A Medical Device Daily

Baxter Healthcare (Deerfield, Illinois) reported that the FDA has classified Baxter's recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue.

IIPV may result in serious injury or death from conditions such as: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion. Children and non-verbal patients may be at increased risk because of their smaller size and/or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.

Baxter said it is continuing to investigate the causes, fixes, and mitigations associated with IIPV and use of the HomeChoice device. Current mitigations under development and implementation include changes to device labeling and software, which are intended to address issues such as prescription and patient errors, including bypassing alarms. Patients will receive new Patient At-Home Guides, which contain expanded information about IIPV, the symptoms, warnings and cautions, and how to address IIPV, should it occur. Baxter said it has also developed and is validating a software modification to address this issue and plans to submit a 510(k) to the FDA midyear. The software update will include additional user interface messages and alarms, and change default settings and allowable ranges to reduce risk of excessive accumulation of fluid in the peritoneal cavity.

HomeChoice systems are intended for automatic control of dialysis solutions exchange in the treatment of adult and pediatric renal failure patients undergoing peritoneal dialysis. The recall notice does not require the physical return of HomeChoice units and patients may continue using them, the company said.

"We are committed to providing peritoneal dialysis patients with the safest and most effective therapy possible," said Bruce McGillivray, president of Baxter's Renal business. "We stand ready to support our patients and the nephrology community as we develop and implement measures intended to reduce the occurrence of IIPV." The company said it does not expect the corrections required to address the IIPV issue to be financially material.

Mazzo begins term as AdvaMed chairman

The Advanced Medical Technology Association (AdvaMed; Washington) reported that Abbott Medical Optics (Santa Ana, California) president James Mazzo has begun his two-year term as chairman of the AdvaMed Board. Mazzo succeeds Edwards Lifesciences (Irvine, California) CEO/chairman Michael Mussallem who has led the organization since 2008.

For the past two years, Mazzo has chaired AdvaMed's international board committee, where he worked toward streamlining the medical device approval process in Japan, clarified product approval and recall provisions in China, and expanded the committee's work in emerging markets. He has also chaired AdvaMed's board committee on the value of technology initiative and the association's political action committee, AdvaMed PAC.

"I am honored to have the opportunity to serve our industry and to represent AdvaMed and what it stands for: ensuring patients benefit from advancements in medical technology products and services," said Mazzo. "Our vibrant and diverse industry is fueled by entrepreneurial companies that are the engine of growth in communities across the country. As AdvaMed chair I intend to work to implement policies that encourage innovation for the improvement of patient care everywhere."

During the next two years, Mazzo will lead the industry's efforts to: support the FDA's review process so patients continue to have timely access to safe and effective medical technologies; ensure innovation thrives as payers and providers experiment with new health care delivery models; and support global regulatory harmonization efforts.