Earlier this year, a TV show featured a report on how counterfeit golf clubs bearing the prestigious Callaway brand label were being manufactured in China and sold here in the United States to unsuspecting consumers.

As a golfer who needs help, this of course piqued my interest, not to mention my concern. Basically what the reporter said was that while these counterfeits look like the real thing, they don’t perform like the real thing. Sure, they hit the ball, but that’s where the performance similarities end. Even in the hands of the most skillful golfer, the precision of the swings made with these counterfeit Callaways is consistently off. When you buy real Callaway clubs, you’re not getting just golf clubs, you’re paying for the engineering, the quality materials, the craftsmanship — the consistent performance and total value that Callaway offers.

And now as a society, we’re also dealing with news of counterfeit drugs and medical devices. It’s no longer just about getting ripped off and brand reputation suffering. Quality of care may suffer too. The recent news about the counterfeit surgical blue e-mesh that’s being uncovered, is a prime example of how counterfeit products can put not only performance at risk, but they can ultimately put patient safety at risk.

                               
                                               Photo courtesy of Callaway Golf

Whether you’re a golfer or you work with surgical mesh, you may have unknowingly come across other products that don’t, for some odd reason, perform as well as they used to. They just don’t feel right. They just don’t work right. What’s going on here?

Armed with a new awareness about such scams, you should consistently analyze your future purchase decisions more closely. For instance, did you know that there are third-party medical device repair vendors who claim to sell original equipment manufacturer’s (OEM) parts for endoscopes, when in fact they don’t? There are a number of websites advertising this. I’ve even seen such ads in trade magazines.Care and caution should be taken when making repair decisions about your endoscopes. They are complex medical devices that provide the healthcare community with invaluable diagnostic and therapeutic capabilities. Properly maintaining and repairing these delicate instruments is essential to ensure their ongoing reliability and precision performance.

Aftermarket alterations that significantly change the OEM’s specifications are common and well documented by medical device manufacturers. Unfortunately, many materials managers, facility risk managers, nurses, G.I. physicians and surgeons may be unaware of these alterations made in the repair process. After service is performed by a non-OEM (third-party) repair vendor, an OEM endoscope may cosmetically look like the original product. However, there can be many problems inside the scope that are indiscernible to the user until the instrument is disassembled. The casual substitution of a non-OEM part for an OEM part by a third-party repair vendor and the use of non-validated repair methods may have a significant impact on clinical outcomes, reduce the life expectancy and alter the overall performance of the endoscope.

When it comes to evidence of third-party repairs on Olympus endoscopes, we’ve seen everything. From spliced biopsy channels and braid mesh wrapped with Teflon plumbers tape, to angulation cables soldered together and boot extenders used to hide buckled insertion tubes. We’ve even seen Olympus insertion tubes replaced with cheap imitations, and holes and cuts in insertion tubes covered with thick patches. When this happens to the insertion tube, which is a vital part of the endoscope, it can result in increased rigidity or floppiness in the hands of the endoscopist.

Bottom line is, when an endoscope is repaired improperly, it is more likely to malfunction during a procedure. This can cause procedural delays, adversely affect clinical outcomes and may jeopardize patient safety. Parts, repair methods, and materials from third party repair vendors may also introduce biocompatibility issues with the human body.

The best way to ensure the performance of your devices, achieve superior clinical outcomes, and protect the safety of your patients is to ensure your facility is utilizing OEM-certified repair parts, services, and people.