by K Richard Douglas
You’ve just made it through a three-hour surgery and the doctor reports that they have reason to believe that the surgical instruments used were not fully sterilized. They fear that you were exposed to a dangerous bacteria. While microorganisms may have not been in the forefront of your mind hours ago, the importance of disinfection and sterilization has just hit home.
The Central Sterile Processing department is nearly as invisible to the patient as the clinical engineering department can be. Yet, every surgical procedure and a large number of hospital stays, might present the patient with the same bad news if disinfection and sterilization weren’t a part of hospital procedures.
Sterilization is big business, with the market for sterilization equipment expected to reach $5.3 billion by 2018. The overall market for sterilization and disinfection is projected to reach $14 billion by 2017.While the FDA may have approved radiation treatment for the sterilization of poultry and vegetables, it is the patient’s own flora that presents a challenge in surgical prep. Zapping a patient with radiation isn’t an option, so the patient, the disposables and the surgical instruments must be clean, disinfected and sterilized.
It’s not only surgical instruments that pose an infection hazard to the patient. In one study, three out of 20 gastrointestinal endoscopes were found to have unacceptable levels of contaminants that posed an infection risk. Contaminated endoscopes lead all medical devices as a source of illness caused by the spread of bio contaminants such as hepatitis B and C as well as HIV.
Along with endoscopes, rigid and flexible cystoscopes require a unique reprocessing. The challenge to find sterilization methods for all instruments, and for manufacturers to produce instruments that are easier to sterilize, is a goal of everyone involved.
With these concerns affecting the well-being of a growing patient population, what steps are being taken to address this crucial element in healthcare and what technologies will clobber the bioburden contamination?
Companies on the cutting edge of this market provide a glimpse into how it is done and what the future may bring.
“Healthcare systems are focused on infection prevention practices and strategies in their facilities. The importance of following recommended practices and guidelines is being emphasized at every level,” says Barbara Trattler, RN, MPA, CNOR, NE-BC director, clinical education consultant for Advanced Sterilization Products (ASP).
“For example, in order to safely reprocess a device, facilities must adhere to the manufacturer’s Instructions For Use (IFU),” she says. “IFUs give specific instructions for cleaning, disinfecting and sterilizing a device after use. Adhering to specific cleaning and sterilization directions as indicated in a device’s IFUs can be a huge challenge for facilities as the parameters on sterilizers have to be changed in order to comply with the different IFUs.”
Trattler also says that “facilities must ensure that their staff has been fully trained to reprocess devices safely according to the IFUs.”
TRIED AND TRUE
Steam sterilization is the granddaddy of effective and time-tested techniques. Endorsed by the National Institutes of Health and the Federal Drug Administration, this method of sterilization uses heat and moisture to affect the annihilation of microorganisms.
“Steam continues to be the most widely used process for device sterilization. Most consider steam a very well described process and also very forgiving,” says Gerry McDonnell, Ph.D., vice president of scientific and clinical affairs for Steris Corporation, Inc. “This may be true in some cases but not in others.”
“For example, a recent outbreak of patient infections due to Pseudomonas (a leading case of hospital acquired infections) was described in the journal Infection Control and Hospital Epidemiology (Tosh et al, ICHE 32:1179, 2011); although cleaning of the associated devices was not optimal, the organisms in the device potentially survived the steam sterilization process,” McDonnell says.
“Although the presence of soil could have compromised the effectiveness of the steam process, it is still remarkable that it could have survived given the process temperature.”
Another issue has been the recommendation of ‘extended’ steam cycles. A typical time for steam sterilization at 132C (270F) is four minutes, which includes a significant safety margin; some instructions for use include longer times of even up to one hour,” McDonnell says.
“In the USA, such sterilization cycles would not typically be approved for use on steam sterilizers, which causes a practical problem for hospitals,” he says. “But why are such long cycles recommended?”
McDonnell explains that a typical steam sterilization cycle has three phases: “condition, to get the load ready for sterilization, the actual sterilization phase and then drying.”
He says that for this reason, a typical sterilization process can take up to one hour to complete.
“Conditioning is important as it should remove air, ensure steam penetration and that the load is at the right temperature; if this is not achieved in a load — due to factors such as its density, weight (or) type of devices — then steam sterilization will not be achieved,” McDonnell says.
“Inefficient conditioning phases are often tested and subsequently fail sterilization tests; the sterilization phase is often extended to compensate for this,” he says. “Such extended cycle conditions create confusion to end users when trying to follow instructions for reprocessing provided by manufacturers.”
Three other considerations are worth mentioning.
“The first is the impact of water quality; poor water quality (or purity) used to make steam can cause a variety of problems to include corrosion, spotting and even wet loads,” McDonnell says. “The purity of the water should be routinely monitored to ensure it meets recommended specifications.
“A second is the array of indicators that can be used to monitor the success of steam sterilization, to include physical, biological and chemical indicators,” he adds. “New examples include improved rapid read biological indicators and chemical indicators that only pass on exposure to a stated sterilization cycle conditions (Class 6 indicators).”
McDonnell concludes that wet packs continue to be a common concern for facilities.
“A wet pack is when moisture is detected on, or in, a sterilized load following the process, which can lead o compromised sterile packaging,” he says.“When these are observed, the causes can often take some time to identify and resolve to include reducing the weight of heavier loads, correct maintenance of steam generation and supply, and correct maintenance of the sterilizer (e.g., checking drains).”
Beyond traditional steam what are the alternatives to the steam process?
“Within the hospital, the most commonly used alternatives to steam sterilization are gas plasma, vaporized hydrogen peroxide, ethylene oxide, liquid chemical sterilization and to a very minor extent ozone,” says Wally Puckett, Ph.D., vice president of science and technology and general manager of healthcare consumables for Steris Corporation, Inc. “While gamma and e-beam are very effective sterilization modalities, these methods are primarily used for single use devices in standalone facilities outside of the hospital environment.”
There are instruments that are not candidates for the steam process to begin with. There are also instruments which require low temperature methods.
“That category of medical devices is actually the fastest growing category of innovations and new products that come to market,” says Janet Prust, global marketing manager for 3M.
“Those types of complex devices are often comprised of components of a variety of different types of materials; plastics, different types of optical materials, different types of polymers and different types of metals that typically can’t withstand the harsh conditions of high temperature sterilization like steam; with the high heat and the high humidity,” Prust says.
“They need to be low-temperature sterilized. And actually, the category of devices used in healthcare settings that require low-temperature sterilization continues to increase,” she says. “Whereas 10 to 15 years ago, it may have been 10 to 15 percent, it is now closer to 20 to 25 percent of all devices and that continues to grow. Particularly around devices that are used for minimally invasive surgery procedures and endoscopy procedures.”
Prust says that nearly all of these types of devices consist of multiple materials, including optics, and require either low-temperature sterilization, or in some cases, can be steam sterilized with some degradation of the instruments.
latest technologies the cMs changes that have dinged hospital budgets have also affected soMe trends in sterilization and disinfection.
“As costs in healthcare continue to rise, continuing emphasis will be placed on reducing the time required to reprocess medical devices within the perioperative loop,” says Puckett. “One means of reducing this time is to reduce the cycle of time of the sterilization event itself. New reduced time cycles have been introduced in the vaporized hydrogen peroxide modality targeting the type of load being reprocessed (eg non-lumened device loads can be reprocessed in much less time than loads containing lumened devices).
“Insuring the safe use of devices is also being emphasized. Manufacturers of reprocessing systems are being required to show that medical devices reprocessed in their systems pose insignificant risks to patients either from residuals left on the reprocessed devices or from damage caused by the reprocessing itself,” he says.
“New potential claims are in discussion among sterilization/disinfection providers and regulatory agencies especially with regard to biofilms and prions,” Puckett says. “Both biofilms and prions are well established as causal for human disease, yet neither of these disease causing agents have a regulatory path in the U.S. FDA for making cleared and legally marketed claims.”
The environment is also a concern.
“Finally the issue of environmental sustainability is becoming increasingly important in healthcare,” he says.“This issue is captured in a mosaic of manifestations from lower utility requirements and reduction of physical wastes to making ‘green’ certifications for chemicals used throughout the healthcare environment.”
Some trends also involve changes by the device manufacturers along with increased use of low-temperature methods.
“There are efforts to try to redesign the devices so they can be more durable within steam sterilization processes,” Prust says. “Also, there continues to be new innovations in low-temperature sterilization processing systems to be able to improve efficacy or increase the speed of the process.
“The types of low-temperature sterilization that are used in healthcare settings now basically fall into two categories; traditional ethylene oxide sterilization processes that have the highest level of efficacy, because the ethylene oxide gas is able to penetrate through lumens or long, narrow channels within the devices and it is also gentle on materials and it doesn’t break down materials after repeated reprocessing.”
Because it penetrates well, according to Prust, it takes a period of time to have it removed or aerated out of the material; something that can take up to 20 hours.
“The other category of low-temperature systems used in hospitals are vaporized hydrogen peroxide systems, that are faster,” Prust says. “Typically those cycles will range anywhere from 30 minutes to 90 minutes. However, the hydrogen peroxide has limitations relative to its ability to penetrate down certain types of long, narrow lumens and there are also some materials that hydrogen peroxide systems are not compatible with.”
The perfect system would be a combination of the current processes.
“The ideal low-temperature system would have efficacy similar to ethylene oxide and materials compatibility similar to ethylene oxide, but it would have the speed closer to the hydrogen peroxide systems,” Prust says. “So, depending on what the devices are, and what the individual facility’s requirements are, as far as reuse and turnaround time of specific devices, are factors that go into selecting the appropriate method for the particular types of devices they have to process.”
THE BIOMED’S ROLE
“It is important for clinical professionals to be involved in the decision-making process for sterilization modalities at their facility,” Tattler says. “The healthcare team should do their research to determine the best products and solutions for their facilities and seek out vendors who will help them navigate the market and provide ongoing education to help ensure staff is up-to-speed on best practice guidelines now and in the future.”
Being mindful of the process is vital when it comes to sterilization.
“The key trend in sterilization is just increasing scrutiny and ensuring that there is good quality control and quality insurance practices,” Prust says. “There are guidelines that tell healthcare facilities how they should be doing their processes and there are guidelines, primarily from AAMI, to give guidance on how to not only design the sterilization, but how do you design the area where the sterilization department, or central processing department, is.”
Prust points out that there are guidelines for everything from steam to chemical sterilants, ethylene oxide to liquids and disinfectants. She points out that the main focus of those guidelines is that there is some type of quality control process in place. Facilities need to have good documents and policies and procedures, along with monitoring, to tighten up practices. She says that every audit by the accrediting bodies includes the sterilization department. That is a change from the past.
The role of many biomeds is something that Prust addresses directly.
“Increasing pressure for efficiency; turn-around time. Keep(ing) things running,” she says. “Within the sterilization process, it’s basically, how can you do everything right and correctly and still move really fast? Increasing the speed at which things need to be done. And assuring that you have the quality control systems in place to do that.
“Some of the new things within the sterilization area are faster biological indicators and the beginning of some digital monitoring tools to use for sterilizers and washer-disinfectors,” Prust says. “It’s really incorporating technology into some of those processes. Readers that can read monitors and automatically record the results and put it into the electronic documentation system.”She says that the new technological advances in sterilization can help reduce errors and medical mistakes that natively affect the patient and patient safety.
“With the array of existing and new technologies available, or becoming available, it will become increasingly important to balance the safety, efficacy, practicality and training required to use these technologies successfully,” Puckett says. “A new emphasis on the cleaning of medical devices was recently begun jointly by U.S. FDA and AAMI that will drive new levels of cleaning and process compliance.
“The healthcare environment is a complex and variable theater and well rationalized strategies must be employed to arrive at the optimum solutions for sterilization, disinfection and decontamination appropriate to each care center’s unique needs,” Puckett says. “Medical devices reprocessing and healthcare space decontamination will be under increased scrutiny as more information on HAIs become more widely known. These issues will also be driven by the lack of reimbursement from CMS for HAIs contracted in the hospital setting.”