It‘s so easy when you know how! Maintence and Inspection ...%26+Inspection... · Manual disinfection and cleaning • Folowl the manufacturer‘s instructonsi when disassemblngi

It‘s so easy when you know how!

Maintence and Inspection of surgical instruments

PAULA SINGLETON-HOBBS 11TH MAY 2016

The prerequisites for ...

... manufacturing of a quality product

• High-quality material • Reliable production processe • Strategic quality testing

... maintaining the value of a quality product

• Proper use • Careful reprocessing • Regular maintenance and inspection

...an efficient quality management system

Instrument Circle

Utilization

Wet / Dry disposal

Procurement / Repair

Disinfecting Cleaning

Inspection / Maintenance / Function test

Taking out of service / Repair

Packaging

Sterilization

Storage

Supply

Demands on Surgical Instruments Dull instruments e.g Clamps - Corrosion resistance Forceps - High elasticity Hooks – Optimal toughness Probes - Resilience Cutting Instruments e.g Scissors – Corrosion resistance Scalpels – Sufficient elasticity Knives – Great hardness Chisels – High wear resistance

Selection of stainless steels for surgical instruments Instruments Din material Description Cutting Scissors X46Cr13(1.4034) C=0.42-0.50% Scalpels Cr = 12.5 – 14.5% Hardness 50-58 HRC Knives AAG steel alloy C = 0.42 – 0.50% Chisels X45CrMoVI5(1.4166) Cr = 12.9-13.55 Mo = 0.45 – 0.60% V = 0.10 – 0.15% Hardness 43-48 HRC

Selection of stainless steels for surgical instruments Instruments Din material Description Dull Clamps X20Cr13(1.4021) C=0.17-0.25% Forceps Cr = 12.14% Hardness 40-48 HRC Hooks AAG steel alloy Cr = 0.17-0.19% Probes X20CrI3(1.40210 Cr = 12.9-13.55 Hardness 43-48 HRC

Causes of instrument damage during the operation

What you should avoid at all costs:

Placing instruments in physiological saline solution can lead to corrosion:

Pitting

Stress corrosion

Cause: Chloride

What you should do: Remove residual surgical debris intraoperatively. Use a sterile, damp cloth towel (e.g. a compress or abdominal towel).

Keep exposure to chloride to a minimum


What you should avoid at all costs: Pinching off metal wires with unsuitable forceps or scissors can lead to deep scoring or indentations and to irreparable damage

Luer

Liston


What you should do:

Use wire-cutters

Always refer to manufacturer‘s recommendations regarding wire diameters (from 0.3 to 0.6 mm)


Causes of instrument damage after the operation

What you should avoid at all costs: „Throwing aside“ instruments will damage them

For example:

Chipping of tungsten carbide inserts on scissors or needle holders; bent or broken instrument tips; damaged insulation

What you should do: Lay instruments down gently

• Contaminated instruments should be desinfected and cleaned as soon as possible

• Avoid long delays overnight or over a weekend, as this can lead to corrosion

• When cleaning instruments mechanically, place them in standardized wire baskets, e.g. DIN, ISO

• To ensure effective mechanical cleaning, open joitned instruments (scissors etc.) and instruments with boxlocks at a 90° angle

• Follow the manufacturer‘s instructions when disassembling detachable instruments

• Avoid rinsing shadows

Post-operative disposal procedures General rules


It‘s so easy when you know how! Post-operative disposal procedures Wet disposal of instruments

• Use a disinfecting solution for wet disposal (but manufacturer should verify the tolerance of the materials to the solution)

• Do not use corrosion-removing solutions of any kind

• All surfaces and lumina must be completely wet

• Do not immerse instruments for extended periods of time (risk of corrosion)

• Rinse instruments thoroughly under cool running tap water prior to mechanical cleaning and disinfecting

• Residual disinfectant can cause a reduction of the efficacy of disinfectants


Manual disinfection and cleaning

• Follow the manufacturer‘s instructions when disassembling detachable instruments

• Immerse instruments in a suitable combined cleaning and disinfection solution (refer to the manufacturer‘s recommendations)

• All exposed surfaces and lumina must be covered completely by the solution

• Dissolve all powdered preparations in water completely


Manual disinfection and cleaning

• After chemical disinfecting, clean the instruments thoroughly under cold running tap water

• Make certain that the diameters of brushes are the right size for the lumina they are being used to clean

• Do not use abrasive cleaning agents or metal brushes as these can cause (among other things) damage to the protective passive layer


• Perform the final rinse in demineralized or distilled water

• Dry instruments with an absorbent, lint-free cloth towel

• Dry all lumina and cavities with compressed air

Mechanical disinfection and cleaning


• Load baskets / brackets in the prescribed arrangement

• Select washer program settings and cleaning agent according to the tolerance of instrument and container materials, e.g.: • Stainless steel: alkaline cleaning agent (cleans well)

• Aluminium: pH-neutral cleaning agent (doesn‘t harm the materials)

• Always follow the manufacturer‘s instructions

• Perform the final rinse in demineralized water

• Make certain that the drying phase is long enough

• Remove instruments from the washer immediately after the program ends (to prevent condensate from forming, which can cause corrosion)

Mechanical cleaning and disinfection

Possible change in surface characteristics of surgical instruments Grayish black discoloration of stainless chromium steels caused by acid

Causes:

• A fault in the automatic program or

• incorrect dosage can lead to carry-over of cleaning agents or neutralizers based on phosphoric or citric-acid into the final rinse

• Acid residues adhering to the instrument can cause a surface reaction during thermal disinfecting and / or subsequent sterilization

Manifestations at low concentrations

• Grayish black, uniformly shiny discoloration through the formation of an inert ferric phosphate- or chromium oxide film

• Leads to: enhanced corrosion resistance (poses no hygiene risk)

Possible change in surface characteristics of surgical instruments Grayish black discoloration of stainless chromium steels caused by acid

Manifestations at high concentrations • Grayish black, dull discoloration

- activation of the surface caused etching • Leads to: destruction of chromium oxide film

Risk of surface corrosion

What you should do: • Instruments with black, uniformly shiny discoloration can

be left in the reprocessing cycle. The formation of this inert film enhances corrosion resistance

• The inert film cannot be removed using basic chemical cleanig agents

• Instrument manufacturers recommend risk-free mechanical surface treatment (after the cause of the problem has been removed)

• Sort out and scrap etched instruments with dull black discoloration, since this is an irreversible surface damage

Possible change in surface characteristics of surgical instruments

Grayish black discoloration of stainless chromium steels caused by acid

Preventive measures:

• Optimize machine program

• Ensure the recommended dosage of acidic cleaning agent and / or neutralizer is used

• Prevent carry-over of acidic cleaning agent and neutralizer

Possible change in surface characteristics of surgical instruments

Grayish black discoloration of stainless chromium steels surfaces caused by acid

Inspect instruments following each manual and mechanical cleaning cycle Inspect visually for cleanliness, i.e. the instruments must be free of protein residues and other contaminants Check the following with particular care: Grooves, serrations, joints, tubular shafts

Instruments that are not clean enough must be cleaned again: - Manually or possibly with ultrasonic treatment - Immerse in 3% hydrogen peroxide solution H2O2 for approx. 5 minutes and rinse well

HERE‘S AN INDISPENSABLE RULE OF THUMB: Instruments have only been disinfected and sterilized effectively if they look clean


Sterilization

is not a substitute

for cleaning

Ultrasonic treatment

• Used prior to machine preparation to pre-clean instruments with encrusted contaminants

• Used for basic and intensive cleaning of instruments that still have embedded blood after machine preparation

• An effective electromechanical complement to manual cleaning


Perform ultrasonic treatment in accordance with the manufacturer‘s instructions:

• Use suitable cleaning and disinfecting agents

• Open instruments prior to sterilization

• Place the instruments in suitable baskets

• Avoid acoustic shadows (e.g. air)

• All instrument cavities must be completely filled with solution

• Solution temperature must not exceed 55°C


Perform ultrasonic treatment in accordance with the manufacturer‘s instructions:

• Processing time 3 - 5 minutes / 35kHz

• After ultrasonic energy cleaning, remove loosened residues manually under cold running tap water with a medium hard brush

• Perform the final rinse in demineralized water

• Dry instruments by hand with a lint-free cloth towel or with compressed air

• Residues in the ultrasonic basin will reduce the effectiveness of the cleaning process

Possible changes in the surface characteristics of surgical instruments

• Discoloration

• Water spots

• Corrosion


Substances of content Effects in automatic decontamination

Hardeners (calcium carbonate/sulfate; magnesium carbonate/sulfate)

Calcification and deposits in the machine and on the items being rinsed

Heavy and non-ferrous metals (iron, manganese, copper)

Dark discolorations and deposits

Silica / silicate Stubborn yellowish brown to purplish blue glassy deposits (rainbow colors)

Chloride Pitting (with stainless steel)

Silicate deposits discoloration / spotting Causes:

Excessive amounts of silicate/ silicic acid in the final rinse of a mechanical washer (e.g.from leakage of silicic acid during the production of demineralized water with ion exchangers)

Carry-over of cleaning solutions containing silicate Manifestations: • large area / yellowish-brown to blueish-purple (Rainbow

colours)

• Clearly defined margins

• Teardrop-shaped or geometrically irregular islands


Silicate deposits discoloration / spotting What you should do:

First, eliminate the sources of the problem:

• Optimize machine program settings

• Eliminate carry-over from cleaning agents containing silica

• Change cleaning agents if necessary (use agents that contain little or no silica)

• Perform the final rinse in silica- and mineral- free water

• Optimize steam generation


Silicate deposits discoloration / spotting What you should do:

After eliminating the cause, the following (if desired):

• Remove deposits with a chemical cleaning agent → partially possible depending on: appearance and thickness of the film

Not recommended for instruments with tungsten carbide inserts or chromed / nickel-plated surfaces

• Instruments surfaces could be etched → passive layer damaged

• Instrument manufacturers recommend: risk - free mechanical reconditioning of instrument surface


Water spots

Causes: • High concentrations of mineral (e.g. limestone) or

organic substances in rinse water / autoclave steam

• Excessive load weights in autoclave → increase condensate formation


Water spots Manifestations:

• Silicic acid / silicate:

• Clearly defined margins

• Teardrop-shaped or geometrically irregular islands

• Yellowish-brown to blueish-purple discoloration

• Lime Pale gray spots


Water spots What you should do:

• Lime spotting: can usually be wiped away with a damp cloth

• Silicic acid / silicate spotting:depending upon the thickness of the film, can under some circumstances be treated with phosphoric or hydrofluoric acid cleaners (use with stainless steel only)

Not recommended for instruments with tungsten carbide inserts, laser inscriptions or chrome- or nickel- plated surfaces

• Instrument manufacturers recommend: risk-free mechanical reconditioning of instrument surface


Water spots


• Perform final rinse in demineralized water

• Use sterile steam (EN 285)

• Avoid overloading autoclaves


Corrosion

The manifestations of corrosion vary → according to the type of metal

Corrosion invariably leads to permanent damage to the instrument or to its destruction

Stress corrosion

Pitting

Friction corrosion


Types of corrosion

Surface corrosion

Extraneous rust

Rust film Contact corrosion

Fretting corrosion

Pitting corrosion

Crevice corrosion

Stress corrosion


Surface corrosion

Causes: • Chemicals (e.g. acidic or alkaline agents)

Manifestations:

Damages the entire outer metal surface

For example:

• in carbon steel (disposable scalpel blades) • practically never occurs with stainless steel

• in anodized aluminium with natural or colored surfaces (the latter fade)


What you should do:

• Set aside faulty instruments


• Never sterilize disposable products (e.g. disposable blades made of non-alloyed carbon steel)

• Use neutral or mild alkaline cleaning and disinfecting solutions on anodized aluminium surfaces

Surface corrosion


A chisel in which chloride ions caused pitting

Macroscopic view

Microscopic view (magnified 20 x)

View of pitting through the electron microscope, magnified 2000 x, with integrated chloride “line scan“ measurement curve


Pitting - affects metallic materials only

Causes:

• Primarily caused by chloride ions (in blood, water, physiological saline solution)

• Other halogen ions (jodide, bromide)

Manifestations:

• Crater-shaped

• Surfaces have hollowed-out or needle prick-like indentations with brown or iridescent rings

• Reddish brown, partial discoloration

• Rust comes out of indentations


Pitting - affects metallic materials only

What you should do: Set aside faulty instruments

Preventive measures: • Clean instruments immediately after use

• Remove materials containing chloride (e.g. blood, physiological saline solution)

• Perform final rinse in demineralized water

• Adhere to reference values for steam quality, EN 285


Causes: • Chemical reaction (e.g. embedded residual blood) Manifestations: • In narrow (functional) crevices • Brownish discoloration in and around crevices • Rust comes out of the crevice

Crevice corrosion


Crevice corrosion

What you should do:



• Immediately remove residues containing chloride

• Clean methodically


Stress corrosion

Causes:

• Improper use (overstraining) of clamps, needle holders, etc. • Strain on closures due to ratchet being completely closed

during sterilization • Defect in material or in manufacturing

Manifestations:

• Cracks / fractures in - functional joints - tips (in most cases the weakest stress point)


What you should do:

• Set aside faulty instruments (irreparable)


• Leave instruments open during cleaning

• Immediately remove contamination containing chloride

• Regularly lubricate joints with a sterilizable water-permeable lubricant (paraffin oil or white oil)

• Close ratchets prior to sterilization (no higher than the first notch)

Stress corrosion


Possible chloride-induced effects on instrument-grade steel that could lead to stress corrosion and / or pitting

• Physiological saline solution

• Blood, saliva, sweat

• Medications that contain chloride

• Chloride in water

• Carry-over of regenerating salts

• Chloride in autoclave steam

• Residues of cloth towels


Fretting corrosion Causes:

• Mechanical damage to the in passive layer on the stainless steel

• In cases of inadequate lubrication → metallic friction

•Chemical (e.g. embedded blood)

Manifestations:

• Corrosion in narrow crevices or joints

• Brownish discoloration in and around hinges

• Rust comes out of the rubbed-off parts in the presence of humidity

Fretting corrosion


What you should do:



• Immediately remove residues that contain chloride

• Lubricate hinges regularly and with care

Fretting corrosion


Fretting corrosion

Maintenance and Care • Allow instruments to cool to room temperature

(to avoid metal abrasion)

• Apply lubricant manually to hinges or threads

• Distribute lubricant evenly on hinges by repeatedly opening and closing the instrument

Objective: • To prevent fretting corrosion caused by

friction between metal surfaces


Requirements for lubricants for instrument maintenance

• Basic lubricant: paraffin oil or white oil

• Must be in accordance with the current pharmacopeia

• Must be steam-permeable, sterilizable, histocompatible

• In addition, it must not be sticking or gumming even after repeated use

Warning: • Do not apply lubricants to rubber or latex goods. This will cause the materials to expand, leading to irreparable surface damage


Manifestations: e.g. rust rings / rust islands

Warning: not to be confused with pitting

Remedial and preventive measures:

• Use demineralized water • Set aside faulty instruments. If necessary, have surface reconditioned

Causes: • Contact between stainless steel and non-stainless steel instruments (needles, burrs, etc.)

• Nickeled or chromed instruments whose protective layers have flaked off

Contact corrosion


Manifestations:

• Corrosion build-up on the inside wall of the autoclave chamber, on the autoclave packaging and on the surfaces of the instruments

• e.g. partial or broad areas of rust and / or corrosion

Causes:

• Rust particles from corroded instruments and / or

• decontamination facilities, steam supply systems (e.g. piping system has lead pipes)

• Nickeled or chromed instruments whose protective layers have flaked off

Extraneous rust and rust film can lead to secoundary rust



• If purified steam is not available and a piping system with lead pipes is installed:

- Ensure that steam generation facility will run continuously

- Install a purifying steam-to-steam exchanger

- Remove impurities with a filter (can be very cost-intensive in some settings)

- Add suitable corrosion inhibitors /




• Piping systems made of:

- Chromium nickel pipes (V2A/V4A) for purified steam

- Plastic pipes to carry tap water and demineralized water to steam boiler

/



What you should do:

• If necessary, use phosphoric acid cleaners for instruments, decontamination facilities and sterilization chambers (use with stainless steel only)

Not recommended for instruments with tungsten carbide inserts, laser marking and chrome or nickel plated surfaces

• Depending upon marking extent of damage, set aside corroded instruments; or if necessary have them repaired and / or send instrument to manufacturer for reconditioning



Visual inspection and function test

• Before cleaning, disinfecting, drying and sterilization

• Inspect visually for cleanliness

• Particularly delicate and fine instruments should be examined under a magnifying glass

• The function tests must be carried out in such a way as to make absolutely sure that instruments no longer suitable for their intended uses (e.g. because they are worn or damaged) are set aside

• In case of doubt, the user should ask the manufacturer for advice as to suitable testing procedures


General criteria:

Checking for surface damage

• Corrosion can lead to ... ... rust film, contact corrosion, secoundary rust What you should do: Set aside instruments, have them repaired, or have faulty components replaced

• Nickel or chrome plating that has flaked off can lead to ... ... rust film, contact corrosion What you should do: Set aside instruments and if necessary replace damaged instrument components


Inspecting instruments for damage:

• Worn tungsten carbide inserts e.g. in needle holders and forceps)

• Bent or broken tips / jaw parts • Stress cracks in joints

• Faulty ratchets → instrument opens

What you should do:

• Have faulty instruments repaired • Set aside instruments according to extent of damage

Warning: Patients‘ safety must under no circumstances be compromised by functional damage of instruments


/

Visual inspection of scissors for:

• Soiling

• Metal abrasion in the joints

• Corrosion (e.g. pitting, stress corrosion)

• Cracks in rings, joints or blades

• Nicks, burrs

• Broken off pieces of carbide inlays

• Bent or broken tips


/

Function check of scissors

Cutting test:

• Close the scissors at an even speed, without applying any lateral force

• 2/3 of the blade length should cut

• The scissors should cut cleanly through the test material and not tear or shred it

• Use different test materials according to the scissors‘ characteristics: gauze bandage, cotton compresses, rayon, cotton jersey


Visual inspection and function test of forceps

• Forceps with serrated jaws must be resilient and aligned when they are closed, beginning at the jaw tip

• Forceps with teeth must not hook up, and no teeth should be missing

• Springs must not be bent

• Forceps with guide pins must not stick

• Surfaces must not be soiled and must be in mint condition


Function check of atraumatic clamps

• Check for residual soiling in the atraumatic teeth, the surfaces of the joints, etc.

• Performance test options for atraumatic clamps:

• The jaw teeth, when closed, must not perforate a heat-sealed polyethylene bag (wall thickness 0.05 mm) that is half filled with water

• The jaw teeth, when closed, must not perforate tissue paper


Packaging instruments

• Detached instruments must be assembled in accordance with the manufacturer‘s instructions

• Close ratchets (not higher than the first notch)

Objective:

Avoidance of stress cracks in the joints when the instruments are heated and cooled during sterilization


Packaging instruments

• Avoid transport damage by storing instruments on special racks, on silicone cushioning pads etc.

Objective:

To safeguard against abrasion, pressure, shocks and slipping


DIN EN 285: Limit values for impurities in the generation of purified steam for instrument sterilization

Vaporization residuesSilicon oxide, SiO2IronCadmiumLeadTraces of heavy metals apartfrom iron, cadmium, leadChloride (Cl)Phosphate (P2O5)Conductivity (bei 20°C)PH-valueColor

Hardness

< 1,0 mg/kg< 1,0 mg/kg< 1,0 mg/kg< 0,005 mg/kg< 0,005 mg/kg

< 0,1 mg/kg< 0,1 mg/kg< 0,1 mg/kg3 µS/cm5 through 7ColorlessTransparentNo residues< 0,02 mmol/l

< 10,0 mg/l< 1,0 mg/l< 0,2 mg/l< 0,005 mg/l< 0,05 mg/l

< 0,1 mg/l< 2,0 mg/l< 0,5 mg/l15 µS/cm5 through 7ColorlessTransparentNo residues< 0,02 mmol/

Impurities Condensate Boiler feed water

Storing sterile goods

Observe DIN 58 953, Part 9

• Store in dust-free and dry spaces

• Spaces that are free of vermin

• The surfaces in the room must be smooth, devoid of cracks and easy to clean and disinfect

Storing sterile goods

Observe DIN 58 953, Part 9

• Excerpt

“Loss of sterility results less from the duration of the storage period than from outside influences and effects during storage, transport and handling.

Storage time periods, which can vary according to discipline and setting, should be defined in writing. In doing this, the type of packaging and storage conditions should also be taken into account.“

The results of instrument reprocessing ...

... can never be better than the weakest link in a chain

The informed employee

is always

Documents

It‘s so easy when you know how! Maintence and Inspection ...%26+Inspection... · Manual disinfection and cleaning • Folowl the manufacturer‘s instructonsi when disassemblngi