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Copyright © 2012

People, Places, Processes & Products that Influence the Supply Chain

 
 

INSIDE THE CURRENT ISSUE

May 2009

Central Services


 

Troubleshooting
wet packs


1. Verify Cycle Parameters:

a. sterilization cycle must meet minimum guidelines set forth by sterilization manufacturer, AORN, AAMI

b. Cool down with door cracked (suggested 20 minutes)

c. Cool down out of chamber on cart with wire racks (suggested 30 minutes)

2. Check Instrument Sets, Configuration and Loading

a. Container/tray must should be adequate size to distribute mass. Heavy overloaded trays = slower heat up & slower heat transfer = inefficient drying

b. Disassemble complex instruments. This avoids trapping steam/condensate

c. Load containers/trays FLAT

d. Plastic containers/trays= nearly impossible to dry completely

e. Containers and heavy sets should be loaded on bottom shelf with wrapped instruments above

3. Ensure that sterilizer manufacturer’s specifications have been met

a. Hospital Utilities

• dynamic water pressures

• dynamic steam pressures

• properly delivered, piped, & trapped steam from source

• condensate free steam between 97% and 100% saturated vapor

• vacuum depths

• valves working to specs

b. Sterilizer functioning

• software level current

• pressure xducer calibrated

• vacuum leak verified

c. Instrument sets

• Tray too small/wrong kind

• Tray perforations occluded?

• Tray too dense/overloaded?

• Instruments that trap steam/condensate

• Non absorbent tray liner?

• Wrong position on load cart?

• Inconsistent technique—assembly/load?

Wet packs can occur randomly for many reasons. Infrequent wet packs can most likely be traced to inconsistent technique.

Frequent wet packs can indicate serious problems and must be thoroughly researched. Isolating a specific set or container that has wet pack problems may require marking a problem set and documenting its specific properties.

If a specific set in a specific sterilization container is causing an issue, challenge the integrity of the container by wrapping the set and determining if wetness occurs when the set is wrapped. If wetness does occur, the container may be defective and should be returned to the manufacturer in accordance with the warranty.

SOURCE: Marilyn Burns, RN, BS, CNOR, clinical product manager, Specialty Surgical Instruments

Curbing wet packs takes dedication, detective work

by Julie E. Williamson

In the harried world of sterile processing, wet packs remain a lingering – and frustrating— challenge for technicians, as well as clinicians who are forced to wait for instruments to be reprocessed as a result.

While random wet packs will happen to even the most quality-driven, conscientious SPDs, frequent occurrences tend to signal a bigger problem – one that requires prompt, proactive detective work to determine the cause and appropriate resolution (coupled with a hearty dose of staff training to reduce the risk of repeat occurrences).

Because numerous factors can contribute to wet packs, and because just as many approaches can help prevent them, Healthcare Purchasing Newsasked sterilization accessory vendors to weigh in on the subject and help sterile processing professionals make better sense of wet packs, while, hopefully, also helping to make frequent occurrences a thing of the past.

What are the top several mistakes SPDs make that contribute to wet packs?

Case Medical’s laporoscopic basic set

In my experience, the top mistakes leading to wet packs in SPD are putting wet instruments into the trays prior to sterilization. This is often the case when staff is pressured to rapidly process sets. The increased use of flash sterilization cycles leads to wet packs. Wet packs are also due to inadequate dry time in the autoclave even for terminal sterilization. Wet packs can occur when sets are removed from the sterilizer without adequate cool down which can cause condensation and in turn produce wet packs. Poor steam quality, poor maintenance of autoclave and older sterilizers also contribute. Inadequate drying of instruments in the washer/decontaminators can also lead to assembling wet loads. Avoiding wet packs may not be a top priority in SPD as it may be caused by many factors and the individual technician may be trained to look at only one aspect of the job.

— Marcia Frieze, CEO, Case Medical Inc.

Each of these can contribute to wet packs:

• Placing wet instruments in sets (instruments should be completely dry)

• Overloading trays

• Too much metal mass placed in a set

• Inadequate or inappropriate wicking materials used as a packaging aid

• Inappropriate loading of the sterilizer

• Inappropriate or overuse of plastic trays (the design of many are prone to moisture retention)

• Use of non-absorbent packaging materials

• Improper backpacking techniques

• Use of too much multi-layer packaging

— Ray Taurasi, director of clinical sales and services,
Healthmark Industries

Genesis case by Cardinal

Load size, inappropriate set configuration, poor quality steam supply issues and cooling too rapidly are the most common mistakes that can result in residual water after processing. Excessive condensation created during the cycle is difficult to dry in normal dry times, and cooling too quickly after the cycle can result in remaining condensation or even re-forming condensation -- all leading to wet sets.

—  Sue Christensen, Senior Market Manager, V. Mueller Genesis Containers

 

I believe the number one factor is poor technique by staff. Most wet packs can be traced to improper/inconsistent technique! Other causes include:

• Insufficient drying time

• A wet product prior to packaging

• Excessively large instruments being sterilized

• Instrument sets not being permitted to cool and equilibrate to room temperature

• Instruments cooler than room temperature at start of sterilization process

• Cool down process interrupted or too brief

•Weight & density of set too great

• "Wet steam"

• Re-condensation

• Blocked filter areas

• Sterilizer malfunction

• Sterilization container too small for instrument set

• Defective vacuum drying system

– Marilyn Burns, RN, BS, CNOR, clinical product manager,
Specialty Surgical Instruments

Aesculap Rigid container system product example

A lack of understanding of "how" the sterilization system works will prevent the SPD technician from being able to resolve the "why" it is not working properly. When the expected result is not achieved, assume nothing is working correctly and re-check everything. Some starting check points to help identify and resolve the problem include: are AAMI guidelines being followed; was it a dry load going into the sterilizer? Have there been any recent changes in the SPD (something new or recently "fixed")?; Has the set weight or packaging changed recently? Was the cart loaded improperly (with heavier sets on top of lighter ones?) What time of day did the wet pack occur? Was the exposure time accurate for the load? Were there changes in steam quality?

— Ed Nuber, sterile container product manager, Aesculap Surgical

 

In your experience, how can wet pack-related mistakes be resolved most
effectively?

Through continuing education, proper training and super, careful selection and use of packaging materials and equipment, and adherence to manufacturers’ recommendations of use.

— Ray Taurasi, Healthmark

Through knowledge and training. The importance of SPD technician training and certification cannot be stressed enough. It is critical the SPD technician is viewed as a healthcare professional by the hospital and proper training and certification is encouraged. Better set organization is also important. Sets get overloaded by continuously adding instruments here and there without ever monitoring their usage. Before you know it, you have way too many instruments in the tray and some are hardly being used. Reduce set density and weight by monitoring instrument usage. A computerized instrument tracking system can be very helpful in monitoring set lists.

— Ed Nuber, Aesculap

Quality controls, including a visual check for moisture, needs to be incorporated into prep and pack procedures. All instruments should be dry when placed into trays. If needed staff should be encouraged to dry wet instruments before assembly into the trays. Secondarily, staff should be given adequate time to process sets. More dry time may be required. Cracking the door of the autoclave helps tominimize the potential for condensate formation. Staff should allow for adequate time to fully cool down loads after sterilization before placing into service or storage. Finding more efficient ways of processing sets instead of flash sterilization or processing with abbreviated dry time. Staff needs to be more aware of sterilizer malfunctions and the importance of preventative maintenance. Routine checks of steam quality should be established. Staff should be encouraged to report all findings including wet packs and wet instruments to management.

— Marcia Frieze, Case Medical

Through ongoing staff training and immediate trouble shooting of any and all wet pack situations. When a wet pack issue is resolved, immediately educate staff on the resolution and treat each occurrence and resolution as a learning opportunity in order to reinforce proper technique in the future. Routine maintenance of sterilizers is also essential.

— Marilyn Burns, SSI
 

  • Reducing the overall weight of a container is one of the most successful practices known to reducing residual water issues.  

  • Breaking up the internal density of the container contents by using multiple baskets instead of a single basket can improve the drying capabilities of the set.  Using helpful organizing accessories to divide, separate and secure instruments can also improve the outcome by creating a more even distribution of the condensation within the container as it is formed during the sterilization cycle. It is easier to dry individual beads of moisture within the container than a large puddle formed under a mass of instruments. The same amount of condensation is formed, but by breaking up the density, the condensate does not result in puddles. 

  • Good steam quality is essential to achieving dry sets.  

  • The thermodynamics of achieving a dry set are based on how much water is produced during the cycle and how effective the radiant heat properties of the packaging material are in drying the condensation created. The amount of condensation formed is relative to the amount and type of materials placed inside of a container as well as the thermal conductivity properties of the container itself. The greater the ability of the material to conduct and retain heat and to cool slowly, the higher the likelihood for dry results. For instance, aluminum is an excellent conductor of heat and cools slowly; whereas, plastics are insulators and cool quickly, creating a greater thermodynamic deficiency to evaporate the condensation. 

  • Properly drying instruments prior to sterilization. There is an old saying, “What goes in wet, comes out wet.” Again, it is all about thermodynamics, and it is easy to tip the scale unknowingly.  

  • Use of perforated-bottom containers. There has been controversy over the drying results of using perforated bottom containers verses solid bottom containers.  As an interesting point, the original European container concept introduced into the U.S. market in the early 80s were only available with a solid bottom. The perforations were later punched into the bottom to accommodate the great number of gravity displacement autoclaves in use in the U.S. market at the time. Drying was not an issue with solid bottom containers in Europe.    

Note: One practice that can have an adverse affect on drying is the use of basket liners. The practice of using absorbent towel liners can actually alter the cooling properties of the container and absorb the energy intended to evaporate the condensation, resulting in a damp towel or residual moisture. Non-absorbent polypropylene wrappers, silicone or foam products may have absorbent properties that can also hinder drying. All of these liner products can create challenges for the rigid container to dry, especially if the steam quality is poor.   

The manufacturer of the particular container system should be able to provide test data indicating whether or not such products should be used for good drying results. Not all manufacturers require these products for good drying results.

—  Sue Christensen, Senior Market Manager, V. Mueller Genesis Containers

KimGuard sterilization wrap from Kimberly-Clark Health Care

Addressing wrap-related wet pack misconceptions

There is a common misconception that wet packs are caused by the sterilization wrap used in the steam sterilization process. Actually, the type of sterilization wrap chosen can hide or magnify an existing wet pack problem rather than cause it. Remember, a wet pack is simply the presence of moisture in or on a package which has been steam sterilized. In one case, consider a disposable, such as SMS polypropylene wrap, which is water-repellant. If a wet pack problem exists, moisture will be found as droplets on the surface of the wrap or inside the package. In another case, consider a reusable cloth wrap like cotton muslin, which is absorbent. Any residual moisture after steam sterilization will be absorbed into the cotton wrapper and may appear to be dry. Thus, when a facility switches from a muslin or other absorbent reusable wrap to a repellant synthetic wrap, it often appears that there is an increase in wet packs. It is often just more visible. The key is that a wet pack issue may exist in both cases, but it is not caused by the sterilization wrap.

Source: Kimberly-Clark Health Care, KnowledgeNetwork

Why do you believe wet packs continue to be such a problem for SPDs?

The personnel in SPD have a terrific challenge of processing myriad instrumentation and materials every day at non-stop paces and are often short-staffed. ‘Through-put’ can often overwhelm the attention to detail sometimes needed on a per-set basis.

With today’s high volume of heavy orthopedic sets, overloading containers is easy to do. It is easy to understand the resistance in SPD to breaking the heavy sets into multiple smaller, less dense sets. Change can be hard, and sometimes wet packs can be elusive -- making the need to reduce the weight or break up sets seem less urgent until a real problem arises and affects the surgical schedule.

Wet Packs can occur randomly for many reasons. Even with a well educated staff, it can be quite a challenge to trouble shoot the problem and come to a resolution. With the fast pace of OR’s today, infrequent and/or random wet packs can sometimes be "lost in the shuffle" and not addressed until the issue becomes severe. It is time consuming to adequately trouble shoot the problem and it requires thorough research, initiative, follow through and co-operation from the OR to successfully resolve the issue—many times SPD personnel may "give up" before the problem is resolved and just hope that the event does not occur.

— Marilyn Burns, SSI


I believe numerous factors are at the root of the problem: lack of resources and good management and supervision, poor quality assurance processes; work-related stress and pressure for fast turnarounds, staff complacency; and the design and materials of certain containment devices used (such as plastics).

— Ray Taurasi, Healthmark Industries


The personnel in SPD have a terrific challenge of processing myriad
instrumentation and materials every day at non-stop paces and are often short-staffed. ‘Through-put’ can often overwhelm the attention to detail sometimes needed on a per-set basis.  

With today’s high volume of heavy orthopedic sets, overloading containers is easy to do. It is easy to understand the resistance in SPD to breaking the heavy sets into multiple smaller, less dense sets. Change can be hard, and sometimes wet packs can be elusive -- making the need to reduce the weight or break up sets seem less urgent until a real problem arises and affects the surgical schedule.

—  Sue Christensen, Senior Market Manager, V. Mueller Genesis Containers


Staff is rushed to process sets. More education is required to understand why wet packs pose such a problem as well as staff taking responsibility and personal pride in the job. Staff needs to be aware that any moisture in the container is considered not sterile unless it is for flashing for immediate use. Some vendors have instructed SPD staff to believe that moisture within a rigid container is sterile. This is not the case. Many loaner trays provided by major medical manufacturers are made of polymeric materials, which are not highly perforated, densely packed and then wrapped with polypropylene wrappers may not be the choice of the SPD department.

— Marcia Frieze, Case Medical

Are wet packs more prevalent in wrapped items or rigid containers? What are the benefits/drawbacks of either packaging method?

It all depends on proper use. That said, wraps are more prone to tearing and all wraps are not created equally. Some wraps may provide better wicking, which can facilitate drying, while some polypropylene wraps are more prone to moisture retention. Container devices provide better protection, but whether they will facilitate better drying is contingent upon material composition (aluminum has superior heat conductivity, which usually provides greater and more rapid thermal transfer, and it maintains heat longer, which also facilitates more thorough drying). Aluminum is alsodurable and won’t crack, so it’s more cost-effective in the long run. As with sterilization wrap, containers must be used in accordance with manufacturer instructions – and they may not be compatible with all sterilization methods.

— Ray Taurasi, Healthmark Industries

Theoretically, the occurrence of wet packs should not vary between wrapped and rigid; however, rigid sterilization container systems vary by manufacturer and some systems have a lower occurrence of wet packs than others. Since the metal mass within the sterilizer itself can lead to wet packs in some cases, that may be a drawback for some container systems.

— Marilyn Burns, SSI

Both wrapped items and rigid containers can lend to wet packs, but wet pack issues are more easily identified when using rigid containers. Rigid containers are less forgiving than more porous materials, and – because they do not absorb moisture – users can more easily identify problems with wet steam, over-packing or quick-cooling conditions. Wrapped items have more have time to breathe and dry prior to the point of use – making it more difficult for users to identify root causes of the problems.

Rigid containers provides critical processing information that alternative wrappers do not. While the conditions they are subject to are always changing, the physical properties of rigid containers do not change – lending to greater sterility assurance. In essence, the container can communicate a problem somewhere in the sterilization process that would have otherwise gone undetected with conventional wrappers.

—  Sue Christensen, Senior Market Manager, V. Mueller Genesis Containers

Wet packs are more prevalent in wrapped packs because most wrap used is a plastic material. Many of the trays that are wrapped are manufactured from autoclavable plastic materials or stainless steel. They do not have the thermal conductivity necessary for heat transfer. Rigid containers that are made from anodized aluminum with aluminum inserts provide the best thermal conductivity. In fact, as a material, aluminum is highly thermal conductive, more than 40 times more conductive than plastic and 10 times more conductive than stainless steel. Another factor is the degree of perforations of the inner trays to be wrapped and the perforations in the vents of the rigid container. For example, perforated bottom containers provide for better drying especially for heavy loads.

— Marcia Frieze, Case Medical

Making blanket statements are unfair, since wet sets are dependent on the overall process and instrument load rather than the packaging system. Rigid containers, however, add the consideration of container system weight. Lightweight aluminum container systems are less prone to wet sets than heavy aluminum container systems.

— Ed Nuber, Aesculap
 

Can you offer any additional advice or suggestions that might help SPDs minimize their risks of wet packs?

In order to realize all of the benefits of rigid containers, users should consult with the manufacturer of their systems to better understand manufacturer recommendations and why they are making them.

—  Sue Christensen, Senior Market Manager, V. Mueller Genesis Containers

 

SPDs need to visually inspect each set prior to sterilization to ensure that there is no moisture on instruments to be packaged. SPDs should be encouraged to use trays and containers that are designed to provide maximum thermal conductivity. They should also find ways to work with the OR to minimize flashing or utilize a sealed container designed for flash sterilization which would provide them with a dryer outcome and comply with current standards and recommended practices.

— Marcia Frieze, Case Medical

Become the Sherlock Holmes of your SPD. Think about what is going on inside the sterilizer and become the detective. Continue to check everything. One of the quickest ways to resolve a wet set issue is to add a wicking material to the bottom of the tray (refer to AAMI ST79 Section 8.4.5 regarding the use of tray liners).

— Ed Nuber, Aesculap

What can/should SPDs be asking of their vendors that may inhibit wet packs (more diligence re: instrument set weights, for example)?

When selecting a rigid container vendor, consider the following points:

Weight of Container System: This is so important. A full-size container can weigh more than 10 lbs and that can differ according to vendor. Following the AAMI ST79 guidelines of 25-lb. total set weight, that leaves 15 lbs for instrument load. Selecting a lightweight container vendor with a broad portfolio is also extremely important.

In-service training: Knowledge is key. Today, SPD’s are being stretched to the breaking point, and a "do more with less" mentalityleads to a greater reliance on vendor service. The customer must be able to leverage the vendor’s sterilization experience to address their issues.

Instrument set organization: Weight is not the only factor. Also consider how the instruments and weight are distributed. The customer must be able to leverage the vendor’s instrument set care and handling experience to their set configuration.

— Ed Nuber, Aesculap

Reduced set weight is important to avoid wet packs as dense sets are more difficult to dry. However, the issue of weight is more related to ergonomics and the safety of staff lifting the tray. If the instrumentation is properly organized in the tray and not densely packed the outcome would be greatly improved. Vendors need to provide adequate and truthful information to their users and follow AAMI and AORN standards. SPDs should be encouraged to question vendors and ask for documentation in wiriting. Set dryness should be demonstrated and should be one of the parameters for acceptance. Communication channels should be developed between SPD and their vendors as well as purchasing to address the issues related to set weight, wet packs and the choice of tray systems.

— Marcia Frieze, Case Medical

SPDs should ask for the general history of wet packs for the specific vendor product and should also carefully trial the product before purchasing it. The trial should include challenging the product with  a variety of sets that have different weights, instrument configurations and density/complexity of instruments.

— Marilyn Burns, SSI 

SPDs should follow manufacturer s’ recommendations, because each manufacturer understands the dynamics of their product the best and can work with SPDs to identify possible causes in the facility. Working together with the sterilizer manufacturer as well as maintenance staff is the most effective approach to resolution.

—  Sue Christensen, Senior Market Manager, V. Mueller Genesis Containers

 

Brushing up on brush basics

Curbing wet packs takes dedication, detective work

Accessories vendor chart