ArabLab, the premier Mideast convention for laboratory equipment solutions, is gearing up for the 2010 season. In January from the 9th to the 12th the trade show will be hosted at the Dubai International convention and Exhibition Centre. Of the hundreds of exhibitors expected to attend, there are more than 40 autoclave suppliers and manufacturers represented. Several South Korean companies will be making an appearance to promote their product lines at this international event.

First up is Daihan Scientific - a Seoul based supplier of scientific products. This company was founded almost 30 years ago by Mr. Chong-Ku Shu. The corporation partners with more than 85 domestic and foreign manufacturers to offer over 25,000 different items. In 2003, Daihan began production of its own line of lab instruments as well. The company’s mission is to “serve the development of scientific technology all over the world”.

This distributor sells the Wiseclave steam sterilizer series. Models are available in sizes from 45 -100 liters. These top loading units feature casters for enhanced mobility. A microprocessor controls each fully automated cycle and the display makes all parameter information readily viewable. In addition to a number of safety features, these machines carry product liability insurance.

JISICO is another autoclave manufacturer located in the capital city of South Korea. This company has been in business since 1967. Since the sixties, JISICO has developed over 100 lab products including incubators, drying ovens and glove box systems. This corporation counts many science/engineering research facilities and industrial institutions among its customers. They offer several autoclave series including models with reactors that are suitable for high temperature and pressure applications.

Labtech has its headquarters in Kyonggi-do with secondary locations in Daejeon and Singapore. This company offers air and ocean freight shipping to international customers around the globe. Their production line complies with ISO 9001 quality control making them a viable player in the world market for lab equipment. Their autoclaves offer HEPA filtration to ensure a high level of sterility during the drying process. A self-diagnostic system monitors each cycle for any problems and sensors check for low water, overheating, and leaks.

More About ArabLab

At Arablab, solutions for analytical instrumentation, environmental sciences, bio technology and much more are on offer each year. This business show brings together vendors from all over the world to network with buyers from Africa, the Indian sub-continent, Asia, and the Middle East. Medical research is a current growth industry in many of these regions, so it is not surprising that many leading U.S. and UK manufacturers will be making the trip to Dubai this year to participate. Prioclave, Astell, and Fisher will all be presenting their wares. Thermo-Scientific is actually a platinum sponsor of the event.

Of course, you don’t have to fly halfway around the world to get your autoclave. You can find out exactly what you need from the comfort of your office. Request our free report to help you narrow down your choices for a new autoclave or sterilizer. We can help you sort through the hundreds of available options to discover what will work best for your business and your budget.

In a press release on 8 August 2009, Tuttnauer dealer BaySide Technical Services announced a ‘cash for clunker’ program to boost autoclave and sterilizer sales.  These heavy discounts for new machines with trade-ins have nothing to do with any government policy or program.  This is simply a dramatic way to call attention to a favorable customer incentive program during a severe economic recession.

BaySide is certainly not the first to take advantage of the namesake of the popular government stimulus program.  This is common practice with refrigerator dealers too. One recent addition to this sales ploy is the communication business.  The phone industry is moving toward VoIP/IP technology.  At the ITEXPO from September 1 - 3, 2009 in Los Angeles California, phone companies plan to offer this very same type of trade-in program during the conference for telephone network systems.  If it is good enough for business in these other industries, why wouldn’t it work for autoclaves and sterilizers too?

Incentive Details

Whether it is a discount or a rebate like the car program, a “clunker” deal can mean cash in the customer’s pocket. Qualifying trade-ins under the BaySide program include tabletop models with a chamber 7, 8, 9, 10, or 11 inches in diameter.  The dollar amount of the discount for a new model depends upon the age and condition of the old one.  Obviously these trade-ins will not be destroyed within a few days like the government program for cars.  Instead, these autoclave and sterilizer machines will likely be refurbished for later resale or used for spare parts.  Completely outdated parts will be recycled for materials. 

Unlike the car program, you don’t have to make less than $50,000 dollars in yearly income to qualify.  Anyone who has the right size and model type should be able to get in on the deal. There is a limit of one trade-in per purchase transaction. Unfortunately, the dealer is not accepting broken autoclaves.

The Bayside Technical Services store is located in Worcester, Massachusetts. No end date is mentioned on the press release, so there is no way to know how long the incentive will last. In addition, there is no word on whether autoclaves must be presented in person or if they can be shipped in from other states.

This incentive is separate from Tuttnauer USA’s previously announced “Twitter” coupon program.  In fact, that manufacturer’s coupon program appears to be continuing.  It is still listed on the Tuttnauer site; even though the end date is listed as 30 June 2009. The manufacturer does not appear to be participating in a trade-in program of its own at this time.

Competition is tough, especially during a significant recession.  Sales ‘gimmicks’ can have real value to the customer in some situations.  However, getting the right equipment should always take precedence over saving a few bucks. If you are about to upgrade your existing equipment, take a little time to investigate your options fully. Our free report can help you find other ways to save money in the short term and the long term when you buy your next autoclave.

So far this year, the FDA has publicized several incidents involving sterilizer malfunctions. These Manufacturer and User Facility Device Experience (MAUDE) records offer a glimpse into potential problems that can occur when certain devices are used in healthcare settings. SPD departments should watch out for similar problems when using these equipment models. Often MAUDE Adverse Event Reports are simply records of unusual occurrences. However, sometimes glitches can result in serious injury.

In March, an Eagle 3017 ethylene oxide sterilizer put a healthcare professional in the hospital. The operator opened the door of the machine after it had been sitting idle over the weekend. This model typically maintains a temperature of 130 degrees (f) while idling. The employee who opened the chamber was inundated with a rush of hot air. Exposure to the vapor caused eye and throat irritation severe enough to require a trip to the emergency room. The employee was hospitalized for observation and subsequently released.
 
This sterilizer is a product of STERIS Mexico, a manufacturer based in Nuevo Leon, Mexico. A technician was contacted to inspect the equipment following the accident. An unidentified oily substance with a strong odor was found not only in the malfunctioning unit but in all the other 3017 ETO sterilizers on site. Originally, the compressors were suspected as the potential source of an oil leak. However, these models do not feature compressors that use oil. No source or explanation was found for this contamination. The facility removed the broken sterilizer from service but continued to use the other 3 units.

Other 2009 MAUDE Reports

Sometimes, the equipment is not the problem. Earlier this year, a serious error occurred in a sterilization facility. An employee allegedly poured CIDEX biocide into the water reservoir of an autoclave. This Advanced Sterilization Product solution is not intended for such a use.

The inside of the autoclave chamber was permanently stained by the introduction of the biocide during a cycle. Fortunately, the instruments that were in that load were not distributed for use. No injuries were reported from contact with the residue from the biocide.

In April, a malfunction was reported regarding a Getinge sterilizer. An instrument tray was inside the chamber and the cycle was partly completed when the machine simply quit working. Because the cycle was not finished, the safety lock would not release. A service call was placed to fix the problem.

In the meantime, staff members were faced with a dilemma. The only two remaining trays of instruments were unsterile. Flash sterilization was the only remaining option to get a set ready for the waiting doctor. This incident brings up an interesting point for small clinics and dental offices that have only one autoclave. What happens when it breaks down and traps all your instruments inside?

Do you have a backup plan for what may happen if you experience equipment failure in the middle of a busy day? Request our free report to explore the option of increasing your fleet of sterilizers. A small investment in a benchtop model might pay for itself the next time you have a sterilization emergency.

The Department of Health in the state of Ohio has released an updated Infection Prevention and Control manual for 2009. This comprehensive document covers topics as far ranging as the management of pandemic influenza and how to deal with the threat of bioterrorism. One segment in this booklet deals specifically with issues of interest to sterile processing departments.

Section 4 focuses on disinfection and sterilization of surfaces, instruments, and equipment. The DOH divides items into 3 categories - Critical, Semi-Critical, and Non-Critical. Critical instruments are those that penetrate the tissue or vascular system of a patient. Needles, catheters and surgical instruments fall under this heading. All critical items must either be designed for single use or go through pressurized steam sterilization in an autoclave after each use.
 
Semi-critical instruments include speculums, many dental tools, and respiratory equipment. These come into contact with mucous membranes or skin that is not necessarily intact. They are subjected to high-level disinfection. The Ohio DOH has opted not to use glutaraldehydes. Instead, they prefer autoclaving for this level of disinfection also. The use of disposable products is another acceptable solution.

Thermometers fall into the category of semi-critical but are only required to be cleaned using intermediate disinfectants such as isopropyl alcohol. Thermometer sheaths are recommended as an additional protective measure. Non-critical items such as stethoscopes and blood pressure cuffs can also be wiped down with alcohol if they become contaminated. Low-level disinfectant such as diluted household bleach (which kills most viruses, fungi, and bacteria) is the standard for most non-critical items and surfaces. However, this is replaced with a stronger biocide if there is any risk of tuberculosis transmission.

Autoclave Maintenance Instructions

All DOH personnel using autoclaves must follow the manufacturer recommendations for validation. The use of chemical indicators is stipulated for individual loads. This is supplemented weekly with biological monitoring using spore strips. A control ampule that has not been subjected to autoclaving is compared to the sterilized spore sample to ensure an accurate result. 24 hour and/or 7 day incubation periods are used depending on the location. These QA documents are filed with the county health department.

Copies of all records are required to be kept on-site also. This way, if there is a problem any inadequately sterilized instruments can be more easily identified. If they have already been distributed and used, patient notification and monitoring must be carried out as well.

In addition to test results, the data for each sterilization load is also documented. This information includes the date, length of cycle, pressure, and temperature. A signature is required to add a level of accountability. Any failure to achieve a temperature of 121 degrees Celsius and a pressure of 15 psi for 30 minutes results in the autoclave being pulled from service. The instruments in the load must be reprocessed in a properly functioning sterilizer prior to use.

If you have experienced a sterilizer equipment malfunction, it may be time to buy a new autoclave. You can read our free report in just a few minutes. This small investment of your time can pay off in a big way by ensuring that you have the information you need to make a wise purchasing decision.

In April 2009, a new line of medical autoclave - the BRAVO series - received FDA approval to proceed with marketing. The new sterilization product was developed by SciCan Ltd.in Canada and is just now making its rounds in the US.  These are table top vacuum steam sterilizers that operate at high pressures. This optimizes the conditions necessary to penetrate a load and effectively kill infectious organisms in a short period of time.

The equipment’s microprocessor allows for complete automation during sterilization cycles. Instruments are placed inside a sterilization tray that readily fits inside the autoclave chamber. There are 10 preset sterilization cycle programs to choose from.  Once the cycle is selected and the door is closed, simply press the button.  This activates the chamber door locking mechanism and the selected cycle runs automatically.

Models include capacities of 17 or 21 liters.  The new autoclaves function with an advanced fractionalized vacuum system that completely removes air from hollow and porous materials during the sterilization process.  It has a dedicated and exclusive steam generator that is designed to be gentle on instruments yet effective at the same time. 

Superior processing speed and stability is maintained by the advanced control system.  The thermodynamic parameters are monitored throughout each sterilization cycle.  The convenient LCD display informs the operator of any errors and supplies guidance on how to fix the problem.  A cycle can be interrupted at any time by pressing and holding the stop button for three seconds.  Pressure within the chamber is returned to normal.  Reset instructions are displayed.  An error code for the cycle is recorded and printed out on any attached printer.

The door can only be opened manually once it is safe to do so. The drying phase of the cycle depends upon the preselected setting.  A gradual return of the chamber to normal atmospheric conditions is preprogrammed.  Once completed, the door can be safely opened for the retrieval of the processed load.

The intended market includes hospitals, clinics, and individual medical and dental practices.  Only medical and dental instruments that are heat and moisture resistant and those that are certified by the manufacturer as compatible with the steam sterilization process should be used with this device.  This autoclave was not intended for the sterilization of any liquids or pharmaceutical products.

About SciCan Ltd

The company started in 1957 as a way for its founder, Arno Zwingenberger, to introduce European podiatry products into the Canadian market.  Since then, they have drastically expanded and now supply over 5400 different products to the medical and dental community. They are currently headquartered in Toronto, Canada and have approximately 400 employees worldwide.  They do business primarily in the North American and European markets.

One of the most notable products manufactured by SciCan Ltd is the Statim Cassette Autoclave.  It is known for its rapid and efficient 6 minute sterilization cycle.  The convenient way this equipment is set up and operated makes it ideal for the dental and body art markets.  One of the primary advantages of using their system is maintaining organization of all instruments.  An added plus is that instruments can often be sterilized in between patients with little wait time. This drastically reduces the need for multiple instrument sets.

Some of these advantages were kept in mind during the design and development of the Bravo series.  It only makes sense to get the most out of what is available on the market.  Click on this free report for helpful tips in finding the best autoclave for your business.

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 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.

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.

In May, Thomasnet featured a short piece introducing Sussman’s new, high quality saturated steam “ES” boiler model. This versatile unit can be used in many industries. The company’s electric boilers are found in hospitals, laboratories, and food processing plants - anywhere pressurized steam is required. This equipment requires only electrical and water connections so installation is straightforward.

Sussman‘s machine can produce steam at pressures of up to 100 psig. The ES model features a safety valve and vessel that meet ASME requirements. It also comes with automated controllers for liquid level and pressure monitoring. Vessel components that come into contact with moisture are made of stainless steel. The fittings and pressure vessel undergo passivation to make them corrosion resistant. During this chemical process, a thin layer of oxidized/inert material is formed on the steel surface. Passivation removes excess iron molecules that could rust and flake off. 

These boilers meet UL and CSA standards. They are designed and constructed in the U.S. for both domestic and foreign markets, so the manufacturer is very familiar with international criteria for safety and reliability. Each unit is fully tested to ensure proper operation. Sussman boilers can be used with laboratory and medical autoclaves. The SSB model is specifically designed to produce clean steam. This purified, superheated water vapor is largely free of substances that can cause unwanted buildup and possible contamination in the sterilizer chamber and around the valves.

More About Sussman Electric Boilers

This manufacturer boasts a 75+ year history as a leader in the industrial boiler field. The company offers steam generators for large and small scale applications. Many models can be used for hot water creation, humidification, and booster heating. These electrical units provide clean operation since they do not require any on-site combustion process to generate heat.

All of Sussman’s boilers are designed to work with water that has 1 meg ohm-cm specific resistivity. This is a fancy term that refers to the purity of the water and its mineral content. A water treatment service company can conduct the appropriate tests to measure the resistivity of water in a particular feed supply. They can also recommend additives that will correct any alkaline deficiencies. Sussman offers the option of complete automatic blowdown systems to effectively handle the buildup of dissolved solids in the equipment. The actual blowdown and drain valves come standard.

Other standard features include a sight glass that allows the operator to visually check the water level. In addition, a cut-off device automatically goes into action if the level becomes too low for safe operation. The pilot light indicates whether or not the boiler is on and a manual on/off switch allows the user to be in complete control of the boiler’s electrical circuit. Each unit is supplied with a long lasting, industrial grade heating element.

If your company has a boiler in place and is looking for a compatible sterilizer or autoclave, check out our report. This free information covers the basics you need to know about selecting the right equipment for your facility.