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INTERLOCK AND KEY SURGICAL MERGE TO CREATE LEADING GLOBAL PROVIDER OF STERILE PROCESSING AND OPERATING ROOM SUPPLIES

Water Street Facilitates Merger of European and U.S. Providers; Combined Company Offers Comprehensive Product Portfolio Focused on Surgical Safety and Efficiency

LENSAHN, Germany and MINNEAPOLIS – June 6, 2017 – Interlock Medizintechnik GmbH and Key Surgical, Inc. announced today that they have merged to create one of the world’s leading providers of sterile processing and operating room supplies.

The newly combined company also gains products from Clinipak Ltd., a United Kingdom provider acquired by Interlock last year. Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, led the merger of the European and U.S. providers and invested in the newly combined company.

Continue reading.

Using a single barrier layer – Clinipak lecture at IDSc Conference in Blackpool

Our Clinical Lead, Joy Markey, has held a lecture on “using a single barrier layer” at last year’s Institute of Decontamination Sciences Annual Conference in Blackpool. The purpose of this presentation was to provide guidance on using a transportation layer alongside a Standard Certified Barrier wrap highlighting that if presented aseptically, this combination satisfies the requirements of ISO 11607.

At present, standards do not clearly define the number of wrap layers that must be used when tray sets are prepared for sterilisation. Current practices consequently vary among hospitals and wrap choices are often based on how each hospital has wrapped trays in the past. There are various combinations which can range from 3 wraps to a single layer, although the 2 wrap combination is most common. The layers themselves also vary from 2 layers of compliant wrap with alcohol repellency to one compliant barrier layer.

Clinipak has supported the overall view that, in a 2-layer wrapping system, only one germ-proof barrier is necessary to ensure that all set contents are reprocessed appropriately and fit for patient use. Provided the internal barrier layer is protected by a strong outer layer that is resistant to tearing, one barrier wrap is adequate in preventing germs from entering an instrument set after sterilisation.

Please find the whole article (page 24-15) in the IDSc Journal and here.

Company News: Clinipak and Interlock Join Forces

We are pleased to announce that, effective immediately, Clinipak Ltd have joined forces with Interlock Medizintechnik GmbH.

With a combined portfolio of over 5000 products, Clinipak and Interlock have formed the world’s leading provider of consumables for instrument processing and central sterilization. interlock-logo

We are now operating as one company, holding similar values and philosophy for doing business. We strongly believe in accomplishing excellent results for customers with an emphasis on honesty and integrity and the importance of maintaining a positive attitude at work.

Our goal is to continue delivering innovative and high quality products to our customers.

We are confident that our services will grow stronger, with an even more diverse product range, better quality management, and a stronger set of resources to service our customers needs.

Click here to visit the Interlock website 

Click here to view the Interlock catalogue 

Instrument wrapping systems: how to always ensure compliance whilst making effective time and cost savings…

Our Clinical Lead, Joy Markey comments in a recent Clinical Services Journal article investigating packaging of instrument sets before sterilisation.

The article covers all commonly queried areas of instrument packaging, including:

Compliance with ISO 11607:
“ISO 11607 does not state how many layers of wrapping should be used… what it is clear about, however, is the aseptic presentation of the contents of the set of instruments.”

• Complicated terminology explained
• The Clinipak method of “…Transportation Wrap, alongside a standard certified barrier wrap”.

Cost and Time savings:
In today’s healthcare environment any new wrapping method being considered needs to be able to offer both cost and time saving benefits without compromising aseptic technique.”

• Is the single wrap method best?

Previous research:
“There was no ingress of viable bacteria during a 13 month period of storage following sterilisation.”

• Research study results from a Dublin university hospital on pack integrity.

AB C14-102 - Copy
Click here to read the full article.

Find out more and request free samples of our transport wrapping systems by clicking here.

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.

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

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