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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.

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.

 

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