The power of social media isn't lost on us. Apparently it isn't lost on FDA either. The agency recently went after a pharmaceutical company for using the Facebook Share function, which could be the first time FDA has warned a company for Facebook promotion. The problem? FDA says that use of the button—at least where the drug Tasigna is concerned—is incomplete and misleading.
"The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug," the FDA letter says, signed by Karen Rulli from FDA's Division of Drug Marketing, Advertising, and Communications. "In addition, the shared content inadequately communicates Tasigna's FDA-approved indication and implies superiority over other products."
Definitely something to keep in mind for medical device OEMs as they try to find ways to harness the power of...

August 11th, 2010

Medical filters used to prevent blood clots should be removed from the body as soon as the clot risk has passed, says an advisory report from FDA.

The warning comes because of 900 reports about problems with these filters collected since 2005. Problems can arise when filters are left inside veins too long. The devices can shift, and pieces can break off, drift through the bloodstream and perforate vital organs including the heart, according to adverse event reports.

"It's thought that too many retrievable filters stay in permanently because patients are lost to follow-up," or doctors don't know problems can occur when the devices are left in long-term, the FDA's Dr. Bram Zuckerman said in a phone interview with the Associated Press on Monday. He is director of CDRH'...

August 10th, 2010


Little by little, I’m learning about the medical device industry. With my EE background, I’m finding that it’s not as hard as I expected to pick up the terminology. While I don’t expect to be performing surgery any time soon, neither are the readers of this space. They do, however, make the products that are used by the surgeons in many cases.

My medical-device education got a boost yesterday when I visited the folks at Micro. If you’re not familiar with Micro, and I admit I wasn’t before the meeting, they are a full service contract manufacturer that specializes in medical assembly and precision metal stamping, amongst other things.

It was pretty remarkable hearing some of their success stories, such as how they saved one of their customers time and money using an advanced metal injection...

August 10th, 2010

I came across a whitepaper recently that I thought deserved a special mention. It’s called “Improving traceability and auditability across the development lifecycle.” As its name suggests, the whitepaper explains how, using a set of software tools, users can get the traceability that’s needed to ensure overall product quality while also improving project communication.

What’s interesting about this process is that its roots are based in embedded, real-time software. Systems and software development teams creating these complex end products are being put to the test by conflicting priorities like faster time-to-market, demands for higher quality and increasing governance requirements. But fear not, there is a solution.

I suggest you give it a read.

Rich Nass

August 10th, 2010

Myomo Inc.'s (Cambridge, MA) robotic prosthetic arm has been available since 2008, but now the company is offering the device directly to patients at a discount. The NeuroRobotic System isn't covered by insurance and had previously been sold to rehab centers and hospitals for $7000. The company has slashed the price to $4750 and will be offering the device to patients who pass a screening process. Patients will also need a doctor's prescription.
The prosthesis attaches to the arm and reads muscle signals to help patients as they move a limb. The Boston Globe reports that the company is currently conducting a 30-patient study to evaluate the most effective way to use the device.

August 9th, 2010

CDRH says moving forward with a risk-based approach for providing regulatory oversight over laboratory-developed and commercially marketed tests will help assure physicians and consumers that test results are reliable. Speaking at a July 19 FDA public meeting in Hyattsville, MD, CDRH Office of In Vitro Diagnostic Device Evaluation and Safety personalized medicine director Elizabeth Mansfield said that such an approach would be likely phased in with higher-risk tests receiving agency scrutiny before moving to lower-risk tests.

Laboratory-developed tests (LDTs) have received considerable public attention lately. In May, FDA objected to San Diego–based Pathway Genomics' attempt to market an over-the-counter genetic test collection kit at Walgreens drug stores because it is outside the boundaries of the regulatory safe harbor for such tests, which are regulated by CMS. The agency has been bothered by broader claims made by test marketers. CDRH Office of In Vitro...

August 5th, 2010

Got something to say to FDA? If you live in California, you just might be in luck.
From FDA:
The meeting will be held on October 7, 2010, beginning at 8:00 a.m., at the following location:

Hilton Irvine/Orange County Airport Hotel
18800 MacArthur Blvd
Irvine, CA 92612
Phone: (949) 833-9999

The meeting will not be videotaped or webcast.

Online registration is available. Registration will close on Wednesday, September 22, 2010.
If you wish to make an oral presentation during any of the sessions at the meeting, you must have indicated this at the time of registration. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled...

August 5th, 2010

FDA released a 120-page report late yesterday detailing proposed changes to the maligned 510(k) process. The report was split in two, with the first part addressing preliminary recommendations to improve the process. The second part is a separate report from a CDRH task force that evaluated how the agency incorporates new scientific information into its regulatory decision making. 
The recommendations will be open for public comment before any changes are actually made. Some of the highlights:

  • FDA recommends developing guidance to clarify when other medical devices should not be used as a benchmark. The agency wants help from the public and industry to make these definitions clear.
  • The agency also wants to reiterate its authority to rescind prior device approval.
  • FDA recommends creating a subset of Class II medical devices that would require clinical or manufacturing data to demonstrate that they are substantially...
August 4th, 2010

AAMI and FDA have announced a groundbreaking summit aimed at improving the safety of infusion pumps. The summit is scheduled take place Oct. 5-6 at FDA headquarters in Silver Spring, MD.

Now is the time to have your voice heard in this unprecedented effort to build a consensus and find constructive solutions to one of the top concerns in the healthcare community.

Infusion pumps are among the most widely used medical devices in today's healthcare system. Yet, between 2005 and 2009, FDA has received approximately 56,000 adverse events associated with their use.

This summit will be open to individuals and organizations that have a key interest in the improvement of these devices and in patient safety. Expected participants include:

  • Hospital and industry senior executives
  • Design engineers
  • Researchers and developers of drug delivery devices
  • Academicians
  • Pharmacists
  • Nurses
  • Surgical...
August 3rd, 2010

A study published online in Mayo Clinic Proceedings says that in the United States withdrawing left ventricular assist devices (LVAD) at the end of a patient's life is ethical. According to the report “it is ethically and legally permissible” for physicians to comply with requests by patients (or their representatives) to “refuse or to request withdrawal of life-sustaining treatments” such as hemodialysis or artificial nutrition.
The researchers describe 14 cases where patients or their health-care surrogates requested the assist device be turned off. They say that withdrawing LVAD support isn’t the same as assisted suicide or euthanasia because there’s no “new pathology” introduced to cause death. All 14 patients died within a day of turning off the device. But their death was due to the underlying heart failure, researchers write. So assuming patients or their representative know the consequences of deactivating the...

August 3rd, 2010