The Need for Biocides in the Health-Care Sector

The Need for Biocides in the Health-Care Sector (Special Focus on Prevention of Nosocomial Infections) Elena Piecková Assoc. Prof. in Public Health, Head of Mycology and Ntl Ref Ctr Disinf & Steriliz Slovak Medical University, Bratislava, Slovakia

Agenda A short general sketch on nosocomial infections in the EU and worldwide Overview of biocides and disinfection procedures used in health care - their efficacy and sensitivity vs resistance Good disinfection practice in health-care units Laboratory testing of biocides intended to be used by health and social care institutions - EU (OECD) legislation

Marc Sprenger, ECDC Director: Protecting hospital patients from healthcareassociated infections is a joint task. Policy makers, hospital managers and authorities at EU and national level, as well as patients themselves, need to cooperate in this shared responsibility.

Terminology Healthcare associated infections (Nosocomial infections) = diseases or pathologies related to the presence of an infectious agent or its products in association with exposure to healthcare facilities or healthcare procedures or treatments Patient safety = freedom, for a patient, from unnecessary harm or potential harm associated with healthcare Process indicator = an indicator referring to the compliance with agreed activities such as hand hygiene, surveillance, standard operating procedures etc.

HAI legislation EC COUNCIL RECOMMENDATION (2009/C 151/01), 9 June, 2009 on patient safety, including the prevention and control of healthcare associated infections: - in Member States between 8 % and 12 % of patients admitted to hospital suffer from adverse events whilst receiving healthcare European Centre for Disease Prevention and Control (ECDC), 2012 - on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4.1 million patients a year in the EU, and that 37 000 deaths are caused yearly

European Health Forum Gastein (EHFG) over the past decade - an indispensable institution in the scope of European health policy a platform for discussion for the various stakeholders in the field of public health and health care a decisive contribution to the development of guidelines and the cross-border exchange of experience, information and cooperation in the field of interest

03-04/10/2013-6th EHFG EU-wide point prevalence survey of healthcareassociated infections and antimicrobial use in European hospitals - on any given day, about 80 000 patients, i.e. one in 18 patients in those hospitals has at least one HAI an estimated total of 3.2 million patients (95% confidence interval: from 1.9 to 5.2 million) with a HAI in European hospitals each year

40 % + prolongation of the length of stay 7.5 25 d - US nosocomial BSI, estimated to account for 250 000 epis/yr - the mortality rate directly attributable to BSIs in ICU patients ~ 16 40 % + prolongation of the length of stay 7.5 25 d

Developing countries the risk for patients to develop HAI - significantly higher than in developed countries one-day HAI prevalence surveys in hospitals: in Albania - 19.1 %, in Morocco - 17.8 %, Tunisia - 17.9 %, the United Republic of Tanzania - 14.8 % prevalence of SSI: 30.9 % in paediatric hospitals in Nigeria, 23 % in general surgeries in the United Republic of Tanzania, 19 % in maternity units in Kenya

NI - socioeconomic consequences since the mid 1970s in the USA first studies on the costs - calculating indirect costs and true economic impact on the community and on the workplace economy well described parameters drug, esp. antibiotic acquisition, and increased length of stay in the hospital extra cost of NI include: bed, intensive care unit stay, hematological, biochemical, microbiological and radiological tests, antibiotics, other drugs, extra surgical procedures and working hours high mortality rates related economic loses represent the ultimate justification for measures of control of this entity hospital epidemiology and healthcare outcomes research better estimation of the current personnel and financial resources necessary to support infection control activities and to prevent NI

European Environment and Epidemiology (E3) Network E3 Geoportal designed by ECDC - to collect and make available a wide range of information for anybody interested in infectious disease epidemiology in Europe (patients) metaanalyses

International Classification for Patient Safety by WHO and the Council of EC Classify and measure patient safety at Community level, by working with each other and with the Commission: (a) to develop common definitions and terminology, taking into account international standardisation activities

(b) to develop a set of reliable and comparable indicators: - to identify safety problems, - to evaluate the effectiveness of interventions aimed at improving safety and - to facilitate mutual learning between Member States; account should be taken of the work at national level and of international activities (e. g. OECD) healthcare quality indicators project and the Community Health Indicators project

International Classification for Patient Safety by WHO and the Council of EC Adopt and implement a strategy at the appropriate level for the prevention and control of healthcare associated infections, pursuing the following objectives: (a) implement prevention and control measures at national or regional level to support the containment of healthcare associated infections - in particular:

enhance infection prevention and control at the level of the healthcare institutions by encouraging healthcare institutions to have in place: (i) an infection prevention and control programme: - organisational and structural arrangements, - diagnostic and therapeutic procedures (e. g. antimicrobial stewardship), - resource requirements, - surveillance objectives, - training and information to patients

Resumé #1 the increased emergence of antibiotic resistant microorganisms suggests the need for heavier reliance on disinfection practices to prevent initial infection

Relationship between hand hygiene and the acquisition of health care-associated pathogens

World Health Organization, 2009 WHO Guidelines on Hand Hygiene in Health Care First Global Patient Safety Challenge

Biocidal products: Regulation (EU) No 528/2012 published on 27 June, apply from 1 September 2013 BIOCIDAL PRODUCTS - contain or generate active substances and - are used against harmful organisms (pests and bacteria) - both to protect human and animal health - include household products (disinfectants, rodenticides, repellents, insecticides) and for industrial applications as well

The 22 Product Types ( PTs ) of the Biocidal Products Regulation (528/2012) Group 1: Disinfectants Human hygiene 1 Biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp. Disinfectants and algaecides not intended for direct application to humans or animals.- used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs.

biocides - disinfectants widely employed in controlling hospital infection their activity depends upon several factors: concentration period of contract ph, temperature type, nature and numbers of microorganisms to be inactivated the presence of organic soil or other interfering material

The 22 Product Types ( PTs ) of the Biocidal Products Regulation (528/2012) Usage areas: inter alia, swimming pools aquariums, bathing and other waters, air conditioning systems; walls and floors in private, public and industrial areas and in other areas for professional activities Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.

Human hygiene products Efficacy/efficaceous - the (possible) effect of the application of a hand hygiene formulation when tested in laboratory or in vivo situations Effectiveness/effective - the clinical conditions under which a hand hygiene product has been tested for its potential to reduce the spread of pathogens, e.g. field trials Surrogate microorganism - a microorganism used to represent a given type or category of nosocomial pathogen when testing the antimicrobial activity of antiseptic - selected for their safety, ease of handling, and relative resistance to antimicrobials.

Review of hand hygiene Water Plain (non-antimicrobial) soap Quaternary ammonium compounds Alcohols Chlorhexidine Chloroxylenol Hexachlorophene Iodine and iodophors Triclosan Other agents

Evaluation methods of the antimicrobial efficacy of handrub and handwash agents and formulations for surgical hand preparation: Current methods: CEN standards EN 1499 and EN 1500 (E. coli); ASTM E-1174202 (Serratia marcescens); EN 12791 (surgical hand preparation; ASTM E- 1115 (surgical hand scrub) Shortcomings of traditional test methods The need for better methods

Disinfectant Effectiveness Tests AOAC International analyses include carrier tests & use-dilution tests for bactericidal, mycobactericidal, sporicidal, fungicidal, and virucidal activity In EU, efficacy can be demonstrated in: Kelsey-Sykes Capacity test European Committee for Normalization (CEN) TC 216 work program Chemical Disinfectants and Antiseptics

EN testing 1276 or 1040 (bacterial suspension test) 1650 (fungal suspension test) 13704 (sporicidal suspension test) 13697 (carrier test) 14476 (viral Testing) 14348 (TB Testing) AFNOR (France) NFT 72-150 Suspension NFT 72-190 Carrier Test DGHM (GER; Carrier & Suspension Tests) TGA (Australia)

Common AOAC International Tests (last rev. 2012) Use-Dilution Method Tests for Liquids 955.14 S almonella enterica 955.15 Staphylococcus aureus 964.02 Pseudomonas aeruginosa Germicidal Spray Products Test Confirmatory Tuberculocidal Activity Test Fungicidal Activity of Test Substances Sporicidal Activity of Disinfectants (966.04) EN-13697 offers valuable insight into quantitative surface testing

Testing / Validation Protocols Regulatory United States Methods typically taken from AOAC INT L: Primarily qualitative Primarily use ring carriers Pass/Fail Criteria differ for bacteria, TB, fungi and spores Europe Methods divided into 3 tiers: Phase 1 - Basic suspension tests Phase 2 - Simulation studies - Use hard surfaces Phase 3 - Tests under practical conditions

Examples of the protocols Sterilant (60 carriers each on two surfaces); spores of Bacillus subtilis ATCC 19659 and Clostridium sporogenes ATCC 3584; 3 lots (720 carriers) Disinfectant (60 carriers representing 3 lots) against 3 bacteria; S. enterica ATCC 10708, S. aureus ATCC 6538, P. aeruginosa ATCC 15442 Fungicide (10 carriers rep. 2 lots killing all spores of Trichophyton mentagrophytes ATCC 9533) Tuberculocide (2 lots killing all Mycobacterium tuberculosis var. bovis (BCG) on all carriers) or 4 LRV in quantitative test Virucide (2 lots at 4 replicates per each dilution showing inactivation at all dilutions if no cytotoxicity) 4 LRV (3 LRV if cytotoxicity) Sanitizer-N-FC (3 LRV on surfaces within 5 min against S. aureus ATCC 6538 and Klebsiella pneumoniae ATCC 4352 or Enterobacter aerogenes ATCC 13048

Sanitizers 3-5 log reduction (99.9-99.999 %) of disease causing bacteria within a population or a specific test population allowable kill time to determine the efficacy max 30 s

Disinfectants must destroy min. 99.999 % of bacterial pathogens within 5-10 min not necessarily able to kill spore-forming bacteria or all viral pathogens must kill more pathogenic bacteria than a sanitizer not recommended for use on human skin for environmental surfaces or water

Identification of organisms (mould, yeast, and/or bacteria) to End-User Disinfectant Validation Components In vitro testing Suspension testing (Time Kill Study) Carrier Testing (Coupon Testing) In situ testing Environmental monitoring Data trending (6-12 months, reviewed monthly)

Examples of In Vitro Options for Testing AOAC Use-dilution Test Methods (955.14, 955.15, 964.02) Sporicidal Activity of Disinfectants (966.04) Germicidal Spray Products as Disinfectants ASTM Time Kill Method Spray Slide Sanitizer method Wipe method Quantitative Carrier Method Biofilm Method Viral Testing (Suspension) &Viral Testing (Carrier)

Microorganism Selection

RESISTANCE CLINICAL MICROBIOLOGY REVIEWS, 0893-8512/99/$04.0010 Jan. 1999, p. 147 179, Vol. 12, No. 1 Antiseptics and Disinfectants: Activity, Action, and Resistance GERALD MCDONNELL1* and A. DENVER RUSSELL2 STERIS Corporation, St. Louis Operations, St. Louis, Missouri 63166,1 and Welsh School of Pharmacy, Cardiff University, Cardiff CF1 3XF, United Kingdom2

Disinfectants mode of action work environmentally = totally different from antibiotics and many pesticides by absorbing onto any microbial cell increased absorption and the permeability of the cell membrane - ultimate rupture + leakage of the contents of the cell

Disinfectants result of the action cell death NO CHANCE OF MUTATIONS! - microbes live after disinfectant use - not because of mutations, but.nonselective disinfectants - possible miss of microbes with disinfectants

Biocidal resistance Worry about the development of super, mutant bacteria? No problem in the overuse of disinfectants or many pesticides, but problem in the overuse of antibiotics, some pesticides, and antibacterial products for the general public use.

Antiseptic and disinfectant tolerance intrinsic, in particular the ability to sporulate in bacteria adaptation of pseudomonads the protective effects of BIOFILMS - 3,000 x more resistant than plankton

Plasmids vs resistance of G- bacteria to antiseptics and disinfectants? heavy-metal resistance - Hg, Ag increased MICs have been confirmed also for staphylococci

Resumé #2 clear that antiseptic and disinfectant products can vary significantly, despite containing similar levels of biocides the need for close inspection of efficacy claims and adequate test methodology +

Guidelines for GCP Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 W.A. Rutala,1,2, D. J. Weber, 1,2, and the Healthcare Infection Control Practices Advisory Committee (HICPAC) 1Hospital Epidemiology University of North Carolina Health Care System Chapel Hill, NC 27514 2Division of Infectious Diseases University of North Carolina School of Medicine Chapel Hill, NC 27599-7030

Good Cleaning Practice disinfectant rotation practised in hospitals? hospital isolates - often more resistant to biocides than laboratory or standard strains long-chain quaternary compounds posess the greatest antimicrobial activity

most cleaning, disinfecting, and sterilizing of patient-care supplies - in central processing department, i. e. easier quality control orderly processing of medical and surgical instruments: protect patients from infections minimizing risks to staff preserving the value of the reprocessed items the same level of efficiency and safety in supplies in operating rooms, respiratory therapies etc.

commercial formulations - unique products and must be registered (EPA, EC) given product - designed for a specific purpose and used in a certain manner - read labels carefully! disinfectants - not interchangeable! incorrect concentrations and inappropriate disinfectants - excessive costs occupational diseases among cleaning personnel (e.g., formaldehyde, glutaraldehyde, and chlorine) - precautions (e.g., gloves and proper ventilation) to minimize exposure!

Resumé #3Keys to a successful disinfection Antimicrobial agent Choosing the proper disinfectant for the job Testing protocol (practical, achievable & verifiable) Choose the method that best fits the situation Sanitization procedures Set up the proper rotation of disinfectants to control all organisms Change control Have all processes organized

Thank you for your attention! All the citations are available upon request.