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HYGIENE
Medical Devices & ProcessesBasic Course Tuttlingen
(Tuesday, January 16th 2018, 3.00-5.00pm)
Dr. Thomas Fengler
How to preserve hygiene & function
KARL STORZ GmbH & Co. KG
Global Quality Management & Regulatory Affairs
Department CLEANICAL®
Example: Poster for the promotion of hygienic
awareness in developing countries
By CAWST - Flickr, CC BY 2.0,
httpscommons.wikimedia.orgwindex.phpcurid=41792574
Hygiene is prevention
Hygiene
Definition
Hygiene is “the science of prevention of
diseases and the preservation, promotion
and strengthening of health.“
It is related to microbiology, infectiology
and environment protection.
And circumstances…
Microorganisms might be pathogenic
Pathogens are substances or
organisms that might cause
harmful processes in other
organisms.
Those are assigned in medicine
the property of pathogenicity.
Pathogens can be bacteria, fungi,
parasites, viruses or prions.
Not all microorganisms cause
diseases but many can potentially
do so.
Parasites
(fleas, worms,
bedbugs)
misfolded
proteins (prions)
Spores of
Bacillus etc.
Bacteria Virus Others
Enterococcus
Staphylococcus
Streptococcus
Mykobacteria
Bacillus (aerobic)
Clostridia (anaerobic)
Candida
Aspergillus
Penicillium
HIV
Polio
Rota
Noro
Herpes
Fungi
Overview: Pathogens
Protozoa
Plasmodium
falciparum/
malariae
Transmission needs Circumstances
Airborne infection:
transmission through tiny secretion droplets, originating from human airways,
flying through the air and being inhaled by other people.
Smear infection:
indirect transmission by touching an object, which is contaminated with
infectious body secretions (e.g. saliva, urine, feces).
Contact infection:
transmission of infection from a sick individual to a healthy individual by direct
physical contact or touching contaminated materials or surfaces.
Preconditions to successful MD Processing
• MD are used in humans and thus can transmit infections.
• Nobody knows what happened to the processed, reusable MD so far.
• The individual’s actions are determined by their technical and hygienic knowledge
and understanding.
• There is a separate set of rules and regulations
Do we have suitable premises?
• Professional, competent and willing staff, professionally prepared for the MD.
• Procedural/work instructions (SOP “standard operating procedure”)
• Regular training and further education
• Appropriate work environment (room & equipment)
• Appropriate (validated) machine processes and/or standardized manual methods
• Processing on the actual level of science and technology (state of play)
• Gapless traceable documentation with available tracking technology
• Quality assurance system including evaluation of occurring risks
Hygiene is part of a quality cycle:
What does (Re-)Processing of Medical Devices imply?
traceability
sterilize
waste use
stock
clean &
disinfect dry
inspect waste
sterilize
wrap &
label
raw
material
A Process oriented Quality Concept
Responsibility for Results
• Operator responsibility pertains to all services of a hospital or
other health care facility, which includes the processing of
medical devices (MD), usually carried out in a Sterile
Processing Department (SPD) or Central Sterile Supply
Department (CSSD) or Reprocessing Unit for Medical Devices
(RUMED).
• There is an obligation to actively request/seek out information
in order to keep up with current developments.
• The delegation of responsibilities (e.g. to service providers)
does not affect the responsibility for the results. The onus of
control is on the operator, within his stipulated mandate to
provide care.
• The manufacturer provides the necessary information for use
(IFU) and after sales services supporting the customer.
13
The Impact of Processing in Legal Terms
• The risks of reprocessing are considered to be „fullymanageable“.
• The incidence of nosocomial infections remains unclear, since they are difficult to trace back. Some of them (perhaps: 20-30%) could be prevented.
• „The hygiene- and sterilisation risk has to be kept to theinevitable residual risk, according to the state of science andtechnology.“ (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 tofurther their education „to the limits of what can reasonably beexpected“ (quotations from relevant verdicts).
Task
(legal and standard conformous) processing of MD
Implementing
Laws, standards, guidelines, recommendations
Prior arts, state of technologies and sciences
Qualitiy Management establishment and practice
Evaluation of risks
Education and training
Goal
Safety of patients, staff and third parties
Aiming to lower residual risks
Job professionalism instead of „training on the job“
Medical Devices and Regulatory Affairs
Medical
Device
Regulation
(MDR)
Medical Device Act
Medical Device Operator
Ordinance – MPBetreibV
Accident Prevention Regulations
Recommendations, guidelines
Prior arts
(State of sciences and technologies)
standards (DIN, EN, ISO), guidelines,
recognized rules, recommendations
Pyramid of Regulatory Affairs
Global quality management
Risk evalution
Liability
https://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Hygiene_Requirements_Medical_Devices_2012.pdf?__blob=publicationFile
KRINKO
Step by Step to hygienic Function:
Processing of medical devices
(instruments, endoscopes, and accessories)
Step by Step to hygienic Function:
Transport from OR to
CSSD
Recirculation for use
Un-clean
Sterile
Time (minutes)
5 60 5 15 30-60
Dry transport
Ultrasound
Dissasembly
Pre-washing
Automatized
Washing
Drying
Thermal Disinfection
Soft Packaging
Containers
Sterilisation
Steam
Formaldehyde
Ethylene
oxide
H2O2 „Plas a“
Clean
Inspection
Re-washing?
Repairs?
Maintenance
Assembly
The “Swiss cheese model”
Appropriate Equipment & Installations
- Sink
- Basins and tubs
- Sufficient working surfaces
- Leak tester
- Ultrasound (basin)
- Hand washing area
- Medical pressurized air pistol
MD design and manner of clinical use
(Spaulding classification 1968 - modified)
Contact to intact skin
Non-critical
Contact to mucousmembranes or unhealthy skin
Semi- critical
Penetration of skin
Contact with blood
critical
Processability of the MD
Thermostable
simple design
smooth massive surface
A
Thermostable
complexe structure, cavities,
difficult to access-surfaces, lumen
B
Thermolabile
C
Safeguard Measure Vaccination
Example: needlestick injuries (NSI)
• Needlestick injuries (NSI) are generally understood to be pricks, cuts and scratch injuries of the skin by needles, cannulas, scalpels or similarinstruments
• Needlestick injuries are among the most frequently occurring in clinical routine work accidents
• They are often not reported, the alleged true figure is between 50% and 90%
• In Europe the following pathogens pertain the greatest risk:Hepatitis C virus (HCV)Hepatitis B virus (HBV) (if no sufficient vaccination is provided)Human Immunodeficiency Virus (HIV)
Cleaning is Disinfection
ISO/FDIS 17664: 2017
3.1 cleaning
Removal of contaminants to the extent necessary for further
processing or for intended use.
Note: Cleaning consists of the removal, usually with detergent
and water, of adherent soil (e.g. blood, protein substances and
other debris) from the surfaces, crevices, serrations, joints, and
lumens of a medical device by a manual or automated process
that prepares the items for safe handling and/or further
processing.
3.3 disinfection
Process to reduce the number of viable microorganisms to a
level previously specified as being appropriate for a defined
purpose
• Contact time (t)
• Temperature (T)
• Mechanics (M)
• Chemistry (Ch)
– Type of active component
– Concentration
– pH-value
Sinner Circle
Removal or inactivation of any contamination
Main agent is water, as means of transport.
And for rinsing in between…
Influencing Parameters
Drinking water may not contain potentially infectious
microorganisms, from the water company/utility to the tap.
Water availability and its quality may be problematic.
- Pipes not properly installed or maintenance problems
- Dead zones
- Flow speed too low
- Cold water close to hot water (not insulated)
Water Supply & Availability
Water Quality for Processing
Automated or manual cleaning/disinfection – wherever:
Drinking water quality required for cleaning and disinfectionsolutions (including precleaning, change of water, cleaning, and rinsing processes in between).
If possible use desalinated water1
To determine thermal or chemical disinfection:
Final rinse with desalinated water1
Manual disinfection with desalinated sterile water!
1 conductivity value <15µs (EN 285)
Program specifications
Pump pressure
MD load
Water quantities
Water quality
Wetting
Distribution of water
Spray arms‘ distribution and rotation
Nozzles‘ distribution and diameters
Temperature
Time
Cleaning agent
Many Parameter enable Cleaning
Cleaning and biocidal action
are separate steps
Cleaning, rinsing, biocidal action (“disinfection”) and final rinsing
with sterile desalinated water have to be executed separately!
Dis-infection by biocidal Action
Disinfection
Inactivation of infectious agents
by biocidal action (instead of
reduction/removal by cleaning)
Target: infection impossible!
Automated reprocessing
- Thermal disinfection
(≥90°C)
- Chemical disinfection
(≤60°C)
Disinfection manually or Device-supported
manual „automated“
Concentration
Immersion time
Rinsing / neutralization
Recommended detergents
Water Quality and Formation of Biofilms
Biofilms are developing from use to use depending on formation
of specific microorganisms at boundary layers, mainly in
aqueous systems often adherent to solid phases.
Biofilms consist of slime (film) that might cover bacteria, algae,
fungi, protozoes (some of which produce the slime).
Therefore cleaning by brushing is crucial. Disinfectants might
loose their biocidal effects, since the bacteria are protected by
the biofilm.
1. Cleanliness, dryness, changes (e.g. corrosion)
2. Oiling (joints, ratchets)
3. Assembly
4. Functional inspection
5. Packaging
Maintenance & Sterile Barrier System
Sterilization
• Steam Sterilization 132-137°C, 4-18 minutes
(preferred method where applicable)
• Low-temperature Sterilization max. 60°C
(thermolabile MD like flexible endoscopes)
– H2O2
STERRAD 100S, NX, 100NX
(Advanced Sterilization Products - ASP)
VPro, VPro Max (STERIS Corporation)
– Formaldehyde (FA)
– Ethylene Oxide (EO/EtO)
– STERIS System 1/1E (PAA)
Information for Use (IFU) e.g. Rigid Scope
● This processing step is part of the validated process.
○ This additional processing step may be optionally performed to support cleaning.
The sterilization procedure has been approved in terms of material compatibility, but its effectiveness must still
be validated by the on-site operator.
x This processing step must not be performed as it may cause damage.
How to process this rigid scope?
Processing Information e.g. Rigid Scope
Rigid Telescope
• Cleaning
Manual or automated
max. temperature 95°C (110°C for drying)
recommended chemicals
• Disinfection
Manual or automated
thermal/chemical disinfection process
• Maintenance
Clean optical surfaces with 70% alcohol (Ethanol / Isopropyl)
• Sterilization
Steam sterilization (in an „autoclave“) at 134 – 137°C
Alternatives: H2O2 (STERRAD / STERIS V-PRO), ETO, FA
Information for Use (IFU) e.g. Forceps
How to process the forceps?
● This processing step is part of the validated process.
○ This additional processing step may be optionally performed to support cleaning.
The sterilization procedure has been approved in terms of material compatibility, but its effectiveness must still
be validated by the on-site operator.
x This processing step must not be performed as it may cause damage.
Processing Information e.g. Forceps
MIS-Instrument (ClickLine)
• Preparation
Disassembling
Brushing inner lumen, outer surfaces / flushing channels
• Cleaning
Manual or automated thermal disinfection process
• Disinfection
(Manually or) automated
• Maintenance
Functionality check
• Sterilization
Steam sterilization (autoclave) at 134 – 137°C
Thermolabile methods are regarded as second best
Processing Information for Flexible Scope
Flexible Endoscope (Fiberscope / Video-Endoscope)
• Preparation
Leakage test, brushing channels, wipe surfaces
• Cleaning
Manually or automated
max. temperature 65°C !!
recommended chemicals
• Disinfection
Manual or automated chemical disinfection process
• Maintenance
Clean optical surfaces with 70% alcohol (Ethanol/Isopropyl)
Leakage test
• Sterilization
Low temperature processes: (IFU)
H2O2 (STERRAD / STERIS V-PRO), ETO, FA
The Spectrum of Disinfectants
A killing vegetative bacteria, mycobacteria, fungi & fungal spores
B inactivating viruses
C killing anthrax spores
D killing clostridia spores
Bactericide = inactivating bacteria
Fungicide = inactivating fungi
Virucidal = inactivating virus (B)Coated viruses are surrounded by a lipid membrane (e.g. HBV, HCV and HIV,
and influenza viruses). The lipid membrane is fragile and can be destroyed
with alcohol. Coated viruses can be killed with disinfectants, which have a
limited virucidal activity spectrum (A).
Not coated viruses are not surrounded by a membrane coat (e.g. noro- or
rotavirus). Not coated viruses have a higher resistance to chemical, physical
processes and other environmental influences and may require the use of
particularly powerful disinfectants, which are declared as virucidal (B).
Personal Protective Equipment (PPE)
All products have to adhere to the relevant standards
• Hair Covering
• Eye protection such as goggles or glasses with solid side
shields
• Respiratory protective face mask
• Gloves
• Apron/gown with reinforced sleeves that acts as a barrier to
fluids
• Skid-resistant, antistatic footwear
Which Areas to disinfect?
• Surfaces with frequent skin-
or hands-contact like door
handles, handrails,
keyboards, phone
• Treatment and patient-
friendly surfaces like
medical equipment, dental
chair, couch, bedside table,
bed frame
• Surfaces in communally
used sanitary areas like
toilets, showers, tubs, sinks
• all sorts of working surfaces
Hygiene is prevention. Prevention is more than disinfection!
• Sufficient and appropriate medical devices (MD)
• Equipment for processing (tools, quality/quantity of machinery)
• (Further) education/training (general/technical knowledge)
• Processes (parametric release, verification & validation)
• Acceptance criteria (countable, „narratable“)
• Processing „by the book“ (standards, regulation)
Documentation > Evaluation of risks > Quality management
Problems > Tasks > Solutions