Sterilization & Disinfection: Core Components

Transcription

1 Sterilization & Disinfection: Core Components Dr Ling Moi Lin Director of Infec0on Control and Sr Consultant, Pathology Singapore General Hospital Adjunct Asst Professor, Duke- NUS Graduate Medical School Outline Facility design Sterile storage and distribu0on Personnel considera0ons 1

2 Outline Facility design Sterile storage and distribu0on Personnel considera0ons Centralized CSSD It is strongly recommended that, wherever possible, reprocessing should be performed in a centralized area that complies with the physical and human resource requirements for reprocessing Decontamina0on Nega0ve pressure and at least 6 ACH Steriliza0on and storage 10 ACH with posi0ve pressure in the sterilizer equipment room Ref: The ASEAN guidelines for disinfection and sterilization of instruments in health care facilities 2

3 CSSD and TSSU Central Steriliza0on Supply Department (CSSD) Advantages Cleaning, disinfec0on, inspec0on, packing, steriliza0on, storing and distribu0on are carried out by specialized, experienced personnel Ensures beter control and more reliable results, i.e. a reduced risk of hospital- acquired infec0ons More economical - pooled resources require less personnel and equipment, freeing the hospital staff to concentrate on the pa0ents well- being CSSD and TSSU Theatre Sterile Supply Unit (TSSU) Decentralized steriliza0on facility, or substerile department A rela0vely small unit usually located close to where the sterilized items are used Advantage Time of circula0ng the instruments is shorter and transport is more or less eliminated 3

4 Central reprocessing Reprocessing performed outside the centralized area must be kept to a minimum and must be approved by the Infec=on Control Commi?ee or those accountable for safe reprocessing prac=ces and must conform to the requirements for reprocessing space. Ref: The ASEAN guidelines for disinfection and sterilization of instruments in health care facilities Design layout The environment where cleaning/decontamina0on is performed must: a) have adequate space for the cleaning process and storage of necessary equipment and supplies; b) be dis0nctly separate from areas where clean/disinfected/sterile equipment/devices are handled or stored; c) have easy access to hand hygiene facili0es; d) have surfaces that can be easily cleaned and disinfected; e) have slip- proof flooring that can withstand wet mopping and hospital- grade cleaning and disinfec0ng products; f) have restricted access from other areas in the se]ng and ensure one- way movement by staff 4

5 Speci<ications Function of space Soiled or decontaminat ion room Clean workroom P in relation to adjacent areas Min outdoor ACH Min total ACH All room air exhausted directly to outdoors Air recirculated RH (%) Negative 2 6 Yes No No requirement Positive 2 4 No requirement Temperature 0 C No Max Sterile storage Positive 2 4 No requirement No requirement Max Guidelines for design and construc0on of healthcare facili0es. The Facility Guideline Ins0tute The American Ins0tute of Architects recommends nega0ve pressure and no fewer than six air exchanges per hour in the decontamina0on area (AAMI recommends 10 air changes per hour) and 10 air changes per hour with posi0ve pressure in the sterilizer equipment room. Ref: The ASEAN guidelines for disinfec0on and steriliza0on of instruments in health care facili0es Ventilation issues Recommenda=on 50 Ven=la=on shall be such as to remove toxic vapors generated by, or emi?ed from, cleaning or disinfec=ng agents. Ref: The ASEAN guidelines for disinfection and sterilization of instruments in health care facilities 5

6 General CSSD design concept Physical separation between soiled, clean and sterile zone General CSSD design concept Separated entries and exits for soiled, clean and sterile goods Strict separation of the staff working in the 3 different areas Room ventilation separated - for good production conditions Straight workflows - for simple, reliable working routines to have an economic and ergonomic production 6

7 Guidelines for CSSD design Goods flow access from one side Staff & Supplies Trolley flow By creating an Ushape workflow you often can solve the CSSD design Goods flow 7

8 Structural features Adequate space for maneuvering Size and types of door openings Floor finishes, surfaces Safe and effec0ve people and equipment movement Easy to clean Ergonomics Flow apply LEAN principle Process flow of sterile packs was mapped by the CSSD Tag systems to priori0ze and highlight packs. This helped speed loca0on of packs more quickly than before Layout was reviewed and subsequently re- designed to reduce the amount of excessive walking required during the processing of each tray NHS Sterile Services Dept, UK 8

9 Mandatory requirement: Facility design Func0onal workflow patern; clear dis0nc0on (i.e. physical wall) between dirty and clean Outline Facility design Sterile storage and distribu0on Personnel considera0ons 9

10 Sterile storage Keep the goods free from dust The room must also be dry, to prevent moisture from penetra0ng the packages, which might lead to recoloniza0on of microorganisms Clean/sterile medical/ surgical supplies A room for breakdown for manufacturer s clean/ sterile supplies adjacent space Storage for packs, etc. to include provisions for ven0la0on, humidity and temperature control 10

11 Storage room for patient care and distribution carts Adjacent and easily available to clean and sterile storage Close to main distribu0on point to keep traffic to minimum and ease workflow The Sterile Storage Area Closed or covered cabinets are preferable for high- traffic areas. Open or wire shelving is suitable for confined storage areas, provided that proper aten0on is given to traffic control, area ven0la0on, and housekeeping. Storage areas should be designed to protect sterile items and their packaging from damage. 11

12 Sterile Storage Standards Items at least 45cm from sprinkler heads Items at least 20-25cm from the floor Items at least 5cm from the wall 12

13 Selection of Product/Process for Reprocessing Compa0bility of the equipment/device to be reprocessed to detergents, cleaning agents and disinfec0on/steriliza0on processes Determined by the manufacturer of the equipment/device; and Manufacturer must provide writen informa0on regarding the safe and appropriate reprocessing of the medical equipment/device Sterilants and disinfectants Reviewed by an individual with Infec0on Preven0on and Control at least annually List of sterilants and disinfectants used Safety issues 13

14 Selecting disinfectants - checklist a. Efficacy for the intended use; b. Compa0bility with the equipment/device and surfaces to be disinfected; c. Compa0bility with detergents, cleaning agents and disinfec0on and/or steriliza0on processes; d. The intended end use of the equipment/devices to be disinfected; e. The method for monitoring the product concentra0on; f. Recommenda0ons for rinsing (e.g., water quality, volume, 0me); g. Safety for use, with minimal toxic and irrita0ng effects to/for staff; and h. Environmental safety and biodegradability. Distribution Container All clean or sterile items being transported in uncontrolled environments should be in a covered or enclosed cart with a solid botom shelf. Covered or enclosed carts protect sterile items from inadvertent contact with personnel and other sources of contamina0on and from environmental challenges that might exist along the transporta0on route 14

15 Post- sterilization contamination Journal of Hospital Infection 81 (2012) 231e238 Available online at Journal of Hospital Infection journal homepage: Surgical site infections linked to contaminated surgical instruments S.J. Dancer a, *, M. Stewart a, C. Coulombe a, A. Gregori b, M. Virdi c a Department of Microbiology, NHS Lanarkshire, Glasgow, UK b Department of Orthopaedics, NHS Lanarkshire, Glasgow, UK c Department of Ophthalmology, NHS Lanarkshire, Glasgow, UK Dec Jan Feb Mar Apr May Jun Jul Aug Sep Ortho SSI 5 endopthalmitis Number of patients Weeks Orthopaedic patients: Ophthalmic patients: Date of operation Date of operation Date of surgical infection Date of surgical infection Figure 1. Dates of operation and onset of surgical site infection for 20 orthopaedic and ophthalmic patients. 15

16 Actions Accelerated maintenance inspec0on of the laminar flow facili0es in the 2 orthopaedic theatres Organized environmental cleans on orthopaedic wards Reviewed the an0bio0c surgical prophylaxis policy Developed a staff educa0onal programme on infec0on control Ins0gated a mul0- faceted hand hygiene programme Promoted cleanliness champion training for staff Reviewed Trust guidelines for preven0on of SSI and wards and theatre cleaning specifica0ons Audited the ring- fencing policy for clean orthopaedic pa0ents on a designated ward Analysed staffing levels and skill mix during the outbreak Reviewed theatre decontamina0on processes and provision of specialist dressings Trained staff on management of wound dressings 16

17 Recommendation The manager and all supervisors involved in reprocessing must, as a minimum, have completed a recognized qualifica0on/ cer0fica0on course in reprocessing prac0ces. A plan must be in place for each person involved in reprocessing to obtain this qualifica0on. Ref: The ASEAN guidelines for disinfection and sterilization of instruments in health care facilities 17

18 If re- processing is done, there must be processes for a. Tracking and labeling equipment/devices; b. Recalling improperly reprocessed medical equipment/ devices; c. Assuring proof of sterility or high- level disinfec0on; d. Tes0ng for pyrogens; e. Maintenance of equipment/device func0onality and integrity; f. Quality assurance and quality control; g. Repor0ng adverse events; and h. Provision of good manufacturing procedures Recall procedure a. Designa0on of department and staff responsible for execu0ng the recall; b. Iden0fica0on of the medical equipment/devices to be recalled; if recall is due to a failed BI, the recall shall include the medical devices in the failed load as well as all other devices processed in the sterilizer since the last successfully sterilized load; c. Assessment of pa0ent risk; d. Procedure for subsequent no0fica0on of physicians, pa0ents, other facili0es and/or regulatory bodies, if indicated; and e. Involvement of the facility s risk manager, if applicable. 18

19 Mandatory requirement: sterile storage and distribution Supplies are distributed on a First In First Out (FIFO) basis Outline Facility design Sterile storage and distribu0on Personnel considera0ons 19

20 Support areas for staff Administra0ve/changing room Separate from other areas For staff to change from street clothes to work a]re Staff accommoda0on Lockers, handwashing sta0ons, showers Sterile processing personnel The responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in ALL aspects of sterile processing: Decontamina0on Prepara0on Packaging Steriliza0on Sterile storage Distribu0on of sterile medical devices 20

21 Quali<ications Include Demonstrated knowledge of and documented competence in each aspects of steriliza0on process Demonstrated knowledge of and documented competence in the opera0on of the specific steam sterilizing system used by the health care facility Demonstrated knowledge of and documented competence in worker safety as it relates to medical device processing and steriliza0on It is the supervisor s responsibility to ensure that: Any individual involved in the cleaning, disinfec0on and/or steriliza0on of medical equipment/devices is properly trained and their prac0ce audited on a regular basis to verify that standards are met; Training includes informa0on on cleaning, disinfec0on and steriliza0on, occupa0onal health and safety issues, and infec0on preven0on and control; Orienta0on and con0nuing educa0on is provided and documented for all personnel involved in reprocessing of medical equipment/ devices; and Feedback is provided to reprocessing staff in a 0mely manner Ref: The ASEAN guidelines for disinfection and sterilization of instruments in health care facilities 21

22 Training and continuing education Personnel engaged in sterile processing should receive both an ini0al orienta0on and on- the- job training. Orienta0on program is recommended and should be designed to lead to competency- based knowledge and skills in all tasks performed in the sterile processing department. Documenta0on of training and con0nuing educa0on Training a. Staff assigned to reprocess endoscopes must receive device- specific reprocessing instruc0ons to ensure proper cleaning and high- level disinfec0on or steriliza0on; b. Competency tes0ng of personnel reprocessing endoscopes shall be performed at least annually and c. Temporary personnel shall not be allowed to reprocess endoscopes un0l competency has been established 22

23 Health and personal hygiene WriTen policies on personal hygiene should be developed and communicated to employees Careful aten0on to employee health, safety, and personal hygiene will minimize the poten0al for acquiring or transmi]ng disease. Personal Hygiene Handwashing procedures should be specified. Hair, body, and nails should be clean at all 0mes. Neither nail polish nor ar0ficial nails should be worn. Fingernails should be kept short and clean and should not extend beyond the finger0ps (AORN, 2010f). 23

24 Staff Attire All personnel entering the decontamina0on, prepara0on, steriliza0on, and sterile storage areas should wear clean uniforms that are provided by and donned at the facility. A]re should be changed daily or more omen as needed (i.e., when wet, grossly soiled, or visibly contaminated with blood or body fluids). Shoes worn in the department should be clean, should have non- skid soles, and should be sturdy enough to prevent injury if an item drops onto the foot. Staff Attire The policy on use of cover apparel when employees leave the department to travel to other areas of the health care facility should be determined by each facility and should comply with state and local regula0ons. Employees should change into street clothes whenever they leave the health care facility or when traveling between buildings located on separate campuses. 24

25 Occupational Health and Safety Review Recommended for all protocols for reprocessing medical equipment/devices to verify that staff safety measures are followed and are in compliance with the local Occupa0onal Health and Safety Act Hepa00s B Vaccina0on for all staffs Safety measures Sharps are handled appropriately Local exhaust ven0la0on systems adequately protect staff from toxic vapors Chemicals are labeled, stored and handled appropriately, and Safety Data Sheets (SDS) are readily available An eyewash fountain is installed to prevent a poten0al hazard to the eye due to contact with a biological or chemical agent; and Personal protec0ve equipment (PPE) such as elbow length impervious gloves (insulated if using a steam autoclave) for unloading the autoclave is present and complies with regulatory requirements. Procedures must be in place for immediate response to staff exposure to blood and body fluids or injury from sharp objects All staff working in reprocessing must be immune to Hepa00s B or receive Hepa00s B immuniza0on 25

26 Safety Issues Fire ex0nguishers not blocked Fire alarm pull sta0ons Adjustable worksta0ons Door and pass- through window kept closed Traffic paterns Sterile storage shelves 45cm from sprinkler BoTom shelves solid and 20-25cm from floor No cardboard shipping boxes Mandatory requirement All personnel receive a minimum annual training on departmental policies and procedures All personnel demonstrate competency annually 26

27 Distribution Container All clean or sterile items being transported in uncontrolled environments should be in a covered or enclosed cart with a solid botom shelf. Covered or enclosed carts protect sterile items from inadvertent contact with personnel and other sources of contamina0on and from environmental challenges that might exist along the transporta0on route Thank you 27