FDA Approves Duodenoscope With Disposable Endcap From Olympus

The U.S. Food & Drug Administration (FDA) has cleared the Olympus TJF-Q190V, a duodenoscope with a sterile, disposable distal endcap, the company announced.

This is the latest approval of a duodenoscope designed to improve the cleaning and reprocessing of the device, helping to reduce potential device contamination.

To date, the FDA has cleared five duodenoscopes with disposable components that facilitate reprocessing:

• Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope (fully disposable duodenoscope)

• Fujifilm Corporation, Duodenoscope model ED-580XT (disposable endcap duodenoscope)

• Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V (disposable endcap duodenoscope)

• Pentax Medical, Duodenoscope model ED34-i10T (disposable endcap duodenoscope)

• Pentax Medical, Duodenoscope model ED34-i10T2 (disposable elevator duodenoscope)

As we previously noted, FDA has advised providers to transition away from fixed endcap — and more infection-prone — duodenoscopes and begin using duodenoscopes with disposable components that help with or even eliminate the need for reprocessing.

It is encouraging to finally see the development and approval of these devices. We drew attention to the challenges associated with the cleaning, disinfection and sterilization of duodenoscopes in a 2015 Special Report and recently included "endoscopes testing positive for bacteria after cleaning and disinfection" on our list of "10 of the Scariest Healthcare Infections and Threats."

Coronavirus Guidance and Resources

At the time of this publication, there are 11 cases of confirmed coronavirus in the United States, including a case of human-to-human transmission in Chicago. Despite the significant attention being paid to the coronavirus, we should still be more concerned about the seasonal influenza that is circulating and has claimed more than 10,000 lives, according to the Centers for Disease Control and Prevention (CDC).

Furthermore, many of the precautions healthcare providers should implement for a virus like the new coronavirus are similar to those that should have been in place for the flu as well. Concerning the coronavirus, the CDC released the following statement: "We continue to believe that the immediate health risk from this new virus to the general American public is low."

With that being said, the team at Infection Control Consulting Services (ICCS) is not advising inaction. Rather, non-acute care settings — which are typically not as prepared to respond to a potential case of an illness like the coronavirus — should ensure they are screening at the point of entry and managing the flu season and coronavirus appropriately. You will ultimately need to make decisions regarding preparation as it suits your setting.

Recommendations for Coronavirus Preparation and Response

The following are recommendations worth considering, some of which you have hopefully already instituted:

• As soon as possible, institute enhanced screening of every patient by phone (as is typically done in the outpatient surgery setting) followed by screening upon admission (visitors, too) for elective admissions. Include questions about travel outside the United States, particularly China, and specific signs and symptoms such as a fever, sore throat, cough and runny nose. You do not want such patients in your facility in any event if they're symptomatic for the flu or other respiratory viruses.

• Reschedule if the patient on the phone is suspicious for a respiratory illness. The screening staff should ask patients to let them know by phone if they wake up in the morning with any symptoms of the flu before coming into the facility. Since that may not happen, it is imperative to be prepared if someone arrives at the facility and is exhibiting symptoms.

• If phone screening is not part of your practice, ICCS suggests that at the time of presentation at the front desk, staff should ask the same questions above of every patient and visitors. Front desk staff should have masks available to hand to patients and visitors, if necessary.

• Fully implement a respiratory hygiene program, especially in the waiting room, mandating the donning of a mask to anyone exhibiting symptoms of a respiratory illness and immediate exiting of the facility. Some patients may present in the waiting room despite being telephone screened. Encourage hand hygiene in the waiting room, particularly after use of tissues following wiping a nose, covering a cough, etc.

• There is a reported shortage of medical face masks. While the use of face masks is often warranted (as discussed earlier), and a shortage is quite concerning, at this juncture, staff members walking around in masks for the duration of a shift is impractical compared to placing a patient in a mask until they can leave the facility. However, if any healthcare worker must render care to a patient with a suspicious presentation, even if the patient is wearing a mask, we suggest healthcare workers wear one as well until the patient leaves.

• N95 respirator masks are part of an OSHA/NIOSH respiratory program that is complex and mainly used in the hospitals or extenuating circumstances in other settings. To learn more about what is required to run a respiratory protection OSHA/NIOSH program, click here. 

• To review the interim coronavirus guidance from CDC, which includes screening, click here. (Note: This guidance receives regular updates.)

Coronavirus Assistance

Guidance will continue to evolve, and the team at ICCS will continue to closely monitor the situation. Facilities in need of assistance with coronavirus management or providing PPE and respiratory hygiene training to employees can contact ICCS.

High Infection, Injury Rates Lead to Medicare Penalties for Several U.S. News' 'Best Hospitals'

Seven of the 21 hospitals on U.S. News' "Best Hospitals Honor Roll" have been penalized by Medicare for higher rates of infections and patient injuries than other hospitals, according to a Kaiser Health News (KHN) report.

Last week, the Centers for Medicare & Medicaid Services (CMS) identified the nearly 800 hospitals that would receive lower payments (i.e., hospital-acquired condition (HAC) penalties) for a year under the "HAC Reduction Program," a pay-for-performance program intended to link Medicare payments to healthcare quality in inpatient hospitals. Those hospitals identified represent the "worst-performing" 25% of all general care hospitals, minus those in Maryland as the state has a different payment arrangement with CMS. The program is controversial, with critics questioning its scoring methods and overall value.

Performance is determined via a scoring system, with every hospital receiving a Total HAC Score. For 2020, the Total HAC Score was based on data for six quality measures:

• CMS Patient Safety Indicator (PSI) 90 measure. It includes 10 component measures, such as pressure ulcer rate, in-hospital fall with hip fracture rate, respiratory failure rate and postoperative sepsis rate.

• Five Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) healthcare-associated infection (HAI) measures:

  • central line-associated bloodstream infection (CLABSI);

  • catheter-associated urinary tract infection (CAUTI);

  • surgical site infection (SSI) – colon and hysterectomy;

  • methicillin-resistant Staphylococcus aureus (MRSA) bacteremia; and

  • Clostridium difficile infection (CDI).

In the KHN report, the only penalized "best hospital" to comment on its penalties was UCSF Medical Center in San Francisco, which attributed its high HAC rates on its "thoroughness in identifying infections and reporting them to the government."

Three of the other penalized "bests" had avoided payment reductions in all six previous years of the program.

Coronavirus Update: Cases Surpass 7,500, Deaths Top 100

In just the past few days, there have been significant developments concerning the Wuhan coronavirus (2019-nCoV). Here is a summary of some of the latest key facts and figures:

• The number of cases in mainland China is quickly approaching 8,000.

• The virus has infected more people in China than were sickened there during the 2002-2003 severe acute respiratory syndrome (SARS) outbreak.

• There have been at least 170 deaths associated with the virus.

• China's National Health Commission confirmed the virus can be transmitted from person to person.

• The Centers for Disease Control and Prevention (CDC) confirmed the first case of person-to-person spread of the coronavirus in the United States. It is the second case of the virus in Illinois and sixth overall in the United States.

• There are more than 100 confirmed cases, but no deaths yet, in 20 places outside of China. These include the United States, Canada, France, Germany, Finland, India and Australia.

• The World Health Organization (WHO) is expected to decide today (January 30) whether to declare the epidemic an international public health emergency. Update: WHO has declared the outbreak an international “public health emergency.”

• A detailed analysis of the first 99 patients treated in China has been published in the Lancet.

• A growing number of airlines are suspending flights to and from mainland China.

• Thousands of passengers on a cruise ship in Italy are banned from disembarking because two Chinese passengers are suspected of having coronavirus. 

• Russia has closed off its far-east border with China in an effort to prevent the spread of the virus.

• Misinformation about coronavirus is spreading online.

This is a rapidly developing situation, and one can expect the number of cases to continue to increase in the coming weeks, particularly in China. As we advised in our previous coverage of the coronavirus, providers should continue to prescreen for fever, respiratory symptoms and international travel, particularly to and from China. If patients have traveled from the affected countries, further information will be needed to decide "next steps."  

Infection Control Consulting Services (ICCS) suggests facilities — particularly outpatient settings — develop or review existing policies for standard precautions and transmission-based precautions, with an emphasis on respiratory protection. Guidance will continue to evolve, and the team at ICCS will continue to closely monitor the situation.

Facilities in need of assistance with coronavirus management or providing PPE and respiratory hygiene training to employees can contact ICCS.

Sources include:

• CDC

• CNN

• The New York Times

• The Telegraph

• Bloomberg

CDC Confirms 5th U.S. Case of Coronavirus; China Death Toll Exceeds 80

The Centers for Disease Control and Prevention (CDC) has confirmed a fifth U.S. case of a new coronavirus (2019-nCoV).  

This virus, which has caused an outbreak of respiratory illness, was first detected in the Chinese city of Wuhan. Media reports are noting that Chinese health authorities have reported nearly 3,000 thousand infections and 80 deaths connected to the virus as of Monday, January 27 — figures likely to increase.

The five U.S. cases of 2019-nCoV were confirmed in recent travelers from Wuhan in four states: Arizona, California, Illinois and Washington. Other countries with confirmed 2019-nCoV cases include Australia, France and Japan.

Symptoms of 2019-nCoV infections include fever, cough and shortness of breath. CDC believes at this time that symptoms of 2019-nCoV may appear in as few as two days or as long as two weeks after exposure. 

As CDC notes, many of the initially confirmed patients in Wuhan reportedly had a link to a seafood and animal market, which suggested animal-to-person spread. However, a growing number of patients reportedly have not had such exposure to animal markets, which suggests that person-to-person spread is occurring.

The World Health Organization (WHO) recently convened an emergency committee regarding the outbreak. WHO has also issued the first edition of infection prevention and control guidance intended for healthcare workers, healthcare managers and infection prevention and control teams. This guidance can be downloaded here.

Infection Control Consulting Services (ICCS), a U.S.-based team of infection prevention and infection control consultants, is advising its clients that at this juncture, continue to have office staff prescreen for fever and respiratory symptoms. If patients give a positive history, staff should ask these patients if they have been traveling out of the country, namely to Asia. 

Clients with a heightened level of concern can begin screening all patients for travel to/from China as an additional line item. If clients choose to take this approach, they should have a plan for how they will respond to confirmation of such travel. While ICCS is a firm believer in being proactive, there are many viruses circulating and one should not assume those with common winter colds and flu have coronavirus.