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.