FDA Scrutinizes Medical Device Companies

Anybody involved in the medical device industry can’t help but notice how much bigger a presence the FDA is these days.

Within the past month, the agency has taken two notable actions with regard to vascular access and infection control — areas of particular concern to clinicians and companies, including several of our coalition partners and client companies.

Most recently, the FDA has issued a recall of certain Huber needles used for vascular access. The needles, the agency said, could produce cores — slivers of silicone — when they penetrate a vascular access port. That could lead to infection and other complications. More info at http://tinyurl.com/2v4k9kw.

Even more significantly, earlier this month the agency notified virtually every maker of needleless IV connectors that they would have to do major post-market studies to determine if their positive-pressure needleless IV connectors were associated with an increased risk of potentially deadly catheter related bloodstream infections (CRBSI).

Interestingly, it appears that the only maker of needleless IV connectors NOT affected by the recall was RyMed Technologies, which makes only neutral-pressure (AKA zero-displacement) connectors. (Full disclosure: RyMed is one of our clients.)

More about that FDA action on connectors at http://tinyurl.com/3az47ko.

And of course, beyond these actions, every regulatory person in the medical device industry has a story to tell about increased FDA scrutiny of device applications for marketing clearance.

EARLY Act on Breast Cancer Gains ACS Support

The EARLY Act is making progress toward passage in the Congress. To learn more about the bill and register your support with your senators, visit http://earlyactawareness.org. Thanks to recent changes, the bill is now supported by the American Cancer Society.

Dowling & Dennis has been working with the nonprofit Tigerlily Foundation and NeoMatrix, makers of the HALO Breast Pap Test, to get this legislation passed. Among other activities we have:

* Assisted the Tigerlily Foundation with a major Capitol Hill event; and
* Worked with breast surgeon Ernie Bodai, MD, to place his op-ed piece in the Sacramento Bee.
* Done outreach to all the major breast cancer advocacy and clinical organizations;
* Helped create the EARLY Act Website;

This valuable legislation would provide federal funding for educating young women and healthcare professionals about breast cancer in women 45 and younger. That age group accounts for more than 5% of the total breast cancer cases in the US every single year. The bill provides for $45 million in funding over five years.

Along with Tigerlily, NeoMatrix is committed to educating young women about what they can do to avoid breast cancer, and how they can assess their individual risk of getting the disease – thereby taking steps to potentially protect themselves against ever getting breast cancer.

Rep. Debbie Wasserman Schultz, herself a breast cancer survivor, is the original author of the bill. It’s being carried in the Senate by Amy Klobuchar. The EARLY Act has more than 360 cosponsors in the House and more than 30 in the Senate.

For the latest info, check http://earlyactawareness.org.