How to Research Reprocessing Companies
It’s very important to select the reprocessing company that best serves your needs and can deliver the optimum benefits to your facility. The types of questions to ask when researching reprocessing companies include (click on each line for additional detail):
How long have you been in business?It’s best to choose a company that’s been operating successfully for at least 5 years, with an established track record.
Are you registered with the FDA?
Every reputable company registers with the FDA annually and must provide a list of devices reprocessed in their facility. If a reprocessor cannot show evidence of FDA registration, that alone is a red flag.
Do you have a 510(k) on file for each item you reprocess?
This is the documentation that proves the reprocessor has met all FDA requirements for the original equipment manufacturer (OEM) of the product. The company is not permitted to reprocess devices for which they do not have 510k’s on file with the FDA.
How much liability insurance coverage do you carry?
The company should carry at least $5 million in liability insurance.
What are your policies and procedures for cleaning, sterilizing and packaging reprocessed devices?
Make sure there are clear-cut written procedures spelled out for each reprocessing step and that specific policies exist for each distinctive category of device that the company reprocesses.
What are the types of devices / device categories you reprocess?
Some reprocessors limit their services to “non-critical” items that come in contact with skin only and they do not engage in sterilization (they just clean and disinfect such devices), so understand the full scope of capability with the company you choose.
Describe the level of device functionality testing you perform.
The company you select should have trained technicians who test, sharpen and/or refurbish devices to achieve optimal functionality.
What are your prices?
On average, the price of a reprocessed device should be about half of what it would cost brand new. Some companies however do not offer consistent pricing, so one device may be discounted while another is nearly the cost of what you’d pay an OEM. For sake of your budget process, check the pricing of the devices you intend to submit and make sure there is consistency with the reprocessor’s charges. Keep in mind also that freight charges will typically apply, though some companies will pick up the cost of shipping your devices to their facility.
Will we get back all of my own devices?
Some reprocessing companies won’t guarantee you’ll receive back the exact devices you’ve submitted. This is because they mix devices between customer orders to accommodate their own inventory needs. What can then happen is that some devices end up back-ordered and a customer won’t receive their entire shipment back for months.
What is your average turnaround time?
Average turnaround is 4-6 weeks; some companies come in under that on a regular basis while others are hit and miss in terms of return timelines. For purposes of your own inventory management, get a firm understanding of the maximum turnaround time for each device you wish to have reprocessed. Be aware that some reprocessors mix customer orders to meet their own inventory needs and that can substantially delay full receipt of your submitted devices.
How do you track the devices you reprocess?
A reprocessor should have methods through which to track:
- The number of times a device has been used so it can be disposed of when it’s no longer able to be reprocessed. Companies should either use a micro-etching process or some type of code cleaning to identify the reprocessing cycles of each device.
- Each customer’s shipment so there is a record of every device received and its history with the reprocessing company.
- The unique specifications of each device so each can be properly reprocessed.
- The original manufacturer number of each device to ensure customers receive back their own devices.
What type of expertise do you have on staff? Specifically:
a) Do you employ experienced biomedical engineers in your process?
b) What type of training do you offer your reprocessing techs?
c) Are they certified central service technicians?
b) What type of training do you offer your reprocessing techs?
c) Are they certified central service technicians?
Describe the Quality Control approach for each step of your reprocessing program.
Every company should be able to walk you through their reprocessing steps, ideally making their facility available to you via an in-person or virtual tour.
What is your reclamation rate?
This reflects the percentage of submitted devices which are successfully reprocessed so the higher the rate the better.
Do you guarantee each device you reprocess?
After a device has been reprocessed, the company should guarantee that it will meet all FDA requirements and be fit for their intended purpose.
How are devices transported between my surgery center and your facility?
The reprocessing company should have a means through which devices are collected on your premises and then shipped to their facility without undue staff time or expense. Once the devices are reprocessed, the company should then arrange for shipment back to you (albeit with a likely shipping charge to return your devices).
How do we track our shipments to you and the status of the devices we’ve submitted?
You should be provided access to your order and shipping records so you can efficiently monitor status of your devices, review shipping lists and measure financial results. A “user friendly” on-line access via a web portal is ideal.
Do you have field personnel who can help us maximize our savings and also serve as an advocate on our behalf with their corporate office?
The reprocessor should have resources available to help you analyze your case mix and how you match up to industry standards in order to identify all the potential savings opportunities. Field personnel are vital in conducting periodic account reviews intended to maximize your financial benefits or in assisting you with any questions or issues that tie back to their corporate office.