FAQ’s
How long has MEDISISS been in business?We were founded in 1997 and have been successfully operating ever since, with an increasingly solid track record and a growing customer base.
Are there compelling reasons to reprocess?
Yes, definitely. Here in fact is a link that elaborates on the various reasons why you should reprocess.
How is the safety and effectiveness of a reprocessed device regulated?
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 as well as safe and effective (“substantially equivalent”) as when they were brand new. In addition, the reprocessor is considered to be and treated as the manufacturer of the device once it’s been reprocessed.
Reprocessors must submit 510(k)’s and receive clearance from the FDA while also undergoing more frequent FDA inspections than device manufacturers. Consequently, the reprocessor must adhere to even stricter standards than the Original Equipment Manufacturers (OEM’s)
Are you registered with the FDA?
Yes. Every year we register with the FDA and submit a list of devices that are reprocessed in our facility.
What is a 510(k)?
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 has been 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 make 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 have a 510k on file for each item that requires it?
Yes, we maintain 510k’s on file for every item that requires one.
Describe your Quality System as it pertains to your reprocessing program.
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 maintaining stringent controls through our extensive Quality System. For more details on this, here is a link to the Safety measures we have in place that govern our reprocessing methods.
Will you make your facility and quality manuals available for review by customers?
Yes, we will conduct in-person tours if logistically viable and we offer a virtual tour on our web site. We also will share information from our quality manuals upon request.
What are your policies and procedures for cleaning, sterilizing and packaging reprocessed devices?
We possess clear-cut written procedures for each reprocessing step as well as specific policies for each distinctive category of device that we reprocess. For more detail on our process, here’s a link that elaborates on each step.
What is the level of device functionality testing that you perform?
We have on staff trained technicians who test, sharpen and/or refurbish devices to achieve optimal functionality. We test inspect every device we reprocess and guarantee functionality for 100% of the devices we return to customers.
How do you transport devices to and from the customer’s facility?
We currently have a contractual carrier arrangement with Fed-Ex, who picks up devices at customer premises (in MEDISISS-provided collection bins) and then returns them once they’re reprocessed. Every customer receives at least two bins so as one is filled up and sent in, the other can remain in use at the facility (in addition, as soon as we receive a bin of devices, we send it back to the customer so there should never be a time when the facility collection process is interrupted).
How do customers track their shipments to your facility as well as the status of the devices they’ve submitted?
We provide customers with access to their order and shipping records through a unique on-line tool, OnDemand that is only available through MEDISISS. The capabilities of this “user friendly” web portal system enable customers to efficiently monitor status of their devices, review shipping lists and measure financial results, among to other applications.
What is the average turnaround time for a customer to receive back the devices they’ve sent you?
Our average turnaround time between receipt of customer devices and shipment back to their facility is between 15-20 days, one of the fastest in the industry.
Do customers receive their own devices back after reprocessing?
We guarantee that the same devices collected at a customer’s facility are returned to them. Once we receive the devices, we photograph and record them, identifying them as having been collected from the specific facility. They are then reprocessed together, packaged and returned together. This process ensures that each facility receives the same devices that were collected on their premises.
What is your reclamation rate?
"Reclamation rate" actually covers two aspects of reprocessing:
- The percentage of reprocessing-eligible devices that are submitted to us by the customer. Our customers work hard to send us as many eligible devices as possible, but in most cases, we are able to advise them as to how they can increase their submissions and therefore their overall savings.
- The percentage of submitted devices which we are able to successfully reprocess and return.
To date, our reclamation rate of 70-75% ranks as the highest in the industry.
How many times can a device be reprocessed?
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. The maximum number of times we will reprocess a device is five (which means the customer will get up to six uses). We track the number of times a device has been reprocessed through a micro-etching process so if we receive a reprocessed device with the maximum number of marks, it will be rejected.
What devices can be reprocessed?
The state-of-the-art technologies we employ enable us to reprocess thousands of Class I and Class II single-use devices, used in all OR departments as well GI labs. Some of the more common device categories that we reprocess include:
- Arthroscopic Ablation Electrodes
- Arthroscopic Shavers and Abraders
- Carpal Tunnel Release Blades
- Compression Sleeves (DVT)
- Electric & Non-Electric Biopsy Forceps
- General Surgery Instruments:
- Staplers
- Suture Passers
- Knot Tying Instruments - Laparoscopic/Endoscopic Trocars and Cannulas
- Non-electric Laparoscopic Instruments:
- Scissors
- Dissectors
- Graspers - Opened/Unused/Expired Items
- Orthopedic Instruments:
- Trocars/Cannulas
- Drill Bits
- Saw Blades
- Burrs
- Rasps
- Curettes - Phacoemulsification Needles/Tips
- Tourniquets
- Ultrasonic Instruments (Harmonic Scalpels)
What devices cannot be reprocessed?
SUDs which can't be cleaned, sterilized or ensured to be functionally equivalent to new devices are not reprocessed. As a current policy, we don’t 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 is not driven by the FDA. Many in the healthcare industry believe OEM’s label product 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 programs. In addition, labeling a product as single use alleviates the need for the OEM to spend time and money on developing validation processes inherent with multi-use devices.
What kind of savings might a customer achieve by reprocessing?
Typically, in the range of 40-60% of the costs associated with brand new devices. Most of our customers achieve an average of 50% savings but this figure will be affected by the facility size, the types and volume of procedures performed, and of course the degree to which the facility has committed to reprocessing.
To explore the potential savings your facility might achieve, check out this link.
Are you consistent with your pricing of reprocessed devices?
Some companies do not offer consistent pricing, so one device may be discounted while another costs nearly as much as a brand new one. For sake of our customers’ budget process, we maintain a consistent pricing schedule on all of our devices.
Do you have field personnel who can help customers maximize their savings and serve as an advocate on their behalf as needed?
Yes, we offer resources who will help customers analyze their case mix and how they match up to industry standards in order to identify all potential savings opportunities. Our field personnel conduct periodic account reviews intended to maximize financial benefits and assist with any questions or issues.
What kind of product liability insurance do you have?
We assume liability for any device we reprocess. We maintain $6 million in liability insurance and have never had a claim 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 physician negligence is involved.
How are reprocessed devices reimbursed?
There is no difference in reimbursement for a procedure using a reprocessed device versus a procedure that uses 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 an SUD is utilized. Only investigational or experimental devices require special patient consent. Providing information regarding the use of reprocessed devices is up the individual healthcare facility but the bottom line is that there is no legal, medical or ethical basis for requiring patient consent with regard to the use of a reprocessed device.