Advocacy Updates

05/31/2019

Pharm D Solutions Recalls Sterile Products

Pharm D Solutions is voluntarily recalling all sterile compounded drug products due to concerns that practices at the pharmacy have the potential to pose a risk of contamination. Read more.

05/31/2019

FDA Authorizes Marketing of Diagnostic Test for Zika Antibodies

The FDA has authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S. Previously, tests for detecting Zika virus IgM antibodies had been authorized only for emergency … Continue reading “FDA Authorizes Marketing of Diagnostic Test for Zika Antibodies”

05/31/2019

FDA Approves Marketing of Test to Detect Joint Infections

The FDA approved marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant. Read more.

05/29/2019

FDA Approves Modified ERBEFLO Port Connector

The FDA cleared the ERBEFLO 24-hour multipatient use port connector after a design modification added a backflow prevention feature to reduce the risk of cross-contamination of the irrigation system. The FDA clearance also required revised labeling to identify compatible endoscopes and accessories, as well as clear and specific warnings to assure proper use. Read more.

05/29/2019

Heritage Recalls Injections Due to Lack of Sterility

Heritage Pharmaceuticals has voluntarily recalled Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), manufactured by Emcure Pharmaceuticals, due to detection of microbial growth in one lot which may indicate lack of sterility. Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of … Continue reading “Heritage Recalls Injections Due to Lack of Sterility”

02/19/2019

APIC increases advocacy for CMS CoPs and antibiotic stewardship programs

APIC is taking strong steps to advocate for CMS to finalize proposed revisions to the Hospital/CAH Conditions of Participation (CoPs), which include the first update to infection prevention and control requirements since 1986 and includes a requirement for hospitals to establish antibiotic stewardship programs. Without further action, the proposed improvements will expire on June 16, … Continue reading “APIC increases advocacy for CMS CoPs and antibiotic stewardship programs”