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Storage of RIMD – What is the Best Practice?

To avoid risk of infection to, and cross-infection between patients, all sources of contamination must be given attention. These not only include decontamination, handling and transportation, but equally as important – the storage of reprocessed instruments prior to patient use.

Transportation of items should take place in clean and dry cabinets or trolleys, and sterile packs should be inspected at every stage of transportation to identify damage at the earliest possible point. Different coloured inner and outer wraps can make this more easily noticeable.

Similarly to transportation, appropriate “fit for purpose” storage is just as important as all other decontamination practices, including cleaning and sterilisation.

So what makes for the best storage conditions?

1. Storage shelving along with the environment should be designed in a manner to ensure that packs are kept dry, at moderate temperatures, and with strict humidity controls.

2. Sterile items should not be stored anywhere but on, or in, designated shelving, counters, or containers. Other areas may not be sufficiently clean, and window sills collect condensate that forms due to differences in outside and inside temperatures.

3. Handling should be kept to a minimum to prevent any damage to the packaging.

4. If handling is unavoidable, packs must be treated carefully, avoiding any dragging, crushing, bending, compression or punctures. Packs should be carried level and parallel to the floor.

5. Stock should be effectively rotated to ensure that packs are not left unused longer than necessary.

6. Stacking of packs should be reduced to a minimum.

7. There should be enough space between shelves and racking to allow an adequate passageway between fixtures.

Shelving and Racking should:

1. Afford adequate space to store the required stock

2. Free from defects and friction between the shelf and the pack (i.e. from dragging) should be minimised.

3. Items should be stored in racking for good manual handling and to reduce the need to drag and slide packs across shelves.

4. Purpose built, easily cleaned and maintained.

5. Should enable items to be clearly labelled.

Under optimal storage conditions with minimal handling, properly wrapped items can be considered sterile as long as they remain intact and dry. Be mindful that contamination is event related, not time related.

5-uflex-storage-system


Click to view our storage products here

How to avoid damage to sterilisation tray wraps

As we know, decontamination is essential to:

  1. Maintain the functionality of RIMD
  2. Maintain the integrity of biopsy specimens
  3. Protect the patient from adverse consequences of non-sterile contaminants

Failure to adequately decontaminate RIMD will increase the risk of infection to patients and transmission of cross-infection between patients. Many reprocessed medical device instrument sets are returned to the CDU as the wrapping material has torn or punctured, adding additional pressure to resources in the unit and adding to the ever increasing costs associated with the decontamination process. In some instances, this can even result in a Theatre surgical cancellation.

This non-conformance can be resolved or greatly reduced if the appropriate packaging, handling and storage conditions are maintained throughout the cycle.

It is advisable that as part of the Risk Assessment process that an evaluation of the current wrapping materials is conducted to determine if it is suitable and robust enough to withstand the handling and transportation required in a particular unit. In many instances, the addition of a transportation wrap has proved beneficial to provide additional strength and durability for sterilisation tray wraps.

 

Clinipak 104AB Still C15 018

 

Packaging systems are designed to:

  • Maintain the sterility of the contents from post-sterilisation to use of contents
  • Provide a microbiological barrier
  • Protect the contents post-sterilisation, during storage and in transit to the point of use

Consequence of Compromised Sterility  = Potential compromise of Patient safety

 

Packaging systems must:

  • Be appropriate to the items being sterilised
  • Be appropriate to the method of sterilisation
  • Provide adequate seal integrity
  • Provide an adequate barrier to particulate matter and fluids
  • Be compatible with and able to withstand physical conditions of the sterilisation process
  • Allow penetration and removal of sterilant
  • Maintain integrity of the pack
  • Permit use of material compatible (i.e. non-degradable) with the sterilisation process
  • Be used according to the manufacturers’ instructions
  • Resistant to punctures, tears and other damage which may break the barrier and cause contamination
  • Resistant to penetration by microorganisms from the surrounding environment
  • Free of holes
  • Free of toxic ingredients
  • Low-linting
  • Tamper proof and able to seal only once
  • Provide an adequate barrier to particulate matter and fluids

Handling

Handling should be kept to a minimum to prevent any damage to the packaging. If handling is unavoidable, packs must be treated carefully, avoiding any dragging, crushing, bending, compression or punctures.  Pack should be carried level and parallel to the floor to avoid damage.

The Use of PPE: Minimising Risk of Infection

Standard precautions and safe work practices are required to minimise the risk of infection to both Patients and Staff. They include, but are not limited to, good hygiene practices, particularly hand-washing, the use of Personal protective equipment (PPE) and the appropriate handling and disposal of waste.

PPE involves use of protective barriers such as gloves, gowns, aprons, masks or protective eyewear. PPE also provides protection against other hazards in the healthcare facility such as chemicals and physical injury.

PPE should be worn by personnel when decontaminating reusable medical devices to reduce the risk of exposure to potentially infectious material. Decontamination Unit Managers should ensure that PPE is made available and all personnel including contractors and personnel responsible for ensuring the correct use and disposal of same.

All personnel working in the decontamination unit should wear freshly laundered low linting attire (low-linting attire minimises bacterial shedding and provides comfort and professional appearance should be selected).

  • On leaving the decontamination unit, staff should change into their normal day wear.
  • Hands should be decontaminated before leaving the changing area.
  • Work attire should never be worn outside the decontamination unit.

Gowning for entry to the wash room

  1. The first item to be donned should be a clean, single-use, low lint surgical hat or hood that confines all hair.
  2. The hat or hood should be designed so that microbial dispersal is minimised.
  3. All hair should be confined as well as covered.
  4. After use, headgear should be discarded in the appropriate healthcare waste stream (note: Make-up or jewellery should not be worn in the decontamination unit).
  5. Staff should wear single use PPE to reduce the risk of body fluid exposure from splashing and spraying of blood or body fluids, protection for eyes/nose and mouth should include the following: a) face shield that covers the eyes, nose, mouth and chin; b) fluid repellent mask and separate goggles; c) fluid repellent mask with integrated eye shield; c) removed immediately if moist or visibly soiled and discarded in the appropriate healthcare waste stream.
  6. Goggles, masks and face shields should be: a) single-use; b) fitted and worn according to the manufacturers’ instructions; c) removed immediately if moist or visibly soiled and discarded in the appropriate healthcare waste stream.
  7. Goggles, masks and face shields with integrated eye protection should be: optically clear, anti-fog, distortion-free, close fitting and shielded at the side.
  8. Staff should wear plastic aprons or impermeable gowns with long cuffed sleeves and tuck-inside-gloves during procedures that are likely to generate splashes of blood or body fluids or during activities that may contaminate clothing, uniforms and/or personnel with microorganisms or infectious material.
  9. Fluid repellent attire and aprons should be changed whenever they become visibly soiled or wet.  After use, fluid repellent attire and aprons should be discarded in the appropriate healthcare waste stream.
  10. Using alcohol gel.Staff should decontaminate their hands before and after removing gloves by: a) handwashing; b) alcohol gel.
  11. Wearing gloves should not replace hand washing, as gloves may have defects that are not immediately obvious, or may become damaged during use. Gloves should be: a) used for handling contaminated RIMD, waste and when performing environmental cleaning activities; b) selected and worn according to the task and if torn or perforated.
  12. When removing gloves, the outer surface of the gloves should not come into contact with skin. Avoid letting the gloves snap, as this may cause contaminates to splash into eyes or mouth or onto skin or other personnel in the area.
  13. After use, gloves should be discarded in the appropriate healthcare waste stream. It is important to remove used gloves and decontaminate hands before touching a clean surface such as worktops.
  14. Staff should wear non-slip enclosed footwear that can protect them from injury or contact with sharp objects (e.g. if sharps are dropped accidentally). Please note: a) footwear should be regularly cleaned and disinfected; b) all footwear should be appropriate for the area in which healthcare worker is designated.
CLOGCART    Clogs (without holes) 

Reassembly of Reusable Invasive Medical Devices for decontamination

The fundamental reasons for the reassembly of reusable invasive medical devices (RIMD) and checking is to ensure that:

  • All RIMD are present in accordance with RIMD list.
  • All RIMD are assembled correctly in accordance with manufacturers’ instructions.
  • All RIMD are placed in the correct tray in a manner that ensures ease of use by the user.

RIMD should be assembled in accordance with the manufacturers’ instructions prior to packaging and/or further reprocessing. In preparing RIMD for wrapping and sterilisation, it is essential that all surfaces are presented to the sterilisation media (i.e. steam). Where the manufacturers’ instructions indicate that RIMD to be sterilised are disassembled, it is essential that they are presented in this state. For RIMD with ratchets, they should be closed on the first ratchet only, to ensure steam can penetrate to all surfaces.

Similar RIMD should be kept together when placing in tray. For example; artery forceps can be placed on a pin together. The RIMD tray should be selected so that the RIMD can preferably be placed in one single layer.

Tray liners should be placed in the base of the RIMD tray. RIMD should be spread evenly by weight over the tray surface, this helps prevent condensate flowing together. Each RIMD should be checked against the RIMD list specific to the tray being assembled. Plastic items should be evenly placed in the tray; avoid collecting them in one area. Ensure sharp RIMD are assembled correctly to avoid penetration of the outer packaging.

Protectors including card corner tray protectors and protectors to be placed on sharp RIMD should be validated for steam penetration. Ensure that delicate RIMD are placed in the tray in a manner which will not cause damage.

Any RIMD missing from a tray should be reported to the supervisor for further action and non-conformance documented. Any extra RIMD found while assembling tray should also be reported to supervisor for further action and non-conformance documented.

 

Clinipak 076Clinipak 123

 

Set weight

The ability of a given sterilisation cycle to produce a dry load is largely dependent on the configuration and thermal mass of the load. The condensate is produced as the steam heats the load, the heat from the load is used to boil-off the condensate during the vacuum drying stage. The mass specific heat and thermal conductivity determine the efficacy of this process for any particular set of RIMD.

Splitting the contents of sets to two/three etc. sterilsation baskets to reduce the weight/mass of the set may prevent “wet packs” from occurring. Ensure that the set contents of trays are identifiable this can be achieved by clearly labelling the contents for example (tray 1, 2, 3, of set 1, 2, 3 etc). The addition of soakage sheets and/or dry wrapping materials may also combat “wet load” issues.

 

Note: The configuration of sets of RIMD required to permit dry loads should be established during performance qualification testing of the steam steriliser. The validated configurations should be documented as specifications for use during packaging.

The importance of disinfection in the decontamination of reusable instruments

Disinfection is defined as a process that inactivates infectious agents, using either thermal (moist or dry heat) or chemical means. The level of disinfection achieved depends on the temperature, exposure time and/or type of chemical disinfectant used.

 

High-level disinfection — this is the minimum treatment recommended for reprocessing REUSABLE INSTRUMENTS that cannot be sterilised, for use in semi-critical sites or when there are specific concerns regarding contamination of surfaces with species of mycobacteria – for example, mycobacterium tuberculosis. 

Low-level disinfection — this is the minimum treatment recommended for reprocessing REUSABLE INSTRUMENTS for use in non-critical sites.

Thermal disinfection can be achieved in a thermal washer–disinfector by choosing the appropriate cycle. If items can withstand heat and moisture and do not require sterilisation, then thermal disinfection using moist heat at temperatures and times that destroy pathogenic agents is the simplest, most efficient and cost-effective method of disinfection.

Automated equipment, such as washer-disinfectors are recommended for use in thermal disinfection processes. As we know the level of disinfection depends on the water temperature and the exposure time. Thermal washer–disinfectors can be programmed to deliver a range of disinfection levels, depending on the cycle selected (i.e. set temperature and exposure times). If carried out appropriately the thermal disinfection process should provide adequate assurance of the required microbial lethality.

Note: The manufacturers’ instructions should be followed to achieve the required level of disinfection.

Chemical disinfection can be achieved with a compatible REUSABLE INSTRUMENTS-grade disinfectant of the required level, used alone or in conjunction with a chemical washer-disinfector.

 

Disinfection should be carried out using a thermal disinfection process whenever practicable. Chemical disinfection should be employed only when required by the REUSABLE INSTRUMENTS manufacturers’ instructions. The ability of chemical disinfectants to effectively inactivate contaminating infectious agents depends on a number of factors, including the initial number of agents present, temperature, pH and concentration hence the importance of robust cleaning . Only REUSABLE INSTRUMENTS disinfectants or sterilants are suitable for use with REUSABLE INSTRUMENTS.

Chemical disinfection processes should provide adequate assurance of the required microbial lethality. Chemical disinfection processes should be validated microbiologically (usually by the disinfectant manufacturer). This should define the concentration, contact time and minimum/maximum temperatures.

It is important to remember that the effectiveness of the disinfection process cannot be verified retrospectively by inspection or testing of the product alone, and can only be guaranteed if correct conditions are created throughout the washer-disinfector chamber and the load during every cycle, therefore the separation of reusable instrument tray sets prior to cleaning and disinfection is vital.

Place reusable instruments in mesh basket in a manner which ensures effective cleaning/disinfection. Do not place reusable instruments one on top of the other.

 

AB Still C14-243Clinipak 102

 

Overloaded baskets will result in ineffective cleaning/disinfection.

Arrange REUSABLE INSTRUMENTS in an orderly fashion in mesh trays so that all surfaces are exposed to the action of an automated cleaner, if used. Placing each jointed REUSABLE INSTRUMENTS in the open position in the mesh basket. If extra mesh baskets are required for cleaning/disinfection purposes of an REUSABLE INSTRUMENTS set, a tray identification label should be placed in the extra baskets to identify the set name and number. Ensure heavy retractors and/or other heavy REUSABLE INSTRUMENTS are placed on the bottom or in a separate tray/baskets. Secure small and light items with a hold down screen or by other means, to ensure they are not free to move around during the cleaning process. Place scissors, lightweight REUSABLE INSTRUMENTS, and microsurgical REUSABLE INSTRUMENTS next. Receivers and gallipots should not be placed over REUSABLE INSTRUMENTS, as they may interfere with the cleaning/disinfection process.

 

Why Clean Reusable Invasive Medical Devices?

Cleaning is a critical and essential prerequisite for disinfection and sterilisation processes, given that organic residue may prevent the disinfectant or sterilant from contacting the Reusable Invasive Medical Devices (RIMD) being processed. This residue also has the potential to bind and deactivate chemical disinfectants as well.

In essence, if RIMD are not effectively cleaned, they cannot be effectively sterilised as a result.

Although automated washer disinfectors are the most commonly recommended method of decontamination, some RIMD require pre-cleaning prior to automated cleaning and disinfection.

This practice usually applies to:

  • Grossly contaminated RIMD
  • RIMD for manual cleaning only (as per manufacturers recommendations)
  • Cannulated RIMD

Manual Cleaning Methods:

  • Immersion
  • Non immersion (this method is used for instruments that may become compromised by soaking in an aqueous solution, for example: electrical instruments)

Immersion method:

  • Ensure that the instructions established by the RIMD manufacturer for reprocessing have been followed
  • Prepare the solution (detergent) in line with manufacturer recommendations for the correct concentration, dilution and water temperature
  • Totally immerse RIMD in solution and consider the importance of contact time.
  • Remove all visible soil
  • Flush all lumen RIMD with jet gun (discharge under water)
  • Use appropriate cleaning brushes and ensure they are replaced or disinfected on a daily basis
  • Rinse RIMD in warm-to-hot water unless contra indicated
  • Dry using mechanical dryer, lint-free cloth or medical air
  • Inspect the RIMD to verify the effectiveness of cleaning.
  • Maintain and document the records of each RIMD that has been manually cleaned.

Non immersion method:

  • Ensure that the instructions established by the RIMD manufacturer for reprocessing have been followed
  • Prepare the solution (detergent) in line with manufacturer recommendations for the correct concentration, dilution and water temperature
  • Using a single use cloth soak the cloth in the solution
  • Start cleaning the RIMD from the least visibly soiled part of the device to the most visibly soiled
  • Repeat until all visible soil has been removed
  • Flush all lumen RIMD with jet gun (discharge under water)
  • Use appropriate cleaning brushes and ensure they are replaced or disinfected on a daily basis
  • Rinse RIMD in warm-to-hot water unless contra indicated
  • Dry using mechanical dryer, lint-free cloth or medical air
  • Inspect the RIMD to verify the effectiveness of cleaning.
  • Maintain and document the records of each RIMD that has been manually cleaned.

The Transportation and Return of used Reusable Invasive Medical Devices

All Reusable Invasive Medical Devices (RIMD) are considered to be soiled, contaminated and a potential source of infection after each use. Contaminated RIMD should be handled, collected and transported in a manner that avoids dissemination of contamination. Transport of soiled RIMD to the decontamination area should be accomplished as soon as possible after use. If delay is unavoidable, the user must make sure that the item is safely contained and secured to await collection.

 

On Site Transportation/return of used RIMD

Containers and trolleys:

  • Contaminated RIMD should be placed in closed, sealed, secured containers and trolleys (transport containers). These must be transported to the wash room as soon as possible after use.
  • Transport containers should protect the product during transit and the handler from inadvertent contamination.
  • Bins with lids and closed sterilisation container systems are among the types of containers that may be used to transport contaminated items.
  • Impermeable bags should be used to maintain RIMD within the container as well.
  • The selection of containers should be based on the characteristics of the items being transported.

In particular, the containers and trolleys should be:

  1. Leak-proof.
  2. Rigid enough to prevent enclosed RIMD becoming a hazard to anyone during the handling process and to protect them against accidental damage.
  3. Capable of being closed securely.
  4. Lockable, where appropriate, to prevent tampering.
  5. Clearly labelled to identify the user and the contents where applicable.
  6. Robust enough to prevent RIMD being damaged in transit.
  7. Have the ability to be easily cleaned, disinfected and dried, or discarded (as appropriate) using agreed methods.

Designated containers should be used for the collection of RIMD unless the central decontamination unit is equipped with a washer-disinfector for the cleaning and thermal disinfection of containers after each use. RIMD sets should be separated from healthcare risk waste at the point of use and sharp instruments should be removed and placed into approved containers conforming to BS. Reusable textiles should be held in appropriate linen bags and returned to the laundry service. All fluids (e.g. blood, bodily fluids, cleaning and antiseptic solutions) should be disposed before placing RIMD in transport containers. All transportation equipment has to be cleaned in accordance with local policy.

 

On Site Transportation/Return of Reprocessed RIMD:

Note: Reprocessed/Sterile RIMD should be transported in a manner that will not compromise their status. Loss of sterility is event related and depends on the extent and nature of handling, environmental conditions during transportation and storage, and the quality of the packaging material.

Reprocessed/Sterile RIMD should be transported in clean, dry conditions and in a manner that not only provides segregation from sources of water and contamination, but provides mechanical protection which can prevent damage to devices and flexible packaging.

  • Sterile RIMD should be cooled before they can be transported.
  • Sterile RIMD should be transported in closed, solid-walled containers
  • Or in carts which are enclosed with solid-bottom shelves to protect them from exposure to environmental contaminants along the transportation route.

Off Site Transportation/Return of used RIMD:

In the event that used RIMD are transported by road, the containers should meet the requirements and be lidded containers which are UN3291 approved. All vehicles used in the process should be dedicated to the transportation of used RIMD and provide appropriate segregation for the transport of RIMD which are either sterile or used. The loading area should be constructed so that it is easily cleanable.

 

Off Site Transpiration of Reprocessed/Sterile RIMD:

Reprocessed/Sterile RIMD should be transported in clean, dry conditions and in a manner that not only provides segregation from sources of water and contamination, but provides mechanical protection which can prevent damage to devices and flexible packaging.

  • Sterile RIMD should be cooled before their subsequent transportation.
  • Sterile RIMD should be transported in closed solid walled containers.

All vehicles used in the process should be dedicated to the transportation of used RIMD and provide appropriate segregation for the transport of RIMD which are either sterile or used. The loading area should be constructed in a way so that it is easily cleanable.

Note: Where small quantities of sterile RIMD are to be transferred or where it is only occasionally required, they may be transported in a socially clean general purpose vehicle provided they are contained within a closed solid walled container.

 

We now sell Wipak!

A high quality range of pouches and reels with a unique 9-layer film.

Key features of the range:

Unique 9 layer film features seven polypropylene (PP) layers which makes it very elastic, tough and durable.

Suitable for all common methods of sterilisation.

 

Range of sizes which can be used for individual items or smaller sets, some larger and heavier items as well as instrument and laundry sets.

Excellent strong seals. The factory-made seals withstand vigorous processing and handling. The package is safely closed and is not bursting open during autoclaving.

Safe clean peel feature. The closure and seals are the critical part of a sterile barrier system. The strong seals are not too strong and they peel open cleanly without tears and breaks.

Stock Codes and Sizes

Product range available:

  • Regular Flat Pouches
  • Regular Flat Reels
  • Regular Pouches with Gussets
  • Regular Reels with Gussets
  • Regular Self Seal Pouches
  • Self Seal Plus Pouches
  • Tyvek Pouches and Reels

For stock codes, sizes and prices please ask a member of the sales team.

uk_map UK Distribution Only

Distributor Training Feb 2014

Another fantastic session of distributor training was conducted at the end of February.

This initiative is proving to be extremely beneficial for both Clinipak and for our distributors. We are able to improve relationships with distributors by opening up lines of communication and offering solutions to any problems. It is a great opportunity to understand export markets more clearly.

We are also able to give more in depth training on Clinipak’s extensive product portoflio.

We are really looking forward to conducting more training with a wider range of
distributors throughout the rest of 2014.

Please get in touch if you would like more information about being a distributor or about attending a distributor training session.

CBM Range

Permaside Aluminium Containers are rigid, EN868-8 and ISO11607-1 compliant containers designed to be used in steam sterilizers conforming to EN285. The body is made from anodized aluminium for increased corrosion resistance, particularly against modern alkaline washing cycles, whilst the lid is manufactured from stainless steel for improved scratch resistance.

Permaside Aluminium Containers employ permanent PTFE filter cartridges which are certified for more than 2000 cycles, giving them a general shelf life of 5 years. The expiration date is engraved on each cartridge. The filters cartridges are located on the side of the container, avoiding problems arising from stacking.

Each container is supplied with a unique serial number barcoded on the lid and body.

Compliance

Permaside Aluminium Containers comply with the essential requirements of the Medical Devices Directive EC 93/42 – 2007/47/EC – Class 1. The containers are CE Marked.

Sterilisation Compatibility
Permaside Aluminium Containers are compatible with steam sterilisation at temperatures up to 137°C. Permaside Aluminium Containers are not compatible with any other type of sterilisation process.
Stock Codes and Sizes

For stock codes and sizes please conatct a memeber of the sales team.

View products

A selection of products to support each
stage of the decontamination process.

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