Overheard at GMM HQ
"Medical device marketing has changed more in the past 2 years than the past 15."
~ Holley Malia, President & CEO
WHAT THE INDUSTRY IS BUZZING ABOUT
GAME OF THROATS
Deadly superbugs are the reason an advisory panel to the Food and Drug administration has recommended elevating the cleaning techniques for duodenoscopes. The apparatus has been linked to several outbreaks in Seattle, Los Angeles and outside Chicago. If the FDA chooses to advocate for these changes, it would set a precedent for nearly all medical devices. If they don't act, it leaves open the more chilling possibility of an ABC movie of the week featuring child stars from the 80's – an outcome that would please no one.
THOROUGH CLEANING – IT'S A GAS
The panel of experts suggests that hospitals sterilize scopes with ethylene oxide gas before reuse, an expensive and extremely toxic method. UCLA has already adopted the practice, but the gas is so toxic that doctors must wait longer before reusing the device. This delay has the potential to weigh down already strained tee-time schedules and/or require additional duodenoscopes be made available to practices.
With bacteria upping their game, the medical community needs to bring it. That'll mean added steps, techniques and costs just to keep up.
GUDID A GOOD IDEA?
The public now has online access to the Global Unique Device Identification Database (GUDID) – that's the reference catalog for every medical device with a Unique Device Identifier (UDI). The beta release is in the first phase of a five-year rollout and includes only class III devices. Currently there's about as much content as a Justin Beiber song (not much).
WHICH COST IS THE COSTLIER COST?
While the FDA intends for UDI implementation to improve patient safety and modernize post-market surveillance, the push to have medical devices included in the registry has created two camps of thought. Advocates point out that a UDI system is a way to pinpoint problems with medical devices quickly, and save lives. Manufacturers are concerned about costs, citing a recent study about the recall of a defibrillator that was implanted in 268,000 patients before the FDA ordered it removed from the market. While the UDI system would have helped manage the recall, it would have cost the manufacturer up to $1.19 billion.
The world is rushing forward as an information society, and the expectation for transparency is only going to rise. Will the public use GUDID or will they be too busy looking up how much their doctor is getting paid under the Sunshine Act.
SUDDENLY WE'RE OK WITH EGG ON OUR FACE
Researchers believe they have found a way to create bioplastic materials with antibacterial properties using egg whites, whey and soy proteins. This would be a great alternative to petroleum-based plastics (sorry, Big Oil ☹) currently used for wound dressings, catheter tubing, sutures, etc.
The CDC estimates that 1.7 million infections acquired in hospitals lead to 99,000 deaths each year. Many of those infections occurred after the bacteria involved formed a biofilm on traditional petroleum-based plastics used in hospitals. New antibacterial plastic could address this issue. In the future they might also be able to infuse antibiotics and other medicines directly into the material for additional benefit.
There seems to be nothing but upside to bioplastics – providing answers and new solutions to old problems.
GOOD TO KNOW
Does the Valencia or X-Pro II filter make gout look better? Figure 1 is being called the "Instagram for Doctors." If Selfies don't make your stomach turn, this will do the trick.
HAPPY FATHERS DAY FROM GMM!
Good news for dads: Women everywhere decided that beer bellies are sexy. #dadbod.