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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.

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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 

Is your packaging safe? A Clinipak Keynote

Clinipak is pleased to announce that our Clinical Lead, Joy Markey, will be giving a keynote speech providing wrap guidance on using a single barrier layer at this year’s IDSc conference.

Suitable packaging is an essential component in protecting the sterility of a surgical instrument or set. Various combinations exist, and choosing the right process for you can be a minefield.

Joy’s talk will cover many frequently asked questions, including:

  • The requirements of ISO 11607 and how to meet them.
  • The evolution of germ-proof tray wraps.
  • Why current practices differ between hospitals and what the combinations consist of.
  • The specific requirements that constitute a Sterile Barrier System and why.
  • How to use a single barrier wrap successfully.
  • How to recognise an ideal wrap.

Dedicated to assisting with the cleaning, disinfection and sterilisation of reusable invasive medical devices, Clinipak offers an extensive range of packaging and transportation solutions for your instrument sets. From common problems such as condensate and tearing, to bespoke products and training for individual needs, we ensure support for your decontamination cycle.

Join us on Wednesday 30th November at 9:30am for Joy’s keynote, or visit our stand throughout the event for more guidance, give-aways, and product samples.

For more information on packaging systems, click here to read our Wrap Guidance document today.

Surgical Set Wrapping: Have Your Say

ISO 11607 does not state how many layers of wrapping should be used on instrument sets. What it is clear about, is the aseptic presentation of the contents of the set of instruments. Clinipak works with clients to ensure that they ‘aseptically’ present the instrument set contents when using a single layer of compliant wrap, with a layer of transportation wrap.
But what’s your opinion? Use our voting poll below to join the debate on different wrap methods:

Given the choice which wrapping solution would you use

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Periodic testing and Bowie-Dick test packs: FAQs

What is it?

Periodic testing consists of a programme of tests that are intended to demonstrate that a steriliser’s performance is satisfactory.

When should it take place?

The tests should be carried out at daily, weekly, quarterly and annual intervals.

Who’s responsible?

It is the responsibility of a Test Person or qualified person (AED) and the decontamination unit manager to ensure that periodic testing is carried out.

What are Bowie and Dick tests?

Clinipak Bowie-Dick Test Pack

Clinipak Bowie-Dick Test Pack

One of the critical daily user tests is the Steam Penetration Test (Bowie and Dick Test).

The steam penetration test is intended to show that steam will penetrate rapidly and evenly into a test device that is at least as difficult to sterilise as the intended load.

The test device contains an indicator that responds only when steam penetration is adequate (usually it changes colour – and should do so completely).

NB – If a cycle is provided specifically to test the effectiveness of steam penetration, it should have the same air removal stage as used during routine sterilisation cycles.

 

Test procedure – our advice:

A standard test device should be placed in an otherwise empty chamber, in the position specified by the manufacturer. At the end of the process the test device is removed from the chamber. The test device is checked for a pass or fail in accordance with the manufacturer’s instructions. The test results should be recorded.

If the test is failed, the test should be repeated. If the repeat test fails, contact the appropriate personnel and record results.

 

For more information on periodic testing, or for a free sample of our Bowie and Dick Test Packs, get in touch by calling 01628 810626 or emailing us at sales@clinipak.co.uk

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.

Manual Cleaning for Instruments

The use of automated cleaning methods may be contra-indicated for washing certain delicate or complex instruments including the removal of gross soil prior to the Automated Washer Disinfection process. These instruments should be carefully cleaned and rinsed according to the manufacturer’s instructions.

AB C14-059

We suggest the following:

• Consult the manufacturer’s instructions for specific guidance on cleaning and decontamination process and to determine whether the instrument will tolerate immersion.
• They should be cleaned, handled and inspected according to manufacturer’s instructions.
• The instructions for cleaning and sterilisation should be such that if correctly followed the device can be reused, without causing injury to patients and personnel using the instrument.
• A separate dedicated sink should be used to manually clean/pre clean instruments.
• There should be adequate space provided as a “Dirty” put-down area adjacent to the wash sink close to the rinse sink.
• A validated method of dispensing a measured quantity of detergent should be in place and set as per chemical manufacturer’s recommendations.
• A method of controlling temperature of the water in the wash and rinse sinks including thermostatic mixer taps are preferred.
• A selection of brushes in a range of diameters and lengths for cleaning both the external surfaces and the internal surfaces of instruments should be available and used in accordance with the brush and instrument manufacturer’s recommendations, as some brushes are “single use”.
• Cleaning brushes should be identified for cleaning only and should be washed, thermally disinfected, and stored dry (if reusable).

Click here to see our range of manual cleaning products.

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.

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

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