Medical equipment manufacturers thrive on new product development and the subsequent sale of a new line of medical devices. Of course, new technologies are invaluable in creating better methods and techniques for dealing with a wide array of health issues.
But what happens when a manufacturer puts out a cutting-edge device with the hope of making a killing (no pun intended), but fails to perform sufficient testing to ensure that the new technology has zero or limited negative side-effects.
That’s where the FDA steps in with regulations regarding Reconditioned Hospital Equipment the testing of new medical equipment. The FDA has instituted testing standards for manufacturers before they are allowed to release a product to the general market.
However there are those that say the FDA does not do enough to regulate recently developed devices. They claim that lobbying and under-the-table bribes creates lapses in governmental oversight in the release process for new medical equipment. To their credit, the FDA has announced that they are instituting scores of changes this year to the so-called fast-track 510(k) medical device clearance process. Clearly this is a move in the right direction, as the fast-track program might have allowed sub-par equipment to slip through the cracks and get unwarranted approval. At this point it’s hard to tell if new equipment is really problematic in general, but these concerns are generating a lot of buzz in the industry.
This issue coupled with the global recession, has generated an increased interest in reconditioned or refurbished medical equipment. When considering used equipment, doctors, clinics and hospitals can now buy ultrasound machines, EKG’s and patient monitors, and much more at very affordable prices. More importantly, they can buy these machines with the knowledge that they already have a solid track-record without any glitches or defects that could threaten a patient’s wellbeing.
Of course, buyers should make sure they are not buying junk. But this can be done by checking how old the machine is, checking out pictures, and requesting a 3-6 month warranty from the seller. Another option that is helpful for cash-strapped institutions is to go for a trade-up with a manufacturer. Although this does not solve the issue of bleeding-edge technology that might not have been properly tested, it certainly helps with finances. With a trade-up, a doctor or medical clinic (or hospital), can trade their old machine for a new one, and essentially reduce the price of the new equipment in a very significant way.
