Integrated Endoscopy is revolutionizing the arthroscopy market with the FDA approved nuvis Single-Use Rigid Arthroscope, which delivers first-time quality in every procedure.
Since the endoscope was introduced more than 50 years ago, the fundamental design and reprocessing requirements of traditional reusable endoscopes have not changed significantly. Today, nuvis Arthroscope combines 21st century technologies to create a low-cost, single-use arthroscope with superior high-definition optics that has the same look and feel as reusable endoscopes while being compatible with existing video systems and attachments.
Only nuvis Arthroscope:
- Provides superior optics due to exclusive integrated optical design and Molded Glass Technology
- Eliminates OR down time and inventory logistics associated with reusable arthroscopes
- Eliminates arthroscope reprocessing, bioburden and healthcare-associated infections
- Reduces total endoscope cost
Lab testing shows that the nuvis Arthroscope offers better optical quality than conventional reusable endoscopes—up to 45 percent better image quality on the off-axis horizontal measurement.
A recent study published in JAMA showed that more than 67% of the ambulatory surgery centers inspected had at least one lapse in infection control, and more than 17% had lapses in three or more of the five infection control categories1.
Only nuvis Arthroscope eliminates bioburden and the risk of healthcare associated infections due to lapses in instrument reprocessing.
nuvis Single-use Arthroscope
Eliminates the need for sterilization or high-level disinfection
Traditional Reusable Arthroscopes
Must be cleaned and sterilized or high-level disinfected after every use
May accumulate bioburden
Eliminates the risk of healthcare-associated infections due to instrument reprocessing
Lapses in reprocessing can expose patients and staff the healthcare-associated infections
Bioburden, healthcare associated infections, and endoscope reprocessing in the news:
OR Today, June 2015
The Centers for Medicare and Medicaid Services (CMS) has launched a renewed effort to reduce the frequency of hospital-acquired conditions (HACs) in U.S. hospitals. The HAC-reduction program penalizes hospitals ranking in the bottom quartile by reducing one percent of CMS IPPS reimbursements. Lisa Spruce, DNP, RN, CNS-CP, CNOR, ACNS, ACNP Director, Evidence-Based Perioperative Practice for AORN, said, “Approximately one out of every eight hospital patients in the U.S. suffers a potentially avoidable hospital-acquired condition.” HACs describe any condition affecting a patient that arose during a hospital stay, including hospital-acquired infections and other conditions. By eliminating or reducing HACs, hospitals will see benefits including shorter stays for patients and lower readmission rates, improved reputation, fewer costly and time-consuming lawsuits, and better operational efficiency. HAC scores are posted on the Medicare Hospital Compare website, allowing patients to make more informed hospital choices. “This will hit hospitals in the pocketbook in terms of reduced CMS reimbursements and fewer patients choosing to have surgeries performed there,” Spruce said. “So it is in the best interest of hospitals to do everything they can to reduce incidences of hospital-acquired conditions.”Click here to access the article
Infection Control Today, May 3, 2015
In the wake of several recent, highly publicized incidents of patient exposure to dangerous pathogens due to contaminated endoscopes, healthcare facilities, infection preventionists, and sterile processing professionals are examining their procedures, re-evaluating priorities, and implementing new guidelines issued by federal agencies. This article provides a comprehensive overview of the infection issues surrounding both flexible and rigid endoscopes, and the strategies of hospitals, manufacturers, professional organizations, and the FDA and CDC to address this serious patient safety problem. Importantly, the author notes that outbreaks tied to contaminated, improperly reprocessed medical devices are “nothing new,” and have been well documented in the press and medical literature. However, outbreaks also have occurred with instruments that were reprocessed in accordance with manufacturer’s guidelines. In one outbreak involving arthroscopy procedures, an infection outbreak caused by remnant bioburden occurred despite the fact that the reprocessing procedures used were consistent with the manufacturers instructions. Donna Swenson, president of Sterile Processing Quality Services, Inc., says that it’s going to take a collaborative effort between regulatory agencies, manufacturers and reprocessors of medical devices, standards-setting organizations, and test labs, to address and resolve the issues contributing to endoscopic infections.Click here to access the article
American Journal of Infection Control, May 2015
As reusable devices such as endoscopes have become more complicated, reprocessing has become more difficult and the risk of cross-contamination has increased. A study in the American Journal of Infection Control showed the effects of frequent reprocessing on the surfaces of endoscopes, one of the most common reusable medical devices. The study compared the differences between aged and new endoscopes and found significant variations between the two groups after frequent reprocessing, including abrasions, scratches, and cracks. Potential contaminants were found more frequently on the aged endoscopes due to alteration of the surfaces because of repetitive use and reprocessing. The authors concluded that the incidence of endoscope contamination was directly proportional to the number of times an instrument was used and reprocessed. Despite the increased risk of infection, the life span of endoscopes is usually based on the quality of the optical parts—alteration of the material caused by repetitive use and reprocessing is typically not considered. The results suggest the necessity of limiting the duration of time reusable medical devices may be used.Click here to access the article
Scientific American, March 12, 2015
The U.S. Food and Drug Administration announced strict new recommendations for the prevention of antibiotic-resistant infections spread through reusable medical devices, following incidents at several U.S. hospitals that exposed hundreds of patients to pathogens and led to patient deaths. New recommendations will now require device manufacturers to provide proof that the disinfecting process works. In the past, manufacturers have simply submitted instructions for disinfecting the devices between uses, and the FDA has trusted that the procedures worked. For devices already in use, whose disinfection protocols were not subjected to validation, the Centers for Disease Control and Prevention issued a protocol calling for swabbing the devices to see if microbes grow in detachable colonies. The older, swabbed devices are not to be used again until the device is proved clear of infectious colonies. The new recommendations will apply to most medical devices intended for repeated us, including duodenoscopes, bronchoscopes, and other endoscopes. Dr. William Maisel, the FDA’s deputy center director for science, told reporters that the agency does not “have the authority to require manufacturers to change their [device’s] design,” even if it prevents disinfection.Click here to access the article
AORN Periop Briefing, March 2015
A recent AORN report highlighted the problems and complexities of endoscope reprocessing, and the issue of reprocessing lapses that can lead to infection outbreaks. Although flexible duodenoscopes have been the focus of attention based on their role in recent infection outbreaks and some outbreaks occurred despite no lapses in reprocessing protocols, there is significant opportunity to improve reprocessing compliance for all endoscopes. The complex design of endoscopes makes them difficult to clean, and each model has its own set of instructions that must be learned and followed by reprocessing staff. These reprocessing instructions are lengthy and complex. Many endoscope reprocessing guidelines also recommend cleaning the devices until there is “no visible residue,” but the interior of endoscope channels is often impossible to see with the naked eye. In addition, personnel are often taught reprocessing protocols by fellow employees instead of through an in-service vender or professional educator, and studies have shown that protocols are often not followed—with lapses of one or more reprocessing steps occurring frequently. Reprocessing personnel also have reported health problems stemming from reprocessing activities, and many feel pressure to work quickly when reprocessing scopes. Automated technology, improved training, certificate programs, and routine monitoring using rapid indicator tests and microbiological cultures all are discussed to address the problem, but these efforts also come with increased costs for facilities.Click here to access the article
Forbes, February 27, 2015
In a recent Forbes article, Dr. Jonathan E. Aviv stresses that the medical community should be focusing its efforts on the cause of the infection outbreaks, and less on the type of infection that was spread. The potential for widespread harm to patients through contaminated endoscopes is a real threat. Based on the needs of physicians, different models of endoscopes have been created, but since each endoscope’s channels and crevices are unique, cleaning becomes more complex; no two endoscope models use the same process for cleaning. Dr. Aviv believes the best way to eliminate cross-contamination in endoscopic procedures is through the use of one-use, disposable scopes. While some endoscopes are available with disposable components that would be safer for patients, device manufacturer and physician gridlock over issues of need, cost, and willingness to replace existing equipment has hindered progress. In light of the recent outbreaks, Dr. Aviv hopes the medical community will be more motivated to take steps to prevent of infection outbreaks and eliminate cross contamination through the adoption of disposable endoscopic technologies.Click here to access the article
The Wall Street Journal, February 19, 2015
The Wall Street Journal featured a report on the high risks of surgery, including an analysis from last year showing that 46 percent to 65 percent of adverse events in hospitals are related to surgery. The number of recorded surgical site infections alone was 157,000 in 2003. The consequences of surgical errors and infections are huge, both for patient health and hospital finances. Stricter safety protocols are beginning to be enforced, and many hospitals face expensive penalties for “never events.” As a result, efforts to make surgery safer for patients and hospitals are taking on new urgency, and hospitals are searching for ways to improve their safety ratings.Click here to access the article
Outpatient Surgery Magazine, January 23, 2015
Recently, contaminated duodenoscopes have made news at Virginia Mason Medical Center in Seattle, Wash., for infecting 35 patients with deadly carbapenem-resistant Enterobacteriaceae (CRE), possibly contributing to 11 deaths, between 2012–2014. Investigators report that the infection outbreak occurred despite the fact that the endoscopes had been reprocessed according the manufacturers’ instructions. Similar endoscopes have been linked to a growing number of infection outbreaks, such as in Los Angeles in 2014, suburban Chicago in 2013, and Pittsburgh in 2012. The design of duodenoscopes makes them extremely difficult to clean and disinfect, even when the manufacturers’ instructions are followed.Click here to access the article
USA Today, Jan. 22, 2015
A January 2015 article in USA Today focused on the growing concern among public health officials and healthcare providers about the transmission of serious infections and “superbugs” associated with the use of endoscopes, including several cases in which a number of patients died. Experts reported that these cases are likely only the “tip of the iceberg.” Endoscopes accumulate bacteria that are not always removed or killed by conventional cleaning, allowing infections to pass from patient to patient. The U.S. Food and Drug Administration stated that, “Some parts of the scopes may be extremely difficult to access and clean thoroughly, and effective cleaning of all areas of the duodenoscope may not be possible.” As a result, the FDA is studying the problem and working with manufactures to determine whether new cleaning protocols should be required or the scopes redesigned. However, progress has been slow, and patients continue to be at risk.Click here to access the article
American Journal of Infection Control, 2015
A 2015 commentary published in the American Journal of Infection Control summarized key information from a public workshop on biofilms and medical devices co-sponsored by the U.S. Food and Drug Administration and Montana State University’s Center for Biofilms Engineering. According to the author, 80 percent of all human infections are attributable to microbes in biofilms, and research indicates that many medical device-associated infections may be attributable to biofilm-associated microbes remaining on devices after the cleaning and sterilization process. The commentary focuses on the serious problem of biofilm on medical device implants and also describes the presence of biofilm as a very real infection control issue.Click here to access the article
The risk of cross-contamination from flexible endoscopes due to inadequate reprocessing has been on the ECRI Institute’s list of the Top 10 Health Technology Hazards for seven straight years—since its debut at the No. 1 spot in 2009. The inclusion of endoscope contamination on the list is a reflection of the growing awareness about the problem and its potential negative impact on patients and healthcare facilities. The organization continues to warn healthcare facilities about the importance of strict adherence to cleaning, disinfection, and sterilization guidelines for the devices.Click here to access the article
The New England Journal of Medicine, March 27, 2014
A prevalence study published in The New England Journal of Medicine was conducted in 183 hospitals in 10 geographically diverse states to determine the frequency of healthcare-associated infections and update estimates of the national burden of infections. Of 11,282 patients included in the survey, 452 had one or more healthcare-associated infections, for a total of 504 infections. The most common types of infections were surgical-site infections (21.8 percent), pneumonia (21.8 percent), and gastrointestinal infections (17.1 percent). Device-associated infections accounted for 25.6 percent of Clostridium difficile cases, the most commonly reported pathogen. The authors estimated that there were 648,000 patients with 721,800 healthcare-associated infections in U.S. hospitals in 2011.Click here to access the article
AORN Connections, January 2014
AORN Connections discusses issues concerning the need to reprocess complex instruments safely and efficiently, despite the demand for fast turnaround and increasing complexity of surgical instruments. According to the author, “Reprocessing complex surgical instruments can be an intricate, time-intensive process, and if not done properly, poses significant risks to patients.” The most common problems with reprocessing continue to be not having the manufacturers’ Instructions For Use (IFUs) available and not meticulously following the detailed instructions. Correct reprocessing is a multi-step process of cleaning, decontamination, inspection, packaging, sterilization, and storing in a controlled environment, with the process tailored to each instrument. To improve reprocessing compliance, healthcare facilities must obtain IFUs for all instruments used during procedures and ensure that they are accessible to reprocessing staff. Facilities also must provide sterile processing personnel with the equipment, resources, education, and time to be compliant with the IFUs.Click here to access the article
Outpatient Surgery, January 2014
Endoscope reprocessing is a time consuming, multistep process designed to ensure patient safety and prevent infection outbreaks. A recent article in Outpatient Surgery magazine highlights tips for staff to prevent errors in the process. First, despite the pressure to keep on schedule or speed up the process, staff is urged not to cut corners. The manufacturer’s instructions for reprocessing must be followed exactly, and different endoscope models may have different reprocessing steps. Professional organizations offer routine in-service sessions and certification courses, which reinforce the importance of following protocol. Other steps include investing in the right tools and resources to ensure that the sterile processing team is adequately equipped and trained to do the job, and frequent spot-testing to assess the effectiveness of endoscope reprocessing. These steps, along with continuing education and certification, can be costly and time consuming, but they are critical to ensure that reprocessed endoscopes are safe for patients.Click here to access the article
AORN Journal, 2014
A special report published in the AORN Journal provided a sobering look at issues surrounding the use of flexible endoscopes, which become heavily contaminated with bioburden during use, and are complex and difficult to clean and reprocess. According to the authors, current standards of practice for endoscope reprocessing are vulnerable to human error, including inadequate, delayed, or incomplete reprocessing. The complex design of endoscopes also often prevents thorough cleaning, disinfection, and sterilization. The emergence of drug-resistant bacteria and increasing reports of endoscope-associated infections have fueled concerns that the current standards of reprocessing may not be adequate to protect patients from infection. The authors note that estimates of endoscope-related infections may only be the “tip of the iceberg” because device-related outbreaks may be missed or not connected back to the endoscope, and a single contaminated endoscope may contribute to multiple patients being exposed to infections.
Medical Design Technology, August 28, 2013
The development of high-quality single-use medical instruments is increasing rapidly, especially in the field of orthopedic surgery. For years, facilities have relied on costly and difficult-to-clean reusable tools in the operating room. However, several factors are driving increased demand for single-use devices, including ease-of-use, lower cost, instrument accuracy, and the elimination of infection risk. A wide range of specialized tools is needed to treat complex orthopedic cases. Major OEMs in the orthopedic market are now replacing reusable tools with single-use instruments. Disposable instruments arrive in a ready-to-use, sterile tray. They reduce the chance of surgical site infection, increase patient safety, improve operating room efficiency, and reduce hospital and ASC costs—making disposal instruments the “way of the future.” Global demand for disposable surgical instruments, procedure kits, and related supplies is expected to grow 6.4 percent per year through 2016 to about $32 billion.Click here to access the article
FDA Webinar, June 12, 2012
A webinar presented by the U.S. Food and Drug Administration, featuring speakers from University of Michigan Health System, UCLA Medical Center, and Scripps Memorial Hospital La Jolla, focused on the issue of surgical fires, which occur an estimated 550–650 times per year in U.S. operating rooms. Heat from the distal tip of fiber optic light cords used for instruments, such as endoscopes, can reach up to 700 degrees, contributing to the risk of surgical fires. Most fires start due to improper placement or unsuitable holstering of light cords, which can then ignite surgical drapes. Interestingly, odor typically alerts the surgical teams, as there is usually no initial flame or smoke, just a melting away of the drape.Click here to access the article
Infection Control and Hospital Epidemiology, December 2011
Infection Control and Hospital Epidemiology published a peer-reviewed study attempting to determine the source of seven organ/space surgical site infections (SSIs) that occurred after knee and shoulder arthroscopy in a Texas hospital over a 16-day period in 2009. The infections were due to Pseudomonas aeruginosa, a species of aerobic gram-negative bacteria found in the environment, primarily in water sources. The study attempted to draw a connection between SSIs and endoscope instrument reprocessing protocols through a series of controlled observations and tests. The authors concluded that the SSIs were likely caused by contaminated endoscopes, which had retained tissue with the P. aeruginosa present despite being reprocessed and sterilized. After the outbreak, the U.S. Food and Drug Administration released a safety alert focused on the issue of retained tissue within arthroscopic equipment.Click here to access the article
The Cost Advantage
nuvis Arthroscope compares favorably to reusable endoscopes when a full assessment of the total cost of ownership is made.
Studies show that the total average per-procedure cost of using a reusable rigid arthroscope is more than $172, not including the cost of labor, fiber optic bundles, light bulbs and other items2.
nuvis Arthroscope eliminates costs associated with:
|Repairs and refurbishment|
|Sterilization, including reprocessing equipment, chemicals, staff time and record keeping|
|Backup inventory requirements|
|OR delays and downtime|
|Healthcare associated infections – legal and liability costs of a sterility break|
- Schaefer M, Jhung M, Dahl M, et al. Infection control assessment of ambulatory surgical centers. JAMA. 2010;303(22):2273–2279.
- Reusable Rigid Endoscope Cost Analysis. Toronto, Canada: Millennium Research Group; 2006.