Medical Device Daily Washington Editor

FDA recently reported a class I recall of Healon, a viscoelastic fluid made by Advanced Medical Optics (AMO; Santa Ana, California) due to reports of inflammation following eye surgery using the device. The company reported a voluntary recall on Oct. 30, 2008, of more than 4,400 units of Healon D from one lot after the complaints of inflammation, including toxic anterior segment syndrome. AMO received a total of 66 reports of adverse event and tests of the affected lot disclosed elevated levels of an endotoxin, but the FDA statement did not disclose the identity of the toxin.

The FDA action was prompted by the fact that as of Dec. 3, AMO had retrieved only 964 of the 1,450 units released for domestic distribution, leaving 484 in circulation. Healon is used to maintain space in the eye during surgery and because of that function, the fluid is regulated as a medical device.

Steve Chesterman, media relations director for AMO, told Medical Device Daily, "we reported [to FDA] that there are approximately 471 used in surgery and are not retrievable," which "leaves us with about 15 units that are unaccounted for." He said that "the majority of the [affected] lot was in our warehouse" and that the company is "comfortable that none of the product is still in the public domain and won't be used for surgery."

Chesterman said AMO is not yet certain as to the source of the endotoxin, but that "we're investigating now." The company's plant in Uppsala, Sweden, makes all the company's viscoelastic products, and Chesterman said AMO has owned the facility for about four years. The plant was previously owned by Pharmacia and was taken over by Pfizer (New York) after its purchase of Pharmacia. "We've never had any issues at the plant and this is a single-lot issue," Chesterman said.

CMS memo for apnea diagnostic

The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed decision memo for diagnosis of obstructive sleep apnea (OSA) after receiving a request in 2008 from Itamar Medical (Caesarea, Israel) for clarification on the means by which OSA is measured. At least one observer of the world of OSA thinks that the memo will help providers separate the winners from the wanna-bes.

CMS noted that it had addressed the coverage of continuous positive airway pressure devices in three earlier decisions, but that "we have not, at a national level, specifically addressed coverage of the tests themselves," leaving the issue "to local contractor discretion."

CMS proposes to cover polysomnography only in sleep labs, but will cover other modalities in home and clinical settings, including tests of airflow, pulse oximetry and actigraphy, which measures gross motor movement.

Edward Grandi, executive director of the American Sleep Apnea Association (Washington) told MDD that the decision memo "clarifies the role of the non-traditional devices" used to diagnose OSA and that "there was some confusion after the last memo."

Grandi said that the difficulty for CMS is that "there is no gold standard" for diagnosing OSA, not even polysomnography, which measures a wide range of physiological behaviors. He said the memo "gives equal weight to all these diagnostic devices," which he depicted as a good development to the extent that "they'll now be able to compete" and the poorer performers will be weeded out of the market.

Cardiologist busted for Medicare fraud

The Office of Inspector General at the Department of Health and Human Services recently announced that it had helped convict a cardiologist practicing in Lafayette, Louisiana of healthcare fraud for using procedures and devices unnecessarily.

According to the Jan. 2 statement, Mehmood Patel, MD, was convicted by a federal jury after a three-month trial, which included six days of deliberation, but which nonetheless resulted in conviction on 51 counts of healthcare fraud. OIG states that Patel had falsified patient symptoms and findings on medical tests, and performed "unnecessary coronary procedures such as deploying angioplasty balloons and stents ... in coronary arteries that had little or insignificant disease."

Patel was indicted in February 2006 after a complaint was filed with HHS, which was apparently related to the execution of a search warrant for Patel's office in November 2003, about the time when Our Lady of Lourdes Hospital (also Lafayette) commenced with procedures to suspend Patel's privileges at the hospital. The Louisiana State Medical Board subsequently stripped the interventionist's license to practice interventional cardiology, but he continued to practice internal medicine.