CENTRAL STERILE SUPPLY SERVICES POLICY
CENTRAL STERILE SUPPLYSERVICES POLICYMEDICAL DEVELOPMENT DIVISIONMINISTRY OF HEALTH MALAYSIACentral Sterile Supply Services Policy1
This policy was developed by the Clinical Support Services Unit,Medical Development Services Section of Medical DevelopmentDivision and the Drafting Committee of Operational Policy of CentralSterile Services Department.Published in August 2018.A catalogue record of this document is available from Library andResource Unit, Institute for Medical Research, Ministry of HealthMalaysiaMOH/P/PAK/336.17(BP)e ISBN 978-967-0399-72-0All copyrights reserved2Central Sterile Supply Services Policy
ACKNOWLEDGEMENTMedical Development Division would like to acknowledge thecontributions of the following groups and individuals toward thedevelopment of this document;An appreciation to Dato’ Dr Hj. Azman bin Hj. Abu Bakar, DeputyDirector General of Health (Medical) for his endless support indeveloping this policy.Matron Hjh Mek binti Jusoh and the Drafting Committee onOperational Policy of CSSU for their dedication and continuingsupport for ensuring that the policy is materialized.Thanks to others who are directly or indirectly involved in formulatingthis policy.Central Sterile Supply Services Policy3
CONTENTPREFACE/FOREWORDDeputy Director General of Health (Medical)iiHead of Central Sterile Services unit (CSSU)iiiTHE ARTICLES21INTRODUCTION22OBJECTIVE23GENERAL POLICY23.13.23.33.43.53.63.74Traffic ControlFood and SmokingHealth and Personal HygieneDress CodeCSSU Space and EnvironmentSafetyMaintenancePOLICY ON astructureEquipment in Decontamination ZoneSize and Number of Washer DisinfectorPersonnelReceiving and HandlingInspection, Repair and OngoingMaintenance4.8 Sorting of Instrument4.9 Method of Cleaning4.10 Chemical Disinfection4.11 Porter Services4.12 Counter Services5POLICY ON PACKAGING5.15.25.34ObjectivesPhysical Set UpGeneral ConsiderationCentral Sterile Supply Services Policy23451012141414151818191920212121212222222223
6POLICY ON sStorage and HandlingPOLICY ON TRANSPORTATION ANDDISTRIBUTION OF STERILE PRODUCTS8.18.29ObjectivePurchasing, Commissioning andMaintenanceLoad MonitoringEfficiency Tests for SterilizationMalfunction SterilizerRecord Keeping SterilizerCleaning the SterilizerSteam Sterilizer SafetyEthylene Oxide Sterilization SafetyPOLICY ON STORAGE OF STERILE PRODUCTS7.17.2823ObjectiveGeneral ConsiderationPOLICY ON STERILIZATION OF IMPLANTABLEITEMS9.19.2ObjectivesGeneral 0POLICY ON SHELF LIFE3111POLICY ON PRODUCT RECALL3211.111.2ObjectivesGeneral Consideration323212POLICY ON SINGLE USE ITEMS3313POLICY ON NON-FUNCTIONAL / LOSTINSTRUMENTS3314POLICY ON INCOMPLETE PROCEDURE SETS3315POLICY ON BIOHAZARD CASES3316POLICY ON LOANER INSTRUMENTATION34Central Sterile Supply Services Policy5
17REFERENCES3518DRAFTING COMMITTEE FOR CENTRAL STERILESUPPLY SERVICES POLICY396Central Sterile Supply Services Policy
PREFACE /FOREWARDCentral Sterile Supply Services Policy7
PREFACEI would like to begin with praise to Allah SWTfor blessing us with wisdom and strength incompleting the Central Sterile Supply ServicesPolicy.Central Supply Services Unit (CSSU) is a crucialpart of Clinical Support Service. Despite beingovershadowed by other clinical services,its presence is indispensible in the Ministry ofHealth’s visions to combat the rising incidenceof hospital acquired infections.CSSU ensures the standardized method of process for supplying sterileinstruments and materials under strict quality control, henceforthenabling the clinicians at the forefront to focus on the care and safetyof our patients. This policy is written beyond the process and storageof clinical equipments, but also to armour the CSSU personnel whendealing with hazardous and infectious wastes.In recent decades, Malaysian healthcare system too is facing theeffect of global inflations in healthcare costs. Additionally, new andimproved clinical equipment, processes and practices are constantlyevolving, and it is our duty as a care provider to be cognizant withthe latest medical advancement. This is aligned with ministry’s visionto provide highly efficient, cost-effective, innovative, equitable andtechnologically-appropriate healthcare system.This new Central Sterile Unit Standard Operational Policy is producedwith endless commitments from the committee members andstakeholders in addressing concerns relating to issues of efficiencyand quality of sterilization service. Therefore, I would like to offer thecommittee the highest commendation for embarking such initiatives.My hope along with the updated guideline is that, CSSU will continueproviding the best care to our patients, as well placing the healthand safety of our personnel at the foremost importance.Dato’ Dr Hj Azman bin Hj Abu BakarDeputy Director General of Health (Medical)Ministry of Healthii Central Sterile Supply Services Policy
FOREWARDFirst and foremost, I would like to offer mygratitude to the Medical Development Divisionfor giving the Central Sterile Services Unit anopportunity in developing this policy.The healthcare professionals responsiblefor sterilization and disinfection of reusablemedical devices are confronted with everincreasing range of challenges.Clinical sterile items must be delivered intimely and cost-effective manner. Adding on to this challenge, theinstrumentations to accomplish sterilization and monitoring standardshave become increasingly sophisticated.The policies must therefore be in place and implemented to ensurethe safety of healthcare personnel and environment. This policy ispublished to guide CSSU operators within the mandated regulationsand voluntary guidelines. It is my sincere hope that all healthcareworkers involved find this booklet informative, beneficial andinvaluable in performing their daily operations effectively.It is a concise and applicable tool which can be useful for orientation,training and instructional programmes in healthcare facilities as wellas educational institutions.Finally, with much pleasure, I present to you the Ministry of Health’sCentral Sterile Supply Services Policy.Matron Hjh Mek binti Hj JusohHead of Service of CSSUMinistry of HealthCentral Sterile Supply Services Policy iii
iii Central Sterile Supply Services Policy
THE ARTICLESCentral Sterile Supply Services Policy1
1. INTRODUCTIONCentral Sterile Services Unit (CSSU) is an integrated service inhospitals that performs sterilization and other actions on medicaldevices, equipment and consumables. This unit ensures safemanagement of decontamination services in the healthcarethrough safe, efficient, effective and reliable systems.This Policy of CSSU is an introductory text developed to provideguidance and reference for safety of patients and health careworkers. It highlights procedures pertaining to the processes ofdecontamination, cleaning, assembly, packaging, sterilization,storage and distribution of sterile products.2. OBJECTIVEThe purpose of this document is to provide a framework toenable the clinical and non-clinical department to understandthe operational and management of CSSU service.3. GENERAL POLICY3.1 Traffic Control3.1.1Traffic Control shall be strictly enforced inCSSU.23.1.2Alldoorsopeningare to remain closed at all times.Central Sterile Supply Services Policyinto themaincorridor
3.1.3The door at the main entrance is the onlydoor used to enter the CSSU.3.1.4Only CSSU personnel are allowed to enterthe unit.3.1.5Other personnel that require entry into CSSUe.g. engineers, technicians, support veallowedtoenter the Unit.3.1.63.2Limited entry by staff and visitors to the Unit.Food and Smoking3.2.1Food and beverages are only allowed at thepantry and shall be restricted from all other areas.3.2.2Cooking shall not be allowed.3.2.3NO SMOKING in CSSU.Central Sterile Supply Services Policy3
3.3Health and Personal Hygiene3.3.1 Personal hygiene shall be adhered to andcommunicated to all employees:i. Hair, body and nails shall be cleaned at alltimes.ii. Neither nail polish nor artificial nails shall beworn.iii. Fingernails shall be kept short and clean.3.3.2All personnel working in CSSU shall be freefrom skin diseases, infectious diseases, mentalillness and physical handicaps.3.3.3CSSU clinicalattireorothergarmentsthat become soiled or wet shall be changedimmediately.3.3.4Hair and goatee/beard except eyebrows andeyelashes shall be completely covered.3.3.5Jewelleryandworn.4Central Sterile Supply Services Policywristwatchesshallnotbe
3.4 Dress Code3.4.1All personnel working in CSSU shall wear theCSSU Clinical Attire and change upon leaving.(Refer Figure 1)Figure 1: CSSU Clinical Attire3.4.2Shoes/clogswornintheUnit shall becleaned, non- skid soles and sturdy.3.4.3Visitors entering CSSU shall adhere to CSSUclinical attire.3.4.4Attire shall be changed daily or as needed.Central Sterile Supply Services Policy5
3.4.5Thefollowingdresscodeappliestoallpersonnel working in the CSSU:3.4.5.1Collection (Refer Figure 2)i.Personnelhandling contaminatedmedical devices during collectionshall wear: Head covers / Surgical cap Mask Longsleevedapron/longsleeved water repellent gown Rubber Gloves ShoesFigure 2: Collection Dress Code6Central Sterile Supply Services Policy
3.4.5.2Decontamination Zone(Refer Figure 3)i.AppropriatePPEshouldbeworn: Long sleeved gowns which shallbe impervious and disposable Elbow length latex glove Mask Protective eye covering / visorshield ii.BootsThe attire shall be removed anddisposedoffintheproperreceptacle before leaving.iii.Head covers / surgical cap andboots to be changed daily andas needed.iv.v.Boots shall be removed whenleaving the zone.Cover gown shall be backlessand non-permeable.Central Sterile Supply Services Policy7
Figure 3: Decontamination Zone Dress Code3.4.5.3Packaging Zone (Refer Figure 1)i. PersonnelpackagingzoneinshallthewearCSSU clinical attire.ii. Personnel3.4.5.4workingworkingwithsoftdressing and linen preparationshall wear mask.Sterilization Zone (Refer Figure 4)i.PPE shall be worn by personnelhandling ‘HOT’ medical devicesfrom the autoclave.8Central Sterile Supply Services Policy
ii.Elbow length leather gloves shallbe used during loading andunloading.iii.Sweater / cardigan shall not beused.Figure 4 : Sterilization dress code3.4.5.5Distribution Of Sterile stributionshall wear CSSU clinical attire(Figure 1).Central Sterile Supply Services Policy9
3.5 CSSU Space And Environment3.5.1 All work surfaces in the CSSU shall be cleaned withapproved germicidal disinfectant at the end ofeach work shift.3.5.2 Lockers shall be provided for all personnel workingin the CSSU.3.5.3 An area shall be designated for CSSU employees tochange their clothing.3.5.4 Every zone in the CSSU shall be provided with properdedicated air exchange rate to promote maximumremoval of foul air/contaminants from the areas.3.5.5 The pressure differential scheme shall be strictlydesigned and employed to ensure the movementof air from clean to less clean areas.3.5.6 Temperature within CSSU shall not be more than23 C. Temperature in the sterile store shall bemaintained between 20 C – 22 C and the humidityshall be kept at 50% - 60%.3.5.7 Proper ventilation system at the plant room must beprovided and the temperature inside the plant roomshall not be more than 35 C to prevent damage tothe machine components.10 Central Sterile Supply Services Policy
3.5.8The installation of sterilization equipment shalladhere to the requirement of noise and vibrationlimits as stipulated by the Occupational Safetyand Health Department.3.5.9Each sterilizer processing area shall have exhaustventilation to remove heat, moisture and odor.3.5.10The installation of Ethylene Oxide (ETO) machine,sensing device, positive pressure, local exhaustventilation and chamber ventilation shall beprovided.3.5.11All sources of contamination shall be properlydiluted and discharged.3.5.12Exterior shipments cartons shall not be brought intosterile supply storage or processing areas.3.5.13Exhaust fan shall be provided in soft dressing andlinen preparation area. Use of fans is not allowed.Central Sterile Supply Services Policy11
3.6 Safety3.6.1 All new equipments / machines for the unit shall beproperly tested and commissioned.3.6.2 CSSU Manager shall be responsible in developing,supervising and maintaining the safety training ofthe unit.3.6.3 CSSU Manager is responsible for notifying the SafetyOfficer of any hazard.3.6.4 All CSSU employees shall report of any defectiveequipment, unsafe conditions or hazards to theCSSU Manager.3.6.5 Keep electrical cords clear of passage ways. Do notuse electrical extension cords without consent fromthe Engineering Department.3.6.6 All equipment and supplies shall be properly stored.Do not store heavy items on top of the shelves.3.6.7 All personal electrical appliances shall have suitablystar-rated and certified safe to be used by theEnergy Commission.3.6.8 All electrical appliances shall be inspected by theEngineering Department before use.12 Central Sterile Supply Services Policy
3.6.9Scissors, knives, pins, razor blades and other sharpinstruments shall be safely stored for use.3.6.10All heat producing machineries shall be switchedoff when not in use.3.6.11Immediate notification to the concession companyfor any ventilation breakdown or illumination signwarning.3.6.12Only authorized personnel shall operate autoclavesand other high pressure equipments.3.6.13To store all combustible supplies at least 44 cmheight from the ceiling.3.6.14First Aid Kit shall be readily available and checkedat all times.Central Sterile Supply Services Policy13
3.7 Maintenance3.7.1 The installation of all machines shall allow adequatespace for the maintenance and repair activities.3.7.2 The maintenance shall be performed from theunsterilized side of the machine.3.7.3 Maintenance activities of equipment shall beperformed by certified personnel.3.7.4 Only new original parts shall be used to replaceany broken/faulty components. Re-used partsfrom other machines shall not be permitted at anycircumstances.4. POLICY ON DECONTAMINATION4.1 Objectives4.1.1 To ensure that all soiled medical devices receivedin the Decontamination Zone are processedaccording to Standard Operating Procedure andrendered safe for handling.4.1.2 To protect staffs and patients from any infection riskof soiled medical devices and equipment.4.1.3 To eradicate or significantly reduce the numberof microorganisms on soiled medical devices andequipment.14 Central Sterile Supply Services Policy
4.1.4 To adhere to standard of decontamination forcleaning and disinfecting soiled medical devicesand equipment.4.1.5 To adhere with the standard requirements neededto achieve safe environment.4.1.6 To ensure staffs perform and adhere to theirprofessional duty of care with regards to providinga safe environment.4.2 Infrastructure4.2.1 Decontamination Zone4.2.1.1It shall have adequate and designedelectrical supply, water supply, lightingand ventilation systems.4.2.1.2It shall be supplied with negative pressureair conditioned with a minimum of 10 airexchanges per hour.4.2.1.3The loading area shall be adequate forstaff and trolley maneuverability.4.2.1.4The floor shall be made of heavy dutymaterials,anti-slippery,anti-dustinnature with no water accumulation atany time.Central Sterile Supply Services Policy15
4.2.1.5Walls shall be painted with bright coloranti-fungal paint.4.2.1.6Stainless steel double sinks with hot andcold water supply shall be available.4.2.1.7An outlet for air gun shall be available.4.2.1.8The drainage system shall be designedwith proper sizing to prevent back flow,appropriate material to withstand thewater temperature and proper levelingto prevent flooding.4.2.1.9There shall be an in-built outlet for reverseosmosis water.4.2.1.10Each washer shall have individual pipeswith individual socket outlets.4.2.1.11An appropriate number of machinesshall be connected to an essential powersupply. Quality of water supply shallfollow the recommended standards.4.2.1.12A cart wash area and trolley bay areashall be made available.16 Central Sterile Supply Services Policy
4.2.1.13Detergent store with exhaust fan anddedicated stainless steel shelf shall ale staff.4.2.1.15The main door shall be an automaticsliding door.Central Sterile Supply Services Policy17
4.3 Equipment In Decontamination Zone4.3.1 Decontamination room shall be equipped with thefollowing:i.Washer disinfector/ decontaminator withaccessoriesii.Ultrasonic washeriii.Dryeriv.Collection trolleyv.Stainless steel mobile workstationvi.Magnifying lamp.4.4 Size and Number of Washer Disinfector4.4.1 Estimated size and number of washer disinfectorvaries with the application.4.4.2 Quantity of washer disinfector required is based onestimated workload divided by actual work loadper basket per week.Example:Total workload: 1400 basket / weekTotal actual output: 1600 basket / weekNo of washer required: 1400 0.875 1 unit160018 Central Sterile Supply Services Policy
4.5 Personnel4.5.1 Team leader in decontamination area shall beheaded by a trained nurse with a minimum of 2years working experience. All staffs involved withdecontamination procedure shall be trained.4.5.2 All personnel entering the Decontamination Zoneshall be properly attired. (Refer Figure 2)4.5.3 All personnel assigned to the DecontaminationZone shall be strictly confined to the designatedarea. If needed, the personnel shall bathe andchange into attire accordingly.4.6 Receiving and Handling4.6.1 AllmedicaldevicesreturnedtoCSSUareconsidered contaminated and shall be received indecontamination area.4.6.2 Delicate and precision instruments shall be handledwith care to avoid damage.4.6.3 Returned supplies shall be inspected to ensure allparts of medical instrument are complete.4.6.4 Notify CSSU Manager for any missing parts orinstruments received.Central Sterile Supply Services Policy19
4.6.5Malfunctioning instruments shall not be used andto be kept in a separate place.4.6.6Users are responsible to return all instrumentsregardless opened or disassembled (if applicable)prior to cleaning and disinfection.4.6.7Any single use items received shall be discardedand not to be processed.4.6.8Gross soil shall be removed at the point of usewhere immediate containment, transportationand cleaning may not be feasible.4.6.9Personnel shall wear appropriate PPE and followgood work-practice when handling contaminatedmedical devices.4.6.10High Filtration Efficiency (HFE) facemask and eyeprotection shall be used for any risk of splash oraerosols.4.7 Inspection, Repair and Ongoing Maintenance4.7.1 Every medical device shall be inspected uponarrival.4.7.2 All parts of rigid sterilization container systems shallbe cleaned between each use.20 Central Sterile Supply Services Policy
4.8 Sorting of Instrument4.8.1 Contaminated medical devices shall be sortedand prepared for cleaning.4.8.2 Non-interchangeable component assemblies shallbe kept together to ensure correct reassembly.4.9 Method of Cleaning4.9.1 Cleaningshallbeaccomplishedmanually,mechanically or combination of both methods.4.9.2 The cleaning method or methods selected shallbe effective, not affecting the functionality of thedevice and safety.4.10 Chemical Disinfection4.10.1 Select appropriate type of disinfectant and followmanufacturer instructions.4.10.2 Protective measures for personnel shall be appliedat all times.4.11 Porter Services4.11.1 Used medical devices shall be collected andtransported using suitable containers and trolleys.4.11.2 The transportation carts / trolleys / containers shallbe cleaned and disinfected after used.Central Sterile Supply Services Policy21
4.12 Counter Services4.12.1 All personnel shall wear CSSU clinical attire (Figure1) during receiving of soiled medical devices.4.12.2 Soiled medical devices shall be received in suitableclosed containers at the Decontamination Zone.5. POLICY ON PACKAGING5.1 Objectives5.1.1To provide guidelines for evaluation, selection anduse of packaging materials for item to be sterilized.5.1.2Packaging material shall ensure sterility of packagecontents until opened for use.5.2 Physical Set Up5.2.1The room shall be equipped .5.2.2Sufficient lightingThe floor and wall must be able to withstandfrequent cleaning.5.2.3Packing table should be constructed of suitablematerial (stainless steel material / epoxy coated)with attached magnifying lamp.22 Central Sterile Supply Services Policy
5.2.4Adjustable packing chair with backrest.5.3 General Consideration5.3.1All wrappers shall be double layered.5.3.2Medical devices shall be wrapped completelyand packed to provide aseptic opening.5.3.3No package shall be above the maximum size of30cm x 30cm x 50cm nor should it weight morethan 5.5 kilograms.5.3.4Chemical Indicators shall be placed for all sets. TheInternal Indicator shall be examined before use.6. POLICY ON STERILIZATION6.1 calinstruments which are introduced into the humanbody site, traumatic or operation wound shall beprovided sterile.6.1.2Sterilization shall be achieved by means of heat,steam, chemicals and low temperature sterilizersused under carefully controlled conditions.Central Sterile Supply Services Policy23
6.1.3Each item being processed shall be traceable bya batch coding system.6.2 Purchasing, Commissioning and Maintenance6.2.1Sterilizers and associated equipment ional Standards and shall meet userrequirement.6.2.2The number of sterilizers required will depends onthe cycle time and the chamber size. The minimumnumber of sterilizers required to the workload canbe calculated as below:Number of sterilizers required WorkloadCapacity6.2.3It is mandatory for all type of sterilizers to be certifiedunder the Occupational Safety and Health Act(OSHA) before use.6.2.4Each autoclave shall have a valid design approvaland a certificate of fitness for operation from theDepartment of Safety and Health (DOSH) before itis handed over to the department.6.2.5Operating instructions shall be displayed at sterilizersites.6.2.6The manufacturer shall provide written instructionsfor preventive maintenance of the sterilizer. The24 Central Sterile Supply Services Policy
maintenance shall be carried out by a qualifiedindividual. Preventive maintenance and repairrecords shall be retained for reference.6.2.7Every sterilized item shall have a load controlidentification that indicates the sterilizer use, thecycle or load and the date of sterilization. Itspurpose is to readily retrieve items in the event ofa sterilization failure or recall.6.3 Load Monitoring6.3.1All sterilizing processes shall be monitored andrecorded accordingly.6.3.2Notifythe Supervisorimmediately for anyabnormal result.6.4 Efficieny Tets for Sterilization6.4.1Dummy Run shall be done daily for steamsterilization.6.4.2Leak Test shall be done daily and after majorrepair.6.4.3Bowie Dick Test shall be tested daily in separateand special cycles.Central Sterile Supply Services Policy25
6.4.4Chemical Indicator6.4.4.1 A chemical indicator shall be used in eachpackage to be sterilized.6.4.4.2 Sterile products shall not be used if theinterpretation of the external processmonitors suggests inadequate processing.6.4.5Biological Monitoring6.4.5.1 All biological monitors are preassembledby manufacturer.6.4.5.2 Biological monitoring shall be done oncea week, each load for any transplant andafter major repair (3 times consecutivelydaily) on all steam sterilization loads.6.4.5.3 Biological monitoring shall be done withevery ethylene oxide load.6.5 Malfunction Strerilizer6.5.1CSSU Supervisor shall notify the engineeringpersonnel.6.5.2A recall system shall be initiated immediately ifbiological culture is positive.6.5.3Stop using the sterilizer until repair is done andtested negative for three (3) consecutive biologicalcultures.26 Central Sterile Supply Services Policy
6.6 Record Keeping Sterilizer6.6.1A maintenance record in either hardcopy orelectronic format shall be kept for each sterilizer.6.6.2The record shall be kept according to the ArchiveAct.6.7 Cleaning the Sterilizer6.6.1Cleaning and maintenance of the mechanicalpart of the sterilizer is the responsibility oftheappointedmaintenancecompany.Theappointed maintenance company shall alsoresponsible for cleaning the sterilizer service areawhich is the enclosed room located directlybehind the sterilizer.6.6.2The appointed maintenance company shallshut off the steam supply valve of high vacuumsterilizers at night of the cleaning process.6.6.3CSSU staff shall be responsible for direct cleaningof all sterilizers.6.8 Steam Sterilization Safety6.8.1All new equipment shall be tested jointly bythe supplier and the representative from theEngineering Department, appointed maintenancecompany personnel, and department personnelbefore it is put into use.Central Sterile Supply Services Policy27
6.8.2Autoclaves shall be operated only by trained andcertified personnel.6.8.3A preventive maintenance shall be carried outby an appointed maintenance company for allsterilizing equipment. They shall be responsible forall repairs.6.8.4Timing cycle shall follow recommendation bymanufacturer for a specific product.6.8.5Time and temperature settings shall not bechanged unless a manufacturer of an itemrecommends different parameters.6.9 Ethylene Oxide Sterilization Safety6.9.1Operated only by trained staff.6.9.2An appointed maintenance company shall beresponsible for the activation of the emergencyplan in the event of an ethylene oxide spillage orleakage.6.9.3Ethylene oxide tanks shall be stored in a controlledventilated area at a temperature that does notexceed 37.7 C.28 Central Sterile Supply Services Policy
7. POLICY ON STORAGE OF STERILE PRODUCTS7.1 ObjectivesTo have proper storage and handling of sterile products.7.2 Storage and Handling7.2.1Staff assigned to the sterile store shall be free fromupper respiratory tract infection (URTI) and skindiseases.7.2.2Staff shall be trained in handling sterile items.7.2.3Storage systems7.2.3.1 Basic systems for storing sterile 3.2 Open shelving shall be 25cm from thefloor, 5cm from outside walls and 44cmfrom ceiling.Central Sterile Supply Services Policy29
8. POLICY ON TRANSPORTATION AND DISTRIBUTIONOF STERILE PRODUCTS8.1 ObjectivesTo maintain sterility and prevent damage of sterileproducts.8.2 General Consideration8.2.1 To have dedicated carts/trolley for deliveryof sterile items and shall be kept clean at alltimes.8.2.2 Sterile products shall be transported andprotected from contamination and damage.8.2.3 Supply of sterile products shall be transportedvia dedicated or scheduled route.9. POLICY ON STERILIZATION OF IMPLANTABLE ITEMS9.1 ObjectivesTo control and ensure effective management ofinstrument and implantable items for quality service.9.2 General Consideration9.2.1 Sterile implantable items shall be supplied by themanufacturer.30 Central Sterile Supply Services Policy
9.2.2If the implantable items are not sterile, it shouldbe sterilized according to the manufacturer’srecommendation.9.2.3An implantable item shall be monitored andquarantined until results of Biological Indicator (BI)reads negative.9.2.4Detailed protocols should be available from themanufacturer, regarding handling and sterilizationof implant.10. POLICY ON SHELF LIFE10.1The shelf life of a packaged sterile item is EVENTRELATED.10.2Stock shall be rotated according to the principleFIRST IN, FIRST OUT (FIFO).10.3The integrity of the pack shall be inspected beforebeing released to the user.10.4Sterile products shall be labeled, ‘STERILE UNLESSOPENED, DAMAGED OR WET’.10.5Quality Audit of sterile products shall be done byCSSU personnel as scheduled.Central Sterile Supply Services Policy31
11. POLICY ON PRODUCT RECALL11.1 ObjectivesTo ensure complete removal from central inventoryof all products and equipment that may be unsafe asestablished by notification/ alert or internal surveillance.11.2 General Consideration11.2.1 Positive Biological Indicator (BI) results shall beimmediately reported to the Supervisor.11.2.2 The CSSU manager shall determine the causeof sterilization failure and arrange for correctiveaction.11.2.3 Retrieve all unused items from affected loads.11.2.4 Malfunction sterilizers shall not be used untilrepaired and BI tests are negative.11.2.5 The CSSU manager shall keep a record of allincidents.32 Central Sterile Supply Services Policy
12. POLICY ON SINGLE USE ITEMS12.1A device designated for ‘single use’ SHALL NOT bereprocessed.13. POLICY ON NON-FUNCTIONAL / LOST INSTRUMENTS13.1Damaged or spoilt and lost surgical instrumentsshall be accompanied by Breakages and LostForm signed by the Supervisor.13.2The user shall lodge a police report if an instrumentor sets are found lost.14. POLICY ON INCOMPLETE PROCEDURE , SHALL NOT BE USED and returned toCSSU.15. POLICY ON BIOHAZARD CASES15.1All surgical instruments used shall be doublebagged and labelled Biohazard.Central Sterile Supply Services Policy33
16. POLICY ON LOANER INSTRUMENTATION16.1Arrangements can be made with the vendoror other healthcare facilities. Request for theloaner of instruments shall be directed to theresponsible personnel only.16.2All items shall be delivered directly to CSSUdecontamination area.16.3CSSU shall not be responsible for any itemsnot listed on the vendor’s inventory list.16.4CSSU shall monitor proper count of the itemsborrowed and
be impervious and disposable Elbow length latex glove Mask Protective eye covering / visor shield Boots ii. The attire shall be removed and disposed off in the proper receptacle before leaving. iii. Head covers / surgical cap and boots to be changed daily and as needed. iv. Boots shall be removed when leaving the zone. v.
6 2. Disinfection / sterilization and storage of instruments and equipment a) Use pre-packaged, disposable sterile acupuncture needles whenever possible. b) Check the expiry dates of sterile items before use and make sure the packages are intact. c) Package should be opened just before use to prevent contamination. d) Unopened sterile items, e.g. alcohol pads, sterile needles, sterile cotton
Message From The Central Sterile Processing Initiative Director Thank you for purchasing this e-course, an introductory and review survey of the basics of sterile processing, Sterile Processing Basic Training: SPD Boot Camp. Thank you, enjoy the program, and I am always just an e-mail away if you have questions or need my
Box of 50 Electrolase disposable, non-sterile blunt tips Box of 50 Electrolase disposable, non-sterile sharp tips Sterile and non-sterile sheaths Operator’s manual, warranty card Two videos: “Common Dermatologic Procedures” “Hyfrecator 2000 Inservice” Hyfrecator 2000 EsU (International Units Available) Ref No
represented by sterile pyogranuloma/granuloma syndrome (SPGS), nodular sterile panniculitis (NSP), juvenile sterile granulomatous dermatitis and lymphadenitis, reactive histiocytosis (RI), sterile sarcoidal granulomas and xanthomatosis. In these cases histopathological examination is necessary for the diagnosis. Here, we described
Stryker System EHD(296-98), 2000(2108), S4(4108), S5(4208), S6(6208), S7(7208), S8(8208) Stryker 120 250 085 150 Thickness 1,50 mm Non Sterile Sterile R 85 mm 25 mm Ref 120 250 085 127 120 250 085 130 120 250 085 137 120 250 085 140 120 250 085 147 Thickness 1,27 mm 1,30 mm 1,37 mm 1,40 mm 1,47 mm Non Sterile Sterile R 85 mm 25 mm STRYKER Ref
2 Scientific Products Catalog kiMTECH PUrE* A5 Sterile Cleanroom Apparel** Code Description Case Pack Weight Case Dimensions Pallet layers/Stack 88800 Small Coverall, Sterile 25 12.25 19.5" x 11.75" x 14.375" 8 x 5 40 88801 Medium Coverall, Sterile 25 13.25 19.5" x 11.75" x 14.375" 8 x 5 40 88802 large Coverall, Sterile 25 14.25 19.5" x 11.75" x 14.375" 8 x 5 40
as described in USP 797 . Kit Contents 1 x 700ml Sterile Tryptic Soy Broth Bag 6 x 125ml Empty Sterile Bags 6 x 20ml Empty Sterile Vials 1 x Write-on Whirl-Pak Bag 1 x Results Log Sheet Cat. no. HVM1 5ml 5ml Three 5ml transfers using syringe 5ml 5ml 100ml 100ml 700ml Sterile Tryptic Soy Broth Bag 5ml 5ml 5ml Three 5ml transfers using syringe .
3 The guidelines cover areas pertaining to the aspects of compounded sterile preparations, including personnel, facilities, transport and processes involved to produce a sterile medicinal product.
