Pre-Owned Decompression Devices
Sometimes, the most cost-effective way to get into a top-quality piece of equipment is getting it used. That’s why North American Medical offers factory refurbished equipment that we have carefully inspected, upgraded and quality tested.
It’s important to note, second-hand resellers that are not a manufacturer or not authorized by the manufacturer are not accountable to FDA or to any quality monitoring system. There is nothing to prevent use of inferior replacement parts or sloppy repairs that could render a medical device unsafe. And because the FDA cannot track these devices, there is no documented service history on devices that have changed hands.
Because of traceability concerns like these, the FDA started GUDID. With this system, FDA is trying for more accurate reporting, analysis, and of course, corrections related to adverse events in the field. This ongoing, long term analysis data also helps manufacturers correct software bugs and improve or prevent other issues for devices in the field.
North American Medical has over twenty years of data and performance analysis that we constantly track from our Accu-SPINA’s in the field. No one knows our product like we do.
As used devices get older, the risk of adverse events is of particular importance especially if they are not factory maintained. There are serious challenges and risks unauthorized third-party resellers create when attempting to restore or repair devices to their original specifications having no training, factory support or proprietary knowledge. Therefore, possible public health issues can easily arise from these activities.
When purchasing second-hand decompression tables, who is at risk?
Public health issues obviously put the patient at risk when medical products don’t perform according to specification.
Risk also passes to the healthcare provider when something goes wrong because of possible liability exposure:
• Used equipment re-sellers are not required to carry product liability insurance, so buyers of these second-hand devices are left to shoulder that risk.
• Manufacturers product liability insurance policies become immediately VOID after any unauthorized third-party product tampering, servicing, etc.
• The provider (used equipment owner) must still answer to the FDA, and relevant medical board, should they ever be visited, questioned or audited regarding their equipment safety or practices.
I have owned an Accu-SPINA® System for ten years, providing IDD Therapy® to my patients with disc problems at Mecca Integrated Center in Fairfield, New Jersey.
As a healthcare professional and colleague, I want to tell you about the two most essential items you need to decide before buying a treatment device for your practice:
1. Deciding what device to buy.
2. Deciding who you want to buy it from.
The first was the most difficult. I wanted a machine that had credible medical research done on the machine I was purchasing. This led me to my Accu-SPINA® System, back in 2009; I learned it had traditionally been purchased largely by medical doctors and groups with bigger budgets. For me, though, there was no question as to the science that went into this product and the unparalleled quality of the machine. To this day, I am still performing IDD Therapy® treatments with my Accu-SPINA® system ten years later. With only routine maintenance, I have never experienced a significant breakdown or malfunction. North American Medical has an excellent service department that responds quickly and professionally.
A good decompression table is an investment in your practice and yourself. I’ve bought used cars, but in doing so, I’ve never been able to communicate with the manufacturer directly. And I never thought I would need to until the day my first “troubled” patient came along. Let’s call him “Mr. X.” This man, Mr. X, had no idea what he was talking about, but clearly he’s read something online about injuries that have happened with so-called “decompression” and traction devices. He also read about false claims made by some companies, and I guess he thought a lawyer would get him a big payday at my expense. With my own reputation on the line, I can tell you, I was really glad I chose a product whose manufacturer is of such high integrity.
I’m not saying that every healthcare provider is going to have a case brought against them. But every doctor is at risk of an unfair claim, and that’s when your business and clinical choices will be brought into question later on. In my case, I was able to show I bought the best system, with the best safety record, and genuine medical and peer-reviewed studies on this device. All the accusations thrown at me pertained to other devices- and NAM helped me with the ammunition to show my product, my treatments, and my practice was in another completely separate class – victory.
Dr. Michael Sapienza
Mecca Integrated Medical Center, New Jersey, US