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Medical devices enter the realm of partisan politics

Duodenoscopes received a lot of publicity in 2015, most of it bad. The final straw was when a Senate committee report linked defective scope designs to 25 infection outbreaks since 2012, 19 of which involved drug-resistant superbugs.

The Food and Drug Administration (FDA) took the brunt of the blame in the Senate report for its handling of the issue. The reports show that while the FDA was aware of the potential risks of dirty scopes, it didn’t warn the public until after a 17-month investigation. By the time the FDA warning was released, there were seven more scope-caused outbreaks, with 68 patients contracting antibiotic-resistant infections.

The report dragged the issue into the public eye and now Democrats and Republicans are both condemning the FDA’s handling of the situation. The Washington Post reports that while both sides agree changes need to be made, they disagree over what needs to be done.

Democrats argue that implementing a bar code system for medical devices would allow hospitals to track what devices are linked to infections or other issues. The Washington Post reports that the bar code program is already being phased in and will cost around $250 million.

Republicans argue that instead of a new system the FDA should simply use the power it  already has, noting that the agency already has the (often unused) power to impose civil and criminal penalties against manufacturers for not reporting injuries or deaths.

You can read the full Senate committee report here,  along with some of our previous coverage on duodenoscopes. 

Joint Commission now taking applications for Patient Blood Management Certification

Healthcare facilities that conduct blood transfusions can now apply for The Joint Commission’s new Patient Blood Management Certification program. The program was developed with the AABB, an international association focusing on cellular therapies, transfusion medicine, and blood management. The certification is based on the AABB’s Standards for a Blood Management Program and is aimed at educating hospitals on the benefits of an evidence-based, multidisciplinary approach to the transfusion decision-making process.

For more on the certification, click here.

Joint Commission unveils new prepublication standards for substance abuse, palliative care

The Joint Commission has released two sets of prepublication standards on its website. The first is for a new certification option on community-based palliative care (CBPC) for home health and hospice care facilities. Home health and hospice facilities already accredited by the Joint Commission will be able to receive CBPC certification for providing a community-based palliative care program.

The second set of standards is an update on the substance abuse and mental health services administration (SAMHSA) guidelines for accredited opioid treatment programs.

Both standards go into effect on July 1.

JAMA: Nurses key to surviving surgery

A study published in The Journal of the American Medical Association has found that surgery patients in hospitals with better nursing environments receive better care without drastically increasing costs. Researchers found the 30-day mortality rate for postoperative patients was 4.8% at hospitals with more than 1.5 nurses per bed (NPB), while facilities with less than one NPB had a 30-day mortality rate of 5.8%.

“It wasn’t just the number of nurses that made the difference. Magnet status hospitals recognized for having excellent nursing programs and cultures do better,” study author Linda Aiken, PhD, RN, said in a press release.  

While there’ve been numerous studies showing the benefits of a bigger nursing staff, the cost of hiring new staff has been an impediment for many facilities. Despite this, better staffed hospitals actually paid less ($163) overall per patient than understaffed hospitals.

Drug makers join forces at Davos to fight superbugs

During this year’s World Economic Forum in Switzerland, drug companies from 16 different countries announced a new agreement to fight the rise of drug-resistant infections, sometimes referred to as “superbugs.” Superbugs are an increasing concern for public health, with the United Kingdom government estimating that superbugs could kill up to 10 million annually by 2050.

The “Declaration on Combating Antimicrobial Resistance” was signed by 74 drug makers, 11 diagnostic test manufacturers, and nine industry groups pledging to work with each other and governments to tackle the issue of superbugs. Several big names have signed, including GlaxoSmithKline, Johnson & Johnson, Novartis, Roche Group, and Pfizer.

The declaration calls for steps including:

• Better education of doctors and nurses on appropriate antibiotic use
• Improved infection control through better hygiene, vaccination and preventive treatments
• Reduced used of antibiotics in livestock
• Higher reimbursements for antibiotics and diagnostic tests in developed markets
• More collaboration between researchers at drug makers and those at universities and government
• More access to antibiotics in countries around the world
• Governments committing funding to implement the World Health Organization’s Global Action Plan to create programs ensuring that health systems use antibiotics appropriately, along with increasing use of fast diagnostic tests and boosting reimbursements for them to ensure patients get the correct treatment

CDC: No more antibiotics for the common cold

The use of antibiotics and the rise of antibiotic-resistant diseases have been an increasing concern for public health. Studies have shown that the misuse of antibiotics is decreasing their effectiveness against new strains of infection. The Centers for Disease Control and Prevention (CDC) estimates that half the antibiotics currently prescribed for acute respiratory tract infections (ARTI), including bronchitis and the common cold, are unnecessary.

In response, the CDC and the American College of Physicians (ACP) released new guidelines for the use of antibiotics for ATRIs in the Annals of Internal Medicine on January 19. The new guidelines explain when it’s appropriate to give antibiotics to ARTI patients and what steps are needed to make that decision.

“Overuse of antibiotics contributes to the spread of antibiotic resistance, which has led to approximately 2 million people developing antibiotic-resistant illnesses and 23,000 associated deaths in the United States each year,” lead study author Aaron M. Harris, MD, MPH, LCDR, said during an interview with Medscape Medical News. “Furthermore, antibiotics are a leading reason for emergency room visits for drug side effects, responsible for one of every five visits.”

Bronchitis

Don’t start antibiotic therapy unless pneumonia is suspected. Bronchitis symptoms can instead be treated with cough suppressants, expectorants, antihistamines, decongestants, and β-agonists.

Group A Streptococcus

Only give antibiotics to patients once streptococcal pharyngitis is confirmed. Test using a rapid antigen detection test and or/culture if a patient has the symptoms of group A streptococcal pharyngitis.

If patients complain of a sore throat, reassure them that it will typically it will go away in less than a week and recommend that they take analgesics such as aspirin or acetaminophen to ease the pain. Explain that unnecessarily prescribing antibiotics can cause several side effects.

Acute Rhinosinusitis

Only give antibiotic treatment for acute rhinosinusitis patients if:

  • Their symptoms last more than 10 days
  • They experience an onset of severe symptoms
  • They have a temperature higher than 39°C/102.2°F
  • They have purulent nasal discharge or facial pain that lasts at least three consecutive days
  • They develop worsening symptoms after a typical viral illness that lasted five days and had begun improving (double sickening).

The common cold

Never prescribe antibiotics for the common cold.

Instead, explain to patients that symptoms can be treated with other methods and that unnecessarily prescribing antibiotics can cause several ill side effects. Tell each patient to follow up with a physician if symptoms last more than two weeks or worsen.

The full study can be read here. 

Featured Webcast- “CMS Surveys: Preparing With Confidence”

When: 1:00–2:30 p.m. EST, Wednesday, February 24, 2016

What: CMS has increased the frequency of its hospital surveys, and many healthcare facilities are finding themselves unprepared for the bump in federal scrutiny. This webcast will arm attendees with the preparatory steps and strategies needed to survive a CMS survey.  Attendees will also examine a real-life case study for specific examples of survey citations and how to respond to them. 

Why: This webinar will teach you how to:

  • Utilize a compliance plan to develop an organization-specific, comprehensive approach to accreditation and compliance readiness
  • Identify at least three sources of information to review changes in the Conditions of Participation/survey process
  • Implement a gap analysis of your organization’s compliance readiness

Who: Victoria Fennel, PhD, RN-BC, CPHQ, is the director of accreditation and clinical compliance for Compass Clinical Consulting and has 20 years of healthcare leadership experience. She has spent the majority of her career in nursing leadership roles and brings expertise in evidence-based practice, nursing education, quality management, performance improvement, accreditation, risk management, patient safety, and patient-centered care.

Julie Campbell, MHA, BSN, NE-BC, HACP, is the Baylor Scott & White Health North Texas Division vice president and has than 25 years of nursing leadership experience. Campbell assists in survey preparation, development of corporate policies and procedures, communications on revisions to regulations/standards, and recommendations of regulatory changes to various system councils to maintain continuous readiness. 

For more details on how to join the webcast, please visit our website.  

 

 

All Olympus duodenoscopes recalled, replaced with approved FDA model

Olympus Corp., the biggest seller of duodenoscopes in the nation, announced a recall of all its scopes on January 15. The recall was issued a day after a Senate committee report linked Olympus products to 142 antibiotic-resistant infection (ARI) cases.

Duodenoscopes are flexible cameras that are inserted into a patient’s mouth or digestive tract to diagnose cancers, and are used in over 500,000 procedures a year. Recent investigations found that a flaw in the scope’s design made it near impossible to fully disinfect, exposing patients to ARIs and resulting in 25 outbreaks in three years and four countries.

Olympus is the largest of the three companies listed in the Senate Committee on Health, Education, Labor, and Pensions report, controlling 85% of the American duodenoscope market. Olympus voluntarily issued the recall after the Food and Drug Administration (FDA) cleared the company’s new safety modifications to its TJF-Q180V model duodenoscope. 

“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices,” said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. “The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections.”

Olympus says it will call every facility using the scopes and provide them with a free replacement for their recalled devices. There are around 4,400 TJF-Q180V models currently in use in America and Olympus hopes to have them all replaced or modified by August 2016. In the short term, healthcare facilities may continue to use unmodified TJF-Q180Vs, but are urged to meticulously follow the manufacturer’s reprocessing instructions.

 

Senate panel: 250 confirmed antibiotic-resistant infections now linked to duodenoscopes

In December, the FDA linked 45 antibiotic-resistant infections (ARI) cases to Olympus brand duodenoscopes since 2012, with the infections causing 24 illnesses and 21 deaths.

Now, a new Senate committee report has tripled the number of confirmed Olympus duodenoscopes infections to 142. Industrywide, there have been 250 patients since 2012 who’ve contracted ARIs from duodenoscopes made by various companies. Dirty scopes have been responsible for 25 patient outbreaks in 10 states and four countries. Several of the outbreaks involved Carbapenem-resistant Enterobacteriaceae infections, which can kill up to 50% of those it infects and can sometimes share its drug resistance with other bacteria. 

The three companies singled out in the report were Pentax Medical, Fujifilm Medical Systems, and Olympus Corp. The Senate Health, Education, Labor, and Pensions Committee also placed blame on the FDA, saying the agency’s safety reporting system was too slow and cumbersome.

You can read the full report here. 

 

Joint Commission and CDC team up on ambulatory infection prevention project

In November, The Joint Commission and the Centers for Disease Control and Prevention (CDC) joined forces to create model infection control plans for outpatient settings. The initiative seeks to enhance the CDC’s existing guidance on infection control and prevention in ambulatory care centers.

For the initiative, The Joint Commission will be working with 12 outpatient-focused professional organizations and 10 ambulatory healthcare systems. The Joint Commission and CDC also will engage with local chapters of the professional organizations and state health departments that have an interest in enhancing infection prevention and control in their areas.

The goal of this effort, which is supported through a CDC Safety and Healthcare Epidemiology Prevention Research Development contract, is to create model infection control plans and expand the dissemination and adoption of these and other materials to prevent infections in outpatient settings.
The project will focus on a variety of free-standing ambulatory settings and services. The Joint Commission and CDC will select and work with 12 outpatient-focused professional organizations (e.g., medical specialties that primarily serve ambulatory patient populations), and 10 ambulatory health care systems. They also will engage with local chapters of the professional organizations and state health departments interested in improving infection prevention and control.