FDA Medwatch : Coastal Meds Recall of All Products Marketed as Sterile

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AUDIENCE: Pharmacy, Nursing, Risk Manager

ISSUE: FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection.

BACKGROUND: During FDA’s recent inspection of Coastal Meds, investigators observed visible particulates and poor sterile production practices which further raise concerns about particulates in Coastal Meds’ drug products intended for injection.

FDA Medwatch : Certain Implantable Cardiac Devices by Abbott (formerly St. Jude Medical): FDA Safety Communication - Battery Performance Alert and Cybersecurity Firmware Updates

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AUDIENCE: Cardiology

ISSUE: On April 11, 2018, the FDA approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities for certain Abbott ICDs and CRT-Ds. "Firmware" is a specific type of software embedded in the hardware of a medical device (e.g. a component in the defibrillator).

FDA Medwatch : Acrodose PLus and PL Systems by Haemonetics: Recall - Low pH Readings for Platelets Stored in CLX HP Bag

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AUDIENCE: Laboratory

ISSUE: Haemonetics recently received reports of low pH readings for platelets stored in the CLX HP bag in certain lots of the Acrodose PLus and PL systems. In some instances the drop in pH is accompanied by a yellow discoloration of the storage bag.

Platelets with pH lower than 6.2 and a lack of “swirl” may not be viable. Transfusion of these platelets may lead to delayed correction of coagulopathy or low quality prophylactic platelet transfusion, increasing risk of morbidity and mortality.

CGS Publishes Documentation Checklists for DME

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To assist providers in collecting the proper documentation when dispensing and billing for DME products, CGS Medicare has published a set of documentation checklists. The checklists are in PDF format and include:

Surgical Dressings
Therapeutic Shoes for Persons with Diabetes
Lower Limb Prostheses
Negative Pressure Wound Therapy Pumps
and many other DME items.

To get the checklists click here to visit the CGS Website

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