Some people say any media exposure is a good thing. However, Advanced Sterilization Products (ASP) must be starting to feel uncomfortable with all the recent attention its products have been receiving. The manufacturer has been the subject of several FDA enforcement reports since October. This California based technology firm has initiated multiple recalls - each for a different product. So far, all of these sterilizer recalls are classified as level 2. This means that the potential malfunction of one of the devices in question is not likely to cause irreversible or serious adverse health problems.

The latest company recall was posted in mid-February and refers to the Sterrad 50. This model features hydrogen peroxide gas plasma technology. It is a low temperature unit specifically designed to sterilize delicate medical instruments such as endoscopes. A rapid cycle time combined with unit portability make this option attractive for many other uses as well. The manufacturer recently discovered a problem with the design that they say poses a potential (but unlikely) risk of fire. This might occur if a capacitor in the sterilizer’s vacuum pump overheats. Consumers can contact ASP to check whether or not the serial # on their Sterrad 50 unit is in the affected group.

Additional Product Recalls

FDA enforcement reports from November and December of 2008 show several other ASP products that are potentially harmful. The automatic endoscope reprocessor is one of these. This self contained equipment is designed to flush out and sanitize endoscopes for reuse. It performs this sterilization using solutions such as paracetic acid, gluteraldehyde, or ASP’s own specialty formula - CIDEX OPA (ortho-phthalaldehyde). Unfortunately, it is the residue that may be left behind by these toxic chemicals that is the cause for the FDA’s interest. Chemical burns and irritation to delicate mucous membranes have been cited as two potential concerns regarding the use of this equipment.

The Sterrad 100S and Sterrad NX have both been recalled for issues with inadequate sensors/detectors. It has been shown that the 100S may run sterilizer cycles that do not contain sufficient hydrogen peroxide. The door on this model may also continue to close even if there is an obstruction in the pathway. It is possible for an operator’s hand to be caught and pinched by the door as a result. There are over 6,000 of these units currently in use and recall efforts may prove costly. The NX, on the other hand is a model with only about 50 units in place. A defective UV lamp power supply is the culprit revealed in the October notification letter ASP sent out. This defect could potentially cause an inaccurate reading on the hydrogen peroxide monitor.

Even when consumers are reimbursed for the cost of repaired or replaced products, the down time presented by a recall can be a problem. Having access to reliable and safe equipment is a necessity for clinics and hospitals that require a constant supply of sterile instruments. To find out more about what type of sterilizer will present the optimal solution for your location, take a moment to read our free report.

Time is quickly running out for hospitals to notify the EPA of compliance with their latest ruling concerning EtO sterilizers. The May 2009 deadline applies to units installed or rebuilt before November 2006. Users of newer equipment were already required to comply by the end of 2007. This means that all U.S. hospitals should now be using these updated procedures to reduce EtO emissions. Fortunately, this switch does not mean all current users of this technology must purchase new sterilizers. Instead, the regulations set standards for appropriate use of existing equipment.

Running a full load rather than a partial one is required except when there is a medically necessary reason to do otherwise. This common sense approach is the same one most people have for running the dishwasher at home and should already be standard hospital policy. It reduces operating costs and pollution. Of course, batches must be made up of medical equipment that requires the same cycle time. On some occasions waiting to sterilize instruments until a sufficient quantity have accumulated will not be feasible. Under these circumstances it is up to hospital personnel to make the call and run the cycle anyway. Each time the sterilizer is used, a record must be created indicating the date, time, and whether or not the unit was full. This report has to be signed by a staff member noting that running a partial load was necessary. All of these files must be kept available in case the EPA wants to review them.

How To Avoid Excess Paperwork

If all this paperwork seems like a hassle, there is an alternative. An air pollution control device (APCD) can be used to reduce emissions to acceptable levels. As long as this APCD is used every time a cycle is run, the additional record keeping is not considered necessary. These pollution control devices effectively “scrub” EtO emissions that may be created by the sterilizer. This process uses a combination of absorption and hydrolysis to transform potentially harmful chemicals into virtually harmless glycols. The end product can be collected and hauled away after a sufficient quantity has accumulated. EtO scrubbing towers can be bulky. One manufacturer of large capacity units uses a design that is over 8’ tall. The purchase and installation costs can be daunting. However, these APCDs boast a removal rate of over 99% of harmful gases making them an attractive option for locations with strict safety regulations.

The EPA rule applies only to locations that focus mainly on inpatient care. Smaller clinics that treat most clients on an outpatient basis are exempt from this regulation for the time being. It is still a good idea to run as much equipment as possible in each load to save energy costs and reduce possible exposure to fumes. Although sterilizer leaks are rare, they can occur due to poor maintenance, defects, and improper use. Comprehensive operator training is one way to reduce these risks. Sterilization units should also be regularly inspected. If you find that your current equipment is in need of replacement, you can use our free report to help you locate the right machine for your facility.

Mercy Hospital of Folsom near Sacramento California was the site of a dramatically successful test of Lumalier’s TRU-D mobile room air and surface disinfection unit last year.  Since then the healthcare facility has implemented a comprehensive germicidal ultraviolet light disinfection protocol.  The manufacturer had originally claimed that it could achieve a 3-6 log disinfection of an entire room within 17 minutes without using chemicals.  Skeptical DOH officials told the company to prove their claims at the Mercy facility. Lumalier obliged.

That test proved the machine’s ability to sterilize an entire room up to or better than operating room standards.  The hospital continued to use and test the unit in other environments including a quarantined MRSA patient room that was not cleaned at all before the test.  The DOH had already collected 14 positive samples of MRSA from various parts of the room including the toilet; so they knew the room was heavily contaminated. The results reviewed after treatment showed only one colony forming unit left in the entire room at the bottom of the base of an IV pole.  Operating room standards require less than five to remain.

Similar tests were done the same day at a Sacramento sobriety cell in the County Jail with equally impressive results.  These results continued to be repeatable.  Mercy hospital quickly decided to adopt the TRU-D as part of their standard infection prevention program.

What Is Germicidal Ultraviolet Light?

There are three different types of ultraviolet light:  UV-A, UV-B, and UV-C.  Each has different penetrating ability and each has different effects upon living tissue.

Germicidal ultraviolet light is the part of the electromagnetic spectrum that is particularly effective at killing bacterial and viral agents.  No known pathogen can withstand prolonged exposure to UV-C light.  At the same time, it is relatively harmless to humans.  It has little penetration ability because it is absorbed by the outermost portions of the skin.  Only the retina of the eye can be slightly irritated by it. 

UV-C light can destroy pathogens on any surface and within tiny droplets suspended in the air.  The TRU-D is designed to sterilize 360 degrees around the entire machine.   The light can get into nooks and crannies that are difficult to reach by any other means.  This process is beneficial because more thorough decontamination in infectious environments can substantially reduce the risk of hospital-acquired-infections.

More About Lumalier

The company was founded in 1963 to develop technology that would benefit the health of people all over the world.  Their specialty has been air sterilization.  Lumalier’s experience with innovative UV germicidal products has been noticed by the Environmental Protection Agency (EPA), Federal Emergency Management Agency (FEMA), the Center for Disease Control (CDC), the National Institute of Occupational Safety and Health (NIOSH). Various peer-reviewed scientific studies have mentioned their advances toward effective control and elimination of respiratory illnesses.  

There is a growing demand for these products worldwide.  The efficacy of this equipment makes it a very useful tool in preventing further spread of airborne diseases in healthcare settings.  This company has many different UV germicidal products that are designed for specific applications.  Before you buy any machine for sterilization purposes, click on this free report for more information about making a quality decision. 

Sterilization of liquids in an autoclave can be difficult to accomplish safely and effectively. The temperature reading shows the heat of the chamber wall rather than the liquid contents. This means that the cycle time is calculated from the time that the sensor reads the appropriate starting level. At this point the liquid in the vessel may not have reached the correct heat. There is no way to tell (based on the usual reading method) whether or not the appropriate temperature is consistent throughout the load.

One way to combat this problem is through the use of a device such as the PT100 probe. This platinum resistance thermometer can be placed in a bottle within the autoclave chamber. From here it can monitor the temperature of the actual liquid contents. The temperature can be delivered to the display and the appropriate start time for the cycle can then be determined. This type of flexible probe communicates with the microprocessor on the autoclave to make operation simple. PT100 thermometers can withstand temperatures of over 250 degrees Celsius. They are an ideal tool for use in the harsh environment created by an autoclave since a load generally needs to reach 121 degrees during a sterilization cycle.

As an additional benefit, the probe also communicates the rate of cool down. The Systec equipment is designed not to open until the temperature has reached a safe level. Since the liquid load cools at a different rate than the chamber, the main sensor may not be adequate. If such a load is exposed to the outside air while it is still above 100 degrees Celsius, it can create several hazards. Contents may boil over, steam can rush out, and glass vials/bottles may crack or even explode. Basing system readings on the actual liquid temperature via the probe eliminates this risk. The autoclave is then programmed not to open until these specific contents can be safely accessed. The PT100 thermometer can be calibrated to meet the National Institute of Standards and Technology requirements for reliable accuracy.

More About Systec

This manufacturer has been in business since 1994 and is based in Germany. Systec (GmbH Labor-Systemtechnik) focuses on developing and marketing steam sterilization and media preparation equipment. They value feedback from their customers and attempt to couple innovation and quality with cost efficiency. Making autoclaving in laboratory settings safer and simpler are two of their stated goals. Many of Systec’s equipment designs are modular. This allows them to be upgraded easily as technology changes.

Onsite service is only available in Germany, but the sterilizers themselves are sold all over the world. Authorized distributors receive training and support directly from the manufacturer. The company provides units to labs and research institutes in the public and private sector. These autoclaves are produced to meet strict standards in Europe and the U.S. including those of the ASME (American Society of Mechanical Engineers). If you have a lab or research facility in need of a steam sterilization unit, review this free report to discover if one of the models from Systec can meet your requirements.

Germgard Lighting LLC claims to have developed and patented a new, extremely fast surgical instrument re-sterilization system.  This could revolutionize the sterilizer market.  It represents such a quantum leap in the relevant technology that news stories are sweeping the internet.   This six minute sterilization system has captured a lot of interest. Such a piece of equipment would create a huge potential for cost savings. It would also deliver increased treatment efficacy.

However in many reports, there has been an unfortunate lack of detail in the description of the product in question.   Most of the available information focuses upon the generalization that this method is unique and that the company is in excellent position to take advantage of it.  The New Jersey based company stresses the benefits of a short cycle time in comparison with other room temperature and gas sterilization techniques.  They point out that this feature could save billions of dollars for large healthcare facilities, military field hospitals, and ambulatory surgical centers.
 
Germgard has developed (in the past) an ozone generation process that can be used for quick surgical tool sanitation.  When they combined this procedure with an ultraviolet light treatment, synergistic effects help destroy virtually 100 percent of any potential pathogens in just a few minutes.  Both the ozone and the ultraviolet light can penetrate into smaller and more delicate features of instruments than other gas and steam sterilizers can normally do. Simply put this emerging technology does a better job. Short cycle times at or near room temperature causes less wear and tear on devices being disinfected.

These are exciting claims.  Verification that the process works as well as the manufacturer says could trigger drastic changes in how standard sterilization procedures are performed in most healthcare environments.  It seems to do what most thought was impossible just a few years ago. The equipment is slated for availability at a price similar to that of many comparably sized autoclaves.  Consumers interested in the advantages of quick turnaround of critical instruments will no doubt be first in line to buy.
  
Conservative caution is warranted.  Even Germgard says that they would not replace their ‘old steamy’ until this has proved itself admirably under real life everyday working conditions.  Immediate practical applications will likely include those that will simply enhance the current decontamination system.  The transition to any possible total replacement will likely be gradual.

About Germgard

This privately owned start-up company has several patents pending related to sterilization.  Their hand sanitizer is a shoe box sized device that uses UV-C light to remove 99.99% of all pathogens from the surface of bare hands without any irritation in as little as 3 seconds.  Their patented instrument sterilizers have already been mentioned.  They also have an indoor air sterilization system patent pending. 

The founder (Dr. Eugene I. Gordon) has an impressive world renowned background in science and engineering.  He has successfully worked in a number of other industries including semiconductor lasers and fiber optics.  Dr. Gordon has held high profile positions at a number of big named companies, such as AT&T and Hughes Aircraft.   He has also founded a number of other emerging technology businesses.  Co-Founder (Peter E. Gordon) has 10 years of semiconductor and photonic industry experience.  He is also a registered Washington lobbyist for those industries.

Germgard’s specializes in solutions for the medical industry.  They invent, develop, and market cutting edge technology adapted toward sterilization.  Their goal is to partner themselves with others around the world to successfully and rapidly manufacture and distribute their sterilizers.  For more information about autoclaves and sterilizers click on this free report.