Advocacy Updates

05/25/2016

FDA adds Olympus to list of scope manufacturers with AER testing validation

The U.S. Food and Drug Administration (FDA) added the Olympus America OER-Pro model TJF-Q180 to the list of automated endoscope reprocessor (AER) manufacturers/models with completed validation testing that FDA has found “adequate.” Testing is still in process for the Olympus open elevator channel duodenoscope, the TJF-160VF model. Read about the FDA evaluation of AERs.

05/25/2016

CDC recommends diagnostic testing of urine specimens for suspected Zika

The U.S. Centers for Disease Control and Prevention (CDC) issued interim guidance recommending Zika virus rRT-PCR testing of urine collected less than 14 days after symptom onset, along with testing of patient-matched serum samples, for the diagnosis of suspected Zika virus infection. CDC recommendations for Zika virus testing of serum and other clinical specimens remain … Continue reading “CDC recommends diagnostic testing of urine specimens for suspected Zika”

05/19/2016

FDA warns of safety risks associated with ketoconazole oral tablets

The U.S. Food and Drug Administration (FDA) warned healthcare professionals to avoid using ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions. In a July 2013 … Continue reading “FDA warns of safety risks associated with ketoconazole oral tablets”

05/12/2016

FDA advises restricting use of fluoroquinolone antibacterial drugs

The U.S. Food and Drug Administration (FDA) is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections. An FDA safety review has shown that fluoroquinolones, when used systemically (i.e. tablets, capsules, and injectable), are associated with disabling and potentially … Continue reading “FDA advises restricting use of fluoroquinolone antibacterial drugs”

05/11/2016

CDC COCA Call: Drivers of Infectious Diseases — Connections Matter

On Thursday, May 12,  at 2 p.m. Eastern Time, the CDC is hosting a Clinician Outreach and Communication Activity (COCA) call to discuss the relationship between animal health and public health as zoonoses account for nearly two-thirds of human infectious diseases. A multi-sectoral or “One Health” approach that considers the human-animal-environment links can promote synergies … Continue reading “CDC COCA Call: Drivers of Infectious Diseases — Connections Matter”

05/11/2016

Pew reports highlight importance of antibiotic stewardship

The Pew Charitable Trusts issued two reports on antibiotic stewardship. “A Path to Better Antibiotic Stewardship in Inpatient Settings” illustrates the multiple approaches to successful antibiotic stewardship programs (ASP) by providing case studies of ASPs in 10 inpatient facilities. The report’s key findings identified common factors critical to the success of the programs, including having … Continue reading “Pew reports highlight importance of antibiotic stewardship”

04/06/2016

FDA lacks sterility assurance for Medaus products

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy in Birmingham, Alabama, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally. FDA advises checking medical supplies immediately, and any … Continue reading “FDA lacks sterility assurance for Medaus products”

04/06/2016

ASTHO toolkit to facilitate information exchange during HAI outbreaks

The Association of State and Territorial Health Officials (ASTHO) released a web-based toolkit, Improving Your Access to Electronic Health Records (EHRs) During Outbreaks of Healthcare-associated Infections. The toolkit is designed to help health agencies improve information exchange with healthcare facilities for outbreak investigation. Developed in partnership with CDC and the Keystone Policy Center, the toolkit … Continue reading “ASTHO toolkit to facilitate information exchange during HAI outbreaks”

04/06/2016

Zika policy updates

•The U.S. Food and Drug Administration (FDA) announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. Read the FDA announcement. •The CDC hosted the Zika … Continue reading “Zika policy updates”

04/06/2016

Notice of counterfeit N95 respirators

The National Institute for Occupational Safety and Health (NIOSH) has become aware of a counterfeit N95 Respirator on the market. While the TC number and private label holder (KOSTO) are valid, this unapproved unit can be identified by the misspelling of NIOSH on the front of the respirator. Read the NIOSH respirator user notice.