Advocacy Updates

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”

02/05/2019

FDA warns compounders about glutathione

FDA is warning compounders not to use glutathione-L-reduced powder distributed by Letco Medical, to compound sterile injectable drugs for patients. Based on reported adverse events, the agency has concerns about potential endotoxins in the product.

02/05/2019

FDA announces recall of sterile saline products

FDA announced that Smiths Medical is recalling the sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents bacillus infantis and staphylococcus epidermidis because of damage to the containers used to package the finished products. 

12/14/2018

Important NHSN updates

Read about the release of updates to NHSN, including the releases of Version 9.2, 2019 Patient Safety Component protocols, and the new Outpatient Procedure Component. •NHSN Version 9.2, released on December 8, includes many additions and changes, including analysis updates within the Patient Safety, Healthcare Personnel Safety, Dialysis, Long Term Care, Biovigilance and Outpatient Procedure … Continue reading “Important NHSN updates”