Safety
We believe that ensuring the safety of our customers’ patients is our number one responsibility. We demonstrate this commitment by complying with regulations, working proactively to set industry standards and partnering with our customers to ensure their own levels of safety are being met by the devices we return to them.
We comply with all applicable Quality System Regulation requirements and are regulated by the FDA relative to Quality System Processes that include:
- Design Controls
- Validation and Verification of Processes
- Premarket Notification, 510(k)
- Constant Monitoring of all Processes and Quality Assurance on EVERY Device
Our protocols ensure that the highest quality, functionality and sterility of customer devices are obtained before being returned to their facility.
MEDISISS complies with the FDA and the reprocessing guidelines they, in conjunction with Congress, have issued. We also comply with the Medical Device Reporting requirements. Identical to manufacturers of new devices, we receive premarket (501(k)s)in order to reprocess certain devices that require it. We validate every step of our process pursuant to FDA scrutiny and periodic audits (in addition, all results are verified by an FDA-registered independent laboratory). A 510(k) clearance demonstrates that the reprocessed device is “substantially equivalent” to a new device with respect to safety and effectiveness. The validation studies we submit to the FDA encompass Risk Analysis, Cleaning, Sterilization, Packaging and Performance (Functionality) to ensure our products are safe and effective.
The FDA tightly regulates reprocessing of SUDs and several professional societies support the practice. Regarding safety, there is no proof or evidence in any literature that reprocessed devices have a higher infection rate associated with their use.*
*Source: Secrets to Saving with Reprocessed SUDs--Outpatient Surgery; Dan O’Connor, Editor-in-Chief, November 21, 2007
Important safety steps that are always taken by MEDISISS:
| 1 | Decontamination Devices are thoroughly cleaned through a series of disinfection, enzymatic cleaning, hand washing and steaming steps. Before they are sterilized, devices are inspected tip-to-tip for any defects or remaining particulates |
| 2 | Identification We identify each SUD based on the original manufacturer number to ensure customers always receive back their own devices. We also sort each device so each can be reprocessed according to their unique specifications. Every device is also micro-etched to track the number of times the device has been reprocessed. |
| 3 | Inspection MEDISISS technicians inspect every device under magnification for defects. If any devices fail to pass our scrutiny and stringent acceptance criteria, we reject them and take responsibility for the cost of their disposal, while documenting the reason for rejection. |
| 4 | Sterilization Once we’re 100% satisfied that each device will function as new, it’s subjected to an ethylene oxide sterilization process (through a commissioned and certified sterilization system) validated to FDA recognized International Standards: ISO 11135-1. Our devices are sterilized to 10-6 Sterility Assurance Level; ensuring that:
All devices are quarantined until we receive verification of successful sterilization from our independent testing facility. Only then will devices be readies for delivery back to the customer. |
Customers appreciate the fact they can trust MEDISISS and know that every device returned to them is sterilized, safe, and functional...and THEIRS! Doctors are far more comfortable with this assurance than with other reprocessing companies that do not guarantee a customer will receive back their own devices.