Endoscopy is vital in the healthcare world. This non-invasive procedure is a quick and easy way to diagnose and treat several gastrointestinal conditions. However, rates of endoscope-transmitted infections are rising. In light of this danger, proper medical device reporting (MDR) and quality systems are more essential than ever.
Yet last year, the FDA found that endoscope reprocessor Olympus had several violations in regard to both. Below, we’ll cover the details of this situation as well as what you can do to protect your organization from such lapses in information.
Olympus’ MDR Reporting + Quality System Violations & FDA’s Response
An FDA inspection of Olympus’ factory on July 5-8, 2022, uncovered several MDR reporting and quality systems violations. The FDA responded by issuing Olympus its first warning letter on November 2, 2022. The warning letter was directed at Olympus’ endoscope and reprocessing equipment manufacturing operations in their Aizuwakamatsu, Fukushima, Japan, factory.
The FDA conducted another inspection on September 6-9, 2022, which prompted a second warning letter to Olympus. This letter referenced Olympus’ surgical and gastrointestinal manufacturing operations at their Hachioji-shi, Tokyo, Japan, site.
The FDA’s Center for Devices and Radiological Health (CDRH) Director, Dr. Jeff Shuren, commented on the company’s MDR reporting and quality system violations saying:
“During recent inspections, CDRH determined that Olympus did not meet requirements to assure the quality and performance of the devices such as adequate testing and documentation of the device assembly process. In addition, Olympus did not develop MDR procedures, and did not submit MDRs within the required timeframes.”
The FDA highlighted four potential violations in its warning letter to Aizu Olympus:
- Failure to establish and maintain procedures for validating device design;
- Failure to validate results of a process that couldn’t be fully verified;
- Failure to adequately maintain design history records;
- Failure to develop, maintain and implement written MDR procedures.
The FDA told Aizu Olympus that it may postpone premarket approval for any Class III devices if they determine any quality system regulation violations correlate to the MDR reporting discrepancies.
How This Impacts Healthcare Organizations
Manufacturers like Olympus make both endoscope and endoscope reprocessors. Healthcare professionals can reuse endoscopes if appropriately cleaned and disinfected or sterilized to guideline standards. When proper MDR reporting and quality system controls are not followed, however, this leads to fatal infections becoming harder to identify and isolate.
Quality systems violations can lead to more endoscope-transmitted infections. However, manufacturers failing to adhere to MDR reporting guidelines can delay the flow of information to the FDA. This delay allows the problem to continue undetected for longer than it needs to.
How You Can Protect Your Organization
If manufacturers are putting patients at risk, but not following MDR reporting regulations, how can you make sure your organization stays ahead of such risks?
While manufacturers are responsible for submitting MDRs for adverse events originating from their operations, they’re not the only ones who can. User facilities also often participate in MDR reporting.
You can search for these reports using Device Event’s software. It decodes the FDA’s complex MDR reporting forms into clear and consolidated reports with only the information you need. Infection Control departments can search the keywords “tested positive for” OR “cultured positive” and gather and interpret data much faster and take preemptive measures without waiting months or even years for an official FDA recall after patient health has been compromised. If you’re curious about how to leverage our cloud-based solution to keep your organization ahead of the curve, contact us today.