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CDRH Changes Course on Dental Mercury

  WASHINGTON WRAP-UP       CDRH has settled with a consumer group and has abandoned its position that dental mercury amalgams have every right to stay in the marketplace without a warning label.

The deal came three months after a settlement offer from Consumers for Dental Choice. The group had been trying for 10 years to get CDRH to require labels about the neurotoxic side effects of mercury amalgams.

In a news release, attorney Charles G. Brown for the group said: “During a several-hour negotiation session, FDA agreed to change its Web site on amalgam—dramatically.” He continued, “Gone, gone, gone are all of FDA's claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 scientific panel vote affirmed amalgam's safety.”

Instead—see www.fda.gov/cdrh/consumer/amalgams.html—FDA has moved to a neutral course. Its new policy statement recognizes the serious health concerns posed by mercury amalgam, in particular for children and unborn children, pregnant women, and those with mercury immuno-sensitivity or high mercury body burdens.

Brown called the agency's move “a 180-degree reversal from FDA's 30-year policy of protecting mercury fillings...To change FDA policy, we tried petitions, congressional hearings, state law fact sheets, scientific advisory committee hearings, and letters galore—to no avail. So in the great American tradition, we sued.”

This led to judicial direction to mediate, and the agreement was forged May 30 before District of Columbia federal court magistrate judge John M. Facciola.


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“The impact of the rewriting of [FDA's] position on amalgam can hardly be understated,” Brown said. “FDA's Web site will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgam's risk to children, young women, and immuno-sensitive persons on its Web site, I find it inconceivable that FDA will not in some way protect them in its upcoming rule.”

TMJI-CDRH Battle Heads to Federal Court

TMJ Implants (TMJI) has had a contentious, protracted battle with CDRH. TMJI is contesting the center's decision to fine the firm $340,000 for late filing of 17 medical device reports. But the matter could be resolved in the courts soon.

In June, FDA formally denied a petition for stay of decision (imposing the fine) as “untimely.” TMJI filed the petition in May. The Golden, CO–based firm is now seeking redress before the 10th Circuit Court of Appeals in Denver. Hewing tightly to a CDRH brief in opposition, FDA deputy commissioner for policy Randall W. Lutter told the company that it had offered “no justification for failing to file within the 30-day time frame specified in 21 CFR 10.35(b). Moreover, you submitted an amended petition five days later...that again includes no explanation for the late filing.”

Lutter's letter recognized the pending 10th Circuit case regarding that decision and said that “we do not intend to seek payment...while this matter is being considered by the court.”

Larson Cited for QSR Violations

An FDA inspection at Larson Medical Products' Columbus, OH, manufacturing facility in March found numerous quality system violations, according to a May 7 warning letter from FDA's Cincinnati district office. The letter says the company manufactures low-temperature thermoplastics indicated for use as splinting materials. It also makes devices intended to be used for positioning and stabilizing patients undergoing radiation therapy.

Violations cited include:

  • Failure by management to ensure that an adequate and effective quality system is implemented and maintained at all levels of the organization.
  • Failure to establish procedures for quality audits. Also, failure to conduct such audits to ensure that the quality system is in compliance with requirements and to determine the effectiveness of the quality system.
  • Failure to establish and maintain procedures for implementing corrective and preventive actions and failure to document such activities.
  • Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

The warning letter says the inspection also revealed that the devices are misbranded because the firm failed or refused to furnish required medical device reporting information.

The company was given 15 days to respond with specific steps taken to eliminate the violations.

New Tests, Labeling for Contact Lens Solutions?

FDA's Ophthalmic Devices Advisory Committee has recommended labeling changes and additional testing for contact lens cleaning solutions to prevent eye infections. Changes would include discard dates on lenses, a warning to not reuse cleaning solutions, and a recommendation to frequently change contact lens cases.

The recommendations come in the wake of incidents in 2006 and 2007 in which Bausch & Lomb's MoistureLoc solution and Advanced Medical Optics's Complete Moistureplus solution were linked to hundreds of serious eye infections.

FDA officials told the panel that 80% of contact lens problems are caused by users not following label directions. “This is a unique medical device in that patients have enormous control over the rate of infection,” said Malvina Eydelman, CDRH ophthalmic device division director.

Panelists agreed but also said companies could improve their products by testing them against more types of bacteria and fungi, especially Acanthamoeba keratitis, the parasite involved in the Advanced Medical cases. They also considered other FDA suggestions, including whether labels for lens care solutions should have a “rub and rinse” recommendation. Although many multipurpose solutions advertise “no rub” cleaning capability, which is an FDA-approved claim, many doctors still recommend rubbing and rinsing to provide additional safety. Panel members agreed that FDA guidance should include a rub and rinse recommendation.

The panel also said that FDA should consider requiring companies to add discard dates to contact lenses, a practice already followed in Europe.

Experts from the American Academy of Ophthalmology and other organizations told the committee that improving contact lens product testing and advocating universal lens-care guidelines for consumers will help prevent eye infection outbreaks. “Now is the time to tighten the safety net around contact lens products,” said academy spokesperson Elmer Tu.

FDA officials said they will consider the panel's recommendations and the possibility of updating guidance to industry.

FDA Cites Chattem for ‘Icy Hot' Problems

A February inspection at Chattem Inc.'s Chattanooga, TN, facility that manufactures Icy Hot heat-therapy patches found quality, medical device reporting (MDR), and misbranding violations. Several days after the inspection, the company recalled the patches. FDA's New Orleans district office issued a warning letter four months later.

The letter says that the company failed to establish and maintain adequate procedures for implementing corrective and preventive actions (CAPAs). It notes that the firm received some 200 complaints about the patches. Problems mentioned in the complaints included burns, skin removal, and skin irritation. Those are defined in the firm's standard operating procedures as major complaints requiring CAPA, but none were initiated.

In addition, the firm has not provided FDA with documentation showing that personnel have been adequately trained on the new complaint and CAPA procedures that emphasize thorough investigations.

The inspection also found that the company failed to submit an MDR within 30 days of receiving information that the device may have caused or contributed to a death or serious injury. The company acknowledged that it failed to submit 15 reports within 30 days of receiving such information. FDA says the firm also has not provided documentation showing that personnel have been adequately trained on MDR procedures, and that the procedures have been successfully implemented.

The company's response was inadequate, FDA says, because it failed to revise its standard operating procedure to address all regulatory requirements. The firm also did not show that personnel have been adequately trained on the recall procedure.

Chattem was told to take prompt action to correct the violations and to respond within 15 days, outlining specific steps taken with an explanation of how the firm will prevent these and similar violations from reoccurring.

Chattem's Chattanooga Problems

The company also failed to submit a written report to FDA of a labeling correction or removal to reduce a health risk posed by the device. The warning letter cited an unreported labeling change that was implemented to reduce the risk to health from burns, skin removal, and skin irritation associated with the patches. The labeling change was initiated as a response to more than 168 consumer complaints, the letter says.

The inspection further found the product to be misbranded because the labeling doesn't have adequate directions for use. Also, it does not have adequate warnings against use in certain pathological conditions or by children where its use may be dangerous to health.

FDA Cites Sandstone over Laser QSRs

Sandstone Medical Technologies (Birmingham, AL) does not have an effective and adequate quality system in place for its Class II medical laser systems, a warning letter charges. The firm imports and relabels the lasers for distribution in the United States. The firm was also cited in the letter for the following:

  • Failure to establish and maintain corrective and preventive action procedures.
  • Failure to establish and maintain complaint files and associated procedures for receiving, reviewing, and evaluating complaints.
  • Failure to establish and maintain servicing instructions and procedures.
  • Failure to establish and maintain procedures for acceptance activities.
  • Failure to submit annual reports for the laser systems.

Additionally, the warning letter cites the firm for failing to develop, maintain, and implement written medical device reporting procedures. And, it says, labels affixed to each laser do not include the month and year of manufacture, which is required by FDA regulations.

Medtronic Spine Settles Medicare Fraud Case


Medtronic's Settlement by the Numbers

2
Number of employees who
blew the whistle

5
Number of years required
in Medtronic's integrity
agreement with HHS

$75 million
Amount, plus accrued
interest, that Medtronic
paid to the government

Medtronic Spine LLC (Sunnyvale, CA), formerly known as Kyphon Inc., has settled a whistle-blower suit alleging Medicare fraud with a payment of $75 million plus accrued interest to the U.S. government. It also entered into a five-year corporate integrity agreement with HHS.

“[The] settlement demonstrates our commitment to ensure that the Medicare Trust Fund is used to pay for necessary medical care and is not depleted as a result of aggressive marketing schemes intended to increase sales of unnecessary devices or procedures,” said Gregory G. Katsas, acting assistant attorney general of the Justice Department's Civil Division.

Two company employees had charged that Kyphon improperly persuaded hospitals to bill for spinal surgery at a more costly inpatient rate. The alleged fraud involved kyphoplasty, a procedure in which spinal gaps are filled with bone cement.

Medtronic issued a statement saying that Kyphon had reached the agreement with the federal government to settle the suit before being acquired by Medtronic. It said the settlement agreement reflects the company's assertion that Kyphon and its employees had not engaged in any wrongdoing or illegal activity.

The corporate integrity agreement focuses on training about appropriate reimbursement advice to customers, and also requires maintenance and implementation of standard compliance processes. It contains measures to ensure compliance with Medicare regulations and policies in the future.

CDRH Proposes End to ‘Baseline' Reports

CDRH has proposed to stop requiring baseline reporting as part of device adverse-event reports because the information is also contained in MedWatch mandatory reporting forms.

The proposal is proceeding under a direct final rule unless an adverse public comment is received. In such a case, the proposal would move under a proposed final rule. The proposal may be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0310-nfr.pdf.

Copyright ©2008 Medical Device & Diagnostic Industry
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