medical devices

Bill would create federal research institute

Anne Zieger — Mon, 04 Aug 2008 08:51:49 -0400

A new bill has been introduced in the Senate that would create a central federal agency tasked with researching the benefits of various procedures in treating common medical conditions. The bill caps more than a year of discussion and hearings on the Hill on the topic of creating such an agency, which is backed by several high-profile public health experts, including former HCFA (now CMS) administrator Gail Wilensky.

The current bill, backed by Senate Finance Committee Chairman Max Baucus (D-MT) and Budget Committee Chairman Kent Conrad (D-ND), establishes the Health Care Comparative Effectiveness Research Institute. The Institute would be a public-private partnership that would conduct research on surgical procedures, pharmaceuticals, medical devices and other key treatments. Its board would include doctors, patients and drug and device maker representatives. The center, whose annual costs should exceed $300 million after five years, would be paid for by fees from public and private payers, and would operate outside of the government.

To learn more about the proposed center:
- read this Modern Healthcare piece (reg. req.)

Related Articles:
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FDA says CT scans can make medical devices malfunction

Anne Zieger — Tue, 15 Jul 2008 09:39:22 -0400

The FDA has issued a warning that some critical electronic devices may malfunction when patients get CT scans. In fact, CT scans may actually cause some medical devices to shock patients using them, or send out inaccurate signals, the agency said. This squares with an earlier study, published by Mayo Clinic researchers, which found that CT scans often interfered with electronic heart devices. Devices on the FDA's warning list include pacemakers, defibrillators, insulin pumps, neurostimulators, drug infusion pumps, cochlear implants and retinal implants. To date, the FDA has received six confirmed reports of devices that malfunctioned after CT scans, as well as another nine reports of suspected problems, though no deaths have occurred to date.

To learn more about the alert:
- read this Chicago Tribune article

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CMS makes Part D data available for patient-safety efforts

Fri, 23 May 2008 06:59:58 -0400

CMS has issued final regulations that will make Medicare Part D claims data available to the FDA and other agencies, as well as academic researchers, for use in patient-safety initiatives. The FDA has said that it will use the data to pilot-test its Sentinel Initiative, a new electronic system that will let the agency query a large number of health information databases in an effort to more effectively detect post-market adverse events resulting from use of approved drugs and medical devices. This program won't only detect the events, it will allow the agency to monitor the performance of drugs and devices in real time, said FDA and CMS officials. The Sentinel program links claims data from 25 million beneficiaries with prescription drug coverage to other Medicare claims information, including diagnoses, treatments, hospitalizations and physician services.

To learn more about this announcement:
- read this Modern Healthcare article (reg. req.)

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SPOTLIGHT: Progress on comparative effectiveness program

Tue, 15 Apr 2008 06:59:52 -0400

Deciding whether one treatment really does work better than another is one of the thorniest problems faced by providers. Now, it's beginning to look like one proposed solution to the problem--establishing a government agency to compare the effectiveness of drugs and medical devices--could become a reality. Article

Groups ask FDA to push for unique medical device IDs

Fri, 04 Apr 2008 07:59:57 -0400

A group of provider, consumer, research and health quality groups are pushing the FDA to publish planned rules requiring a unique identification system for medical devices. The Advancing Patient Safety Coalition, which includes the American Hospital Association, Federation of American Hospitals and American Association of Medical Colleges, contends that the unique device identification system is crucial to cutting errors, improving device adverse event reporting and improving post-market surveillance efforts. Federal legislation in place since 2007 requires the use of unique identifiers to label medical devices, though it doesn't say which types of devices should be labeled. The FDA has been considering the matter since 2005, working with industry stakeholders to determine which devices should be identified, and how.

To learn more about the coalition's aims:
- read this Health Data Management article

SPOTLIGHT: To cut costs, more hospitals re-using devices

Wed, 19 Mar 2008 07:59:52 -0400

Increasingly, hospitals are recycling medical devices labeled as single-use, from scissors and scrubs to surgical blades. While this is legal--as long as certain FDA guidelines are followed in sterilizing and re-testing them--many critics still argue that this is a questionable practice at best. To date, however, the GAO has concluded that there's no evidence that such reprocessed devices create elevated health risks. Article

Decision makes it harder to sue device makers

Thu, 21 Feb 2008 06:59:57 -0500

A new Supreme Court opinion has come down this week that should make it harder for patients to seek damages for harm caused by FDA-approved medical devices. The ruling held that federal law doesn't allow them to sue device makers using state laws and regs that go above and beyond federal requirements. The suit arose from a case filed by Charles Riegel, who sued when an FDA-approved Medtronic balloon catheter burst as he underwent an angioplasty in 1996. Riegel based his suit on the contention that the device's design and labeling violated New York law. But the high court dismissed the case, holding that Riegel's state claim was pre-empted by the federal Medical Device Amendments of 1976.

To learn more about the case:
- read this Modern Healthcare item

Related Articles:
Guidant to release safety data on its devices. Report
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Study: devices, diagnostics not driving med inflation

Thu, 14 Feb 2008 06:59:54 -0500

Here's a nice piece of advocacy by the Advanced Medical Technology Association (AdvaMed)--a study concluding that implantable devices and high-tech diagnostics are not, mind you, NOT a major cost-driver in overall medical expenses. According to the AdvaMed study, medical-device pricing rose 1.2 percent between 1989 and 2004, as compared with a 5 percent increase in the medical consumer price index. On the other hand, the authors admitted that overall spending on medical devices increased at 8.1 percent during the same period, while overall national health expenditures increased 7.4 percent.

The thing is, even if the study is actuarially faultless, the real issue is not how fast expenses are growing, it's how much value is being delivered by these options versus other interventions. Ultimately, that's what matters. Wonder why AdvaMed didn't go there?

To learn more about this study:
- see AdvaMed's press release
- read the AdvaMed report (.pdf)

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Medtronic faces more kickback accusations

Thu, 27 Sep 2007 06:59:58 -0400

Despite having spent $40 million to settle kickback charges, medical device maker Medtronic has continued to pay millions in consulting fees to spine surgeons, according to a whistle-blower involved in the case. Now Sen. Charles Grassley (R-IA) is asking Medtronic to explain consulting payments made after the July 2006 settlement, which addressed charges that the company had lured doctors with "sham consulting agreements, sham royalty agreements and lavish trips to desirable locations."

According to the whistle-blower's attorney, Medtronic made payments of almost $6 million in consulting fees, with some surgeons being paid in the high six figures in a single year. Medtronic, for its part, isn't denying that it's made consulting payments, but says that the payments weren't kickbacks. Instead, it says, it paid doctors a legitimate fee to assist the company in determining how its devices could be best designed and used.

To find out more about the pending investigation:
- read this piece in The New York Times

Related Article:
Medtronic will settle accusations on kickbacks. Report
Hospital corporation Iasis accused of illegal referrals. Report
Alvarado recovering nicely from scandal. Report

ALSO NOTED: FDA to require device IDs; Pay for performance takes root in Philly; and much more...

Mon, 24 Sep 2007 06:59:50 -0400

> The FDA should soon begin requiring medical device manufacturers to give the devices unique IDs. Article

> Pay for performance initiatives are finding a home within Philadelphia-area hospitals. Article

> Another healthcare organization has decided to give patients and their families direct access to its rapid response team. Article

> A recent study suggests that the odds of a patient being satisfied with physician or medical clinic services are about 50-50. Article

And Finally... You know, I've never craved chocolate enough to take out a second mortgage on my house. Article