Regulatory Editor

Advances in medical technology may seem incremental, but they often come across to the FDA as having hit a regulatory tripwire. This seems to be the case with the Oct. 28 warning letter to Texas Biostetic Instruments (TBI; Colleyville, Texas) alleging that several of the company's offerings require new regulatory filings that the company's president said may force the company to alter its business plan.

The warning letter addressed an inspection that took place in October and November 2014, and cited two deviations from the quality systems regulations, specifically for complaint handling and corrective and preventive action. However, the larger issues revolve around what the agency said is the use of fundamentally different technologies from predicates cited by the company's regulatory filings.

One instance of this is the company's Biolipo LED system, which TBI markets to weight loss clinics. The system uses LED pads to reduce accumulations of fatty tissue, most commonly on and around the waistline, but the system is said to run afoul of the provisions of 21 CFR Part 890.5370, which is slotted for non-measuring exercise equipment. The agency argued that the use of LED lights constitutes the use of fundamentally different technology than this category lists, and hence the BioLipo LED is not exempt from premarket notification requirements.

A similar predicament held for three others of the company's offerings, and TBI's president, Nelson Thibodeux, told Medical Device Daily that the company will attempt to maintain the class I status of at least one of the cited devices. He made note of the lag time between the date of the inspection and that of the warning letter, and said he had responded to the 483 shortly after the inspection, which the FDA corroborated with an acknowledgment in the warning letter of a Nov. 18, 2014, response to the 483.

Regarding the FDA's assertion that the devices were adulterated due to a lack of regulatory filings, Thibodeaux said, "on three of the filings, we provided other filings that were current with FDA that this equipment was a predicate to." With regard to the LED-based Biolipo systems, he said, "it escapes my imagination how an LED light can be a class II device," arguing that it uses the same lighting technology "institutions have used in their facilities for as long as LED lights have been available."

The warning letter also cited the company's Biostetics 2100 microcurrent system for elastin infusion, and Thibodeaux said there are existing class I devices employing the same technology. "Every institution in the nation provides a course on galvanic microcurrent," he asserted, remarking, "it is curious how eBay can sell [similar] class II equipment simply by putting it up there." One example is this 220-volt facial skin care machine, although there are others.

Thibodeaux said the company will re-apply for some units, but that "we've simply withdrawn our application" on the Biolipo LED light system.

HHS advises users of devices on HIPAA

Sometimes it's not the manufacturer, but the user as indicated by a Nov. 24 letter from the Office for Civil Rights at the Department of Health and Human Services. The OCR letter made note of a settlement arrived at with Lahey Hospital and Medical Center (Burlington, Mass.), which is now on the hook for a fine of $850,000 and a compliance program.

The letter addresses a situation in which a Lahey employee had left a laptop in an unlocked treatment room after using the computer to view images produced by a portable CT machine, after which the laptop was stolen. The OCR letter, titled "HIPAA settlement reinforces lessons for users of medical devices," stated that the laptop had data for nearly 600 patients and that an investigation of events at Lahey disclosed "widespread non-compliance" with rules promulgated for compliance with the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

Among the violations said to have been disclosed during the course of the investigation was a failure to implement and maintain policies and procedures for equipment used with diagnostic machinery, along with a lack of procedures for recording any activity taking place at the workstation in question.

OCR directory Jocelyn Samuels is quoted as saying, "it is essential that covered entities apply appropriate protections to workstations associated with medical devices," including those used with diagnostic and lab equipment.

Aetna passes on brush biopsy

Aetna (Hartford, Conn.) has advised in a Nov. 24 clinical policy bulletin that brush biopsy is considered experimental and investigational for any uses associated with cancerous or pre-canceous oral and esophageal lesions. The loser in this outcome is Oralscan Laboratories (Suffern, N.Y.) and its OralCDx system, although Aetna indicated it would revisit its coverage of diagnostics for these lesions in August 2016.

The bulletin noted that the U.S. Preventive Services Task Force (USPSTF) published a 2014 guideline for oral cancer screening, a document said to have included the observation that a number of screening methods, including oral brush biopsy, "have not been adequately tested" in primary care settings other than in dental offices. While there is some interest in screening for oral human papillomavirus, this is not yet endorsed by any medical or dental societies, and FDA has not yet approved any screening test for HPV.

Aetna announced in a Nov. 17 clinical policy bulletin that it had revised its medical necessity criteria for walkers, canes and crutches so as to align them with Medicare policy for durable medical equipment, making note of a Medicare administrative contractor as the source of the Medicare policy, possibly a reference to NHIC Corp. (Hingham, Mass.).

Aetna said its policy is revised to confer medical necessity on walkers with trunk support for beneficiaries who meet the medical necessity criteria for a standard walker and whose physicians have documented the need for "the special features." Aetna said the bulleting is updated to provided a list of components "that are included in the allowance for walkers that should not be separately billed at the same time." //

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