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KSR Publishing, Inc.
Copyright © 2016


         Clinical intelligence for supply chain leadership



December 2015

CS Connection

Instrumental News

Number of young patients with newly diagnosed colorectal cancer anticipated to double

In the next 15 years, more than one in 10 colon cancers and nearly one in four rectal cancers will be diagnosed in patients younger than the traditional screening age, according to researchers at The University of Texas MD Anderson Cancer Center. This growing public health problem is underscored by data trends among 20- to 34-year-olds in the U.S., among whom the incidence of colon and rectal cancer (CRC) is expected to increase by 90% and 124.2%, respectively, by 2030.

Published in JAMA Surgery, the findings build on prior studies of CRC trends but go a step further by providing quantitative estimates of exponentially increasing risk for CRC among patients who fall under 50, the age at which CRC screening becomes recommended for the general public. The authors point to lifestyle and behavioral factors such as obesity, lack of physical activity and a Western diet as major risk factors for CRC, though the exact causes of the predicted increases are not known.

Nearly 137,000 people will be diagnosed with CRC in the U.S. this year, and more than 50,000 will die of the disease. CRC is the third most common cancer among men and women, and the third leading cause of cancer death.

Researchers observed that the annual incidence rate for CRC diagnosed in patients under age 34 is increasing across all stages of disease: localized (confined to the colon or rectum), regional (contiguous and adjacent organ spread, such as to the lymph nodes, kidney and pelvic wall) and distant (referring to remote metastases). The trends indicate that:

• By 2020 and 2030, the incidence rate of colon cancer will increase by 37.8% and 90%, respectively, for patients 20-34. By 2030, this represents a 131.1% incidence rate change of colon cancer in younger patients compared to patients older than 50 years of age.

• Similarly, by 2020 and 2030, the incidence rates for rectosigmoid and rectal cancers are expected to increase by 49.7% and 124.2%, respectively, for the same age group – a 165% incidence rate change compared to patients older than 50 years for these cancers by 2030.

• Among patients 35-49, incidence rates are anticipated to increase 27.7% for colon cancer and 46% for rectal cancer in the same timeframe.

An opposite trend was observed in older patients largely thanks to screening and prevention efforts. There has been a steady decline in the incidence rate of CRC in patients 50 and older, with the most notable declines in regional and distant disease. Based on the predictive model, the researchers anticipate this trend will continue, with incidence declining by 21.2% and 37.8% in 2020 and 2030 for colon, respectively; and 19.0% and 34.3% in 2020 and 2030 for rectum, respectively. The largest decrease is expected for patients older than 75 years.


Chemical weapons

Skillful wielding of sterilants and disinfectants a must in the battle against ‘superbugs’

by Kara Nadeau

Matt Strunk

The widely publicized carbapenem-resistant Enterobacteriaceae (CRE) ‘superbug outbreaks’ of 2015 have driven many hospitals to reevaluate their cleaning, disinfecting and sterilization practices for not only the duodenoscopes tied to the outbreaks but across all instruments and devices used in patient care.

"As many reports of ‘superbug outbreaks’ have recently surfaced it has caused many medical facilities to take a very close look at not only their policies and training, but also at what types of equipment and disinfectants are being used in their facilities," said Matt Strunk, Lead Sterile Processing Technician III, Cincinnati Children’s Hospital Medical Center.

Furthermore, central sterile/sterile processing department (CS/SPD) professionals must keep up to date on changing regulations and recommendations from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) that have resulted from these outbreaks.

Don Williams

"In light of everything going on this year the disinfectants and cleaning products that we use are definitely at the forefront of everyone’s mind right now," said Don Williams, CRCST, CIS, CHL, Manager, Surgical Processing, Overlake Hospital Medical Center. "Since February, there have been four or five different updates from the CDC and FDA on scope processing. It’s tough for us to stay on track with everything that’s going on out there. Instead of running around like the sky is falling, we must take a step back and examine our processes and products to validate whether or not they are effective, versus making changes with no evidence to back them."

In this article, we explore the challenges facing the CS/SPD today when it comes to sterilants and disinfectants, the latest trends in this area and best practices from both CS/SPD professionals and product manufacturers on delivering safely processed instruments in an efficient and cost-effective manner.

If it isn’t clean…

There is general consensus that "dirty" instruments harboring bioburden cannot be disinfected and sterilized. Complex devices with narrow channels that require multiple steps for reprocessing present the greatest cleaning challenge but any instrument used invasively carries the risk for contamination if not properly cleaned.

"Manual pre-cleaning is a mandatory and critical step no matter how you high-level disinfect," said Philip Coles, Founder & CEO of PCI Medical. "Improperly pre-cleaned devices can be impossible to disinfect and were most likely the cause of the ‘superbug outbreaks.’ Safe, clean storage of disinfected instruments is also coming under more scrutiny since recontamination can occur when an instrument is improperly stored."

Weston Balch

To reduce the risk for instrument cross-contamination, the CS/SPD at Jewish Hospital & University of Louisville Hospital has put a process in place where every surgical instrument that is hand washed in decontamination is also disinfected prior to entering the assembly area.

"There is a sort of wild-west right now as it relates to products that do not go through the automatic washing stage, as many facilities simply soak in enzymatic detergent, clean and rinse prior to passing through to the assembly area," said Weston "Hank" Balch, CRCST, CIS, CHL, Director of Sterile Processing Operations, Jewish Hospital & University of Louisville Hospital. "Without some disinfecting stage, these items could be exposing our teams to dangerous microorganisms on a daily basis."

The human factor

Cleaning, disinfecting and sterilization practices and products are only good as those using them. As a result, healthcare facilities must invest in CS/SPD staff training and continuing education in order to facilitate proper instrument processing and patient safety. As part of this investment, facilities must ensure they have instructions for use (IFU) for each and every instrument or device they are processing, and that staff not only have access to these documents but also understand and can execute on their contents.

Tips for sterilant and disinfectant selection and use

When evaluating sterilant/disinfectant products, SteriPro Medical Device Reprocessing Manager Garry Bassi suggests CS/SPD/MDRD professionals take the following steps:

•  Analyze your inventory: Check to see if manufacturer IFUs for medical devices are compatible with your choice of sterilant and disinfectants.

•  Check your facility’s equipment and parameters: Ensure they are compatible with the sterilant or disinfectant. For example, determine if your infrastructure allows for the safe removal of toxic fumes from these chemicals, if your equipment allows for proper disinfection by contacting all surfaces of the medical device, and if your parameters can be changed to accommodate the sterilant/disinfectant IFU.

•  Evaluate staff training and safety: Ensure your staff are trained and equipped on the appropriate personal protective equipment (PPE) relevant to the chemicals they are using. Make the safety data sheet (SDS) for each product readily available to all staff and analyze before-hand if there are any employees who have health restrictions using these chemicals and possible risks associated with any interactions throughout your process.

•  Validate effectiveness: It is also important to take into consideration the ability of your equipment and/or facility to validate that the sterilants and disinfectants have been used in accordance to their IFUs and the required time-temperature relationship can be verified by mechanical or manual means.

"I’m a firm believer that every patient should receive the same standard of care," said Strunk. "In order for that to happen manufacturers need to be sure their IFUs are readily available to any person(s) using their product. Technicians should never have to guess during any step of the process. Safety is reliant on these documents and making sure they can be accessed and are updated should be a top priority of all manufacturers."

But it is not just about the devices and instruments. CS/SPD staff must be well versed on  the sterilants and disinfectants products and modalities they are using in order to ensure effective and safe processing, according to Genti Koci, BA, CRCST, Sterile Processing Professional, Medical Staffing Options, Ohio State University Hospital East.

"Techs must understand the factors under which sterilants and disinfectants must be used to work effectively, including their required temperatures, concentrations and time frames," said Koci. "Mixing products or diluting them is considered processing outside of label and could be dangerous. Furthermore, it is a myth that alcohol is a good disinfectant. Unless a manufacturer’s IFU calls for alcohol to be used in prep and pack, it should not be used. Alcohol has adhesive qualities and helps microorganisms stick on surfaces, which makes sterilization impossible."

Efficiency and cost considerations

In an ideal world, instruments and devices would be processed through the CS/SPD without any consideration for efficiency or costs. But in today’s cost-conscious healthcare environment where most facilities are forced to do more with less, CS/SPD staff must take into consideration how sterilants and disinfectants can help them perform their jobs in an more efficient and cost-effective manner.

"Manufacturers must consult with their end users when developing products, such as enzymatics or high level disinfectants," said Williams. "They tend to test their products in controlled environments, such as a lab setting, featuring ideal conditions. But working in a hospital there are no ideal conditions — it is a very fast-paced, chaotic environment. While 10 minutes of contact time on instruments provides adequate kill, is it practical? We are a heavy ortho facility and with the items we process we don’t have the room or throughput to allow items to soak for long periods. If manufacturers took the time to gain these types of insights they could develop products to better meet our needs."

"Of course, in this economy, another driver is price and managers should understand the price of the product they are purchasing," said Koci. "When evaluating sterilants and disinfectants, sterile processing managers should work in collaboration with their purchasing departments to make sure those products are on contract."

"Cost is definitely in the back of my mind when selecting products," added Williams. "Factors such as the price and whether it is a one-time use versus multiple use product — we take those into consideration. But overall it’s what is best for the patient. If we can have a chemical that works well but may cost a few cents more than another product, obviously if it works better I have no problem eating that cost — we can justify it."

Beth Fritcher, Global Marketing Manager for 3M says ethylene oxide (EO) sterilization can provide a cost savings when compared to vaporized hydrogen peroxide sterilization. According to Fritcher, hydrogen peroxide systems are convenient when fast turnaround times are needed; however, if the device(s) being processed will not be used until the next day or later, EO sterilization can be a much more cost effective sterilization method. She points out how larger chambers with capacities of 8 cubic feet and 5 cubic feet can accommodate more instruments and there are no restrictions on the length or inner diameter of endoscope channels.

"Following recent high-profile CRE outbreaks, multiple affected facilities reported adding Ethylene Oxide (EtO or EO) sterilization to their endoscope reprocessing protocols; following the change, no further cases of CRE were identified," said Fritcher, citing recent studies. "This has many health care facilities looking at EO as a way to reduce patient risk. It has also started discussions on benefits versus risk of using EO."

Robert Dybec

With continued outbreaks of illness attributable to contaminated scopes and instruments, governmental and other regulatory agencies are taking a hard look at cleaning and disinfection practices in U.S. hospitals, according to Robert B. Dybec RN, MS, CPSN, CNOR, Nurse Manager, Operating Room, Winthrop-University Hospital. He points out that hospitals and institutions want to know exactly what enzymatic cleaners and disinfectants are being used and at what dilution rates and temperature in order reduce the risks of cross contamination.

"CS/SPDs must be cognizant of cleaner/disinfectant concentration rates," said Dybec. "Some enzymatic cleaners for example are more concentrated and require more dilution in order to obtain proper dosing requirements. Sometimes end users see these as being more expensive but when you consider that you may need to purchase more of a less concentrated product it ends up costing more in the long run. Check concentration/dilution rates versus usage to see if the product is cost-effective. Automated detergent dosing systems take the guesswork out of this critical step in processing and help the CS/SPD in being more efficient."

Coles recommends that facilities take soak time, number of rinses, reuse period, and instrument manufacturers’ recommendations into account when considering a high-level disinfectant. The shorter the soak time, fewer the rinses and higher the reuse by period the more efficient a facility will be.

PCI Medical’s GUS Disinfection Soak Station with new electric leak tester.

PCI Medical’s GUS Disinfection Soak Stations provide a vapor control system that is compatible with all high-level disinfectants and improve the disinfection process by allowing the CS/SPD to use less disinfectant while disinfecting multiple instruments at a time. The GUS TC-3, for high-level disinfecting TEE probes, now comes with electrodes on the tubes to facilitate leak testing with PCI Medical’s new electric leak tester. The electric leak tester is programmable to a probe manufacturer’s test limits, enabling compatibility with upcoming Intersocietal Accreditation Commission (IAC) leak testing requirements.

Staff safety and environmental impact

While the effectiveness of killing "bugs" is a top priority when selecting sterilants and disinfectants, healthcare facilities must also keep in mind the safety of the CS/SPD staff handling these products, as well as their impact on the environment.

"On any given day, I can come in contact with as many as five different types of sterilant/disinfectants," said Strunk. "These products, ranging from OPA to peracetic acid, all have very specific exposure times, temperature requirements and rinsing instructions just to name a few of the items listed on an IFU. Educating your staff to safely utilize these products is of the utmost importance not only to keep themselves safe, but to make sure patients are receiving equipment that has been properly disinfected and will not cause harm to them."

Balch notes how some may select the most powerful or expensive chemicals on the market thinking they are the most effective, but fail to consider the ramifications of this choice. He points out how these products usually have the greatest requirements for ventilation and safety given their chemistry.

Fritcher notes that despite the recognition of EO as a tool in the fight against endoscope-associated infections, concerns persist, often based on outdated notions of EO sterilization. She explains that much of the misunderstanding about EO today is related to the past. It was the mixed gas systems, installed in the 1970s and early 1980s (and now outlawed in the U.S.) that were a risk to the healthcare worker.

"In reality, the EO sterilization systems of today are nothing like the EO sterilization systems of yesterday," said Fritcher. "The latest systems use small, single-dose cartridges of 100 percent EO, run under negative pressure cycles with mandatory locked aeration, have sophisticated software controlled programs that detect malfunctions and, importantly, have a long track record of safe and effective use. The two newest EO sterilizers on the U.S. market received FDA 510(k) clearance this year in January 2015—the 3M Steri-Vac Sterilizer/Aerator models GS8 and GS5."

 3M Steri-Vac Sterilizer/Aerator GS Series

3M Steri-Gas EO Gas Cartridges, single-dose cartridges of 100 percent ethylene oxide, are one of the many safety features and engineering controls built-in the 3M Steri-Vac Sterilizer/Aerator GS Series, available in models with 8 ft3 and 5 ft3 chambers.

Another consideration is the environmental impact of sterilants and disinfectants. According to Coles, more and more facilities are requiring neutralization/deactivation of high-level disinfectants before disposal, with California and Hawaii having passed laws requiring neutralization.

"High-level disinfectants are still highly biocidal even after they have been used," said Coles. "Neutralizing these disinfectants prior to disposal is a very important step in protecting the users and also the sewer system and environment."

Williams notes that in Seattle, where his facility is based, environmental standards are extremely strict so the CS/SPD must be very conscious of what they are disposing down the drain.

"When we are disposing of glutaraldehyde for example, we have to use certain products because the load of these contaminants going into the sewer systems is too high — that is a huge concern," said Williams.

According to SteriPro Medical Device Reprocessing Manager Garry Bassi, the oxidative chemistry sterilant/disinfectant his facility is using (see sidebar below) does not require neutralization prior to disposal and hence is safe for the environment. SteriPro is currently working with vendors to publish white papers showing the measured fumes emitted into the environment from sterilants and disinfectants and if they comply with the standard established safe exposure values.  

SteriPro boosts efficiency, cuts costs through sterilant switch

SteriPro Canada, which performs reusable medical device reprocessing and sterilization for hospitals and healthcare centers, reduced its costs by 21 percent by switching from glutaraldehyde chemistry to oxidative chemistry as a sterilant and/or disinfectant.

According to SteriPro Medical Device Reprocessing Manager Garry Bassi, the oxidative chemistry test strips also have a longer expiration date from time of opening the bottle compared with ortho-phthalaldehyde (OPA) strips, 180 days versus 90 days respectively. By switching from the OPA strips to the oxidative chemistry strips, SteriPro reduced its costs for this product by 56 percent. He notes that the oxidative solution itself is viable for a longer period from date of opening bottle, 90 days versus 75 days for the OPA solution.

Furthermore, the oxidative chemistry solution is less toxic, requiring no special ventilation requirements versus the ten air exchanges per hour, which are recommended for OPA. SteriPro recommends all reprocessing departments in Canada conduct an assessment of their departments to ensure they have the appropriate air exchanges per hour in accordance with Canadian Standards Association (CSA).

"The switch from OPA to oxidative chemistry has also reduced the number of rinses required and facilitated a shorter soaking time. We now turn around items quicker and save on the cost of sterile water, while fulfilling the needs of the operating room priorities and maintaining patient safety," said Bassi.