Medical Device Daily Washington Editor
FDA announced a class I recall last week for a product with an interesting name and stated purpose, one which harkens back to the 1960s when the phrase "good vibrations" peppered conversations among teens and young adults. In this case, however, the medicinal effect of those vibrations is expected to be taken seriously even by those who are not hip to the vernacular of the day.
The agency's Oct. 1 announcement that the maker of the vibrational integrated bio-photonic energizer multi-frequency field generator — Vibe for short — had sent a letter dated the same day to all purchasers of the unit, instructing customers "to stop using it." According to FDA, the letter also included a label to be affixed to the device "stating that it is not a medical device and should not be used as one" as well as a replacement for the operator's manual that includes "no medical conditions or treatment claims." Recipients are instructed to sign a form and return it to the maker of the unit, VIBE Technologies (VT; Greeley, Colorado), acknowledging receipt of the letter and that they "understand that the Vibe Machine does not affect the structure or function of the human or animal body."
VT was the recipient of an April 11 warning letter that cited the firm for lack of a PMA or a 510(k) for the device, which was based on a November 2007 inspection. According to the letter, the company had corresponded with FDA detailing its intended corrections in two letters, but the agency also noted that the investigator "helped you register your firm during the inspection."
According to the web site herbaldoctor.com, the unit "brings the vibrational level of your body back to its natural state of being." Routine use for between 30 seconds and four minutes a day is purported to "raise your body's vibrations and eliminate lower vibrations from it." The product's use is based on research done by a Georges Lakhovsky, inventor of the multiple wave oscillator. According to herbaldoctor.com, Lakhovsky's research early in the 20th Century suggested that "healthy cells acted like little batteries," and that a boost to the cells offered "great results with all types of physical imbalances, including cancer."
FDA noted that class 1 recalls "involve situations in which there is a reasonable probability that use of the product will cause serious injury or death," but the notice did not provide details on the specific nature of the risk. The warning letter also noted that VT had no quality policy, no procedures for quality audits or for calibration of machines used to test the Vibe units.
Gene Koonce, the company's president, told Medical Device Daily that he was unaware of the regulatory requirements for the device prior to hearing from FDA. "We were calling it an energy device, not a medical device," he said. The company had been promoting the device as "giving you more energy, making you feel better," Koonce said. He also stated that VT began marketing the device, which is basically just a broad-spectrum light, in 2002 and commenced with clinical trials three years later in an effort to expand the indications. When asked who conducted the clinical trials for the device, he named Norm Shealy, MD, of Holos University (Fair Park, Missouri), but Koonce said he was unaware of whether Shealy or an unnamed institutional review board had notified FDA or NIH of the trial. Koonce said the company is still pursuing a 510(k) for the device.
DME supplier reviews said lacking
Medicare's durable medical equipment (DME) program is still the target of intense congressional interest, and an October report by the Government Accountability Office makes clear that administering the program is a lot more work than might be readily apparent.
According to GAO, it and the Centers for Medicare & Medicaid Services conducted an inspection of more than 1,500 DME suppliers in 2007 and identified almost 500 "that failed to maintain a physical facility or were not open and staffed during the unannounced site visits."
CMS revoked all their privileges and reinstated billing rights for 222 of the 243 who appealed, but GAO states in the report that CMS had no criteria for reinstatement. Possible as a consequence of the lack of objective criteria, "two thirds of suppliers whose billing privileges were reinstated ... had their privileges revoked again or inactivated." The GAO report also states that "the U.S. attorney's office indicted 18 individuals in connection with 15 of the 222 reinstated suppliers," convicting 10 for sentences of one to four years and for fines of between $90,000 and $11 million.
GAO recommends, and CMS agrees, that DME appeals should be subject to "a more critical review of the types of evidence submitted by suppliers ... to ensure that fraudulent suppliers are not reinstated. However, the document also states that CMS is of the view that such guidelines "should not impinge on a hearing officer's ability to make an independent determination" of a review. CMS also states in the report that DME suppliers will have to be certified by Oct. 1 of next year in any case.
Michael Reinemer, spokesman for AA Homecare (Arlington, Virginia), told MDD that the association "proposed a 13-point plan that would prevent fraud ... in the DME sector," but he also said a recent congressional report supports the notion that while "DME gets about 98% of the attention" where Medicare fraud is concerned, it "accounts for only 1-2%" of all Medicare-related fraud.
As for whether CMS has the resources to fully pursue fraud, Reinemer said the association's plan addresses this question, which he described as "critical." As for whether Congress sees resources as an issue for CMS, he said that he sees "plenty of interest [on the part of legislators] in stopping fraud, but there seems to be some disagreement on the resource issue."