HCPro.com - Device Regulation Alert: Safety, Compliance and Reimbursement News

Editor's Note: Final issue of Device Regulation Alert today

Sat, 09 May 2009 04:34:00 GMT

HCPro is sorry to announce that this is the final issue of Device Regulation Alert. We thank you for being a loyal subscriber.

If you are interested in information about customizable, compliance e-learning courses for sales and marketing staff, please contact Maureen Croce at 866-464-2776 or mcroce@hcpro.com.

Device maker settles allegations it failed to disclose payments to physicians

Sat, 09 May 2009 04:31:00 GMT

Medical device maker Synthes, Inc., based in West Chester, PA, entered into a settlement agreement with the New Jersey Attorney General (AG) to resolve allegations the company failed to disclose financial conflicts-of-interest among doctors who conducted clinical testing on its products, according to the AG.

Disetronic Medical Systems recalls insulin pumps

Sat, 09 May 2009 04:29:00 GMT

Disetronic Medical Systems issued a recall for its ACCU-CHEK Spirit insulin pumps with serial numbers from SN02119552 through SN10006093 because the “up” and “down” buttons are potentially defective, according to a company release.

Patients use the pump’s “up” and “down” buttons to change the program in the menu or to administer additional insulin. If the buttons do not function, users may not be able to change any programmed setting on the pump.

Disetronic will replace pumps within the affected serial numbers that have intermittent or complete loss of function of the “up” and/or “down” button. Disetronic discovered the problem through the company’s normal quality control monitoring process.

FDA sends warning letter to Nidek Medical Products

Sat, 09 May 2009 04:26:00 GMT

Nidek Medical Products failed to properly document complaints about the company's oxygen concentrators, according to an FDA warning letter.

The FDA said the company failed to evaluate complaints properly to determine whether they should be reported to the FDA, and did not conduct adequate investigations of complaints, including one incident involving a patient’s death.

IOM calls for end to industry support

Sat, 09 May 2009 04:24:00 GMT

The Institute of Medicine (IOM) became the latest organization to call for an end to medical device industry support for academic medical centers, journals, and professional societies.

The IOM wants entities engaged in health research, education, clinical care, and development to establish guidelines for accepting industry support and to strengthen conflict-of-interest policies, according to an IOM report.

Congress should also require medical device companies to publicly disclose payments to physicians, researchers, academic health centers, professional societies, patient advocacy groups, and others involved in medicine, the IOM said.

Smith & Nephew receives subpoena from DOJ

Mon, 27 Apr 2009 15:54:00 GMT

The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound stimulation product EXOGEN from 1995 and onward, the company announced.

EXOGEN is FDA approved for specific fresh fractures and long bone non-unions and was first marketed in 1998.

Smith & Nephew said it plans to comply fully with the request and believes its competitors have received similar subpoenas.

Third former device employee pleads guilty to misbranding

Mon, 27 Apr 2009 04:59:00 GMT

Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the Department of Justice.

As a territory manager for an unnamed medical device manufacturer based in Hopkinton, MA, Doyle promoted the devices designed to promote bone growth for unapproved uses, the DOJ said. Doyle promoted a combination of the devices with bone void filler, and in furtherance of that promotion provided mixing instructions to surgeons, medical technicians and others.

Doyle is the third former medical device employee to plead guilty to misbranding a medical device. Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device in February. In November 2008, Darnell Martin pleaded guilty to similar charge.

St. Jude warned about manufacturing problems

Mon, 27 Apr 2009 04:58:00 GMT

St. Jude Medical received an FDA warning letter citing manufacturing problems mainly related to the Safire ablation catheter, the company disclosed in an SEC filing.

Physicians use ablation catheters to carefully burn heart tissue to disengage electrical signals that cause atrial fibrillation.

The FDA raised concerns about the facility after inspections conducted between December 8 and December 19, 2008, according to the filing. St. Jude detailed proposed corrective actions in a written response to the FDA.

The company believes it can resolve the problems cited in the letter and does not expect customer orders to be affected.

Biomet under investigation for possible fraud

Mon, 27 Apr 2009 04:56:00 GMT

Government investigators are examining allegations that Biomet improperly sold, promoted, and billed for its bone growth stimulation devices, the company disclosed in an April 14 SEC filing.

Federal authorities in West Virginia are investigating sales and marketing practices for Biomet’s subsidiary EBI, which makes electric stimulators for post-surgery patients. The U.S. Attorney in Massachusetts is also investigating possible improper conduct in the sale and leasing of the electrical-stimulation devices.

Quest to pay $302M for subsidiary's alleged misbranding

Mon, 27 Apr 2009 04:53:00 GMT

Quest Diagnostics and its subsidiary, Nichols Institute Diagnostics (NID) will pay $302 million to resolve civil and criminal allegations NID sold misbranded diagnostic tests, according to a Department of Justice (DOJ) release.

NID pleaded guilty to felony misbranding and will pay a criminal fine of $40 million. Quest entered into a deferred prosecution agreement. Quest and NID will also pay $262 million plus interest to resolve False Claims Act allegations relating five assays manufactured by NID that allegedly provided inaccurate results.

Read more about Quest’s resolution of the allegations.

Arrow recalling intra-aortic balloons

Mon, 27 Apr 2009 04:50:00 GMT

Arrow International recalled 45,211 units of volume connectors for its 30-, 40- and 50-cc intra-aortic balloon pump catheters manufactured from January 2008 through January 2009 because of faulty connection tubes.

The FDA classified the recall as a Class I recall, the most serious type of recall, in which there is a reasonable probability that use of these products will cause serious injury or death.

Read more about Arrow’s Class I recall.

Business associates: HIPAA survey

Mon, 27 Apr 2009 04:48:00 GMT

We want to hear from business associates about their need for HIPAA training. Business associates perform services on behalf of a covered entity that involve the use or disclosure of protected health information. If you work as an employee of a covered entity, please do not take this survey.

To thank you for participating in this survey, we will choose one person to win a $50 AMEX gift card.

Please click here to complete the survey.

FDA to review risks for older devices

Mon, 13 Apr 2009 04:55:00 GMT

Manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the FDA for a risk evaluation, the agency announced April 8.

The FDA approved the devices prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act. The Federal Register lists the affected devices and outlines what information manufacturers must provide.

Manufacturers must submit the requested information within 120 days. The FDA will review the submitted data and either require manufacturers to submit pre-market approval applications or will re-classify the devices into Class I or Class II.

Massachusetts disclosure requirements a first for medical device manufacturers

Mon, 13 Apr 2009 04:53:00 GMT

Massachusetts is the first state to require medical device companies to disclose financial relationships with healthcare professionals. This will increase the compliance challenges facing medical device manufacturers.

“Device manufacturers have never had to think through ‘what systems, whether manual or electronic are necessary to ensure the company is accounting for all of the expenses that must be reported to the state,’ ‘what accounts are those expenses coming from,’ and ‘to whom are they being paid,’” says Kate Feola, Esq., an associate with McDermott, Will & Emory, LLP, in Washington, D.C.

Download our free white paper, Massachusetts Disclosure Regulations: New Challenges for Pharmaceutical, Medical Device Manufacturers, to learn more about the new law and how your company can prepare for it.

Johns Hopkins bans gifts

Mon, 13 Apr 2009 04:50:00 GMT

A new Johns Hopkins Medicine (JHM) policy prohibits physicians, scientists, students, and staff members from accepting gifts and meals from medical device companies beginning July 1, according to a Johns Hopkins release.

The Johns Hopkins Medicine Policy on Interaction with Industry also prohibits consulting arrangements that require no real work. Medical device manufacturer representatives may only meet with Johns Hopkins staff members in non-patient areas and then only at the invitation of a staff member.

Read more about Johns Hopkins' new policy to ban gifts.

Stanford to disclose payments from device makers

Mon, 13 Apr 2009 04:47:00 GMT

Stanford University School of Medicine will reveal which of the 1,200 physicians and faculty affiliated with the medical school receive money from medical device manufacturers, the school announced.

The university plans to post medical- and research-related consulting activities of $5,000 or more per year on its Web site annually. The school expects to include the information in physician and faculty profiles by the end of the year. Physicians and faculty members already disclose the information to the university.

ZOLL issues corrective action for automated external defibrillators

Mon, 13 Apr 2009 04:44:00 GMT

ZOLL Medical Corporation initiated a voluntary field corrective action for 180,000 ZOLL AED Plus automated external defibrillators because some batteries do not work properly and self-test software may not detect the problem, according to a company release.

As a result, the AED Plus defibrillator may not deliver shocks during a sudden cardiac arrest. Devices installed for at least three years have the highest risk, according to ZOLL.

The field corrective action requires users to download and install updated software from the company’s Web site.

Charges dropped against four device makers after DPAs expire

Mon, 13 Apr 2009 04:40:00 GMT

The Department of Justice (DOJ) dropped criminal conspiracy charges against Zimmer, Depuy Orthopaedics, Biomet, and Smith & Nephew after 18-month deferred prosecution agreements (DPA) against the companies expired March 31.

The companies entered into the DPAs September 27, 2007. After a two-year investigation, the government alleged the companies provided financial incentives—including consulting agreements, lavish trips, and other perks—to induce physicians to use one company’s artificial hip and knee reconstruction and replacement products instead of those manufactured by another company.

FDA: Medtronic voluntary recall of catheter is Class I recall

Mon, 13 Apr 2009 04:38:00 GMT

The FDA is classifying Medtronic’s voluntary recall for three models of the BioGlide Ventricular Snap Shunt Catheter as a Class I recall, according to a company release.

A Class I recall is issued when “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Read more about Medtronic’s Class I recall.

Judge dismisses suit against Allergan citing preemption

Mon, 30 Mar 2009 04:15:00 GMT

A federal judge cited the February 2008 Supreme Court ruling in favor of preemption for medical device makers in his decision to grant a summary judgment for Allergan in Dorsey v. Allergan.

Judge Robert Echols of the U.S. District Court for the Middle District of Tennessee dismissed a lawsuit filed by Susan Dorsey.

Read more about Echols' decision in favor of Allergan.