Dentist Infection Control

Infection Control Consulting Services Blog


Study: 20% Efficacy Predicted for 2018 Flu Vaccine

A new study predicts that the vaccine used to provide immunity against this fall's flu will have an efficacy around 20%.

This means that 20% fewer vaccinated people will get the flu compared to unvaccinated people. The efficacy rate is similar to that of the vaccine administered in 2016 and 2017.

This is despite the fact that the 2018 vaccine is a new H3N2 formulation for the first time since 2015. As one of the researchers noted in a news release, "The vaccine has been changed for 2018-19, but unfortunately it still contains two critical mutations that arise from the egg-based vaccine production process."

Most flu vaccines are produced by culturing viruses in chicken eggs. The researchers note that mutations which reduce the vaccine efficacy are unavoidable through the egg-based production process.

The study was conducted by Rice University, with its findings published in Clinical Infectious Diseases. Researchers used the pEpitope method to gauge the effectiveness of the new flu vaccine. The method calculates a measure of antigenic distance between two strains of influenza. The study demonstrated that the pEpitope method has accurately predicted flu vaccine efficacy rates for more than 40 years.


FDA Warns Against Use of 24-Hour Multi-Patient Use Endoscope Connectors

The U.S. Food & Drug Administration (FDA) has issued an alert to healthcare providers and facilities advising them against using "24-hour multi-patient use endoscope connectors" because of the risk of cross-contamination.

These are connectors labeled for use with multiple patients over the course of 24 hours without reprocessing. The FDA says it is recommending against their use because it has not received "acceptable testing to demonstrate the safe use of these products."

Endoscope connectors are accessories that attach the auxiliary water channel of flexible gastrointestinal endoscopes to a water source and irrigation tubing. The FDA recommends using connectors with features that prevent patient fluids from flowing backwards into endoscopes to reduce the risk of cross-contamination and infection between patients.

More specifically, FDA encourages providers to use single-use endoscope connectors with backflow prevention features or reusable endoscope connectors with backflow prevention features, and ensure reusable connectors are reprocessed according to their instructions.

The FDA noted that one manufacturer, Erbe USA, currently markets a 24-hour multi-patient use endoscope connector. Called the ERBEFLO port connector, the FDA stated the accessory does not include a backflow prevention feature.


Joint Commission: Infection Control Standard is "Most Challenging" for Office-Based Surgery Practices

For Joint Commission-accredited office-based surgery practices, no standard proved more difficult in 2017 than one concerning infection prevention and control, according to Ambulatory Buzz.

Standard IC.02.02.01 — The organization reduces the risk of infections associated with medical equipment, devices and supplies. — took the first spot on The Joint Commission's annual list of the top 10 challenging standards for office-based surgery practices. It had a reported 63% non-compliance. This standard saw an increase in non-compliance in 2017, up from 57% in 2016.

Also on the 2017 list: IC.02.01.01 — The organization implements infection prevention and control activities. The standard was fifth on the 2017 list, coming in at 27% non-compliance. It also saw an increase in non-compliance in 2017, up from 24% in 2016. On a positive note, two infection control standards on the 2016 list — IC.01.05.01 and IC.02.04.01 — did not appear in the 2017 list.

The standards compliance data used to put together the 2017 top 10 list for office-based surgery practices were derived from an average of 104 applicable surveys.

Note: Read about the top 10 challenging standards in 2017 for Joint Commission-accredited ambulatory healthcare organizations by clicking here.


Infection Control Standard is 2017's "Most Challenging" for Joint Commission-Accredited Ambulatory Healthcare Organizations

An infection control standard was the most challenging for Joint Commission-accredited ambulatory healthcare (AHC) organizations in 2017, according to an Ambulatory Buzz report.

Standard IC.02.02.01 — The organization reduces the risk of infections associated with medical equipment, devices and supplies. — came in first on The Joint Commission's annual list of the top 10 challenging standards for its AHC customers, with a reported 60% non-compliance. It was the only standard on the list exceeding 50% non-compliance. This standard saw an increase in non-compliance in 2017, up from 53% in 2016.

Also on the list, and coming in seventh with 36% non-compliance: IC.02.01.01 — The organization implements infection prevention and control activities. This standard did not even make the list of 2016 top 10 challenging standards.

Rounding out the top three for 2017 were #2: MM.03.01.01 (The organization safely stores medications) with 49% non-compliance.) and #3: HR.02.01.03 (The organization grants initial, renewed or revised clinical privileges to individuals who are permitted by law and the organization to practice independently.) with 47% non-compliance.

The standards compliance data used to put together the 2017 top 10 list were derived from an average of 695 applicable surveys.

Commentary from the Field

Since January 2018, Infection Control Consulting Services (ICCS) has been inundated with a growing number of requests from accredited outpatient centers that have received infection prevention- and control-related citations, particularly for failing to meet "best practices," including those associated with medical equipment, devices and supplies. For the past several years, ICCS consultants have seen a considerable increase in requests from facilities for assistance with reprocessing failures. The requests have increased further this year. The reasons for failure of facilities to adhere to standards are multi-factorial. ICCS will address them in an upcoming special report. To receive notification of this report's publication, sign up for the free ICCS Newsletter.

ICCS provides the ongoing service of implementation of planned infection prevention and control activities and practices included in the overall development of an infection prevention program for facilities that are either cited for failing to meet these standards or when facilities are proactive and request these services ahead of an upcoming survey.


Study: Annual Treatment of Antibiotic-Resistant Infections Exceeds $2 Billion

Researchers have determined it costs $2.2 billion every year to treat antibiotic-resistant infections.

For the study, published in Health Affairs, researchers from Emory University and Saint Louis University first examined data from the Medical Expenditure Panel Survey, a set of large-scale surveys conducted by the Agency for Healthcare Research and Quality (AHRQ) of families and individuals, their medical providers and employers across the United States. With this information, they estimated the incremental costs of treating a resistant infection and the total national costs of treatment.

The researchers found that antibiotic resistance added nearly $1,400 to the cost of treating a patient with a bacterial infection. Using 2014 data on the number of infections, they determined the average annual cost.

Here are a few other key takeaways from the study, according to an analysis by the Center for Infectious Disease Research and Policy:
  • The percentage of antibiotic-resistant bacterial infections in the United States more than doubled over 13 years (from 5.2% in 2002 to 11% in 2014).
  • There are nearly 14 million bacterial infections per year in the United States.
  • The South was the region with the highest share of bacterial infections. The Northeast had the lowest share.
  • Patients with antibiotic-resistant infections were more likely to be female and have multiple comorbidities.
  • Average healthcare spending for patients with antibiotic-resistant infections was 165% higher than it was for patients with non-resistant infections.
Antimicrobial stewardship remains in the spotlight. Some significant developments over the past few years include The Joint Commission's release of an antimicrobial stewardship standard, the Centers for Disease Control and Prevention's (CDC) issuing of an urgent recommendation for nursing homes to improve antibiotic use, a study showing the rise of antibiotic-resistant infections in children and a World Health Organization (WHO) report indicating a growing challenge concerning lack of antibiotics to help combat the threat of antimicrobial resistance.

Note: If your organization requires assistance with developing or improving an antimicrobial stewardship program, contact the experts at Infection Control Consulting Services.


FDA Warns Duodenoscope Manufacturers on Postmarket Surveillance Studies

The U.S. Food and Drug Administration (FDA) has issued warning letters to all three duodenoscope manufacturers.

The letters speak to the failure of Olympus, Fujifilm and Pentax to comply with a federal order concerning the conducting of postmarket surveillance studies to assess the effectiveness of reprocessing duodenoscopes.

In 2015, FDA issued the order to conduct the surveillance study to determine whether healthcare facilities could properly clean and disinfect the devices.

As part of the approved study plans, the three manufacturers are required to conduct a study to sample and culture reprocessed duodenoscopes in clinical use so they can learn more about issues that contribute to contamination. They are also required to conduct a human factors study to assess how effectively trained hospital staff are following the reprocessing instructions.

These orders were issued as part of the ongoing effort to prevent patient infections associated with contaminated duodenoscopes,

FDA states that, as of March 9, 2018:
  • Olympus failed to commence data collection;
  • Pentax and Fujifilm failed to provide sufficient data, as required for their respective studies, to sample and culture reprocessed duodenoscopes that are in clinical use; and
  • Olympus and Pentax did not comply with requirements for their respective human factors studies to assess how well staff are following reprocessing instructions.
Fujifilm has been meeting its human factors study requirements.

"The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we've seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real world clinical settings and whether we need to take additional action to further improve the safety of these devices," said Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in a news release. "We expect these device manufacturers to meet their study obligations to ensure patient safety."

To learn more about the reprocessing issues concerning duodenoscopes, access this 2015 Infection Control Consulting Services special report on reprocessing medical devices.


ECRI: Device Cleaning, Disinfection and Sterilization a Top Patient Safety Concern

The ECRI Institute has identified "device cleaning, disinfection and sterilization" as a significant patient safety concern in its "2018 Top 10 Patient Safety Concerns for Healthcare Organizations" report.

Coming in eighth on the list, ECRI notes the following in an executive brief: "Failure to follow proper cleaning, disinfecting and sterilization protocol at any point can result in a compromised device—and devastating effects for patients. To avoid outbreaks of potentially deadly diseases, a proactive approach is important."

In the brief, ECRI offers several tips, including:
  • ensure sufficient staff and equipment are available to handle the reprocessing workload;
  • ensure staff follow current guidelines and manufacturer recommendations; and
  • ensure the water and environmental filtration system undergoes regular surveillance and maintenance.
ECRI states that it creates the annual list of patient safety concerns to support healthcare organizations to proactively identify and respond to safety threats. The list is compiled using data on adverse events and concerns gathered by ECRI and "expert judgment."

The top three patient safety concerns in the report are:
  1. Diagnostic errors
  2. Opioid safety across the continuum of care
  3. Internal care coordination
To download the free executive brief, fill out the form here.