Infection control and safety expert Jackie Dorst explains why the temptation of low-cost supplies can expose practices to patient harm, legal liability, and reputational damage.
BY GREG THOMPSON
What’s the worst that can happen when using equipment from the gray market?For one orthodontist, a $15 handpiece purchased from a well-known internet auction site failed when its revolving bur detached and fell into a patient’s throat, where it was subsequently inhaled into her lungs. The patient, who was getting her braces removed just before starting college, required surgery to have it extracted.
This incident highlights the severe risks lurking behind the appealingly low prices of gray market products. According to Jackie Dorst, RDH, BS, a consultant and speaker on infection control and OSHA safety, the financial temptation is understandable but dangerous. “A normal handpiece could run anywhere from $400 to $1,000 or more,” says Dorst. “The $15 handpiece was a huge savings, so an orthodontist purchased it.”
The problem, however, was that the tool was intended for single use, but it came with no instructions for cleaning or sterilization. “An orthodontist still put them into use and cleaned and sterilized them for re-use in a similar way to their FDA-approved handpieces,” Dorst explains. A post-incident evaluation revealed the chuck holding the bur had weakened from the heat of autoclave sterilization, eventually failing at high RPMs.
The fallout was significant. “It put the doctor’s reputation at risk,” Dorst says. “They lost productivity in the office. You can imagine the chaos. They also had the liability of a possible lawsuit.”
DEFINING THE GRAY MARKET IN ORTHODONTICS
Gray market transactions occur outside of traditional, authorized distribution channels. While general dentists have long-standing relationships with full-service distributors, Dorst notes that orthodontists have a different history of product acquisition.
“For orthodontists, much of their equipment was purchased from the manufacturers of archwires and brackets,” she explains. “Orthodontic suppliers expanded into consumable supplies, orthodontic instruments, even hand hygiene products as the need increased. As a result, orthodontists did not have relationships with local dental suppliers.”
This history, combined with the rise of e-commerce, has made it easier for orthodontists to search online for supplies, leading them to unauthorized vendors. These channels often come with hidden costs that go far beyond the initial price tag, including voided warranties, patient safety concerns, liability exposure, and reputational risk.
“Legitimate distributors are going to validate that the products they sell are regulated and approved,” Dorst cautions. “They have been cleared by the FDA as is required for medical and dental devices and for products used in direct patient care. The FDA ensures that the equipment does what it’s supposed to do and does no harm. That is key.”
FROM FAULTY ADHESIVES TO TOXIC ELASTICS
The risks extend across nearly every category of orthodontic product. Sub-standard manufacturing in a gray market laser, for example, could lead to an electrical arc or an overheated tip, causing patient injury. Authorized distributors, in contrast, will honor warranties and service devices to the manufacturer’s standards.
Consumables are another major area of concern. Dorst points to the adhesives used to attach brackets. If these products are expired or improperly manufactured, the bond can fail, requiring unscheduled appointments to reattach brackets.
Products sourced from outside the United States present additional dangers. “There is the risk of purchasing products that are either expired or close to expired—and perhaps bought in bulk and repackaged,” Dorst warns. “They may not have the original U.S. manufacturers’ correct label or even have expiration dates changed on the exterior. Then when you open the product, you see a different expiration date on the interior.”
Even something as common as elastics can be hazardous. “In orthodontics, we use elastics,” Dorst continues. “It’s an FDA-approved elastomeric compound that is safe to be in the human mouth when you are eating hot and cold foods. If you’re purchasing on the gray market, there may be chemical additives to that and it could release toxic chemicals.”
IDENTIFYING AND AVOIDING GRAY MARKET PRODUCTS
While lower prices are the main draw of the gray market, especially as high overhead cuts into profitability, orthodontists can take steps to protect their practice. The first line of defense is to carefully inspect all deliveries. Dorst advises looking for red flags like spelling or grammatical errors on the packaging, damaged boxes, and mismatched expiration dates.
Improper storage is another hallmark of gray market goods. “If it’s gray market, it may have been stored in a hot or damp warehouse where there could be mold if moisture gets into the box,” she says. “Exam gloves must be stored in a warehouse with a controlled temperature. If the temperature gets too high, those gloves may deteriorate more quickly and tear or puncture during use. I’ve seen glove boxes where mold was growing on the inside of the boxes.”
Ultimately, curbing the use of gray market products requires awareness of the risks. If a practice identifies a product of lesser quality or suspects it is unauthorized, Dorst recommends reporting it to the FDA through its MedWatch website.
THE ULTIMATE RESPONSIBILITY
While saving money is a constant pressure for any business, the potential consequences of using non-validated products are too great to ignore. In the case of the inhaled bur, a lawsuit was avoided only because the orthodontist was close personal friends with the patient’s family. The practitioner was also lucky to avoid an employee injury, as the bur could have easily struck an assistant in the eye. While these circumstances spared the practice from a potentially catastrophic legal battle, it was a stroke of luck that most practitioners cannot rely on when using non-validated equipment.
The bottom line is that the practitioner is responsible for the tools and materials used in patient care. “If non-FDA products are used, and there is an injury to patients or employees, the doctor is responsible,” Dorst warns. “If it went to a court decision, it will always go back to the standard of care of using FDA-approved products and devices. If non FDA-approved products are used, you can imagine the result of a legal action.” OP
Photo: ID 24108571 © Diana Ruseva Kadreva | Dreamstime.com
Greg Thompson is a contributing writer for Orthodontic Products.
