If you're searching for ways to reduce expenses without compromising quality, chances are you've at least considered the possibility of reprocessing single-use medical devices (SUDs). Savings from reprocessing SUDs can be as much as 50 percent when using a third-party reprocessor or as high as 90 percent when reprocessing in-house. Here's the latest on how to start a reprocessing program at your facility.

FDA regulations
To better regulate the practice of reprocessing, making it more uniform and safer, the FDA developed the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and subsequent updates. The regulatory requirements for reprocessors depend on the class (either I, II or III) and type (critical or semi-critical) of the device.

Critical medical devices penetrate skin or normally sterile parts of the body. These items are in contact with blood and require sterilization, and their reuse carries the greatest risk potential. Semi-critical medical devices, such as endoscopes and respiratory equipment, come in contact with mucous membranes or non-intact skin during use. These devices require high-level disinfection if sterilization isn't practical and reuse carries a greater risk for cross-contamination than non-critical items.

Class I are low-risk items, like bandages that pose the lowest potential for risk and require the least regulation. Class II devices are medium-risk devices, which include items like urethral catheters. Class III devices, such as coronary angioplasty catheters and intra-aortic balloon angioplasty catheters, support or sustain human life and present significant risk factors to the patient.

Before the MDUFMA, facilities that reprocessed class I and II devices were required to have a premarket notification (also called a 510 (k)), unless the device was exempt. The 510(k) demonstrates to the FDA that a device can be reprocessed safely a specific number of times without compromising its function and proves that the device is safe, effective and equivalent to the original. You must submit one 510(k) application for each device you reprocess. Under the new law, some previously exempt devices will no longer be exempt, and facilities will need to submit 510(k)s for these items, including validation data. Validation data is also now required for many reprocessors of SUDs that are currently the subject of cleared 510(k)s. Facilities that reprocess class III devices need to submit a premarket report (a new type of premarket application).

Currently, stand-alone outpatient surgery centers aren't subject to the act. However, you might be if your outpatient facility is attached to a hospital or if your freestanding ASC is owned and operated by a hospital, and you use the hospital's resources for your sterile processing needs, which would include reprocessing.

Reprocessing in-house
Although complying with the new regulations involves a lot of time and paperwork, it can mean tremendous cost savings. Here's how to reprocess safely:

• Use manufacturers' specifications and, if available, premarket approval data to establish form and function criteria against which you can test the reprocessed device.
• Validate the viability of cleaning and sterilizing each device.
• Establish a policy for cleaning and testing each device:
  • Determine and document the methods and procedures for cleaning and sterilizing;
  • identify, monitor and document process controls to ensure consistent reprocessing;
  • determine a sample size to get reliable clinical data;
  • test the device's form and function criteria under real-life conditions, looking at tensile strength and sharpness as some examples of testing;
  • determine the number of times a reprocessed device can withstand the process and maintain its form and function;
  • establish a labeling system to identify the device in the event of product failure; and
  • establish a mechanism to track the number of times a product reprocessed;
  • document all test results.
• Review the test results with facility decision makers and legal counsel to determine which devices to include in the reprocessing program.
• Establish facility policy for pricing reused devices.
• Establish facility policy defining if and when an informed consent will include reprocessing information.

Third-party reprocessor
Given that government regulations are strict, time-consuming, expensive and may require additional staff, equipment and lab services, contracting with a third-party reprocessor is an alternative to consider (see "5 Questions to Ask Third-party Reprocessors"). These companies offer services supporting healthcare facility reuse programs. Most are familiar with the FDA's guidelines, and they employ experienced biomedical engineers to review the original equipment manufacturer's documentation on all devices being reprocessed. Their per-item reprocessing costs can in some cases be lower because they reprocess more SUDs than the average healthcare facility. This may result in a more cost-effective process than reprocessing in-house.

When you decide to contract with a third-party reprocessor, you're responsible for assessing the quality of the services provided and determining whether the reprocessor is following correct procedures. The reuse committee should review the reprocessing company's literature, contracts, documents and other information completely. Both the hospital that contracts and the facility that reprocesses bear full responsibility for the safety and effectiveness of the devices being reprocessed; therefore, it is imperative that you investigate commercial outsourcing firms aggressively before making a commitment.

The facility administrator, risk manager, infection control practitioner, legal counselor and liability insurance carrier should evaluate each item being considered for reprocessing and play an active part in this decision-making process. Validation of the safety, efficacy and integrity of each reprocessed item, along with sterility parameters, should be based on an documented reuse testing procedures. In addition, you should audit the reprocessor annually to identify any changes that could affect the safety or efficacy of the reprocessing procedure.

In general, items arriving at a reprocessor are

• assigned lot numbers;
• decontaminated and cleaned;
• inspected visually and functionally;
• peel packed and labeled (this includes description, name of original equipment manufacturer, catalog number, name of medical facility, lot number, order number)
• sterilized and quarantined;
• inspected after sterilization;
• documented;
• approved and released; and
• shipped back to the surgical facility.

Commercial firms reprocessing SUDs should meet or exceed applicable FDA, AAMI, CDC, OSHA, AORN and AHA standards, and they must register with the FDA as medical device manufacturers. You should do a background check of the reprocessor facility through the Freedom of Information Act (FOI) contact the FOI office in Rockville, Md. Also, find out if the FDA has inspected the reprocessor. If so, ask if the reprocessor ever received a letter of warning and what the action plan was to correct problems found during the inspection. These documents help you assess good intent on the reprocessor's part and the working relationship it has with the FDA. Also ask to see paperwork demonstrating internal audits, problem areas noted and corrective actions taken.

Informed consent
Informed consent usually doesn't include a conversation regarding reused SUDs. The products now must meet the same standards as the original, but we all know it's not a brand new item.

But the consent process is a communication between the patient and physician about the procedure itself, not the instrumentation. Surgeons don't confer with patients to discuss whether a hook electrosurgical instrument or a spatula will be used to remove the gallbladder during a laparoscopic cholecystectomy.

Plus, if your facility feels the practice of reuse is safe, informed consent probably isn't needed. Courts have held that if the probability of risk occurring is so small as to be almost nonexistent, there's no material risk, regardless of the severity of a potential injury.

Some believe that the patient's informed consent to reuse a disposable item is ethically necessary in all reuse situations because there's an obligation among medical staff members not to lie, deceive or otherwise interfere with a patient's free choice. The potential costs associated with risks to patients include the costs of clinical complications, litigation and pain and suffering on the patient's part. If such a risk to the patient exists by using recycled items, disclose this to the patient; omission would constitute negligence.

Handling reimbursement
If you're in a hospital setting, you must also decide how to bill for the reprocessed item. Because the FDA has stated that a reprocessed SUD is considered a new product, it makes sense to charge one price for the new product from the manufacturer and the same for the reprocessed item. You could also charge for the reprocessing fee plus mark up for each reprocessed item or prorate the charge for SUDs and apply it to all patients using that device whether theirs was new or reused. The problem with averaging and prorating is that it's only equitable if the product actually is reprocessed and reused the expected number of times. If it's used less than anticipated, you lose money. If it's used more than anticipated, you earn a profit, which could be an incentive to inappropriately reuse a product more times than is practical. Other considerations include your billing and inventory management software. Can these programs set multiple prices for the same item? Any organization that reuses SUDs needs to reconcile these questions.

Your purchasing contract
Before you start your reprocessing program, don't forget to consider how this could affect your supply contracts. Many of these agreements were based on an expected number of orders. If you start reprocessing, your price may go up as your purchasing goes down. Take a look at your contracts and find out if you have a mandatory minimum number of orders that you must purchase and what that number is. Otherwise you could find yourself in violation of your contract.