FDA also warns GF, Merits

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Friday, March 9, 2012

YARMOUTH, Maine - It looks like the U.S. Food and Drug Administration (FDA) has its eyes on more than just Invacare.

The FDA sent warning letters to GF Health Products/d.b.a Basic American Metal Products and Merits Health Products in December and November, respectively. In the case of GF, the letter was the culmination of an investigation at its bed manufacturing facility in Fond du Lac, Wis., from Aug. 29 to Sept. 23.

"There's no question there's increased emphasis on DME manufacturers right now," said Ken Spett, president and CEO at GF. "We've been inspected before in different locations, but we've never had an inspection lasting three weeks--ever. We didn't think there was that much to look through."

Invacare and the FDA are still trying to negotiate an agreement to address concerns with the company's corporate headquarters and wheelchair manufacturing facility in Elyria, Ohio, according to Lara Mahoney, director of investor relations and corporate communications. In December, Invacare announced the FDA proposed it suspend certain operations at the facilities.

The letter to GF cited 10 violations, including failing to adequately investigate, document and close complaints within the required 30-day timeframe. Since it received the letter, GF has been putting "corrective actions" in place and has been updating the agency on its progress, Spett says. "Eventually, everything in the letter will be dealt with," he said.

The letter states GF's response to the violations has been adequate, with one exception: Failure to report a correction or removal conducted to reduce a risk to health posed by a device. GF has sent another response to the FDA and is waiting to hear back, Spett says.

Additionally, the letter states that a follow-up inspection will be necessary. That's fine by Spett.

"We welcome it," he said. "We spend a lot of money on our internal audits and our third-party audits. The FDA's investigation is free and, in the long run, will help to correct some things."

Repeated calls and emails to execs at Merits Health were not returned.

The letter to Merits Health details the results of an investigation at its manufacturing facility in Taichung, Taiwan, from July 11 to July 14. It cites eight violations, including failure to establish and maintain adequate procedures for implementing corrective and preventative action; and failure to establish and maintain adequate procedures to ensure each production run meets acceptance criteria.

The letter states Merits Health's response to the violations has not been adequate. As a result, the agency may take steps to deny the company's power wheelchairs and scooters, and stair chair lifts--in a process known as "detention without physical examination"--until violations are corrected.

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Comments

THANK GOODNESS the FDA is getting this under control. How ever would a free market weed out all these unscrupulous evil wreckless manufacturers? I'm glad this article left out the fact that Invacare has been leading the charge in trying to stop competative bidding which is ruining DME. That Ohio coincidentaly where Invacare is located got hit with numerous bid areas even when population does not merit the areas. Certainly this is not the FED again trying to punish Invacare for activly going against the machine?

I cannot get out of healthcare fast enough. People weren't meant to live like this.

The FDA harassed my [former] emloyer for three solid days last year and essentially found nothing. In 28 years of Homecare,I had never seen an FDA visit/inspection last more than a couple hours.In all, they wasted a combined total of 100 man hours of our time that would have been better devoted to patient care.In those same 28 years, i do not recall a single instance in which a patient has been harmed by a malfunctioning bed,manual wheelchair or quality of oxygen problem that was directly attributed to poor manufacturing processes. Perhaps some very isolated instances from time to time (usually attributed to improper/unsafe use/modifying from intended use) but nothing to warrant the recent harassment. Overall, the DME/HME industry provides excellent service and equipment to its customers and if properly educated,very safe equipment as well.Until we see a host of law firms advertising on tv for patients to come forward regarding their injuries(like all the ones we see for drugs which are regulated by the same FDA)I can see no problems with the equipment and oxygen provided to our patients and customers.

How deep are industry the pockets? Any class action brought about by any law firm would first measure what could they get. I highly doubt that the entire HME industry would be worth more than a stand alone "Merck", "Pfizer", "Wyeth" or any of the other major drug manufacturers single year's profits. However, that being said everyone should be more than aware the entire industry is under a microscope. The articles I sent and Liz published titled "A Hypocrite and a telling comment" should speak for itself. "Deep Pockets" will always get a "get out of jail free card".

This is very simple, if you attack the providers hard enough and long enough then you can discourage utilization without telling the voters you are denying them access to coverage.

Good point Chris, that is why the availability of and the continuity of care for a patient is one of many arguments raised by my legal team before The Third Circuit Court in The Nichole Medical Case. Follow the case for all the arguments and issues raised pertaining to CMS's gunslinging approach of administering a healthcare system. I have been quoted correctly as saying, "We are on the docket and we will have the ear of the high court," in the article "Provider gets his day in court" Feb 3, 2012. With all the legal research done in the past two and a half years I can safely say "No one in the industry has had the pleasure of saying that concerning these issues". This is why I have been so adamant with my words; this case is tantamount for an industry to survive. The Courts are the only venue for ajudication to cease the continued out of control approach currently utilized by the administration NOT Capitol Hill!