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.

Joint Commission Will Require Catheter Valve Disinfection

The Joint Commission will require hospitals to have a standardized protocol to disinfect catheter luer access valves, starting January 2010. In the face of that new dictum, what’s a hospital to do?

A panel pondering that question – and featuring three national vascular access experts — drew more than 100 nurses at the recent annual meeting of the Association for Vascular Access. Panelists were:

• Lynn Hadaway, M.Ed., RNC, CRNI, infusion therapy expert
• Gregory Schears, MD, Mayo Clinic
• Kelly Fugate, ND, RN, Joint Commission

The panel’s focus: Preventing Intraluminal Contamination from CRBSI’s: Complying with New Guidelines from the Joint Commission & SHEA Compendium.” The event was sponsored by Excelsior Medical, makers of the SwabCap disinfection cap for luer access valves, and moderated by Greg Dennis, of Dowling & Dennis Public Relations.

Dr. Schears led off by outlining the seriousness of catheter-related bloodstream infections, which are all too common despite years of effort aimed at eradicating these potential killers. He said it was a “logical extension” of infection control efforts to cover and disinfect valves with a cap.

Lynn Hadaway outlined a variety of studies on the issue, while Kelly Fugate explained why the Joint Commission has new National Patient Safety Goals that include the disinfection protocol requirement,..

For more on SwabCap, go to http://www.Excelsiormedical.com. Excelsior Medical is a client of Dowling & Dennis Public Relations.