspected cases).

76 European Networks/cooperation: ti why? The response to newly emerging global concerns must be: Coordinated Effective Rapid A trans-national response to trans-national threats

77

78 Needs Ensure a rapid and effective response to health threats deriving from natural infection by highly infectious agents or their deliberate release Stimulate complementarity and prevent duplication Promote exchange of information and international cooperation Share good practice and protocols Cooperation agreement for training, communication, and service availability to other Countries

79 Areas of interest and projects coordinated by INMI in the field of IDs emergencies Laboratory diagnosis and research The European Network of P4 Laboratories (Euronet- P4 and ENP4-Lab Lab, ) 2010) Training European Training in Infectious Disease Emergencies (ETIDE, ) Clinical management The European Network for Infectious Diseases (EUNID, ) European Network for highly infectious diseases (EURONHID, )

80 Conclusions./ It is impossible to predict which,when, where, or how -emergent infection will next threaten t global l public health -deliberate release of a biological agent will occur

81 Conclusions../ It is possible to predict -that infectious disease emergencies will continue to occur with regularity, It is possible, with appropriate planning - to be prepared to meet emergencies in a way that t ensures that they cause as little social disruption as possible.

82 To wrest from nature the secrets which have perplexed p philosophers p in all ages, to track their sources the cause of disease, to correlate the vast stores of knowledge, that they are quickly available for the prevention and cure of disease- these are our ambitions Sir William Osler, 1906

83 For additional i info: giuseppe.ippolito@inmi.it

84 Special thanks to: Francesco Fusco for his entusiasm and to Ramona Iacovino for her tireless assistance in the management of EUNID/EuroNHID Project

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