On February 12, 2009, the FDA held a public workshop on the topic of unique device identification (UDI) in the medical community. The Amendment Act of 2007 mandated the use of such identification systems but the practical details are still being worked out. The gathering in February focused on a number of questions that need to be resolved. The eventual outcome should help healthcare facilities fully integrate this device tracking concept into their everyday workflow. Discussion revolved around such issues as where on each device the identifying mark would be placed (a major concern with small items such as needles). Also covered were considerations regarding what information the UDI should contain and how the related databases should be structured and maintained.

One goal of a device tracking program is to increase patient safety through accurate record keeping. Defective products can be traced and recalled much more easily using this type of technology. Other benefits of UDI include greater inventory control and the ability to keep equipment expenditures to a minimum. It has also been suggested that such a system can be used to display MSDS information and compatibility with other devices. Creating a single standard will make it possible for manufacturers, distributors, and health facilities to share data quickly and effectively.

Benefits For Sterile Processing & Distribution

UDI is of special interest to SPD departments because it delivers the ability to scan instruments each time they go through an autoclave cycle. This will permit technicians to track the number of times each item has been reissued. Metal instruments can even be etched with an information based indicia or 2-D barcode. Such a matrix based code can contain many times the amount of information available through standard barcoding. RFID technology has also advanced significantly. Now, there are chips being produced that can withstand the harsh environment of a steam sterilization unit.

At this time, the FDA has not selected a specific method for UDI. It is up to each facility to make this decision independently. Good sense does dictate that health providers choose platforms and processes that will integrate easily with a universal system in the future. Many interested parties are heavily promoting the GS1 standards. This organization is a global logistics and asset management leader with over 30 years of experience in supply chain tracking. The Health Industry Business Communications Council (a non-profit organization) has also been mentioned favorably in connection with UDI system development. This group advocates educating healthcare providers about ways they can utilize new informational technologies to streamline various processes.

A proposed ruling by the FDA on the topic of UDI is expected by the end of 2009. A final rule is anticipated sometime in 2010. Since implementation of new standards will take time, it makes sense to begin reviewing internal processes now. This will make it much simpler to upgrade existing systems once firm regulations are established. SPD personnel should be involved in the decision making process regarding the marking of reusable medical devices.

To find autoclaves and sterilizers approved by the FDA to be marketed in the U.S., request our free report.

In January of 2009, Isogen began using its advanced sterile processing technology to help fill a gap in the injectable manufacturing market.  They opened a small scale sterile filling service plant in Delaware to fulfill the needs of the pharmaceutical industry.  It now provides Good Manufacturing Processes (GMP) for vial and syringe filling.  The primary purpose of this new business venture is to meet specific customer requirements in contract manufacturing.

This phase 1 facility addresses process and capacity problems normally encountered in low-volume clinical and early stage commercial sterile filling applications.  This market segment is estimated to be worth about 2 billion dollar a year. Often, the small manufacturers lack the breadth of expertise to accommodate the complicated needs of this biopharmaceutical market.  Since this relatively small niche in the overall market is less profitable than large scale commercial filling, the big players tend to stay away.

100 million dollars and 4 years of development are usually required to develop the necessary sterile capacity for a given product.  This is a huge risk and investment considering that regulatory approval of the candidate drug in question may not ever happen.  In other words, the effort could potentially be a huge waste of time and money. The reluctance of companies to expend that kind of capital over an extended period of time is understandable given this level uncertainty over the outcome.

The processes that Isogen has developed create flexibility in their effort to meet the needs of each customer.  They are currently incorporating isolator barrier technology into each of the seven manufacturing suites at the plant. This will allow both potent and non-potent compounds to be handled according to the highest standards.  This isolator technology has won the endorsements to be used in aseptic manufacturing by both the European Medicines Agency in 2003 and the U.S. Food and Drug Administration in 2004.  It is scheduled to go online sometime this year at the Delaware facility.

More About Isogen

Isogen strives “to improve product quality and speed product to market, while enhancing product robustness, scalability, and economics.”   They also seek to be “partners of choice for outsourcing of sterile filling” for clinical and early stage commercial manufacturing.

Their advanced isolation and containment technology offers an integrated approach to safely handle most therapeutic compounds including live viruses and cytotoxics.  Their multiproduct capability allows the streamlining of the process required for getting injectable medicines to market in a timely manner.  The company strives for full transparency during testing and manufacturing operations.  They even encourage in person presence by the customer during these activities.

The highest levels of containment and contamination control are maintained because of the fully segregated filling suites at the facility.  The design promotes safety for both operators and products.  The modular cleanroom design was integrated into the building shell itself.  This smart move saved 8 weeks and 10 of thousands of dollars in construction costs.   The modular approach also made the rooms an effective barrier while allowing them to be demonstrably more cleanable than otherwise.  

Speaking of third party sterile processes, there are still many facilities that routinely send instruments and other materials out for sterilization. However, the cost of purchasing an autoclave for on-site use is much less expensive than the price tag for a full manufacturing operation like the one mentioned above. Now may be the time to invest in a steam sterilizer to handle day-to-day functions in house. Check out our free report to find out which cost effective solution is right for you.

In April, the Certification Board for Sterile Processing and Distribution (CBSPD) issued a helpful news update regarding chemical indicators. One of the organization’s members was concerned that appropriate testing procedure were being set aside in favor of expediency. Nancy Chobin (RN) sent a communication to the FDA to clarify the current standards. In her message, Chobin revealed that several health facilities had been asked to use Class VI indicators to release all load types. This is in contrast to accepted practices of using spore strips to do equipment validation and implant sterility verification.

The manufacturer’s documentation listed the product (apparently the STERIS SixCess chemical indicator) as being appropriate for all these purposes. In addition, Chobin stated that a sales rep represented this product as being cleared by the FDA for use as an adequate replacement for biological indicators. She found this statement troubling and decided to reach out to FDA contact Dr. Sheila Murphy for answers.

Dr. Murphy sits on the AAMI Sterilization Committee with Nurse Chobin and is chief of the Infection Control Devices Branch. This makes her uniquely qualified to answer questions regarding the standard use of indicators. Her response was clear: The FDA has not approved any chemical indicator (CI) to be used in lieu of a biological indicator (BI).

It is a normal practice at many hospitals to use CIs to release standard loads containing instruments and other items. That is not considered a problem. However, these indicators measure only the physical cycle parameters (heat, length, etc). In the case of specialized loads that include implantable devices, best practices still dictate the use of both a BI and a CI. The CDC and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) agree on this point. As with implant sterilization, the longer wait time for receiving the results of a spore test is justified for equipment qualification as well.

More About CBSPD

This non-profit certification board handles examinations for technicians who perform sterilization and disinfection activities. CBSPD creates and administers these competency based certification programs to meet international standards. Since 1991, this New Jersey based company has issued credentials to almost 20,000 individuals around the world. The National Commission for Certifying Agencies (NCCA) has accredited the Technician, Supervisor and Manager programs.

Initial and ongoing education in the sterile processing field ensures that the public is protected from unnecessary exposure to pathogens. CBSPD certification offers a measurable standard of knowledge and experience. The registry is public, so healthcare clients can safeguard themselves by choosing to do business with facilities that employ qualified personnel. This accountability and transparency is good for everyone involved.

Accurate information is one of the most vital aspects of any sterilization process. This is one reason CBSPD has gone above and beyond to make its recent correspondence regarding CIs freely available. Accessing critical SPD facts online has never been easier. For information about what types of autoclaves and sterilizers are ideal for your department or facility, take a moment to read our free report.

Effective sterilization is a process that starts with the manufacturer. Once the FDA is satisfied with the safety of a new autoclave or sterilizer design, it becomes the end user’s responsibility to ensure proper operation. Outside technicians can be hired to test and repair equipment, but each healthcare facility is charged with the ultimate safety and sterility of instruments. Patients rely on careful and thorough processing of all reusable materials to prevent cross infection.

A technical data library (in electronic or physical format) gives technicians speedy access to manufacturer’s recommendations for the sterilization of specific devices.  In some cases these manuals can also provide alternative methods of disinfection should these become necessary.  Sterile processing departments that do not have such a resource are at a distinct disadvantage in their effort to provide efficient and reliable turnaround of critical instruments for their facilities. 

Beyond the documents provided by each manufacturer, users also need the AAMI’s Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities (ST-79).  Such a guide is designed to help any facility meet minimum national standards.  There are also many overviews and tips available from reputable online sources. Infection Control Today’s recent article regarding common mistakes and solutions in SPD is an example of such a resource.

Sterility In Healthcare Environments Is Urgent

The recent outbreak and quick spread of the new 2009 H1N1 flu virus reminds us that effective infection control procedures need to be in place before the fact, not just during or after.  Proactive measures are the best guard against new opportunistic pathogens.  Containment is simply not a realistic option once a large enough community is affected.  While frequent hand washing is the most effective mechanism to slow the spread of an ongoing flu epidemic, other bugs require more stringent regularly scheduled sanitization of equipment.  Some new pathogens are likely to be more deadly than the one currently making its rounds even if the new lethal one does not spread so readily.  It is important to err on the side of caution.

Just as SARS and bird flu were serious warnings to the medical communities in Asian countries a few years ago, this luckily and relatively mild new flu strain is currently a rude wake-up call for Western and European nations.  We had such warnings in the past. The dramatic spread of the deadly 1918 flu virus came in three different waves.  Each proceeded as another mutation occurred.  The first wave of infection was from a mild form, similar in some respect to the new one we are confronted with today. Subsequent waves were far deadlier.

The current imminent pandemic will likely unfold in unexpected ways.  We don’t know whether this pandemic will continue in a similar fashion as the 1918 virus or not.  These events are somewhat naturally unpredictable.  Flu season is almost over in the northern hemisphere.  It is still possible that slowing the flu epidemic down will allow it to fizzle out.  As temperatures rise above 80 degrees Fahrenheit, the virus cannot easily spread.  But the season is just beginning in the southern hemisphere.  It may die a natural death through adequate and normal infection control procedures that should be in place at all times.  Or it could come back with a vengeance after the summer heat is over.

If you are responsible for keeping up with current requirements for sterile processing and believe your equipment needs to be upgraded, please read our free report.

In February, Synthes sent out a notification letter to users of its medical implants, instruments and cases. The company recently re-evaluated the sterilization guidelines associated with the use of their devices. Now, to provide a greater sterility assurance level (SAL) the recommended cycles are based on worst-case scenarios. Parameters for pre-vacuum cycles are set at a minimum of 4 minutes. Temperatures must be at least 270 degrees faranheit and the dry time should be 20 minutes or more. The resulting overkill guards against contamination and is based on AAMI performance expectations outlined in ST77:2006 and TIR12:2004.

The drying period is especially important to note since the actual time needed can vary depending on the materials and wrapping technique employed for instrument sets. Synthes advises end users to independently verify the adequacy of dry times for each application. Wet loads should be re-sterilized. The manufacturer also notes that the protocols for steam sterilization are only valid when instruments have been appropriately cleaned prior to loading. Additionally, the autoclave must be operating properly according to AAMI standards.

Customers processing the following Synthes parts should continue to use the older parameters until further notice:

306.710
304.754
304.688
304.760
304.771
304.686

These items are still being tested with the new guidelines and may be included at a later date. The company is in the process of re-labeling the rest of the product line to indicate updates to its recommendations. It should be noted that the 530.100 power drive is not included in this revamping since the type of steam sterilization being discussed would damage the device.

More About Synthes

This company specializes in creating implants and instruments for reconstructive surgery. They partner with the Association for the Study of Osteosynthesis to develop and test state-of-the-art devices that speed patient recovery time and reduce pain. The manufacturer runs several interrelated business units including Trauma, Power Tool, and Spine divisions. They boast a number of innovations in the biomaterials field including implants that can be absorbed into the body. Their non-fusion lumbar and cervical disc replacements are also considered cutting-edge.

The company has a 10 year history of expansion and mergers. In 1999, Synthes joined forces with Stratec to become a leading medical device distributor. Four years later, the corporation acquired Spine Solutions (and their patented Pro-Disc technology) and merged with Mathys. The result was a global osteosynthesis conglomerate. In 2006, Synthes acquired its current trademarks and much of its intellectual property from the AO Foundation’s commercial subsidiary.

Since that time, the company has gone on to purchase N Spine and Innomedic. These corporations focus on spinal treatments and medical application software respectively. As the population in technologically advanced countries continues to age, Global Synthes aims to serve an expanding patient base. They are also focused on meeting the needs of medical facilities via constant improvement of their product line. Staying abreast of current recommendations in the sterilization field is just one example of their attention to detail.

If your company needs more information about which autoclaves on the market currently meet AAMI standards, please read our free report.

There appears to be a lot going on at ETC these days.  Environmental Tectonics Corporation’s Sterilization System Group (SSG) has secured another major contract worth approximately 2.5 million dollars. This sterilizer retrofit project involves refurbishing 12 industrial sterilizers. The units will be fitted with new state of the art control systems, process vacuum piping, and an additional set of chillers featuring an efficient water loop.   This is part of a “green” initiative to make these machines more environmentally friendly. It will also save the customer a substantial amount of money through lower operating and maintenance costs. 

Wastewater is nearly eliminated by recycling any H2O used for cooling.  Meanwhile the project makes the machines more reliable since additional backup systems create more redundancy.  Although the sterilizers were originally manufactured by a different company, ETC specializes in the servicing of many different systems.  This project will allow the customer to comply with current environmental standards without purchasing all new equipment. 

SSG’s business is to find customized solutions to challenges that are unique to certain cutting edge process systems. They provide steam and ethylene oxide sterilizers, services, consulting, and software systems to the healthcare, medical device, biotechnology, and pharmaceutical industries.

Current ETC News

Although the company faced many financially troubled years, there have been significant signs of a potential turn around since at least November of 2008.  The recent release of the last quarter’s results ending in February of 2009 was encouraging.  The company finally boasted a profit for a single quarter. 

Meanwhile ETC is in the process of delisting their company from the AMEX stock exchange.  They have provided Form 25 to the exchange notifying them of this voluntary delisting.  They recently entered a deal to get extended revolving credit for the company in exchange for delivering certain Series E preferred stock to H.F. Lenfest. This will create compliance issues because of the terms and conditions agreed upon. 

The company intends to relist the stock on the OTB stock exchange, where there should be no compliance issue.  Recent action on the stock price has been mixed, but overall it has risen over the 200 day moving average.   The fact that it remains over that average despite the delisting suggests that stockholders are more confident in the company than they were just a few months earlier.

The best news is that they still are in a position to grow their business because of the new extended level of credit.  The key to their success will be extending their potential profit margin over an entire year.  This will be difficult given the current troubles in the economy.  However, the recent multi-million dollar deal indicates that it is possible. Regardless, ETC stock remains a somewhat speculative play.  The dilution associated with the credit deal, although necessary, may initially dampen the value of each share available. 

Moving Forward

It does appear that ETC and other autoclave manufacturers will continue to benefit from the increased attention being paid to the dangers present in many healthcare settings. Recent news stories regarding inadequate sterilization of medical devices coupled with concerns about swine flu make hospital safety concerns more relevant than ever. If you are responsible for ensuring sterile processing at your facility, find out which equipment will deliver the best value for your application by reading our on our free report.

Steam sterilization times have increased over the years as medical instrumentation has become more complex.  Lumens imbedded in newer devices require lengthy exposure for the sterilizing media to properly decontaminate them.  These instruments feature tiny tubes and crevices that are hard for steam to penetrate. The Association for the Advancement of Medical Instrumentation (AAMI) continues to adjust their guidelines and recommendations regarding cycle times for the sterilization of complex instruments. These also apply to combination loads. The Technical Information Report (TIR) 31 has been updated this year so that manufacturer recommendations for various devices requiring longer cycles are consistent.

Extended sterilization cycles of 10 to 20 minutes of exposure (or more) can seriously delay the delivery of critical surgical instruments to operating rooms.  This is because many other instruments do not require lengthy processing.  Devices or sets of surgical instruments that must be processed using a lengthy cycle may end up requiring a dedicated autoclave just to handle these special needs.  This prevents SPD technicians from using that particular unit to run quick loads.  A sterile processing and distribution scheduling nightmare can ensue.

Exposure times are set based on scientific data to ensure efficacy of the process for each particular instrument.  All sterilization procedures must be documented.  End users are not allowed to simply create their own standards.  Instead, they must follow the guidelines and recommendations distributed by the manufacturers and the relevant associations who create publications compiling this information.  However, manufacturers will listen to the complaints and concerns of their customers.  Whenever possible, they will adjust standards based upon a combination of the scientific data and their client’s needs. 

Of course, such changes do not occur overnight.  They require good communication between vendors and end users.  This also means there must be greater communication between physicians and sterilization departments.  Everybody associated with or using an autoclave needs to be “on the same page”.  Surgeons must be aware of the standard operating procedures at the facility where he or she practices.  Understanding the entire process can prevent delays in instrument turnaround. This lessens the pressure placed on hospital personnel to use less effective flash sterilization procudures.

New Combination Products

A number of pharmaceutical and biologic delivery systems are currently being developed.  These are often blood driven and may include stem cell therapy.  The unique sterilization requirements of these products are currently pushing rapid invention in the autoclave field.  These new and highly innovative sterilizers will require a lengthy FDA approval process

Safety is not just about being able to adequately sterilize a load.  Cycle times and temperature standards must also be met so that the instruments themselves are protected from wear and tear.   If materials are damaged because of the sterilization procedure, this defeats the purpose of recycling these devices.  New autoclave designs must also be proven free from defects that could harm the technicians operating them.

The current poor economy has prompted manufacturers to focus on the development of near term solutions.  In other words, they probably won’t worry about the long term implications of their upcoming sterilizer designs until these complex devices are actually approved for medical use.

If you are unsure about which autoclave you should purchase for a specific application, please read our report for free information.

The issue of steam sterilizer wet loads isn’t new, but it has been getting a lot of attention lately. A number of pertinent articles have reached the autoclave community so far this year. Sterilizer manufacturer ETC issued helpful technical information this month. Healthcare Purchasing News also featured a piece on wet packs complete with advice from many industry professionals on solving this persistent problem.

Excessive moisture can easily build up on wrapped instrument trays during or immediately following an autoclave cycle. When this occurs, the entire load has to be considered contaminated. Reprocessing these materials places a strain on SPD technicians and equipment alike. The delays also pose a serious time management problem for sensitive applications. Unfortunately, flash sterilization is one of the processes most prone to condensation build up. This means instruments that should be rushed to the OR for immediate use must instead be re-sterilized.

Prime Culprits For Wet Load Problems

The causes for wet packs fall into two basic categories: equipment and operation. Generally, the autoclave itself is not the problem. However, the steam supply used often is. If the steam contains too much water vapor, adjusting settings and cycle times may not eliminate the problem. A qualified service technician can perform testing to verify whether or not the steam supply line is the reason of your wet loads. Fixing this flaw at its source may require repair or redesign of your boiler system. Or, you may need to overhaul the insulation on the piping leading to the sterilizer. Making any necessary upgrades is a wise investment.

Other equipment considerations include ensuring proper functioning of steam traps and drains. Introducing steam at controlled intervals can help also prevent the buildup of condensate. Some software and valve configurations allow for this type of adjustment. Adequate heating at the beginning of each cycle is important too. It is possible to add a heat exchanger to the in-bleed air assembly on some models to aid this quick initial heating process.

Once any problems with the equipment have been ruled out, the only other factor is the person operating the autoclave. Adequate training and staffing can reduce many of the common errors technicians make when running cycles. Here are some ways SPD personnel can help ensure dry loads every time:

- All instruments should be dried prior to processing

- Loads should be kept to a reasonable size and weight

- Sets should be wrapped or containerized using approved materials and techniques

- Loads should be distributed correctly within the chamber

- Cycle times should be of adequate length and temperature

- Cool down and drying time should not be shortened

Ensuring the sterility of each load and reducing the number of times instruments must be reprocessed should be the goal of every facility that uses a sterilizer. If you have found no problems with your steam supply or operational techniques and you are still experiencing wet loads, there could be a problem with your autoclave. A service technician may be able to fix the issue. However, you may need to upgrade to a larger model if you are handling a high volume of instruments. For information on finding an affordable replacement, please take advantage of our free report.

Claims that ionizing water turns it into a “miracle liquid” with potent powers of disinfection are dubious.   One of the recent versions of this scam blatantly states that the substance cures athletes’ foot and yet it is safe to drink.  Fish and poultry industries use it without adversely affecting the quality of the food. This simple formula can be whipped up on the spot by any cleaning crew with the right ionizing equipment. This sounds like a great product for use in hospitals, sterile manufacturing and lab environments doesn’t it? Actually, there is not a substantial difference between regular tap water and what comes out of these expensive electrolysis machines.  It’s incredible that electrolyzed sterilizing water claims like this can be successfully spread as fact in today’s information age.

Unfortunately, water hoaxes abound.  One website even pokes fun at this persistent phenomenon by claiming that di-hydrogen monoxide is one of the deadliest chemicals known to man. Inhalation can cause death! This harmful substance can cause severe burns in its gaseous form! Worse yet, you are being exposed to this potentially lethal material every day in your own home! Of course, anyone who stops to think about it recognizes that di-hydrogen monoxide is just plain old H20.

However, consumers who are bombarded with “scientific” terminology can be taken in by all sorts of claims. The information can sound credible because of the way it is presented.  In the case of electrolyzed water, pseudo-science is mixed in with real science. The goal is to encourage customers to buy very expensive but relatively worthless equipment.  

In the case of these electrolysis machines, this is the real story: adding a small amount of sodium chloride (common table salt) and processing the water in one of these devices will at best only result in an expensive way to make a very diluted hypochlorous acid and sodium hypochlorite solution. In laypersons terms, it basically makes household bleach.  While the sterilization abilities of bleach are unquestioned, drinking it is probably not a good idea.  Solutions weak enough to be safe to ingest would most likely have a fairly low sterilization efficacy. 

This Is Nothing New

Health claims circulated in 2002 saying that electrolyzed water is a wonderful anti-aging formula and prevents cancer. However, ionizing water imbues no anti-oxidizing effects.  In fact, ionized H2O with a small amount of NaCl (salt) will become an oxidizer.  Such grand statements have been greatly toned down, but this is still the same old product with a similar emotionally based story line used to manipulate potential customers. 

It would be nice to have a harmless, low cost, and eco-friendly sterilizing agent on hand for cleaning an entire facility. However, consumers should be wary of any claim that seems “to good to be true”. Instead, it makes sense to ensure sterile processing using trusted and tested products. There are a number of cleaning solutions on the market today that are designed to be safe and effective while reducing environmental impact. There are also many sterilizers and autoclaves that operate efficiently and cause minimal pollution. If you are in the market for a piece of sterilizing equipment that really gets the job done, read our free report.

The Association for the Advancement of Medical Instrumentation (AAMI) has just made two updated sterilization manuals available. These latest editions provide comprehensive information regarding processing and standards. Only the first 2 volumes of the 3 volume series have been reissued at this time. They can be purchased in printed form or on CD.

Part 1 is the Sterilization in Health Care Facilities manual. It covers topics of interest to hospitals/end users of autoclaves. One important standard that has been revamped for this edition is the ST65. This portion of the book deals specifically with the processing of reusable surgical textiles. Such materials sometimes contain sharp objects including scalpel blades and needles. These pose a serious health risk to the employees responsible for sorting and laundering the textiles. Safe handling methods are discussed that will help healthcare workers to identify and reduce the risk of injury and exposure to infection during reprocessing.

The document also takes a closer look at permanent stains on surgical textiles. Obviously, where there is a stain there is residue of some kind. A table is included to help those inspecting these materials determine whether or not a stain poses a contamination hazard. Guidance is also offered regarding the use of new, environmentally friendly chemicals for processing fabrics. These altered formulas operate at different temperatures than the older wash chemistries. Knowing the correct parameters is essential for thorough and effective sterilization.

Changes to Volume Two

Part 2, Sterilization Equipment Design and Use, targets manufacturers and those making autoclave purchasing decisions. This volume has just been updated for the first time since 2006. A lot can change in the field of autoclave technology in just 3 years. One of the main areas the AAMI has revised in this book is the ST8 standard. Manufacturers of mid to large capacity sterilizers will be affected by the new requirements regarding steam quality.

The concerns raised by Mark Smith, co-chair of AAMI’s Hospital Steam Sterilizer Working Group, have to do with the moisture level of the steam used in autoclaves. He states that the key to ending up with a dry load at the end of each cycle is to use dry steam. This may seem like an oxymoron since water vapor is obviously involved. However, the specific moisture content of this steam can be reduced by ensuring that condensate does not build up in the lines. Proper set up and equipment design are crucial factors in achieving the desired end result.

This new ST8 also addresses issues regarding load weight. Metal instruments can be quite heavy. When an autoclave will be repeatedly filled with such dense loads as wrapped orthopedic instrument sets, additional precautions may need to be taken to ensure proper sterilization. A 25 lb process challenge device (PCD) is required to test the efficacy of the steam autoclave. This device is placed inside the chamber in what is considered to be the most difficult location to effectively sterilize. If the spores in the PCD are killed, the equipment is assumed to be working well enough to deal with other, less tenacious pathogens as well.

If you have an autoclave or sterilizer that no longer meets appropriate specifications, find out how to replace your equipment. Our free report has more details.