OEM vs. ISO: What you must know before you buy pre-owned endoscopes

While purchasing pre-owned endoscopes can be an affordable option for getting your doctors' hands on great technology, it is imperative to do your homework before making a purchase decision to ensure the equipment performs as intended and doesn't cost more money in the long run.

Consider these important factors when purchasing pre-owned endoscopes.

Same model number, different quality – all refurbished endoscopes may not be created equal
Buying Certified Pre-Owned from an FDA Original Equipment Manufacturer versus an Independent Service Organization

Often the refurbishments made on pre-owned endoscopes are internal and not visible to the naked eye. This means the purchasing organization must trust the representations made by the seller, or commit to the additional time it will take to investigate these refurbishments to ensure the equipment functions as intended. Certified Pre-Owned endoscopes, however, are rigorously tested and refurbished to manufacturers' like-new specifications.

"Typically, OEMs use only original manufacturer parts, allowing the equipment to be brought back to its original like-new specifications, says John Place, Senior Manager of Medical Products Repair at Olympus. "Many OEMs do not sell the proprietary parts that enable endoscopes to function the way they were designed and FDA-approved to function, thus ISOs must do their best to recreate these parts and approximate OEM performance specifications. The results of this reverse engineering by ISOs can lead to performance deficits."

While OEMs and ISOs may sell the same model scope, the quality, warranty and customer support after the equipment is purchased could be drastically different. It's imperative for the buyer to investigate whether the product is refurbished using only OEM parts and components (so it can perform as intended), and whether the endoscope comes with a warranty and after-sales support conducive to a long product life. Failure to do so can lead to costly repairs and replacements in the long run.

FDA inspections and audits ensure that OEMs maintain quality standards
The benefits of quality control through FDA regulation

The FDA does not monitor ISOs in the same way it does with OEMs. OEMs are FDA-regulated, while ISOs are not regulated by the FDA.

FDA-regulated medical device manufacturers such as OEMs are required to comply with regulatory requirements, quality controls and reporting.  

A report by The American Society of Gastrointestinal Endoscopy on endoscope repair performed by OEMs and ISOs reported that ISOs are not required to comply with Quality Systems Regulations, nor are they subject to routine inspection and audit by the FDA:

"OEMs must comply with the FDA's Quality System Regulations [which] requires any repairs [or refurbishments by the OEM] to return the instrument to the manufacturer’s original specifications… ISOs are not regulated by the FDA [and are only responsible for returning the refurbished item to] a reasonable approximation of the manufacturer’s specifications."

The FDA's controls and reporting requirements for OEMs are designed to protect both customers and patients. ISOs are not regulated by the FDA, which places the responsibility of due diligence upon the customer to verify the ISO repaired equipment performs as designed.

Keep your endoscopes clean and your mind at ease
Validation by your automated endoscope reprocessor  manufacturer: Will your endoscope be validated and supported should there be an issue?

Endoscope refurbishment by an ISO can compromise the reprocessing validation performed by both the endoscope and AER manufacturer. Olympus, for example, indicates the reprocessing instructions for flexible endoscopes are invalidated when the endoscope is repaired by an ISO. It is also important to ascertain whether the repairs and refurbishments made to your equipment are validated by your AER manufacturer.

"When purchasing a CPO endoscope from an OEM, the refurbishments completed will bring the instrument back to its original like-new specifications, using only original manufacturer parts and components. As a result, OEM CPO products already are validated by the majority of AER manufacturers," says Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM), and Manager of Infection Control at Olympus.

Always consult the equipment's "Instructions for Use." As evidenced by various position statements, AER manufacturers are uncomfortable guaranteeing the results of their reprocessors when used with ISO-refurbished endoscopes because of the uncertainty surrounding the parts and components used. The AER manufacturers' lack of assurance transfers the risk to the purchasing facility, which then must take extra steps to make sure the endoscopes are reprocessed correctly so safety is not compromised.

Performing to your expectations: Can your pre-owned equipment handle the load?
Will your pre-owned endoscope perform to original OEM specifications?

Purchasing pre-owned endoscopes from ISOs can seem like a more cost-effective option, but additional investment of time and education is needed to verify the endoscope will perform as originally advertised.

"An endoscope is a very sophisticated piece of medical equipment that requires proper care and maintenance throughout its life. Unfortunately, we’re seeing a proliferation of third-party repair vendors that do not have the extensive training, materials, processes and specifications to properly repair endoscopes," says Eddie Garces, Vice President of Repair Operations at Olympus.

Should an endoscope purchased from an ISO not function as expected, the additional OEM repairs to restore the endoscope to its original specifications could exceed any perceived initial savings. Additionally, how an endoscope performs during a procedure and how it handles during reprocessing are important factors facilities rely on to ensure patient safety.

But purchasing a CPO endoscope from the OEM provides benefits beyond safety and reliability.

"Years are dedicated to perfecting the design and function of our endoscopes, and countless hours are spent training employees to provide high-quality service for our customers," says Phil Doyle, Director of Marketing for Gastroenterology at Olympus. "Support after the sale, including on-site training, technical support and troubleshooting can reduce the likelihood your endoscope will be out of commission when you need it most."           

Footnotes

iiASGE Technology Status Evaluation Report, Gastrointestinal Endoscopy, Volume 57, No. 6, 2003, Pgs. 639-642

                            

 

[1] ASGE Technology Status Evaluation Report, Gastrointestinal Endoscopy, Volume 57, No. 6, 2003, Pgs. 639-642

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