1 Manual Cleaning? SOBECC Round Table: Manual and Automated Cleaning Methods th July 2012 Chirurgie-Instrumenten-Arbeitsgruppe Berlin Dr. med. Dipl.-Ing. Thomas W. Fengler
2 What is so manual about Cleaning? 1. Medical devices enable new surgical approaches 2. Remanents are a fact after cleaning 3. (Re-)Processing cycle is a quality cycle 4. We move manually from step to step through processing 5. Cleaning needs specific tools and considerable skills 6. Washing is not Cleaning/ is not automatically happening 7. Process of cleaning has to be documented 8. Countable events have to be identified, verified and validated together with not countable events. 9. Validation is a spot check 10.Operator is responsible in the first place
3 Environment and Hygiene in the Operating Theatre: The Medical Device is just a part of it!
4 Safe Function and adequate Usability
5 Adequate and intended Use Visual and tactile examination
6 Verification and Validation of the safe Function which includes Cleanliness and Cleanability
7 Defining Parameters for Cleanliness
8 6 Hospitals, 6 (Re-)Processing Departments, 6 different Instrument Designs 7 Samples each* *Fengler TW, Pahlke H, Bisson S, Michels W: Are processed Surgical Instruments Free of Protein? ZentrSteril 2001; 9(1): analytical Methods: visual, modified Biuret, OPA for Protein Contamination, Pseudoperoxidase Reaction for Detection of Hemoglobin
9 Why (oh so ) correct (Re-)Processing? The risks of reprocessing are considered to be fully manageable. Correctness is the basic requirement in order to rule out at least one source of infection! Incidence of nosocomial infections remains unclear, since they are difficult to trace back. They might concern patients, resulting possibly in fatalities; some of which (allegedly: 20-30%) could be prevented. The hygiene- and sterilisation risk has to be kept to the inevitable residual risk, according to the state of science and technology. (from a verdict of German Federal Supreme Court [BGH]) From a legal point of view, work in a CSSD is a task of a higher degree. This implies an obligation for the staff, to be guided by the current state of science and technology at all times and further their education to the limits of what can reasonably be expected (quotations from relevant verdicts). 9
10 A Quality Cycle? What does (Re-)Processing of Medical Devices imply: sterilize clean & disinfect dry inspect waste waste use traceability stock wrap & label raw material sterilize
11 Do we know their qualification? Do we care?
12 Parameters of cleaning Chemical Temperature Water Mechanics Time
13 Manual cleaning may waste water (rinsing from the tap) and needs more time by cleaning one part after the other
14 Flexible Bone Drills
15 Washer disinfectors may reduce the waste of water rinsing many instruments at the same time in the same process Important parameters are Water pressure Volume of water Coverage of water Rotation Temperature Selected detergent Quality and quantity of operating means Velocidad Chosen load carriers Positioning of the chosen load
16 Water is moving the easiest way possible
17 Washer disinfector Washer disinfector can rinse inner lumina of medical devices with a defined pressure
18 Beware of the load! Charge it correctly! CEN ISO Part 1-7
19 Cleaning is more than washing
20 Invalidable? The often-advanced argument that manual procedures cannot be validated must be dismissed, because automated procedures require manual steps as well. From a statement of German Society for Hospital Hygiene (Deutsche Gesellschaft für Krankenhaushygiene - DGKH), Dec
21 Manual Reprocessing: Pros Manual tasks have always been and will always be part of the reprocessing cycle; we could not completely automate the whole cycle even if we tried. For instance in the reprocessing of endoscopes manual precleaning is required and considered to be state of science and technology. Manual cleaning may also be neccessary after automated processes, in case of persistant soil Use of Ultrasound-Baths is also considered a manual procedure Manual procedures are always and everywhere available a low-priced alternative to investments in machines allow for specific, intensive cleaning are best combined with automated processes
22 Manual Procedures Manual Reprocessing: Cons more disturbance variables (the human factor) difficult to validate or even reproduce identically (speed of work, pressure of brushing, amount of water in rinsing etc.) higher consumption of water and man-hours higher risk of injuries (fault of concentration, poor performance, lack of discipline, stress and hurry)
23 Be in touch, beware of penetration: Manual steps may be infectious Risk-reduction: wear Personal Protective Equipment (PPE) sharp and pointy instruments (needles, scalpels etc.) should be carefully removed from the trays before handling (preferably in the operating theatre) devices and materials that are not designated for reprocessing (single use devices, gauze pads etc.) should not go in the trays
24 Personal Protective Equipment (PPE)
25 Manual Cleaning: If you do it, do it right! Sticking to the correct order of process steps is very important: use the same order as in automated reprocessing! Use Standard Operating Procedures (SOP)! Validation is very difficult for manual procedures; SOP are the next best thing in order to attain reproducible results. the International Conference on Harmonisation (ICH) defines SOPs as detailed, written instructions to achieve uniformity of the performance of a specific function. The international quality standard ISO 9001 requires the determination of processes (documented as SOP) used in any manufacturing process that could affect the quality of the product (in this case: clean/sterile medical devices). SOP provide employees with a reference to common practices; new employees can have answers to questions without having to interrupt supervisors. Keep SOP short; in easily understandable terms; related to specific workplaces.
26 Manual Cleaning: If you do it, do it right! Are you using TWO basins? one for cleaning, one for disinfection or rinsing under tap water? Then disinfection bath? What size is your containment? Documentation of chemicals? (name, frequency of change, concentration)
27 Manual Cleaning: If you do it, do it right! TWO BASINS are needed, one for cleaning, another for disinfection! Some detergents are combinations of cleaning and disinfection chemicals; but still: TWO BASINS (and two separate solutions with the same detergent) are needed!
28 Manual Cleaning and Disinfection Preparation disassemble instruments if neccessary Pre-Cleaning rinsing off and through instruments under clean running water avoid forming of aerosols (a spray of little drops of water, possibly mixed with blood or contaminants): do not use hard jets of water Cleaning Lay instruments in a basin with detergent (in correct concentration), then brush, rinse, move instruments under the surface. Detergent must be able to reach all (incl. inner) surfaces. Mind correct exposure time! Rinsing rinsing off and through instruments under clean running water, removal of contaminants and process chemicals
29 Manual Cleaning and Disinfection Dry off instrument so as not to dilute the disinfection solution Disinfection Lay instruments in a different basin, containing disinfection solution (in correct concentration) Remove air from tubes and lumina and fill with the solution Mind correct exposure time! Final rinsing off and through instruments under clean running water Final rinsing should be done with desalinated water (reduces risk of pitting corrosion and staining) Dry instrument with (medical) compressed air or fluff-free cloth
30 Manual Cleaning and Disinfection Maintenance according to manufacturer s instructions as laid out in the medical device s manual Do not maintain instruments for ophthalmic surgery, they need to stay free of remnants (oil) Finally, wrap and sterilize medical devices
31 Endoscopes are complexe. During reprocessing they need a lot of care, manually or by an adequate washer disinfector
32 Cleaning is brushing, is mechanical manual action
33 Brushing is helpful against remnants, microbes and biofilmes Cepillos diferentes
34 Space at the working place?
35 Ultrasound bathing or cleaning? Bathing instruments in between? Noisy, dirty, smelling or a well documented precleaning site for specific instruments?
37 Influences to Cleaning and Disinfection Processes Design of Instruments Permeability of the inner lumen Materials and coatings Joints, Hinges Hollows, Cavities Shafts Surface properties
38 Influences to Cleaning and Disinfection Processes Process Chemicals Cleaning agent Disinfection agent Neutralising agent Rinse agent Concentration of the agents
39 Correct means, correct tools at site?
40 Transport without complication in baskets One touch : -> Transport -> Washing -> Sterilization
41 ... y punto de partida para optimizar el portador de los productos médicos Transport Transport of of small instruments/pieces, small secured instruments/pieces, secured against movement against movement Equal Equal heating heating time time for metals for metals and and plastics plastics Few changes Few position position changes necessary necessary Agents Agents for for washing, disinfection washing, disinfection and sterilization and sterilization have have good access good access to to the the entire surface entire surface of of the the instrument instrument Individual instruments Individual fitting fitting of instruments and of and parts parts
42 Modules for technical solutions
43 Sources of infection: Residual moisture (condensate) provides Microorganisms with the possibility of "swimming"
44 Trauma containers are a drama
45 Improving... Instrumentenpflege 1. Visual/tactile inspection 2. Maintenance 3. Function test
46 The right instrument in the right place?
47 Documentation is knowledge Appropriate means? Just do it!
48 Conclusion Medical devices are not always cleaned properly by washer disinfectors. Staff is not always able to work consistently and regular. Manual cleaning remains necessary as automated devices are limited in capacity and capability. (Re-)Processors have limited access to washer disinfectors as well. Validated (re)processing is mandatory. It requires verification of parameters that are predefined, in the case of manual cleaning mainly standard operating procedures (SOP). The specifications of validation must reflect the actual state of science and technology. They are partly measurements, partly descriptions and control of fulfillment (countable/ not countable events).
49 FORUM workshop CLEANICAL Thank you for your attention!
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