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Philips Sleep and Respiratory Care Statement – ResMed ASV Clinical Trial Announcement

On May 13, 2015 ResMed issued a press release and a related Urgent Field Safety Notice. This report described a statistically significant 2.5 percent absolute increased annual risk of cardiovascular mortality for those randomized to a ResMed adaptive servo ventilation (ASV) therapy compared to the control group. In the patient population with LVEF ≤ 45%, 10.0 percent of the ASV group experienced a cardiovascular death each year compared to 7.5 percent of the control group, representing a 33.5 percent relative increased risk of cardiovascular mortality (HR=1.335, 95%CI=(1.070, 1.666), p-value= 0.010).

Philips is actively evaluating the information provided by ResMed and examining if this might impact the medical care of patients who use Philips BiPAP autoSV/BiPAP autoSV Advanced devices. As part of this ongoing investigation, we are working with ResMed in order to better understand their study data. We are also evaluating post market surveillance data, public adverse event data and other published data to identify and assess other safety concerns that may be present. Read more

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People for Quality Care is an advocacy group working to ensure that quality home medical equipment and services remain critical elements in the health care continuum. Below is a story that explores the impact of Medicare audits on homecare recipients and providers.

Written by Lalaina Rabary

When it comes to providing care for her aging parents, Sandra De La Cruz is no stranger to it.

She joins 43.5 million Americans caring for parents over the age of 50. Once or twice a month, she travels to Austin, Texas, where her parents, Roberto and Nora De La Cruz, reside. She stays four days to a week each time. She has been doing this since 2012 and shares the role with her sisters.

“Caregiving for me began when my mother had her first major fall that required her to go to a rehab facility for an extended stay,” says Sandra.  “She has been in rehab six times since that first fall.  She has had two brain surgeries, a broken hip, a fractured pelvis, two separate subdural hematomas, all requiring assistance and support from a rehab facility.”

Since her mother’s fall, she has been coordinating the daily details of her parents’ lives and navigating the complex road of health care services for them.

“I help my parents by making phone calls for them, taking them to appointments and doing whatever they need.”

Caregiving for her parents has become complicated because of Medicare’s red tape.

Trouble started when she began coordinating a wheelchair for her mother.  The $30 transport chair that her mother had been using from Goodwill had broken and a walker was deemed inappropriate for her mother’s needs.

Little did she know that getting a wheelchair for her mother would turn into months of phone calls, paperwork and frustration. Read more