There are many misconceptions about using ISOs for endoscope repair. Perhaps the one with wide-ranging implications is the misconception that using an ISO for service will invalidate the device’s 510K, instructions for use (IFU), or automated endoscope reprocessor (AER) validation.
According to the Food and Drug Administration (FDA)’s guidance, servicing a device without significantly changing its performance, safety or intended use does not require a new 510K. It follows that if the original 501K remains valid, then the device’s original IFU, reprocessing instructions, and AER validation are also unaffected by using an ISO for service.
It should come as no surprise that ISOs can provide a high-quality repair. Many ISOs have already adopted and are audited to the internationally recognized ISO 13485 standard for quality manufacturing of medical devices. Although the FDA currently applies its Quality Systems Regulation (21 CFR 820) to original equipment manufacturers (OEMs), ISO 13485 is virtually identical to the FDA’s regulation and requires compliance with all applicable government regulations. In fact, the two standards are so well aligned that that the FDA has indicated it will adopt ISO 13485.
Objective evidence proves that hundreds of thousands of flexible scopes are repaired by ISOs without incident. According to an ECRI study of medical device failure data reported to the FDA, less than 0.005 percent of all device failures associated with patient harm had any connection to servicing activity.
So, if repairs do not impact reprocessing efficacy, then what factors do? The FDA has researched the factors affecting quality of reprocessing and has concluded that there are three factors unrelated to repairs that impact reprocessing quality: (1) device design; (2) re-processing methodology and (3) methods for validating the cleaning and high-level disinfection and sterilization instructions.
Independent service organizations (ISOs) were born decades ago so healthcare providers had a high-quality alternative to expensive original equipment manufacturer (OEM) repairs. Over time, ISOs have evolved to offer much more than quality repairs at lower prices and faster turnaround time than OEMs. ISOs provide a superior customer experience because of local, focused representatives that can assist with loaners, education, repair prevention and face-to-face customer service. The FDA agrees stating “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.”
As a device owner, you have a right to service that device as you see fit and a responsibility to ensure that the service activity does not adversely impact the device. We encourage you to ask your ISO for information concerning the quality of their repairs.
David Anbari is chairman of the board of the Association for Medical Device Service Organizations (AMDSO.org).
- Refer to the FDA’s guidance document titled Deciding When to Submit a 510(k) for a Change to an Existing Device Guidance for Industry and Food and Drug Administration Staff. Available online at: https://www.fda.gov/media/99812/download
- Refer to the FDA’s document located at https://www.fda.gov/media/123488/download for the specific plans.
- There are multiple references to the ECRI study’s conclusions in the FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices, which can be accessed at: https://www.fda.gov/media/113431/download
- Refer to the FDA’s report titled "Factors Affecting Quality of Reprocessing," which can be accessed at: https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/factors-affecting-quality-reprocessing
- Refer to the FDA’s report to Congress titled "FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices," which can be accessed at: https://www.fda.gov/media/113431/download