Infection prevention

Infections cause human suffering. They cost the healthcare system millions of dollars. And, in many cases, they are avoidable. This month, the Journal of Healthcare Contracting reports on an infection-prevention-related issue that also has caught the public’s eye – the reprocessing of medical devices. In a future issue, we will look at antibiotic resistance, a nagging issue that also has caught the attention of the public and government.

Reprocessing guidelines are sign of the times

FDA document addresses concerns about complex, difficult-to-process instruments

It was four years in the making. But in March, the U.S. Food and Drug Administration issued its long-awaited final guidance document on reprocessing reusable medical devices – the first such update since 1996.

The document underscores the importance of manufacturers designing reusable medical devices with reprocessing in mind, and providing crystal-clear instructions to providers on how to clean, disinfect and sterilize them. It also draws attention to the need for providers to place well-trained, well-qualified people in reprocessing areas.

“This is the most comprehensive set of guidelines on reprocessing available to this point,” says Donna Swenson, president and CEO, Sterile Processing Quality Services Inc., Stickney, Ill. “If you read them, and if you’ve been involved with AAMI [the Association for the Advancement of Medical Instrumentation] and other organizations, you can see that they really have been listening to what the various stakeholders had to say.”

The guidance document reflects the dramatic changes in medical instrumentation and research on reprocessing that has taken place since 1996, says Susan Klacik, central sterile services manager, St. Elizabeth Health Center, Youngstown, Ohio, and the International Association of Healthcare Central Service Materiel Management (IAHCSMM) representative to AAMI committees. It also points to the need for medical device manufacturers and hospital central sterile departments to partner with each other in the name of patient safety. “Our objectives are strategically aligned,” she says. “We both want medical devices to perform exactly as designed – each and every time.”

Complexity of today’s devices
The complexity of medical instrumentation – and hence, the difficulty of ensuring its cleanliness and safety – was one of the primary reasons the FDA began work several years ago updating its 1996 guidance document titled “Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities,” noted Geetha Jayan, PhD, senior science health advisor, Office of the Center Director of the FDA, during a webinar.

The new document, “Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling,” does a few things, she said:

  • Provides recommendations to medical device manufacturers for developing reprocessing instruction that can be easily understood and followed by users.
  • Outlines the FDA’s current recommendations to manufacturers on how to conduct scientifically sound testing to validate reprocessing methods and instructions.
  • Describes measures the FDA is taking to enhance its oversight of the reprocessing of reusable devices.

The document also emphasizes the importance of designing devices that are less challenging to reprocess than some of those on the market today. It also provides recommendations on the “human factors” that can affect device reprocessing, including the ability of healthcare workers to clean and sterilize devices in the everyday work environment.

“In recent years, there has been an evolution toward the development of more complex devices with designs that are more difficult to reprocess,” said Elaine Mayhall, PhD, scientific review, Infection Control Devices Branch, Division of Anesthesiology General Hospital Respiratory & Infectious Diseases, Office of Device Evaluation in the FDA, during the webinar. “However, there have also been significant advances in the knowledge and technology involved in reprocessing reusable medical devices. The recommendations in this guidance reflect the scientific advances in these areas.”

Reprocessing instructions
The guidance document – a draft of which was issued for public comment in May 2011 – includes six criteria manufacturers must meet to ensure that providers understand and correctly follow reprocessing instructions.

  • Criterion 1: The reprocessing instructions should reflect the intended use of the device. Appropriate instructions depend on the physical design of the device, the intended use of the device, and whether it has direct or indirect contact with the patient. They also should reflect the type and extent of soiling and contamination to which the device is likely to be exposed during clinical use. Reprocessing methods are also dependent on the use of disinfectants or other chemicals that might leave harmful residues or adversely affect device materials or performance if inadequately rinsed, and any risk to the patient or the user.
  • Criterion 2: Reprocessing instructions for reusable devices should advise users to thoroughly clean the device. Adequate sterilization or disinfection depends on the thoroughness of cleaning. If a device cannot be cleaned, it cannot be disinfected or sterilized.
  • Criterion 3: Reprocessing instructions should indicate the appropriate microbicidal process for the device. The microbicidal process recommended is dependent upon the intended use of the device and is described by the Spaulding Classification for critical, semi-critical, and noncritical medical devices. (Critical devices are those introduced directly into the bloodstream or that contact a normally sterile tissue or body space during use. Semi-critical devices contact intact mucous membranes or non-intact skin, but do not ordinarily penetrate tissues or otherwise enter normally sterile areas of the body. Noncritical devices contact only intact skin but do not penetrate it.)
  • Criterion 4: Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed. The equipment and accessories needed to implement the instructions should be available for users to obtain. Also, the type of sterilizer, with manufacturer-validated sterilization cycle parameters and accessories, should be available to users.
  • Criterion 5: Reprocessing instructions should be comprehensive and include information about: special accessories and special protection needed during reprocessing; point of use processing or pre-cleaning instructions; disassembly and reassembly instructions, including step-by-step instructions with visual aids; the method of cleaning, including a list of parameters; the cleaning agent or the class of cleaning agent used in the manufacturer’s validation testing; instructions for rinsing the device following cleaning; the type and quality of water that should be used and the duration, volume, and temperature of the water; lubricating agent, if required; instructions for drying the device after processing and before storage; method of disinfection or sterilization, including the validated cycle parameters and accessories that should be used; instructions for reducing sterilant residuals following sterilization by ethylene oxide, hydrogen peroxide, or other processes that may leave sterilant residuals on the device; and more.
  • Criterion 6: Reprocessing instructions should be understandable. The instructions should be clear and legible. They should be presented in a logical, sequential order, from the initial processing step through the terminal processing step, and should be described using simple language. Charts, diagrams, and pictures that can be posted in a workstation are helpful.

Are instructions ‘technically feasible?’
Klacik applauded the FDA and the guidance document for a number of reasons. First, the document says that reprocessing instructions should be technically feasible and include devices and accessories that are legally marketed, she points out. That will eliminate one problematic area – that is, medical device instructions that call for extended sterilization cycles, even if the sterilizer (or indicators and CS wrap) has not been validated for the longer cycle.

Second, the document makes clear that manufacturers must plainly list everything needed to properly clean and sterilize their devices, down to what brush size should be used in lumens. “This helps me when a new product comes to the healthcare facility,” she points out. “CS should be able to look at the instructions to ask, ‘Can I service it? Can I thoroughly clean it? Do I have the right size brushes? The right ultrasonic cleaner? Do I have everything I need to process it?’”

Third, the guidance document discusses the handling of instruments at the point of use, most often, the OR. “That’s important, because a lot of things begin at the point of use,” says Klacik. For example, it has been documented that biofilm starts to form in as little as five minutes after use, she points out. Ideally, lumens should be flushed and gross debris wiped off before then.

Fourth, the guidance document stresses the importance of proper cleaning, and the importance of providing educational resources to those reprocessing their devices.

Fifth, the document talks about validation of reprocessing instructions. “Validation has to be done under the worst-case scenario,” that means inoculating with soils that mimic actual use and in the most difficult circumstances, she says. Instructions must also take into consideration “real life” conditions. “In the decontamination room, we wear thick utility gloves, personal protective equipment and gowns,” she points out. Tactile sensation is diminished, and glasses can fog up, as the work is often performed in crowded workspaces. Manufacturers must take all this into account when developing reprocessing instructions.

“Using simulated studies will identify difficulties in cleaning in the “real world,’” she says. “The difficulties cleaning the duodenoscope is an example of an instrument that is extremely complex to clean, requiring specialized training with proven competency with direct observation to ensure the tech performs the required flushing and raising and lowering of the elevator during cleaning. This scope also requires specific types of cleaning brushes.”

Swenson points to what she considers to be a revolutionary aspect of the FDA document.

Typically, when the agency issues a guidance document, it addresses activities that should take place “from this point forward,” but leaves intact instructions for what has already transpired. “But there is something in this document that makes it a little bit different,” she says.

In the new guidance document, the FDA says that reprocessing instructions for some older, legally marketed reusable devices may not be consistent with state-of-the-art science. Therefore, the provider following those instructions can’t ensure that their reusable devices are clean and safe to use after reprocessing.

“Never before have previous devices been considered adulterated,” Swenson points out. “They are approved, they are on the market and they are legally sold. New technology may come along and make the device obsolete, but if people are still using it, there was nothing to make them stop using it. But if the FDA is saying these devices could be considered adulterated or misbranded – that is, the labeling doesn’t bear adequate directions for reuse – it could potentially tell companies that their products have to be removed from the market.

“This makes a big difference to the hospital too,” she adds. “If the FDA decides these devices are no longer acceptable because the cleaning instructions aren’t adequate, hospitals would have to start replacing them. Having talked to FDA people in the past, they have been of the opinion that eventually, hospitals would stop using outdated devices, which would be phased out. But that hasn’t happened in a lot of cases. You still see first-generation laparoscopic devices out there.

“But this particular section of the document appears to say that if science moves beyond some of these older devices, then when the FDA inspects the manufacturer, they may ask, ‘What are you doing about that?’ Also, FDA shares information with other agencies, she says. And although the FDA does not directly regulate hospitals, other regulatory agencies may ask hospitals, “Why are you continuing to use devices that aren’t acceptable any longer?’”

“Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Final Guidance – March 24, 2015,” is available at

Duodenoscope issue captures public’s attention

Every so often, even the most arcane aspects of healthcare operations – such as the reprocessing of medical devices – capture the public’s attention.

So it was that in February, following reports of injuries and deaths attributed to inadequate processing of duodenoscopes, the U.S. Food and Drug Administration issued a “Safety Communication,” warning healthcare providers and the public that even the most meticulous attention paid to cleaning and disinfecting the scopes may not be enough to protect patients from infection passed on by other users. One month later, on March 12, the Centers for Disease Control and Prevention issued an interim protocol for facilities that want to test their duodenoscopes for contamination with bacteria after cleaning and disinfection.

Perhaps the most alarming thing about the duodenoscope affair was that outbreaks of infection appeared to have occurred even in cases where healthcare providers followed manufacturers’ instructions for reprocessing them.

500,000 procedures each year
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum), explained William Maisel, MD, MPH, deputy director for science and chief scientist, FDA Center for Devices and Radiological Health, on an FDA blog in February.

The scopes are used in more than 500,000 procedures, called endoscopic retrograde cholangiopancreatography – or ERCP – in the United States each year, he said. ECRP is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by tumors, gallstones or other conditions. The duodenoscope is a more complex instrument than other endoscopes and can be more difficult to clean and disinfect.

In its Safety Communication, the FDA said it is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by carbapenem-resistant Enterobacteriaceae (CRE) and Escherichia coli. From January 2013 through December 2014, the agency received 75 medical device reports encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes.

The agency issued its alert after UCLA’s Ronald Reagan Medical Center in Los Angeles reported in February that seven patients who had undergone procedures with duodenoscopes had been infected with CRE. Two of those patients died, and an additional 179 were notified that they may have been exposed.

Culturing could be costly
Writing on the CDC blog in mid-March, Michael Bell, MD, deputy director of CDC’s Division of Healthcare Quality Promotion, wrote that the agency’s interim protocol can help providers detect contamination, whether due to lack of adherence to manufacturer-recommended reprocessing practices or any other reason, and to prompt follow-up action to protect patients if needed.

The protocol suggests techniques for inspection and manual cleaning and drying of duodenoscopes (as well as other flexible endoscopes that have an elevator mechanism), as well as remedial actions to be taken if any duodenoscope is found to be contaminated.

In the protocol, the CDC notes that some facilities routinely culture their scopes to assess the adequacy of reprocessing. “Holding duodenoscopes out of use while surveillance culture results are pending could be considered, especially if performing surveillance cultures after each use,” wrote Bell. “Any duodenoscope found to be contaminated should not be returned to use” until appropriate steps are taken.

That portion of the document has led to consternation among some providers, a point Bell acknowledged in the CDC blog when he wrote: “We recognize that there are both pros and cons associated with using screening cultures. There can be concerns about cost, as using this method will mean that the duodenoscopes will not be available for use while waiting for the results of the cultures. This could mean that a facility would need to buy additional scopes in order to be sure they have the equipment available when needed. Additionally, the failure to grow bacteria from the areas sampled may not guarantee that there are no bacteria present anywhere on the scope.”

Is culturing necessary?
“I don’t agree with culturing scopes or instruments unless you have a specific reason for doing so – e.g., a cluster infection, and you’re trying to figure out the source,” says Donna Swenson, president and CEO, Sterile Processing Quality Services Inc., Stickney, Ill. According to Swenson:

  • Culturing is expensive. It’s expensive to run the test and to obtain the additional instrumentation needed while waiting for results.
  • Culturing comes with its own set of issues. “You have to be sure that whoever is doing the culture isn’t contaminating the device.”
  • Other methods are available to test for cleanliness, including the well-established technique of flushing lumens with hydrogen peroxide and looking for foam.

“People need to develop a comprehensive program, and look at water quality, temperature, the chemicals being used and whether they are being dosed correctly,” she says. “If you would do all of these things and then verify the cleaning of the actual devices, I don’t see why you would need to do culturing.”

Staff training and competency
The duodenoscope issue and CDC protocol demonstrate the importance of training and certification of personnel responsible for reprocessing medical devices, says Susan Klacik, central sterile services manager, St. Elizabeth Health Center, Youngstown, Ohio, and the International Association of Healthcare Central Service Materiel Management (IAHCSMM) representative to Association for the Advancement of Medical Instrumentation (AAMI) committees. “The design of these scopes makes thorough cleaning difficult and requires a true expertise with demonstrated competency to perform this complex task with the specified cleaning brushes,” she says.

In fact, the CDC recommends that competencies be assessed at initiation of employee duties and at least annually and anytime a breach is identified or when a new technique or equipment is introduced. “Competency verification should include direct observation in addition to other assessments per facility policy (e.g., written tests),” says the CDC protocol. “Personnel responsible for reprocessing endoscopes are encouraged to seek certification [in sterile services].”

The good news, says Klacik, is that central sterile processing personnel have access to better information and training than ever before. “We’re evolving,” she says, and suppliers of medical devices can help by providing educational programs, graphics, posters and other sources of information about reprocessing. “We’re like a sponge,” says Klacik. “We’ll take all the information we can get.”

The Interim Duodenoscope Surveillance Protocol: Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing” is at


Healthcare providers are steadily recognizing that better awareness and prevention of healthcare associated infections not only saves lives, but ultimately saves money and drives greater efficiencies in the healthcare system. It takes unique expertise, commitment, skills and enhanced products to do this correctly, and growing numbers of providers are devoting additional resources to this important area. Crosstex/SPSmedical is a leading global company dedicated to delivering innovative infection prevention and control products and services that address these critical issues as we believe infection prevention and control markets will continue to grow for years to come.

Secure Fit® Technology Face Masks from Crosstex are an example of such an innovative product. SecureFit® Technology Face Masks are proven to provide up to 3 times protection over other face masks*. Secure Fit® Technology Face Masks feature aluminum nose and chin pieces that can be adjusted to fit the shape and size of any face, while significantly reducing the gapping on the sides and bottom of the mask, decreasing exposure to airborne particulates and aerosols by more than 3 times that of a standard earloop face mask. SecureFit® Technology Face Masks are made in the USA and come in all 3 ASTM levels. *Study on file.

Greater efficiency, better outcomes
The benefits of a proper fitting mask seem obvious. Supply chain executives need to demand more from suppliers of face masks than they do now. Recent viral threats, including H5N1, H7N9, H1N1, and now EVD, are creating heightened attention and concern over the ability of seemingly simple devices, such as face masks, to make the difference between health and infection. Secure Fit® Technology Face Masks provide up to 3 times protection over other face masks, with better breathability and the fit and feel of a surgical tie-on mask. And because they are made in the USA, they are readily available.

Potential objections by end users
“Ear loop face masks do not offer the same level of protection as surgical tie-on masks.”

Not true. SecureFit® Technology Face Masks come in ASTM levels 1-3. ASTM level 3 masks provide the highest level of protection from aerosols and fluid sprays. The Secure Fit® technology conforms to any size or shape face, giving a custom fit. This reduces gapping around the chin and cheeks for a better fit and increased protection.

“Our current decontamination mask is on contract and is less expensive.”

Yes, but does it provide the protection needed for staff? Concern over unnecessary exposure is very top-of-mind today and this highlights the need for PPE, such as face masks, to provide optimal protection. Healthcare workers want to know that their facility is doing all that it can to ensure the safety of its staff and patient base.

Crosstex/SPSmedical recognizes that protection, comfort, and quality are the most important roles for face masks in the healthcare market. This is why our Secure Fit® Technology Face Masks are made from only the highest quality materials and tested to ensure premium performance, which protects healthcare workers and patients alike.

Crosstex/SPSmedical offers free trial supplies of Secure Fit® masks to any concerned healthcare provider or institution. Visit for further mask education and research, and to order free samples of Secure Fit® masks. Crosstex is a member of the Secure Mask Supply Association

Editor’s Note: Sponsored by Crosstex/SPS Medical.


The B. Braun Introcan Safety® family of peripheral IV catheters offers truly passive safety features that are activated automatically and cannot be bypassed. Both the Introcan Safety and the Introcan Safety 3 Closed IV Catheter minimize needlestick injuries and promote first stick success. The Introcan Safety 3 Closed IV Catheter provides an added safety feature with an automatic, multi-access blood control septum preventing blood exposure after withdrawing the needle and every time the hub is accessed.

Greater efficiency, better outcomes
The passive safety shield deploys automatically and stays in place during disposal. Additionally, it encourages best practice by preventing needle reinsertion. The Introcan Safety Family of PIVCs helps facilities cut costs and go green by generating less waste with smaller, lighter components. Your end users will avoid throwing away unused components (compared to integrated catheters) and help cut costs by reducing needlesticks and cleanup time and materials. B. Braun Introcan Safety 3’s multiple-access blood control septum reduces exposure to blood when the needle is removed and every time the hub is accessed. Additionally, Introcan Safety 3’s integrated stabilization platform improves catheter stability and minimizes movement within the vessel to help reduce catheter-related complications.

Braun provides value-added products with customers and their patients always in mind. In addition to preventing needlestick injuries and facilitating first-stick success, the Introcan Safety IV Catheters are small by design. The smaller, lighter components will save room in sharps containers, generating less waste for the facility and providing additional savings.

Editor’s Note: Sponsored by B. Braun.

Allied BioScience

According to the Centers for Disease Control and Prevention, antibiotic-resistant bacteria, or superbugs, cause a minimum of 23,000 deaths and 2 million illnesses each year. These superbugs thrive in hospital settings, and the CDC estimates a total occurrence of around 1.7 million infections annually. These often-deadly infections compromise care, risk lives and create a massive financial burden that costs the healthcare system up to $35 billion annually.

This cost can now be significantly diminished by hospitals that enlist the help of a new antimicrobial surface coating technology that continuously fights surface pathogens, rendering them harmless on contact.

SurfaceWiseTM by Allied BioScience is a long-lasting antimicrobial surface coating that provides continuous disinfecting action when applied to almost any hard or soft surface. The first technology of its kind to be clinically proven effective in this capacity, SurfaceWise is an invisible thin-film coating that binds to surfaces at a molecular level, creating a long-lasting microscopic barrier on which it is difficult for pathogens to live and multiply. As surfaces are touched, and therefore re-contaminated, the treated surface itself reacts to fight the threat.

The return on investment for hospitals implementing this technology is significant. After treating a mid- to large-size hospital (255 beds) with SurfaceWise, that facility can expect to see a net first-year benefit of approximately 20 percent of annual investment, reaching more than 20 percent ROI each year for three years. The same hospital will see hospital-acquired infection rates drop by 40 to 50 percent or more, considering how drastically SurfaceWise will reduce the spread of surface pathogens throughout the treated area. Hospitals that implement this technology will be equipped with ABS’ proprietary germ-mapping clinical surveillance software system, GermMapTM, to precisely track the decrease in surface pathogens and corresponding infection rates.

Decreased surface pathogens will help increase savings from infection avoidance, including a reduction in the length of patient stays, and it also will reduce clinical staff sick time. Other nominal benefits create additional financial impacts. The ROI-cost analysis encompasses further advantages, including improved patient reputation and reduced potential litigation due to fewer instances of HAIs.

SurfaceWise is designed to augment normal cleaning procedures used in hospitals in the most minimally disruptive way possible. Trained technicians from ABS handle application of the technology to surfaces. This process complements routine EVS procedures so that a hospital room can be treated and returned to service within approximately 45 minutes.

Editor’s Note: Sponsored by Allied BioScience.


The average patient in an intensive care unit has his or her line accessed by a clinician 20-25 times per day. The disinfection of these needleless access sites prior to injection, laboratory draws and medication administration is critically important to reducing the risk for contracting a healthcare associated infection.

The Prevantics® product line is a comprehensive, evidence-based solution that addresses the vascular access continuum of care. The newest addition, Prevantics® Device Swab:

  • Is specifically indicated for the disinfection of needleless sites prior to use.
  • Contains the first and only 3.15 percent Chlorhexidine Gluconate and 70 percent isopropyl alcohol formulation.
  • Has a quick five-second scrub time and five-second dry time to help with staff compliance.

Greater efficiency, better outcomes
Bloodstream infections continue to be a leading cause of mortality and morbidity for patients with invasive catheters. These infections are widely preventable and cost the U.S. healthcare system millions of dollars annually, with an average mortality rate roughly as high at 25 percent in some patient populations. Bloodstream infections also reduce patient satisfaction and clinical outcomes, and increase the costs for care delivery and length of stay. Preventing these deadly infections requires a comprehensive approach to infection prevention for the vascular access process, including both skin antisepsis with the Prevantics® skin antiseptics and disinfection of the needleless access sites with the Prevantics® Device Swab. By disinfecting the needleless access site prior to use with the Prevantics® Device Swab, practicing hand hygiene and adhering to aseptic technique when accessing these devices, the risk for these serious healthcare associated infections can be mitigated through the implementation of these evidence-based practices. Clinicians must address the entire vascular access process as a whole and evaluate for potential sources of contamination that could lead to transmission.

Potential objections by end users
I use alcohol prep pads to disinfect needleless access sites.

  • The CDC guidelines state, “Some studies have shown that disinfection of the devices with Chlorhexidine/Alcohol solutions appears to be the most effective in reducing colonization.”
  • The Prevantics Device Swab has a five-second scrub time and five-second dry time that helps with staff compliance.
  • It is the first and only 3.15 percent CHG and 70 percent IPA solution authorized by the FDA to disinfect needleless access sites.

Unique to the market, the Prevantics® product portfolio contains PDI’s proprietary formula, 3.15 percent Chlorhexidine Gluconate (CHG) and 70 percent isopropyl alcohol, and is a comprehensive approach to infection prevention for the entire vascular access continuum of care.

A wide selection of infection prevention and Prevantics® educational materials, including in-service videos, instructions-for-use posters, webinars and whitepapers, are available at to assist in system-wide implementation throughout your customer’s entire healthcare delivery network and to improve standardization and clinical compliance.

Editor’s Note: Sponsored by PDI.

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