FDA: Stop Using Certain Cardinal Health Surgical Gowns, Packs

The U.S. Food & Drug Administration (FDA) is advising providers to discontinue use of certain Cardinal Health surgical gowns and PreSource procedural packs that include the surgical gowns because of possible contamination.

As an FDA statement notes, On January 11 and 15, Cardinal alerted customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource packs. In the letter, Cardinal Health stated, "We are advising customers to discontinue use and segregate all affected surgical gowns and procedure packs that include these affected surgical gowns from your current inventory."

Level 3 gowns provide moderate risk protection and are used in many surgical procedures, such as open-heart surgery and knee replacements. They are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. 

FDA's is advising customers to discontinue use of these products because "… the manufacturer cannot provide assurance the products are sterile."

A HealthLeaders report notes that Cardinal Health is planning to recall the items after learning of potential cross-contamination at its China manufacturing plant.

FDA states that customers with questions about whether their inventory is affected should contact Cardinal Health. 

Study: Sepsis Contributes to 20% of Global Deaths

The results of a new study indicate that sepsis causes or at least contributes to about 20% of worldwide deaths every year.

The study, published in the Lancet, analyzed death certificates for more than 100 million deaths records in 2017. Researchers found that nearly 49 million incident cases of sepsis and 11 million sepsis-related deaths were recorded worldwide. This latter figure represents 19.7% of all global deaths recorded for the year.

As the study notes, the number of deaths attributable to sepsis (either as cause or contributing factor) is twice as high as previously believed. As the researchers state, "This striking increase is largely attributable to the far higher burden among people living in areas with a lower socio-demographic index (SDI), for whom data had previously been lacking. Nearly half of all sepsis-related deaths occur secondary to sepsis complicating an underlying injury or non-communicable disease. Our results … highlight the need for greater prevention and treatment of sepsis, particularly in areas of the world with the lowest SDI."

On a positive note, the number of global sepsis cases is on the decline. There were an estimated 60 million cases of sepsis in 1990.

The Centers for Disease Control and Prevention (CDC) notes that 1.7 million American adults develop sepsis and nearly 270,000 American die as the result of sepsis each year. One in three patients who die in a hospital have sepsis. It is the most common cause of in-hospital deaths.

Study: Patient Hand Hygiene in ICUs Essential to Reducing HAIs

The results of a new study demonstrate the critical importance of patient hand hygiene in the ongoing effort to reduce hospital-acquired infections (HAIs).

The study, published in The Society for Healthcare Epidemiology of America (SHEA) journal Infection Control & Hospital Epidemiology, was conducted in three intensive care units (ICUs) at a tertiary care center, according to a research brief. It involved 56 patients and was conducted over a 10-week period.

Researchers found that of these patients, seven had at least one aerobic pathogenic bacteria on a hand. Of these seven patients, four patients had at least one multidrug-resistant organism (MDRO). Two of the patients had methicillin-resistant Staphylococcus aureus (MRSA), one had vancomycin-resistant Enterococcus and one had ciprofloxacin-resistant gram-negative bacteria.

What makes these results concerning is that, as the researchers note, "… current best practice recommendations do not provide a strong guidance regarding patient hand hygiene."

Infection Control Consulting Services (ICCS) encourages facilities to continue monitoring hand hygiene, ensuring that feedback is provided to staff at least monthly and sharing "real-time" deficiencies in private and as close to the time the suboptimal practice occurred. Monitoring must be an ongoing process measure that, regardless of success, should not be dismissed at any time.