Tag: Complaints

AMSTERDAM – Philips Respironics filed an additional 70,000 medical device reports (MDRs) with the U.S. Food and Drug Administration between April 2022 and October 2022, the company stated in a Nov. 22 update on its recall of certain CPAP, BiPAP and mechanical ventilator devices.  The vast majority of the 90,000 MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury, the company stated.   “It is important to note that the submission...

WASHINGTON – The U.S. Food and Drug Administration on Nov. 18 sent Invacare a warning letter outlining a number of violations found during an inspection earlier this year.  The violations include, but are not limited to, the following:  Failure to investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation...

YARMOUTH, Maine - Ever since a national mail-order program for diabetes supplies kicked off July 1, beneficiaries have been complaining loud and clear—just not to CMS, say industry stakeholders.“We get complaints every day on the hotline and the majority of the time, when I am talking to them, it is about diabetes testing supplies,” said Kelly Turner, director of People for Quality Care, which runs a competitive bidding complaint hotline.Of the 2,154 complaints made to the hotline...

WASHINGTON - Lawmakers in the House of Representatives and the Senate are asking for “solid data” on the negative impact of competitive bidding on Medicare beneficiaries, according to AAHomecare.As a result, the association is asking providers to collect the following pieces of data:•    Number of calls from beneficiaries regarding Round 2•    Number of callers who have already contracted CMS, and whether CMS addressed the situation•    Number...

I've had a hard time blogging for a few weeks. It's not because of the lack of news; it's because of the glut of news. I can't focus on one topic long enough to churn out a blog. So here are two thoughts that have been buzzing in my head but haven't found a home here yet. HOMES: Home Medical Equipment and Services Association of New England. This is the new name for NEMED. It's an appropriate name for a number of reasons. It emphasizes home and services, and it doesn't include the word dealer. When...