FDA announces recall of antimicrobial susceptibility testing cards
The US Food and Drug Administration (FDA) reported yesterday that French diagnostics firm bioMerieux has recalled two of its antimicrobial susceptibility testing (AST) cards because of false results for some strains of methicillin-resistant Staphylococcus aureus (MRSA).
According to a statement on the FDA website, bioMerieux initiated the recall for the VITEK 2 Gram Positive Cefoxitin Screen and VITEK 2 Gram Positive AST for Oxacillin cards on Jan 26 because of false-negative or false-susceptible results, respectively, for some strains of MRSA. Inappropriate treatment of MRSA because of false susceptibility or false-negative results could cause severe health consequences.
The FDA says hospitals and clinics that use the VITEK 2 system and Gram Positive AST cards to screen for MRSA, and patients who are being screened, are likely to be affected by the recall. BioMerieux has issued a MRSA Safety Alert letter directing labs to implement a custom VITEK 2 System Software BIOART Rule to aid in mitigating potential non-detection of MRSA and to send isolates of suspect strains to the firm for additional testing.
The FDA has identified this as a Class I recall, the most serious type of medical device recall.
Aug 23 FDA statement
Analysis finds ASPs in dialysis clinics could reduce infections, costs
An analysis yesterday in the Clinical Journal of the American Society of Nephrology indicates that implementation of antimicrobial stewardship programs (ASPs) in outpatient dialysis facilities might help reduce infections caused by multidrug-resistant organisms (MDROs) and Clostridium difficile,infection-related deaths, and costs.
For the analysis, researchers from Brown University, Rhode Island Hospital, and global health economics and outcomes research company Cornerstone Research Group developed a clinical decision model to examine the potential impact of implementing a nationwide ASP in outpatient dialysis facilities, where approximately 30% of antimicrobial doses are considered unnecessary. Assuming a 20% reduction in unnecessary doses, the model predicted that nationwide ASP implementation would result in 2,182 fewer infections caused by MDROs and C difficile (a 4.8% reduction), 629 fewer infection-related deaths (a 4.6% reduction), and cost-savings of $106,893,517 per year (a 5.0% reduction).
"This paper emphasizes the importance of improving antimicrobial prescribing in dialysis facilities in improving the health of patients on maintenance hemodialysis," lead author Erik D'Agata, MD, MPH, said in a press release from the American Society of Nephrology, publisher of the journal.
Aug 23 Clin J Am Soc Nephrol abstract
Aug 23 American Society of Nephrology press release
Brazilian study suggests outpatient settings as MDRO transmission source
A single-center study by a team of Brazilian researchers suggests that transmission of community-onset multidrug-resistant organisms (CO-MDROs) in outpatient settings may be underreported and understudied.
In a letter to the editor yesterday in the American Journal of Infection Control, the researchers reported that their study of a 350-bed hospital in the city of Barau identified 166 patients harboring CO-MDROs from 2014 through 2016. The organisms included MRSA (72 patients), vancomycin-resistant enterococci (3), carbapenem-resistant Acinetobacter baumannii (49), carbapenem-resistant Pseudomonas aeruginosa (25), and carbapenem-resistant Enterobacteriaceae (17).
Multivariable analysis found that pulmonary disease (odds ratio [OR], 2.30) and previous hospital admission (OR, 1.51) were risk factors for overall CO-MDROs. But previous hospital admission was only reported for 45.7% of case patients, and only 27.7% had been admitted to a hospital in the previous year. In addition, while previous admission was found to be a risk factor for gram-positive pathogens, it was not identified as a risk factor for gram-negative pathogens. Risk factors for gram-negative pathogens included age (OR, 1.02), pulmonary disease (OR, 2.53) and liver disease (OR, 4.05)
The authors say the detection of CO-MDROs in patients without recent exposure to hospitals or invasive procedures argues for long-term harboring of those organisms or for transmission in other settings. "The association of MDROs with underlying conditions that require outpatient care suggests the possibility of transmission in ambulatory settings," they conclude. "This finding opens a new venue for both research and infection control practice."
Aug 23 Am J Infect Control study