This March, the Muskogee Community Hospital opened in Oklahoma. As a brand new healthcare facility, it demonstrates a fundamental shift in the focus of care. Instead of simply being a location for treatment of disease, its mission now encompasses a much broader scope. The hospital was designed at a fundamental level to exist in a healthy balance with the environment.
 
One feature that stands out is an HVAC system that runs solely on geothermal power. The UV air sterilization technology used in conjunction with this heating/cooling machinery is designed to make it even more energy efficient. Steril-Aire UVC lamps reduce the buildup of bio-film on drip pans and coils. This keeps each HVAC unit running in good condition for longer- reducing maintenance costs.

Of course, the main purpose of the purification system is to reduce the pathogen load present in the air supply. Hospitals have always presented a risk of infection to susceptible individuals. Every sneeze and cough propels bacteria and viruses into the indoor atmosphere. These bugs can easily remain airborne long enough to spread throughout the entire facility through the ventilation system. Even otherwise healthy hospital staff often succumbs to this constant exposure to germs.

In addition to HVAC mounted units, the Muskogee hospital is also using a more direct sterilization approach for critical areas. Each surgical suite and procedure room features high intensity UVC lamps that can be switched on after hours when the rooms are unoccupied. These devices kill pathogens on surfaces as well as in the air.

The process does not create any hazardous waste or byproducts. Unlike aerosol sterilizers, with UV lamps there is no waiting period required prior to reentry into a room after a “cleaning cycle”.  This is because there is no active chemical being used as a decontaminating agent. Simply switching the equipment off makes it safe for personnel to go about their business.

Although the UVC radiation used in these devices is not linked to cancer, staring at a lit bulb can cause significant eye irritation. The lamps installed in these operating rooms are unshielded. This is necessary in order for them to perform their function as surface sterilizers. It is also the reason that the units can’t be run while the rooms are actually being used. Fortunately, the UV treatment in the HVAC system acts as a handy back up by keeping the air quality high 24/7. This minimizes the overall risk of infection during operations.

More About Steril-Aire

This California based manufacturer launched its ultraviolet air cleaning line in 1996 after extensive experimentation and testing. They currently provide this product line to the business, residential, and healthcare sectors. In May, the company launched yet another UVC kit with a patented Emitter™. This device can deliver up to six times the amount of light intensity provided by other brands (according to independent test results).

Each link in the sterilization chain is important when it comes to keeping your facility clear of contaminants. If you need to find the best in autoclave and sterilizer technology, request our free report.

In May of 2009, Sartorius Stedim Biotech announced a new disposable sterile connector that joins two pre-sterilized components normally used in the biopharmaceutical manufacturing process. The purpose of the device is to prevent contamination while supporting the flow of sterile fluid from one component part to the next. The Opta SFT-I connectors do this by creating a 4 step sterile fluid path. This includes the proven barrier system method combined with other well tested features that ensure reliability.

The Opta SFT-I is 100% integrity tested after sterilization by both gamma irradiation and autoclaving. The connector is durable within the confines of its intended single use purpose. It’s built for the highest quality assurance of sterile fluid transfer during critical applications. This disposable device offers an efficient way to implement platform technology for a wide range of tasks.

The Opta connector is comprised of a male and female coupling body.  It can be assembled in a number of configurations that included 1/2″, 3/8″, and 1/4″ hose barbs. This means it can connect various sized and types of tubing. The unit is designed to promote integrity and stability during operation of the components that it joins together.

More About Sartorius Stedim Biotech

The company is part of the much larger Sartorius Group. Sartorius Stedim Biotech is headquartered in Aubagne France and employs approximately 2300 people. 368 million Euros were generated in sales revenue for fiscal year 2008. They own multiple R&D and manufacturing locations in Europe, North America, and Asia. Sartorius also boasts a global network with a worldwide compliment of subsidiary sales companies.

Their business model is primarily geared toward the development of viable solutions for biopharmaceutical industry production.  Sartorius Stedim Biotech provides cutting-edge equipment and services that deliver quality assurance and integrity during the manufacturing process. They focus on purification, filtration, fermentation, and fluid management as integral steps within a larger assembly progression. The company’s expertise is applied science in a sterile manufacturing context.

Sartorius is highly progressive in its approach to developing and implementing new, vital technologies. The company strives to meet the demands of each customer while adhering to all regulatory requirements. This corporation also believes in an integrated community approach that takes into account the needs of society and potential environmental impact as it relates to their business model.

Their website quotes, “A chain is only as strong as its weakest link”.  This probably best describes both the focus of their business and how they conduct their interactions with their customers. It is also the philosophy they aspire to when seeking out the best choices in possible business partners. Elimination of failure is one of their stated goals.

As a customer, you deserve the best product available in every context. You need access to reliable equipment. This is especially important in the pharmaceutical field where ready availability of sterile items is an absolute necessity.  If you are looking for just the right sterilizer or autoclave for your research or production facility, click on this free report for quality information.

In May, the Primus Sterilizer Company received notification that their 510(k) application has been approved by the FDA. This means the updated PSS5 autoclaves can be marketed in the U.S. as medical devices. The manufacturer has classified these sterilizers as Class II equipment for use in hospital, surgical, and laboratory settings.

These newest models are substantially identical to previous versions as far as materials, construction, and software are concerned. They simply incorporate a larger chamber size. The M series can actually be installed in such a way that a filled cart will roll in and out with ease.

Vertical and horizontal doors can be selected on many of these units. Pneumatic power is standard on the larger sized machines for horizontal sliding doors. Pass-through door configurations are available upon request. Primus is also offering optional carbon steel doors (ASME approved) as part of this latest FDA approved product line.

In addition to meeting AAMI/ANSI/IEC standards, the manufacturer conforms to UL codes for safety. The software provided with each PSS5 sterilizer is designed to provide several fail-safe features. It immediately warns the end user of any malfunction. If appropriate sterilization parameters are not met, computer signals alert the operator to the failed cycle. Quality assurance at the Primus factory includes final product testing of each of these systems to ensure that they are in working condition before the unit is sold.

The product design for the new PSS5 models has also been fully tested for the ability to kill pathogens. These autoclaves achieve a Sterility Assurance Level (SAL) of 10-6. Third party testing was used to verify these results. As long as the equipment is maintained and operated correctly, hospitals and clinical facilities can rest easy about the capabilities of this equipment. Appropriate biological and chemical indicators should still be used to validate and release loads according to industry standards.

Product Use

Medical Primus sterilizers are suitable for both porous and non-porous loads. A change in chamber size can affect loading protocol. This means it is important for technicians to review their processes to prevent wet loads. All personnel using the autoclave should be required to read the instruction booklet. Primus recommends that the factory set cycles not be altered. Users who wish to alter these settings should contact the manufacturer for advice.

The laboratory models in the PSS5 line (G.1-L and M-L) can be used for media prep. These liquid pasteurization cycles should only be used for their intended purpose. The manufacturer warns specifically against using these low temperature cycles for sterilizing objects such as surgical instruments.

Multi-functional units can be used for high temperature vacuum sterilization and are available in the G.1-M and M-M models from Primus. The general purpose autoclaves from this company also offer a Test/Vac cycle for regular equipment validation using Bowie-Dick tests.

If you need a sterilizer or autoclave, you have a lot of potential choices. A number of brand new models are hitting the market and you need to know what is available. Our free report can assist you in looking past the advertising and deciding which functions you really need.

At the 2009 ACHEMA show, Fedegari showcased the new FOB4-TS series of horizontal steam sterilizers.  These units are designed for compact and easy installation.  They have similar capabilities as those of the new FOB TS tabletop series. However, they feature a larger average load capacity. Ergonomic design makes this product conveniently functional.

Currently there are two different versions of the machine available for purchase. The FOB4-TS has a single door access with a 150 liter load capacity. The FOB4S-TS has a double door access with a 210 liter load capacity. A bioseal flange is standard for the unloading side of the double door version.  The loading door (or side 1) of the FOB4S-TS can be fitted with the bioseal flange upon request.  Both doors can be fitted with a special double sealing flange that is appropriate for safety level 3 or higher applications.

A user friendly touch screen makes this equipment easy to operate. No special knowledge is needed to fully access the interface.  Their new PLC process controller can handle the cycle demands of virtually any application.  Required parameter and performance information can be tracked and fully validated for safety purposes.  These machines are built for versatility as well as high performance. 

Automatic door opening and closing are part of the management system built in with the software.  Cycle diagrams, process data, auxiliary messages, and alarms make operation of the device reassuringly idiot proof. Modular features within the design provide flexibility for the end user.  All parts are in-house tested to ensure product safety and reliability.

About Fedegari Autoklaven AG

Fedegari Autoklaven AG was established in Lugano Switzerland in the early eighties. Their specialty was (and still is) the development of compact laboratory sterilizers that can be used in the field by the German and Swiss Armies and Civil Defense services. Since then, they have continued to supply state-of-the-art steam sterilizers for various laboratories, research institutes, pharmaceutical companies, food industry, and biomedical businesses all over the world.

They maintain an up to date factory in Bedano Switzerland (along the central southern border with northern Italy) that has about 3500 square meters of space. A specialized production unit called the Canton Ticino (CH) was built in 2000. It produces the latest high technology laboratory autoclaves. These machines are noted for their reliability and versatility.  The company is known throughout Europe for its high quality standards. They also have an experienced international team establishing a foothold in the worldwide marketplace.

Fedegari has developed its own application software for use with its product line.  Sophisticated control systems allow these sterilizers to comply with the strictest GLP/GPM requirements and standards.  The company has the ability to customize their systems for their client’s needs. They pride themselves on these bespoke solutions and excellent customer service.

Any sterilizer or autoclave purchasing issue can be solved if you have the right information. You need to know what your options are and be aware of any potential pitfalls.  Click on this free report for valuable tips that can help streamline your decision making process.

In June, Belimed’s Technick GmbH division made the “Top 100” list for small to medium sized businesses in Germany. This sterilizer manufacturer is being recognized in the areas of innovation-friendly management, marketing, and processes. Former state premier of Baden-Wurttemberg, Lothar Spath, presented this award at an official ceremony on 6/26/09.

The contest is in its 17th year and there were 319 competitors this time around. Being in the top one third may not seem like a big deal; but upon closer inspection Belimed’s numbers aren’t bad. In the two year period from 2006 to 2008, the parent company in Switzerland saw an increase in revenue from 89 million to 130 million Euros. This success is due in no small part to its German based research and production center.

Belimed Technick GmbH employs about 130 people and a significant number of them appear to be directly involved in the innovation process. The board of directors is well represented during brainstorming sessions along with the heads of each department and relevant senior managers. They provide the initial suggestions and set primary goals.

Next, the in-house Research & Development team takes over. These sales and marketing personnel, product managers and directors further define the objectives. This larger group is responsible for getting the ball rolling when it comes to the practical operational aspects of planning and implementing new features.

The company also credits its client base for some of its improvements. This manufacturer fully engages customers in the product development process. The R&D teams use this approach to effectively tap into a valuable resource that many businesses ignore. There is a risk involved in basing major changes on client feedback, but this strategy appears to be working out for Belimed so far.

Securing this recent award will no doubt boost the company’s confidence in its current strategy. Being flexible and addressing challenges in a direct manner certainly played a role in Belimed’s placement in the Top 100 this year. On average, the winners in this category used technical and operational advancements to reduce operating costs by 12 percent. In a shaky economy, the ability to remain profitable will no doubt depend more and more on this type of fearless initiative.

Company Profile

Belimed has its corporate headquarters in Zug, Switzerland. There are 11 subsidiaries in North America, Asia, and Europe. The company’s entire workforce totals over 800 employees. Authorized distributors span over 50 countries. This manufacturer specializes in the steam sterilizer and washer/disinfector field. These products are popular in hospitals for instrument processing. Bio-tech and pharmaceutical clients also make use of this equipment in research and production.

Currently, not all of Belimed’s newest sterilizers are FDA approved. 510(k) clearance is required before these medical grade devices can be marketed in the U.S. This review process can be lengthy. However, since the company has already been through it in the past they will no doubt be able to succeed in achieving approval for their new models as well.

If you are looking for an autoclave or sterilizer, find out which models are currently available for purchase. Our free report can help you understand the requirements for your application and how to get the right autoclave.

Radical, an innovative UK company, has developed a sanitization system for the food processing industry based upon water oxidation.  Their machine creates high concentrations of ozone in a dedicated water supply. The process then goes on to create hydrogen peroxides and hydroxyl ions.  These substances are powerful biocides that dissipate readily after the decontamination of target surfaces.  This new, viable and cheap alternative to chlorine based methods was featured in Food Quality News in May of 2009.

It is a highly effective method for killing harmful microorganisms that are associated with common food borne illnesses.  Some of the bugs destroyed include salmonella and e-coli bacteria.  In addition to all sorts of bacteria, it will eliminate viruses, yeast, and molds.  Getting rid of these pathogens vastly improves hygiene wherever this device is used.

A powerful electric current is passed through water to create unstable forms of oxygen.  Precautions are taken so personnel do not breathe in any ozone generated during this process.  Most of the O3 is used in the formation of more efficient biocide chemicals (such as H2O2) that then actively react with any biologic agent present.  These are so powerful that they will not linger in the environment for long periods of time.  This makes surfaces or objects processed with this method safe to handle after a short waiting period.

Some advantages of Radical over traditional chlorine based systems are its:

- Speed
- Effectiveness
- Low Cost
- Ease of Operation
- Eco-Friendly Design
- Odor Eliminating Capability

More About Radical And Its Clients

Radical Steritrox Ltd is based out of Stockport just southeast of Manchester England.  They have a number of sales offices that handle regions throughout the entire UK.  The company pioneered this method of sanitization without the use of chlorine in 2004. They call it Steritroxing and now have a full line of many different products to handle various client needs.

A number of trials have been performed throughout the UK food industry.  Independent analysis has also been conducted by the Campden and Chorleywood Food Research Association and Manchester University.  These studies assessed the efficacy of this method to eradicate 8 major targeted organisms including listeria. After 3 continuous years of these trials, no problems have been identified.  The method is extremely efficient and effective.

In November of 2008, it was announced in a press release that Hartley Farm Foods had installed this Radical water system for sanitization at their Nelson Lancashire production facility.  Executives and management at the Hartley farms expressed their opinion that this is the most advanced sanitizing system available on the market today.  They plan to use it during all their food processing.

At a major Midlands food processing facility, 1800 cubic meters of space was completely sanitized in less than an hour.  This was done without the application of expensive and dangerous chemicals.  Prior to the use of Radical’s water based sanitization system at that site, the food company had experienced a major outbreak of listeria.  The new system resolved this contamination issue - hopefully for good.

If you need a sterilization system and you are interested in safe, proven products, click on this free report. It can help you make the right choice for your facility.

In a press release in December of 2008, ASP (Advanced Sterilization Products) announced a new product line that would eliminate the need for manual cleaning of endoscopes. EVOTECH^TM is the first available automatic endoscope cleaner and re-processor on the market. In February of 2009, ASP announced an update. 60 units had already been delivered in little more than two and a half months.

The company has already received a high level of positive feedback on the new system from the surgical centers to which it sold the equipment. The automatic cleaning system clearly operates at high standards that meet or exceed the professional guidelines for manual cleaning.  Risk associated with human variability in the cleaning process is greatly reduced if not eliminated.  Results are consistent and predictable.

Hands-free operation makes the device convenient to use and safe. The integrated minimum effective concentration (MEC) monitor limits the possibility of any exposure of personnel to the high-level disinfectant. Readouts assure that the endoscopes are processed properly.  Automatic leak testing both before and after cleaning ensures that the endoscopes are in proper working order.  An alcohol flush cycle promotes thorough drying of these sensitive instruments. An alarm alerts staff when the cycle is completed in 33 minutes or less.

Heat sensitive semi-critical endoscopes (those sensitive to temperatures greater than 60 degrees Celsius) can be cleaned with EVOTECH^TM. This is accomplished using the high-level disinfectant CIDEX® OPA concentrate solution and an enzymatic detergent.  Redundancy in the cleaning process is necessary to reduce the possibility of infection.  The safety features on this machine are a welcome addition for the technicians who are responsible for cleaning endoscopes. 

It is important to note that EVOTECH^TM does not eliminate procedure room bedside precleaning.  The system has several cycle selections.  Manual cleaning is only eliminated when a wash stage is part of the cycle. When the cycle selection is for Disinfect only or Disinfect/Alcohol Flush Cycle, prior hand cleaning is required.  EVOTECH^TM is a specialized instrument washer that can only do a proper cleaning job when operated according to directions.

What’s New At ASP?

Being a division of Johnson & Johnson, ASP has lots of things happening.  From time to time they hold seminars about staying current in this field of study.  The training event was on May 17, 2009. It focused on EVOTECH^TM and the initial results from the CLEANR (Clinical Evaluation and Assessment of ENdoscope Reprocessing) study. This study evaluated the effectiveness and variability of various endoscopic reprocessing methods currently used in clinical practice in the United States.

Repeat recalls on the STERRAD NX and 50 systems have been a recent source of embarrassment for the company. Fortunately, there has been nothing but positive feedback and news about their EVOTECH^TM System.  Hopefully, ASP will continue to rebuild consumer confidence in the high quality of their products. Keeping customers happy is the only way to stay in business in these hard economic times. 

You deserve the best quality equipment that will perform when you need it most.  For valuable information on the selection of a sterilizer or autoclave click on this free report.

In May, MD Publishing featured an excellent IAHCSM article on how Sterile Processing and Distribution departments can “go green”. The article notes that healthcare is among the top 5 energy consuming industries in the U.S. Approximately 2.4 million tons of waste are generated annually by this industry and many of its unsafe byproducts end up in our water supply. Finding eco-friendly sterilization and autoclaving processes would certainly improve this situation.

It makes a lot of sense for healthcare providers to seek to reduce their environmental impact. After all, there are indications that the rates of many types of cancer, birth defects, and other harmful conditions are increased by high pollution levels. The overall health of the planet is the greatest indicator of the quality of life its inhabitants can expect.

The main focus of the IAHCSM (International Association of Healthcare Central Service Material Management) piece was regarding purchasing decisions. They partnered with Practice Greenhealth in recommending a reduction in the purchase/use of several chemical components frequently used in sterilization/decontamination.

The list included glutaraldehydes, aerosol propellants, and ethylene oxide. These three substances contribute significantly to environmental degradation and/or are directly harmful to humans. The issue of disposal was also addressed since many facilities do not have a formal process in place for handling certain hazardous waste products.

“Green” Autoclaving

One sterilization product that did make the cut as being eco-friendly was the autoclave. Of course, reducing waste by cleaning and reusing instruments instead of simply throwing them away is the most obvious purpose of autoclaving. Additionally, pure steam doesn’t create toxic byproducts, it is just water. For items that can withstand high levels of heat, this is the way to go.

There are purchasing decisions that can affect the environmental impact of a steam sterilizer. For example, some manufacturers build in water conserving features (usually in the cooling system) that reduce consumption. Buying the right capacity of autoclave should also be an important consideration for every customer. If you buy a unit that is too small, your SPD department will have to run it more frequently just to keep up with demand. If you purchase a machine that is too large, you will waste energy by running loads that aren’t full.

That brings us to the third aspect of “green” autoclave function - operator training. One big energy, time, and water waster in SPDs is the dreaded wet load. Most of the time, incorrect loading, improper wrapping, and/or inadequate cooling cause this problem. When a tray of instruments shows signs of moisture after a cycle, it has to be completely re-sterilized. Proper education is the key to reducing this type of costly error.

Training is also one way to keep employees safe if a chemical based sterilization system is used instead of a steam autoclave. Hydrogen peroxide and ethylene oxide are both caustic substances that can pose a health risk if exposure occurs during equipment operation.

If you are thinking about your next sterilizer purchase, ask for a copy of our free report before you leave our website. It takes only a couple of minutes to read and can give you a good idea of what options will work best for keeping your facility clean and green.

AORN (Association of PeriOperative Registered Nurses) held its 56th Congress in Chicago in March 2009.  One of the topics of discussion was the correct way to use sterile count sheets with surgical instruments.  Chemicals used to make the paper and toner could potentially contaminate instruments during the sterilization process. Theoretically, this might pose a risk to sensitized patients.

One existing recommendation regarding this process was that “…sheets should not be placed inside wrapped sets or rigid containers”.  The current concern is that ink can be transferred whether the sheets are inside the containers or attached to the outside.  Procedures need to be in place to minimize the risk.  The online group responsible for this discussion may indicate necessary changes in future updates for AORN recommended standards and practices.

This is a special point of interest for AORN because they have for years been recommending the use of this method (using count sheets) for keeping track of instruments during surgery. There must be strict accountability for all equipment inside any operating room. The purpose of these count sheets is to keep surgeons and other OR staff from leaving items inside the patient.  This simple method for counting sterilized instruments can significantly reduce the risk of such a mistake. The ultimate goal is to prevent embarrassing and costly medical malpractice lawsuits.

A potential solution to the problem of chemical contamination is folding the paper so that the ink is on the inside and poses less of a risk of transfer. A second solution that has been tried is placing a sterile towel on top of the set before putting the sheet on top of it.  A third and perhaps better option has been to place the sheet inside its own sterilization bag.

Not having the sheets would present a far greater risk than that posed by the transfer of chemicals or ink.  Each department has handled the problem differently over the years.  Now it is possible that standardization of a proven method may be just around the corner.

About AORN History And Publications

AORN is the national association of OR nurses. It was formed from previous local and regional nursing organizations that existed between 1916 and 1949. They held their first national conference in 1954 and called it a Congress.  The group established the AORN Journal in 1963. Sterilization procedures and aseptic maintenance is one primary focus of this organization.

In 1965, The Standards for Administrative and Clinical Practice in the Operating Room was first published.  This publication’s name was subsequently changed to Perioperative Standards and Recommended Practices. The 2009 edition of these guidelines is now available online through the AORN website. It can be downloaded in Adobe format. Members, of course, receive a discount when purchasing this handbook.

Educating your staff about the proper methods to use during the sterilization process is important. These safety measures help ensure the controlled setting necessary for each patient to have the best chance at full recovery.  For optimal patient care, you also need the best equipment. If you are looking for sterilization or autoclave equipment that fits the budget of your organization and the needs of your patients, click on this free report for guidance.

Yesterday, the Association for the Advancement of Medical Instrumentation (AAMI) issued a press release regarding steam sterilization. Their upcoming new publication will cover 26 specific additions/revisions to existing ST79 guidelines. Copies of the amended standards are expected to be available in published form by early August at the latest. Customers who have purchased the previous version will be able to download the updates via PDF without having to pay an additional fee.

These new standards will focus in part on chemical indicator (CI) use. There are now 6 classes of CIs that can be used in steam sterilizers. Class 1 indicators are very basic and merely distinguish whether or not a particular item or load has been run through a sterilizer. They don’t measure the specific parameters of a cycle. Class 2 CIs are used to monitor the integrity of an autoclave’s vacuum system. They react to air in the chamber and allow the operator to easily detect leaks and pump failure. This is often referred to as a Bowie Dick test.

Indicators in classes 3 and 4 monitor single and multiple cycle parameters respectively. They can be used to measure temperature and/or length of exposure. Many hospitals turn to class 5 indicators (also called integrators) as a substitute for biological indicators for day to day validation. This eliminates the waiting period necessary for culturing BI test results.

The newest level of indicators are referred to as Class 6. They are designed to be the most accurate CI on the market for use in steam sterilizers. However, because they were so recently developed, there is some confusion over the appropriate uses for these testing devices.

AAMI has not yet reached a consensus on any guidelines for the Class 6 CIs. The organization’s revised publication is designed simply to bring this new option to the attention of the Sterile Processing and Distribution community. The current revision does outline what steps personnel should take when a CI shows a “positive” result. The ST79 is being continually updated, so look for more information on this topic once the Steam Sterilization Hospital Practices Working Group has hashed out the details and decided on a final recommendation.

Additional Issues Addressed

Risk analysis is another topic of interest in the updated ST79. Since there is no perfect system, it makes sense to fully assess each sterilization process and all equipment to identify possible future points of failure. Having a protocol in place for handling the aftermath of an error or system breakdown is essential. Trying to come up with a sensible plan on the spur of the moment just doesn’t work. It takes careful planning to cover all eventualities. This applies especially to the potential legal consequences of accidental distribution of unsterile devices.

The AAMI is also addressing testing for flash sterilization and rigid container use. All of these updates are designed to make it easier for SPD techs to do their jobs well. Similarly, our free report is created to help hospital and lab equipment procurement agents make smart decisions. Save time searching for the best autoclave for your facility by reading this guide.