Knowing current FDA Regulations of Ultrasound Transducer Repairs
Knowing current FDA Regulations of Ultrasound Transducer Repairs
Imagine a world where medicine is not regulated. Where anyone who pleases can put up a sign and start treating diseases with unproven, unscientific methods, medications, and equipment. Imagine the risks to human health occurring only because companies are trying to maximize their profits with little concern for patient safety. Fortunately, the practice of medicine is both highly regulated by the FDA and scrutinized by potential patients. These standards put significant pressure on healthcare facilities to provide the highest level of care to earn patients while balancing aggressive budgets.
To comply with updated Medicare and Medicaid standards, the healthcare industry is striving to reduce costs. However, facilities must not sacrifice the quality of treatment or patient safety for incremental cost savings. This is critical, as the public possesses tools at their disposal such as Hospital Compare. This is a government initiative comprised of the efforts of Medicare and the Hospital Quality Alliance. Hospital Compare presents consumers with hospital ratings in a given zip code, allowing them to select a healthcare institution based on the following criteria:
Survey of patients' experiences
Timely and effective care
Readmissions and deaths
Use of medical imaging
Payment and value of care
The higher the institution’s rating, the more likely consumers are to select that institution’s services. A lower rating will not only push patients to pick another healthcare provider, but may also result in significant penalties through reduced Medicare and Medicaid revenues, link here. Safety, reliability, and performance of medical devices impact each of the above criteria significantly. The FDA is endeavoring to curtail low quality products from entering healthcare facilities through promoting certified Quality Management Systems in the third-party medical device market. This is a welcome initiative and a great first step to ensure patients receive the quality of healthcare they expect and deserve.
There are still instances where medicine is either not practiced in accordance with regulations, or existing guidelines are misinterpreted or worse, deliberately ignored. This happens often with ultrasound transducers. Although the FDA has recently announced there is no new regulation of third party suppliers, link here, this does not mean there are not current regulations already in place that must be met to protect patients and provide high quality care.
A well-run hospital or clinic constantly maintains their medical equipment. Even the most cautious practitioner will occasionally have accidents and end up with a damaged transducer. When repairs are needed, healthcare facilities look for suppliers who can help them stay within their budget without sacrificing quality.
With that being said, in the equipment aftermarket, some third-party companies are hiding critical Non-OEM components inside OEM labeled casings to meet demand and lower their costs. Unfortunately, what is being overlooked is the quality of the components and repairs being performed. A video demonstrating this practice can be viewed here. These practices are often lumped into two definitions that are commonly misinterpreted, “Repaired” and “Remanufactured”. Unfortunately, they are misinterpreted by third party medical device organizations, usually to the favor of their financial gain and at the detriment of patient care. The accurate definitions of “Repaired” from the FDA website reads:
A “repaired” product is a type of servicing that returns a component to original specifications, including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device. FDA linkhere.
“Repaired” does not specifically describe replacement of non-working components if non-OEM components are used and does not articulate the full context of all regulation around ultrasound transducers. If non-OEM components are used, the medical device is now considered “Non-OEM” and requires a 510k. FDA link here.
Another misinterpreted medical device term often thrown around is “Remanufactured”. Many organizations avoid the remanufacturing term as this classification directly states from the FDA:
Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's performance, safety specifications, or intended use.” FDA link here.
By definition, anything remanufactured is a modified device as the changes impact the devices performance and safety specifications, which requires a 510k.
Some third party “Remanufacturers” of ultrasound components such as arrays/crystals claim they have access to the original equipment manufacturer (OEM) specifications or can reverse engineer them. But just like any other proprietary formula or process, OEMs do not disclose their designs, specifications and manufacturing processes, especially when it comes to ultrasound transducer arrays. Without this knowledge any reverse engineering is a best guess, a condition unacceptable by any hospital or patient standards.
Many low quality "remanufactured" devices are, in effect, counterfeit, or “cloned” as they have not undergone proper validation with a 510k clearance. They are replicas that may or may not function exactly as the original, with the latter being the case more often than not. To make matters worse, their production and usage are, in fact, not in compliance with current FDA ultrasound transducer regulations, putting patients and hospitals at risk. The exact language is quoted below from the FDA describing this requirement:
“Like new OEM transducers, non-OEM, reprocessed, and remanufactured transducers are new medical devices. As such, they are subject to the 510(k) premarket notification regulations (21 CFR 807.81). They need to have a cleared 510(k) prior to being marketed.” FDA link here.
Grave problems may arise from the use of non-OEM ultrasound transducers:
Electrical safety: water-based gel is used to facilitate conductivity. If electrical components are not well-sealed, there is a risk of shock.
Contamination risk: if the device is not well-built and properly sealed, it can contaminate patients despite sterilization.
The FDA’s answer to the problem of non-compliant medical devices is to issue a 510(k) clearance. If a medical device servicing company has not been issued a 510(k) clearance, it cannot be trusted to service and repair devices safely and correctly. The best action for healthcare facilities to educate themselves on this risk and ensure their suppliers are complying with all regulations.
If you are seeking to have your medical equipment repaired or serviced, please use this link to the FDA’s website to validate they have proper 510(k) clearance for every medical device model that is modified or Non-OEM.
If patients suffer harm to their health or undergo an unpleasant or unprofessional experience during their healthcare interactions, the care-giving institution’s rating will go down, potentially depriving it of the patronage of discerning consumers and unnecessarily reduce Medicare and Medicaid revenues. In short, your patients’ lives are at stake, as is the reputation and future success of your healthcare institution.