ReNewal™ : Frequently Asked Questions

Founded in 1997, we have been successfully operating ever since, continually adding new devices to our product line and expanding our customer base.

The FDA oversees and regulates the practice of reprocessing, with significant oversight from Congress. Requirements have been set forth mandating that devices are as clean and sterile and as safe and effective (“substantially equivalent”) as when they were brand new.

In addition, the reprocessor is considered to be and therefore treated as the manufacturer of the device once it’s been reprocessed. Reprocessors must submit 510(k)s and receive clearance from the FDA for all required devices while also undergoing more frequent FDA inspections than device manufacturers. Consequently, the reprocessor must adhere to even stricter standards than the original equipment manufacturers (OEMs).

Yes. Every year we register with the FDA, in the process submitting the list of devices that are reprocessed in our facility.

A 510(k) is a pre-marketing notification made to the FDA to demonstrate that the device to be marketed is as safe and effective as (i.e., substantially equivalent to) a legally marketed device. The 510(k) process and clearance is identical whether a device is new to the market or is intended to be reprocessed.

As part of the 510(k) process, applicants must compare their device to one or more similar devices currently on the U.S. market and support their substantial equivalency claims. When required, we submit a 510(k) to the FDA in order to receive clearance to reprocess certain devices; this data incorporates validation pertinent to Risk Analysis, Cleaning, Sterilization, Packaging and Performance (Functionality) as required for each product.

Do you document and follow specific policies and procedures for cleaning, sterilizing and packaging reprocessed devices?

We maintain and follow clear-cut, documented procedures for each reprocessing step as well as specific policies for each distinctive category of device that we reprocess.

Our team includes trained technicians who test, sharpen and/or refurbish devices to achieve optimal functionality. We conduct multiple inspections on every device we reprocess and guarantee functionality for 100% of those we return to customers.

How do customers track their orders; both the status of the devices they've sent in for reprocessing as well as the shipment of product back to their facility?

We provide customers with access to their order and shipping records through OnDemand, a unique on-line tool only available through Medline ReNewal. The capabilities of this user-friendly web portal system enable customers to efficiently check status of their devices in transit, review shipping lists and measure financial results, among many other program management functions.

Many SUDs can be reprocessed multiple times, which increases the savings opportunity for the customer. The total number of times will vary by device, depending on its construction, material composition and handling by the clinician. We track the number of times a device has been reprocessed through a micro-etching process; if we receive a reprocessed device with the maximum number of marks, it will be rejected.

Single-use devices (SUDs) which can't be properly cleaned, sterilized or in any way ensured to be functionally equivalent to new devices are not reprocessed. As a current policy, we do not reprocess Class III implantable devices.

Why do original equipment manufacturers (OEMs) label devices "for single use only"?

The decision to label a device as single use is at the discretion of the OEM and not driven by the FDA. Many in the healthcare industry believe OEMs label certain products as “single use” in order to sell more new devices at full price, while discouraging facilities from taking advantage of more cost-effective alternatives such as reprocessing. In addition, labeling a product as single use alleviates the need for the OEM to invest time and money on developing validation processes inherent with multi-use devices.

Do you have field personnel who help customers maximize their savings and serve as advocates on their behalf as needed?

Yes, we offer field and corporate resources trained to help customers analyze their case mix and assess how their program is performing relative to identified savings opportunities. Our field personnel conduct periodic business reviews to present current results and trends along with suggestions to improve the customer's program.

We assume liability for any device we reprocess. In the history of the company, no claim has ever been made on our General Liability Insurance.

If a patient injury occurs due to the failure of a medical device, the device manufacturer and not the physician is held liable (unless it's been proven that physician negligence was involved). This applies to both OEMs and reprocessors.

There is no difference in the reimbursement for a procedure using a reprocessed device versus one that employed a new device.

Should a healthcare facility inform patients or seek their consent regarding their use of reprocessed SUDs?

Reprocessing is codified in federal law and requires FDA 510(k) clearance to ensure the reprocessed device is substantially equivalent to a new one. As a result, there is no special requirement or regulatory policy mandating patient consent when a reprocessed SUD is utilized. Only investigational or experimental devices require special patient consent.

Providing information regarding the use of reprocessed devices is up to the individual healthcare facility but the bottom line is that there is no legal, medical or ethical basis for obtaining patient consent with regard to the use of a reprocessed device.

ReNewal Reprocessing

Learn how ReNewal is redefining medical device reprocessing.

Learn the different steps in the ReNewal process.

Ask a Medline rep how ReNewal is redefining reprocessing.