(Draft Guidelines - 2007)
This document has been prepared taking into consideration the following factors:
The practice of reusing single use medical devices exists in many health care facilities in India.
This practice requires standardisation.
The practices recommended in this guideline aim to be realistic and practical without compromising on safety.
Compiled and Edited by:
Gita Nataraj, Joint Secretary, HIS - MF Assoc. Professor, Microbiology, Seth G.S Medical College and K.E.M HCF
Ajita Mehta, Chairperson, HIS – MF, Consultant Microbiologist, PD Hinduja National Hosptial
FD Dastur, Advisor, HIS- MF, Consultant Physician, PD Hinduja National Hospital
Rohini Kelkar, General Secretary, HIS - MF Prof. & Head, Microbiology, Tata Memorial Hospital
RA Bhalerao, Advisor, HIS - MF Director, PD Hinduja National Hospital
Vidya Acharya, Consultant Nephrologist
Valuable inputs from HIS-MF members
The purpose of these guidelines is to provide best practices for a health care facility for reprocessing of single use medical devices. The practices are aimed at achieving the most important parameters after reprocessing viz. sterility, integrity and functionality.
The practice of reprocessing single-use devices (SUDs) for reuse exists since 1970's. This has increased in recent years bringing with it concerns about the safety of such a process and the ethics involved. The problem has been compounded by the increasing number of complex devices making the process difficult . Will the reprocessed device perform as well as the original device with respect to its sterility, safety, and functionality despite of the reprocessing ?
Economic considerations have played a major role in catapulting reprocessing of single-use devices. In a country like India, where the cost of some of these medical devices are unaffordable to the majority and where the use of such a device is lifesaving, reprocessing becomes a necessity. Scientific studies from all over the world indicate the safety of reprocessing. The experience from India is also the same though evidence is lacking. The Cardiology Society of India in its paper entitled 'reuse of devices in the catheterisation laboratory' published in the Indian Heart Journal 1997; 49:329-331 has provided some direction and descript ion of the process of reprocessing. However, in order to make the process foolproof and provide scientific evidence for its safety and efficacy, it is essential to have guidelines, which include parameters other than cleaning and sterilisation. It is also essential to address / identify a regulatory agency, which can certify / license reuse facilities.
Single use Medical Devices
There are three categories of single-use medical devices
Open and unused
Open and used
Unopened and expired
This document considers best practice guidelines for the reuse of only the fi rst two items viz. open and unused, open and used.
To successfully reprocess a device that has been used on a patient , institutions must be able to clean it thoroughly, sterilise it to acceptable norms, and ensure that reprocessing and reuse will not degrade its functioning. In order that a used or opened but unused SUD can be reused, a protocol has to be established which identifies the method for
Reprocessing, repackaging, and resterilising for all items open and unused.
Cleaning, packaging, and sterilisation for all items that are open and used.
Definitions1(As defined by the USFDA)
is an instrument , apparatus, implement, machine, contrivance, implant, in-vitro reagent or other similar or related article, including a component part or accessory, which is: Medical device
Recognised in the official National Formulary, or the Unit ed States Pharmacopoeia, or any supplement to them,
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolised for the achievement of any of its primary intended purposes.
means a device that is intended for one use, or on a single patient during a single procedure. The labelling identifies the device as disposable and does not provide instructions for reprocessing. Single-use device
is one whose sterility has been breached or whose sterile package was opened but the device has not been used is termed as 'opened but unused single use device' . Disposable single-use device
, with respect to a single-use device, means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition. Reprocessed
means a new, unused single-use device. Original device
means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use. Critical reprocessed single-use device
means a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body. Semi-critical reprocessed single-use device
is a device that is essential, or yields information that is essential to the restoration or continuation of a bodily function that is important to the continuation of human life. Such a device is being " used outside a device user facility" when it is used outside of a health care facility (HCF), nursing home, ambulatory surgical facility, or diagnostic or outpatient treatment facility. For example, a device used in a home or a doctor' s office is being used outside a device user facility. Life-supporting or life -sustaining device
- Failure of a device to perform or function as intended, including any deviations from the device's performance specifications or intended use. Device failure
Distributor - Person / company who furthers the distribution of a device from the original place of manufacture to the person who makes delivery or sale to the ultimate user, i.e ., the final or multiple distributor, but who does not repackage or otherwise change the container, wrapper, or labelling of the device or device package.
- Person / company who distributes to the patient a tracked device intended for use by a single patient over the useful life of the device. The term includes, but is not limited to, licensed practitioners, retail pharmacies, HCFs, and other types of device user facilities. Distributor, final
- Device user facility, rental company, or any other entity such as a home health care agency that distributes a life sustaining or life-supporting device intended for use by more than one patient over the useful life of the device. Distributor, multiple
The population of viable infectious agents contaminating a medical device. Bioburden -
- A process that physically removes infectious agents and the organic matter on which they thrive, but does not necessarily destroy infectious agents. The reduction of microbial contamination depends upon many factors, including the effectiveness of the cleaning process and the initial bioburden. Cleaning is an essential prerequisite to ensure effective disinfection or sterilisation. Cleaning
Contamination- The soiling or pollution of inanimate object s or living material with harmful, potentially infectious or other unwanted material. In the clinical situation, this is most likely to be organic matter and infectious agents but may also include other undesirable substances. e.g. chemical residues, radioactive material, degradation products, packaging materials etc. Such contamination may have an adverse effect on the function of a medical device and may be transferred to a person during use or subsequent processing and storage.
– A process, which removes or destroys contamination so that infectious agents or other contaminants cannot reach a susceptible site in sufficient quantities to initiate infection or any other harmful response. Differing levels of decontamination are used depending on the device and the procedure involved. The levels of decontamination are either cleaning followed. Decontamination
A chemical agent that, under defined conditions, is capable of disinfect ion. Disinfectant -
A process used to reduce the number of viable infectious agents but which may not necessarily inactivate some microbial agents, such as certain viruses and bacterial spores. Disinfection does not achieve the same reduction in microbial contamination levels as sterilisation. Disinfection -
A liquid chemical agent , which can kill bacteria, viruses and spores. However, this term is not precise and is not used. The term high-level disinfectant is preferred. Sterilant -
– A centralised department specifically designed to reprocess re-usable medical devices and equipment and to distribute pre-sterilised, commercially prepared packages for clinical use. Central Sterile Service Department (CSSD)
A process used to render an object free from viable infectious agents including viruses and bacterial spores. Sterilisation -
An automat ed machine intended to clean and disinfect medical devices. Washer - disinfector -
Before undertaking reuse, it is necessary to classify the medical device in order to establish whether reprocessing can be safely and effectively performed. Device classification
of the device and also upon depends on the intended use . For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialised indication is added in the device's labelling such as, " for making incisions in the cornea" . Indications for use can be found in the device's labelling, but may also be conveyed orally during sale of the product. indications for use , that is, the risk the device poses to the patient and/ or the user is a major factor in the class it is assigned. In addition, classification is risk based Class Iincludes devices with the lowest risk and Class IIIincludes those with the greatest risk.
As indicated above all classes of devices are subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and Ill.
-a medical device where general controls provide reasonable assurance of safety and effectiveness of device OR the device is not life threatening/ life sustaining OR its use is not import ant for preventing impairment to human health AND/ OR its use does not prevent a potential unreasonable risk of illness or injury. Class I Medical Device
- General controls insufficient but specific controls exist for e.g. performance standards, guidelines, patient registers, post market surveillance, etc which provide reasonable assurance of safety and effectiveness of device. Class II Medical Device
Neither general controls nor specific controls exist NOR is the device Iife supporting/ Iife sustaining. Class III Medical Device -
BEST PRACTICE GUIDELINES
It can be appreciated from the above that every health care facility (HCF) should identify all such single use medical devices that it wishes to reuse based on available evidence and the capacity of the facility to implement the best practices for the same. HCF reprocessor becomes a secondary manufacturer and hence the practices need to be regulated to assure safety and efficacy of the reprocessed device. This regulation however needs to be provided by the local regulatory authorities. The best practice guidelines should also address issues such as registration and listing, adverse event reporting, medical device tracking, quality systems regulation, labelling, etc. Every HCF, before embarking on this activity, should refer to available regulations from local regulatory authorities and feasibility for complying with the same. The facility then can decide on the list of single use medical devices for reprocessing based on this available evidence.
The reprocessing protocol should consider the material properties and design of the specific device.
The protocol should ensure safety, efficacy and reproducibility.
Essential quality assurance should be performed during reprocessing.
Maximum number of reprocessing cycles should be specified according to devices features, use conditions, and reprocessing protocol.
Pre-sterilisation processing conditions and techniques are critical for sterilisation success.
Decontamination, cleaning, and washing procedures, together with sterilisation techniques could induce chemical, physical and morphological modifications on the treated surfaces and potential toxicity of the steriIised device.
Identify SUDS to be Reused
This is essentially an activity that individual HCFs need to undertake before proceeding any further. This best practice guidelines is dictated by the following factors:
The ability to achieve effective cleaning.
The ability to achieve effective sterilisation.
The compatibility of the device with the cleaning agent, process and sterilant.
Validation of the process of sterilisation to assure safety.
The ability to achieve safe pyrogen and endotoxin levels.
The absorption of the sterilant by the device, which could then be transferred to the recipient (patient) i.e. toxic residues.
The presence of a quality assurance programme demonstrating that the device has not deteriorated in either for m or function during the reprocessing cycle.
The ability to demonstrate that the original performance specifications continue to be met.
The cost effectivity of reuse is calculated for each device based on the cost of:
Performing the reprocessing procedure
Validation (quality assurance)
Maintaining relevant documentation.
The Reuse Committee shall frame the 'reuse' best practice guidelines
This best practice guidelines can be arrived at jointly in consultation w it h the user departments, infection control committee (microbiologists), CSSD personnel , bio -medical engineers and administrators who will form the reuse committee.
Roles & Responsibilities of Committee Members
User Department- should provide the list of devices intended for reuse and the number of times that each such device can be reused based on available evidence and where evidence is not available based on experience with reusing the device without compromising safety and efficacy. Apart from cost considerations, the best practice guidelines should be based on the complexity of the device, which can hamper effective cleaning and sterilisation, and the original method of sterilisation. Plastic SUDs that have been originally gamma irradiated cannot be resterilised by EtO nor can they be gamma irradiated a second time due to toxic residues. The possibility and the number of times that a device can be reused should be based on available evidence and where no such evidence is available based on a document from the manufacturer and if such is not available then on consensus experience. Policies based on consensus experience should then be prospectively studied to provide scientific evidence within a reasonable period of time. The proposal for reuse including the procedure for reprocessing should then be writ ten in consultation with members from infection control committee (ICC), microbiologists, CSSD personnel and biomedical engineers and forwarded to the infection control committee.
CSSD I/Local Reprocessing Units- should assist clinical departments (user) in determining how to effectively clean, decontaminate and sterilise each device. A validation protocol for sterilisation should also be described.
Bio-Medical Engineers -should opine on the compatibility of the device with the cleaning and sterilising agents as well as the integrity of the physical and functional characteristics of the device undergoing single or multiple reuse. They should also consider the safety of disassembly of complex devices compromising with subsequent functionality on reassembly.
Infection Control Committee -should review the proposal that is thus received from the user departments. The committee microbiology members should assist in the microbiological evaluation of items for potential reprocessing / reuse to determine if steriIisation / disinfect ion can be achieved. The validation protocol should be assessed.
The ' reuse' committee thus prepares a list of single use devices that are to be reused, a cost-benefit analysis for each reusable item and a method for reprocessing and authorisation.
Standard Operating Procedure - Reuse
Clinical Departments / User Departments
Each user department prepares a
• list of single use devices that are to be reused.
• cost-benefit analysis for each reusable item.
User Departments, ICC, CSSD, Biomedical Engineers, Microbiologists
A method for completing each of the components/steps to support the reuse of a disposable or single-use patient-care item. Each component/ step must be measurable or observable so that it may be consistently repeated. Each component/ step must be accompanied by documentation to support the method for reprocessing, which includes:
1. Reprocessing area
3. Cleaning and decontamination
•Inspection for physical integrity and functionality
7. Validation of sterilisation process
11. Informed written consent
12. Billing schedule
13. Adverse event reporting
14. Time to withdraw a device
15. Documents for completion of each task above
18. Monitoring and Review
1. Reprocessing area
1.1 Buildings and Environment
The buildings and environment , in which components, devices, and records are received, processed, built or stored and the personnel that perform these operations will be controlled so that finished devices will consistently meet the specifications established by the manufacturer. The degree of control will allow for appropriate changes in such elements as temperature, humidity, bioburden, particles, personnel, components, devices, and records.
The CSSD / local reprocessing units shall have sufficient space and be designed to allow proper cleaning, maintenance and other necessary operations. The design should be such that there is adequate space for receiving, cleaning, packaging, labelling, storing, minimizing contaminants, assuring orderly handling procedures, and preventing mix-ups.
The parameters that need control include particulates from cardboard dust from slitting or cutting operations, microorganisms, humidity, temperature, static electricity, etc. It is recommended to have designated areas for each activity such as receiving, inspection/ testing, cleaning and decontamination, drying, packing, labelling, record keeping, etc. Traffic by personnel who do not work in or manage the designated areas should be held to a minimum.
1.1.3. Orderly Operations
To preclude mix ups, distinct operations or processes should be separated either physically, by walls or partitions, or spatially, by providing enough room between operations to indicated that separate activities are being performed so that no activity will spray, dust , or otherwise have an adverse effect on other adjacent activities.
1.1.4. Environmental Control
Some environ menta l factors to be considered are lighting, ventilation, temperature, humidity, pressure, particulates, and static electricity. The degree of environmental control to be maintained should be consistent with the intended use of device and the Officer-in-Charge CSSD / local sterilisation unit will exercise this control.
188.8.131.52. General Controls
General air conditioning is normally not regarded as an environmental control; however, changes in temperature and lighting can have an adverse effect on employee performance and, in tum, on assuring that the device is properly assembled, inspected, and tested. Air conditioning can control humidity, which, in tum, can affect the generation of static charges. Static charges can damage some electronic components and, in such situations, need to be controlled.
The packaging for sterile devices should be stored in a clean, dry, insect free area.
184.108.40.206 . Specifications
Particulates Maximum of 10,000 of 0.5 micron diameter or larger per cubic foot
Humidity 45 +/- 5 percent
Temperature 72 +/- 2.5°F
Air Velocity 90 feet/ minute +/- 2 percent
Air Pressure 0.05 inches water between the clean room and other areas
Filters should be replaced as per schedule or as needed based on scheduled inspections.
• Adequate space and demarcated area for each activity
• No mix -up bet ween two activities
• Good lighting
• Walls, floors and fixtures made of washable, non-corrosive, non absorbable material
• Adequate ventilation
• Dust, insect and rodent free
1.2 Indicators that should be ensured in CSSD environment include
• Proper attire and dressing anteroom;
• Controlled use of, and entry into, controlled areas;
• Prohibiting eating, drinking, smoking, or gum chewing;
• Preventing use of lead pencils;
• Regulating the storage of glassware and containers;
• Preventing or controlling activities that generate dust/ particulate matter viz. the cutting, tearing or storage of cardboard, debris, etc;
• Cleaning the room and production equipment per written procedure;
• The original design and cleaning of work surfaces and chairs;
• Selecting correct furniture and eliminating all non-essential equipment;
• Controlling room air quality (amount of particulates, pressure, velocity, and exchange rate);
• Ensuring cleanliness of raw materials, components and tools;
• Controlling the purity, and sterility of process water
• Maintaining filters, and electrostatic precipitators.
Records related to facilities, the environment and personnel practices need to be kept simple. The record of cleaning may be a checkmark, initial, or signature. Where a checkmark is used for repetitive work, the person' s name should be on the record at least once. The schedule for cleaning may be posted or filed.
1.4 Personnel sanitation practices
A washroom, dressing, storage, and waste facilities should be provided, as appropriate, for personnel to maintain the needed level of cleanliness. Where necessary, such as in a clean room, special clothing and an area to don and store the garments should be provided. Clean room clothing is not to be worn into uncontrolled rooms or outside the facility.
1.5 Personal Practices
Eating, drinking, or smoking will be confined to specially designated areas such as a lunch room or employees lounge. Directions and containers or equipment should be provided for timely and safe disposal of rejected items, used cartridges, used gloves, EO exhaust, and other refuse.
The person involved for each activity should be first identified and trained adequately for that activity and found to be competent. A record for the same should be in place. They should also be t rained in standard infection control practices (e.g., standard precautions), including those to protect both patients and healthcare workers and should adhere to the same. Written guidelines should be prepared and periodically updated.
All personnel involved in the actual process of cleaning and sterilisation should receive appropriate vaccines - especially HBV. Personnel protective equipment for each activity should be provided as applicable. First aid for eye splashes and post exposure prophylaxis as applicable should also be available.
3. Cleaning and decontamination
Before sending the device for reprocessing, the user should verify that the device can still be reused and has not completed its useful life (has reached the maximum number of reuse stated for that device)
Devices, which have only one end open and are opaque are difficult to clean and should not be considered for reprocessing.
Cleaning is an essential prerequisite of equipment / device decontamination to ensure effective disinfection or sterilisation. Cleaning removes soil (organic matter) and a high proport ion of infectious agents by washing with a solvent (usually water and detergent), which may be heated. It is advisable to use enzymatic detergents especially for devices with a lumen or opaque it ems where evaluation of cleaning or visible check for cleanIiness is a problem.
All devices that have undergone cleaning and decontamination should necessarily be dried before being sent for sterilisation.
Cleaning can be achieved by either manual or automated methods.
The advantage of using automated cleaning equipment is that it provides an efficient, reproducible process that can be more easily controlled than manual methods. It also provides protection for the user in reducing the exposure to aerosols, chemicals and vapours. Automated cleaning equipment include the thermal washer-disinfector s and the ultrasonic baths.
Disinfection with thermal washer -disinfectors will inactivate all microorganisms except bacterial spores, some heat -resistant viruses and cryptosporidium. This process can be used only for devices that will withstand repeated exposure to wet heat at temperatures of about 80°C. The devices must be sufficiently robust to withstand powerful water jets and be compatible with the detergents.
Excluded are hollow or porous items where the hot water will not adequately penetrate any internal lumen unless special adaptors to allow access to lumens are available.
This process does not sterilise but items may be sterilised subsequently by an appropriate process.
The equipment has a high initial cost and requires adequately trained staff to operate and load the machine correctly. Planned preventative maintenance costs may be high and will include routine thermometric monitoring. The process may need water of a specified quality, both to disinfect and then to rinse disinfected devices.
The use of ultrasonic baths and enzyme detergent solutions for cleaning devices is recommended where the process is compatible with the device. All lumens should be irrigated during ultrasonic cleaning to remove dislodged organic matter. Irrigation pumps are available for flushing instrument lumens and components.
Care should be taken in the direct handling of intricate or sharp-edged devices to avoid injury to the handler or damage to the device.
A waterproof protective apron or gown and robust rubber gloves should be worn.
Eye protection may be required if splashing is likely to occur.
The production of aerosols during the cleaning process and the provision of adequate protective equipment should be considered as part of the risk assessment . While flushing it is advisable that the activity is done with the sink fiIled with water.
For devices with lumen special care should be taken while injecting the cleaning solution into the lumen so as not to cause damage.
3.4 Equipment Required
A sink (not a designated hand wash basin), or a receptacle, which will hold sufficient volume of water/ detergent such that the device to be cleaned can be fully immersed.
A compatible enzymatic detergent solution at correct dilution, temperature and used for the correct contact time as available. (Follow manufacturer 's instructions when available)
Brush(es) and jet washer / hand spray.
A receptacle to contain rinse water e.g. a second sink; a drainage surf ace.
A clean, disposable, absorbent, non-shedding cloth or mechanical drying facility e.g. drying cabinet or industrial hot air dryer.
A chemical neutraliser, first aid kit and eye wash station in case of splashing with detergent.
Free flowing potable water
Reusable devices shall be separated from waste at the point of use itself.
Personnel assigned to handle, collect and transport medical devices and equipment shall wear protective clothing to prevent his / her direct contact with blood or other body fluid during handling.
Primary cleaning should be done immediately after a device has been used at the user end it self before transporting to the reprocessing area. Care should be taken to clean both the exterior surface as well as the interior lumen where applicable. At the user end, immediate on site the device is rinsed in potable cold water / tap water at room temperature and forced jet spray and flushed frequently with heparinised saline where required (especially devices which have blood or blood products in their lumen)
The device should be inspected for physical integrity before further processing.
All it ems in direct contact with patients or their body fluids should be considered to be contaminated and should be safely and securely contained. The item should be isolated in a robust, leak-proof box or plastic bag. Items should be transferred to the reprocessing area as soon as possible after pre -cleaning.
Containers and trolleys/ carts used for transporting such items should be easy to clean and disinfect , properly maintained, provide protection for the load and be designed so that items can be securely and safely held during transit.
It ems will be received into the designated dirty items section of the decontamination area. The item should be checked and the user notified if any part of the equipment is missing upon receipt.
Cleaning of contaminated reusable medical devices shall begin as early as possible to facilitate easy cleaning and prevent drying of any left-over soil / organic matter on medical devices.
Devices composed of more than one part shall be disassembled and all jointed instruments opened.
All devices shall be sorted according to the method of cleaning applicable.
The devices are again rinsed thoroughly in potable water.
Care must be taken to remove all organic matter as appropriate to the article especially from lumens and balloons by repeated flushing action.
Clean the device under reprocessing preferably with an alkaline enzymatic detergent from inside as well as outside to make it free from organic and inorganic matter.
Enzymatic detergents cannot be sued at temperatures above 50oC. Meticulously clean the entire surface of the device including all detachable parts, according to the manufacturer's instructions if available. Flush (at least five times) and brush to remove all organic (e. g., blood, tissue) and other residues.
Discard enzymatic detergents after each use because these products are not microbicidal and will not retard microbial growth.
Rinse with potable tap water / sterile distilled water.
Dry with the help of oil, dust and moisture free compressed air using air jet having different adaptors t o f it the different devices.
Inspect the device for complete dryness, any evidence of damage and its function.
Decontaminate used brushes after each use and discard if there are signs of wear.
220.127.116.11 Procedure 2 - for narrow lumen devices
Water spray the cannulae / lumen tilI clear water comes out.
After initial cleaning, immerse the device for at least 2 hours in detergent disinfectant taking care to see that the disinfectant has reached the lumen.
If blood clots are detected in the cannulae, immerse in 5% tri -sodium-phosphate at least for half an hour to dissolve all organic matter.
Wat r spray the cannulae for at least 10 minutes to ensure all foreign matter is removed from inside the cannulae.
3.6. 1. 3 Procedure 3 - Cleaning (manual) - non-immersion
Non-immersion manual cleaning methods are appropriate for certain equipment where items will become compromised by soaking in aqueous solutions, e.g. electrical and electronic equipment.
Alcohol wipes should be used to clean electrical contacts on equipment.
Check for intactness of insulation especially on batteries as repeated sterilisation causes damage to the seals/outer covering.
Preferably an alkaline enzymatic detergent solution compatible with the device at correct dilution.
A clean, disposable, absorbent , non-shedding cloth for application of detergent solution.
A clean, disposable, absorbent, non-shedding cloth or mechanical drying facility (e.g. drying cabinet or industrial hot air dryer) .
An appropriate chemical neutralizer, first aid kit and eyewash stat ion, in case of splashing with detergent.
If the item is electrical, ensure that it is disconnect ed from the mains supply before commencing the cleaning procedure.
Wearing protective clothing, immerse the cleaning cloth in the detergent solution and wring thoroughly.
Commencing with the upper surface of the item, wipe thoroughly ensuring that detergent solution does not enter electrical components.
Periodic al ly rinse the clot h in clean water and repeat the above steps.
Surf aces should be carefully hand-dried using a cloth or indust ial hot air dryer or placed into a drying cabinet .
Safely dispose off cleaning materials and alcohol wipes, after use.
Safety Precautions (additional)
Precautions should be taken when using alcohol, as it is flammable.
The 'pooling' of alcohol on equipment should be avoided and alcohol evaporation ensured, if necessary by forced air drying.
Care should also be taken to ensure that alcohol does not enter the item e.g. via ventilation slots.
3.7 Drying and Inspection
For certain devices (narrow lumen/balloon) it may be necessary to test the functionality before drying.
Ensure drying by passing, oil and moisture free, dry compressed air through it . It shall be kept for atmospheric drying if devices are delicate or not able to withstand air pressure.
Industrial / other blowers also may be used to facilitate this process
Alternatively, flush the channels / device with 70% to 90% ethyl or isopropyl alcohol / ether and dry with forced-air.
The devices shall be inspected for complete dryness, damage and its function performed by user department, after the process of cleaning and decontamination.
If found satisfactory, the device is processed further for steriIisation.
The items will then be contained in clean preferably sterile containers and sent to CSSD / local sterilisation facility for further processing.
3.8 Monitoring and Control
Since there are no standard methods to monitor the process of cleaning, factors that can affect its efficiency should be controlled.
Staff t raining / competence
Detergent type, concentration, contact time and compatibility
Nature of soil (organic matter)
Method of soil removal
Accessibility of fluid to item
Regularly inspect all receptacles, sinks, surf aces including water supply and drains, for damage.
Plan preventive maintenance for all equipment and utilities especially when using automated washers.
Complete the necessary documentation. (Fill checklist, and sign)
3.11 Automated Cleaning & Decontamination
If automated washer/ washer disinfectors are used, validate the equipment, follow manufacturer's instruct ions and use compatible cleaning/ decontamination agents.
Have a planned preventative maintenance programme.
Appropriate packaging ensures the sterility of the product through its intended shelf life, as well as its efficacy at the time of use. For effective EtO sterilisation the packaging material must be breathable to allow the high-humidity EtO gas mixture to infiltrate the package. A partial vacuum is drawn before and after the cycle to facilitate the movement (in and out) of the EtO and moisture vapour. If the package does not have sufficient permeability, the process will be ineffective. As stresses in the seal area are introduced due to the pressure difference between the inside and outside of the package, a seal failure phenomenon known as steriliser creep may occur. The package must also withstand the moderately elevated process temperatures, although this is typically not a problem for most materials. Please check with the equipment /EtO gas provider, the correct packaging material to be used.
If the correct packaging material is not used, packages can burst from the repeated high and low pressures to which they are exposed as EtO penetrates in and evacuates. Some materials with a high affinity for EtO (polyurethane or plasticised PVC) may require several evacuation cycles to reduce EtO residuals. Large amounts of toxic ethylene chlorohydrins can form from chlorine-containing materials in the sterilised product . Excessive temperatures can distort or melt some materials.
The items are wrapped in medical grade packaging roll (one side polythene and other side medical grade paper). Double wrapping shall be ensured to avoid contamination.
Excess air must be removed from packets before sealing, to avoid bursting. This process may not be required while using polypropylene pouches. What is important is to cheque the integrity of sealing.
The devices shall be identified by writing cycle number and date of expiry on the packages.
Commercially available heat sealable pouches and rolls specially made from medical grade paper and polyethylene film (thickness 1-3 mils [one thousandth of an inch] and width 7.5-30 cm) must be used. They have the advantage that the contents are readily visible after packing, to allow for easy identification. These come with printed chemical indicator hence separate chemical indicator need not be used.
5.1 Definitions - Labels and Labelling
A " label" is a " display of written, printed, or graphic matter upon the immediate container of any device." Any information required on the immediate container of a device must also appear on the outside container or wrapper, if any, of the retail package for the device, or be easily legible through the outside container or wrapper.
" Labelling" is defined as: " all labels and other written, printed, or graphic matter"
Upon any device or any of its containers or wrappers, or
Accompanying such device.
If a HCF reprocesses a SUD, the HCF is responsible for ensuring that the device complies with all applicable regulatory labelling requirements. If the HCF does not ensure the device complies with FDA labelling requirements, the device is misbranded, and the HCF may be considered responsible for causing the misbranding of the device in violation of the Act.
Include the name and address of the manufacturer (reprocessor), packer, or distributor.
Bear the common or usual name of the device
State the quantity of contents
The label should clearly state the date it was packed and sterilised, the method of sterilisation, the date of expiry, the storage conditions, and its reprocessing number where applicable. Apart from the above.
Labels may be colour coded to identify the cycle number.
The device shall be sterilised by an appropriate sterilisation method for that device for e.g. ethylene oxide gas sterilisation method or vaporized hydrogen peroxide. The process of sterilisation should be strictly controlled and as per the manufacturer's instruct ions. The Cycle parameters must be verified, using the steriliser manufacturer's instruct ion manual for specific steriliser and load configuration, to be used.
6.1 Ethylene Oxide (EtO)
6.1. 1 Prerequisites
Sterilisation by ETO requires that the devices are dry.
6.1.2 Parameters for EtO Sterilisation.
The critical parameters of an EtO sterilisation cycle are typically given as temperature, pressure, humidity, EtO concentration, and gas dwell time.
The cycle parameters and aeration time should be as per the manufacturer's recommendations.
6.1.3 Monitoring EtO Sterilisation
• Chemical indicator (as per ISP11140-1) shall be placed externally in the form of strips or printed on packaging material itself to differentiate processed from non-processed packages. Class 5 chemical indicators can be used in the same test pack which helps to take immediate decisions about issuing the load instead of waiting for the Bl report.
• A HCF SUD reprocessor should prove during validation studies that each steriIisation process is capable of achieving steriIity for each run. The sterilisation process should achieve a sterility assurance level (SAL) of 10 for devices used in normally sterile areas of the body.
• The efficiency of EtO steriliser shall be tested by challenging a biological indicator (Bacillus subtilis 1264 from 3M or any other supplier) in the centre of each load. The test pack of Bl should be placed at the diagonally opposite end.
• Process chart readings, particularly showing the temperature and pressure reading shall be monitored for each cycle.
• Aeration time and temperature shall be noted for each load.
6.2 Other methods of sterilisation used will depend on the device compatibility with that method
Low Temperature Plasma Sterilisation
Is a combination of hydrogen peroxide vapour and low temperature gas plasma 50°C which can rapidly sterilise medical devices without leaving toxic residues. This process is suitable for heat and moisture sensitive devices.
The other pre-requisites for sterilisation remain the same.
If a device contains moisture, and is inadequately dried, the cycle will be rejected.
Packaging pouches are provided by Tyvek®.
Validation for each cycle should be performed with BIs.
A reference list of compatible medical devices can be obtained from the manufacturer. The materials not compatible with this system are linen, powders, liquids, wood and cellulose because the se absorb hydrogen peroxide, which is therefore not available for the sterilisation process.
6.3 Testing for Residual Chemicals
Especially with EtO sterilisation, it is import ant to check the levels of residual chemicals in order to ensure that they are within acceptable limits. This activity should be carried out every time that a new instrument is installed, at the time that the equipment is recommissioned after major repairs, whenever there is a change in the cycle protocol and once every year.
6.4 Record Keeping
Following observations shall be recorded for each load - Date, load number, process chart for the cycle, aeration time and temperature, list of contents of the load.
A record also shall be maintained of material received and issued. Record of Biological indicator tests shall be maintained.
6.5 Job Assignments
Only trained and experienced labour staff shall carry out the cleaning and decontamination/ disinfect ion process.
Inspection and packing of devices shall be done by trained technicians.
The sterilisation process shall be controlled and carried out under supervision of Section In charge/ Scientific Assistance who documents all the records.
7. Sterilisation Validation
means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. "Validation"
means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Process validation
7. 2 Documentation
Maintain documentation to show that
Equipment has been installed correctly and operates as intended.
The sterilisation process has been validated as being effective in achieving sterility without adversely affecting the devices (chemical and biological indicators, physical parameters).
For each run the specifications for sterilisation parameters have been met.
8. Storage (See section 1 above)
A record should be maintained for all the reprocessed devices giving details about its further distribution. Once the device is bought from the original device manufacturer, an entry should be made in the device distribution register. Apart from the device details this register should have columns to indicate the patients who have received the device. The number of columns used for each device should correspond to the number of reuse allowed. For all such times except the first, the reprocessing date should be mentioned clearly.
10. Inspection before reuse
On receiving a sterile reprocessed device, the sterilisation, package integrity, useful shelf-life and any damage should first be ascertained before use on a patients. One should also ascertain that there is no moisture inside the pack.
11. Informed written consent
Since the original device manufacturer does not recommend reuse, it is necessary to provide an informed choice to the patient about the use of reprocessed single use devices and any risk involved. An appropriate written informed consent should be obtained from the patient and this records should be maintained till the life of the device or patient whichever is later.
12. Billing schedule
A billing schedule to describe the method for patient billing throughout the useful life of the item based on the cost of reprocessing and other related costs.
13 Adverse event reporting
A surveillance strategy to monitor patients for adverse outcomes should be established.
Individual adverse events need to be reported to the regulating authority and to the manufacturer as and when they occur so that prompt corrective measures can be instituted. The regulating authority should prepare a uniform format for the same and define the maximum time delay within which an adverse event should be reported.
As a HCF reprocessor of a device that was previously market ed as single use, the reprocessing HCF has become the manufacturer of that device.
13.2 The Adverse Events to be Reported
as a Reprocessor Inc lude
Malfunctions that do not result in death or serious injury
As a SUD HCF reprocessor, the HCF should report adverse events as early as possible on becoming aware of a report able event(s) that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health
Serious injury" is defined as an injury or illness that :
• Is life-threatening;
• Results in permanent ("Permanent" means, irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage) impairment of a body function or permanent damage to body structure; or
• Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
" is defined as the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labelling for the device. The intended performance of a device refers to the intended use for which the device is labelled or marketed distribution register. Apart from the device details this register should have columns to indicate the patients who have received the device. The number of columns used for each device should correspond to the number of reuse allowed. For all such times except the first, the reprocessing date should also be mentioned clearly. Malfunction
On receiving a sterile reprocessed device, the sterilisation, package integrity, useful shelf-lif e and any damage should first be ascertained before use on a patient. One should also ascertain that there is no moisture inside the pack.
14. Withdrawal of SUDs
The time to withdraw the medical device will be decided by the committee taking into consideration the useful lie of the device and its continued functionality and integrity. The latter evidence will be maintained by CSSD.
A. Supporting documentation for the written proposal
Document attesting that an item can be effectively cleaned and reprocessed.
Document approving the effectiveness of the cleaning and sterilisation / disinfection procedure.
Document certifying that the item can withstand reprocessing and reuse without loss of structural mechanical or chemical integrity.
If no scientific evidence or document exists for any of the activities listed above and the ongoing data collected to validate the same.
B. Documents to Validate the Reprocessing Process
Checklist to be completed at each cycle for the cleaning and decontamination process
Process validation - sterilisation
Equipment validation and maintenance records
Adverse events recording
Tracking of medical devices
Record of toxic residue testing
Before a facility is allowed to reprocess a SUD it should obtain license/ authority to do so from a recognised body for the same. The periodicity of this licensing should be decided by the authorising body, but it is recommended that it should be at least for a period of three years. Since, for India, this would be the first ti me, the authorising body should prepare its own appropriate checklist for the same and notify the reprocessor well in advance so that auditing can be satisfactorily completed by the reprocessor based on the requirements of the regulatory authority.
Once the facility is authorised to carry out reprocessing, the information should be disseminated to all the concerned staff members while requesting a feedback on the effectivity and ease of the procedure.
The process should be reviewed at least annually and every time an adverse event is report ed. Corrective act ion should be taken immediately and the same should be disseminated to all concerned staff members.
Published as a part of draft guidelines in Newsletter No. Vo.3 No.2, May 2007,p5-13