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Implementing A Reprocessing Program:

Article

Implementing A Reprocessing Program:
Success Hinges on Planning

By Deborah Haley, RN, CNOR, MBA

Few headlines regarding the healthcare industry today offer good news, it seems. Across the country, hospitals are struggling to deal with dwindling reimbursements, budget shortfalls and the nursing shortage. Finding programs that will deliver maximum savings to a facility's bottom line is more important than ever.

Medical device reprocessing is helping to meet that need. Each year, the healthcare industry discards millions of dollars in otherwise functional medical devices after a single use. Reprocessing offers a safe, scientific alternative that can help medical facilities realize as much as a 50 percent savings over the purchase price of new medical devices without affecting the quality of patient care.

In late 2000, new regulations by the Food and Drug Administration (FDA) forced drastic changes for hospitals that reprocess single-use medical devices in-house. The FDA guidance calls for hospitals and third-party reprocessors to adhere to the same premarket submission requirements as device manufacturers. For every device a facility wants to reprocess, it now must demonstrate the safety and effectiveness of that device.

Since then, hospitals have had to decide whether to continue in-house reprocessing of devices labeled for a single use (SUDs). Most have concluded that they lack the resources to meet the premarket requirements and have begun outsourcing to third-party companies to safely reprocess their SUDs.1 As a result, the reprocessing industry is experiencing significant growth and hospitals that outsource are seeing considerable cost savings while still providing safe, quality patient care.

CHOOSING A REPROCESSOR

Some hospitals may choose to continue in-house reprocessing. However, those that do must register with the FDA and follow premarket submission requirements to show the efficacy and safety of each SUD it is reprocessing. The FDA is taking steps to ensure that hospitals comply with the new guidance. In July 2002, the FDA issued a warning letter to a Tucson, Ariz. hospital for continuing to reprocess SUDs without meeting the requirements.2

The decision to outsource reprocessing should involve stakeholders from all areas of the hospital, including the operating room, infection control, risk management and administration. Once the votes are in and the decision made, the important question for hospital executives is: How do we maximize savings for our hospital?

First, a hospital must perform due diligence in choosing a third-party reprocessor. From the regulatory standpoint, reprocessors must comply with a host of requirements, the most significant of which is the FDA's Quality System Regulation (QSR) that controls all manufacturing processes, including cleaning, disinfection, packaging, labeling, sterilization and distribution. QSR requirements apply to both third-party reprocessors and device manufacturers.

Not all reprocessing companies are the same, however. Hospitals should look for service and quality that go beyond FDA compliance. The Association for Medical Device Reprocessors (AMDR), the trade group to which the three largest reprocessing companies belong, recommends that hospitals ask a range of questions before choosing a reprocessor. (See accompanying sidebar)

ROAD MAP TO SUCCESS

If a hospital is to maximize savings and reduce the amount of medical waste destined for the landfill, it's important to have a plan in place for implementing a reprocessing program. An implementation plan serves as a road map to success and can help shorten the learning curve typically associated with the launch of any new program.

Involvement of all key stakeholder groups is key to the program's success. For that reason, the goals and benefits of reprocessing must be clearly communicated to ensure that the program is embraced and supported at all levels of the organization.

"If you don't have the key people and departments on board and ready to begin, a program can falter and founder," said David Phillips, nurse manager of surgical services at Horton Medical Center in New York. "Reprocessing represents an opportunity for hospitals to see significant cost savings. But you have to have hospital executives on board as well as representatives from materials management, financial management, senior-level management for managed care and department heads from areas where reprocessing will take place."

Partnering with a third-party company to launch and maintain a reuse program can benefit the hospital in the short term and in the long run. The company can serve as a ready resource to help key hospital personnel anticipate challenges, answer questions and fine-tune details. Company representatives should function as liaisons in various areas, including device collection, in-service training and utilization review to deliver maximum savings.

MEASURING SUCCESS

An effective implementation program guides an organization through the planning, execution and management phases of a reprocessing program. Key steps include creating a steering committee; developing policies and procedures, setting up in-service training; and creating communications tools.

The plan should include steps for measuring the program's success. From benchmarking and usage data, the reprocessor should be able to provide valuable information about how well various hospital departments are complying with the program. A facility also can use the information to determine its cost savings and pinpoint areas where savings opportunities remain.

To be effective, the reprocessing steering committee should include senior managers from operations, the operating room and infection control. In addition, representatives from administration, central supply, the cath lab, the endoscopy lab, materials management, nursing, the medical staff and risk management should be included. A representative from the reprocessing company also should serve on the committee. The panel's role is to guide the program, review and analyze compliance, and identify areas for improvement. The chairperson should understand the financial benefits and function as the "champion" of the program within the organization.

PARTICIPATION IS CRITICAL

If a facility is to achieve maximum economic and environmental benefits from reprocessing, participation across departments is critical. By providing clear direction to department heads, the reuse committee can drive home the importance of consistent collection of devices to be returned to the reprocessing company.

A reprocessing in-service and department orientation should be established for each department, with specific staff training on proper collection of each type of device to be reprocessed. In turn, staff must follow through by consistently placing devices in collection containers. Selecting the appropriate type and quantity of containers and locating them strategically and conveniently throughout the facility will result in the highest collection rates.

In addition, the hospital should take steps to ensure reprocessed devices are returned to inventory and chosen first off the shelves. One person - be it a materials management inventory clerk or an operating room inventory clerk - should be responsible for return and restocking of reprocessed devices. The reprocessor should be able to supply reports to the hospital showing how efficiently the facility is collecting and returning devices for reprocessing.

It is important to know what type of tracking information the reprocessing company can provide. A reprocessor that has cleaned, tested and sterilized millions of devices -- and tracked those devices by using unique identification numbers -- can show the durability of the devices that a hospital is using. In turn, that information may give a hospital insight on which manufacturers from which to buy.

IMPORTANCE OF COMMUNICATION

Communicating the benefits of a reprocessing program helps to educate staff and eliminate concerns based on perception rather than fact. At the program's launch, the steering committee should meet with surgeons, department heads and nurse managers to convey the goals and objectives of the program. The organization's board of directors and medical staff should be notified by letter or with a presentation.

The committee also should meet with the staff education and nursing departments to determine the schedule and content of an in-service training program. It's a good idea to prominently post notices about the reprocessing program and display any other materials that promote the program and encourage participation.

"Reprocessing is another avenue for a hospital to combat the financial difficulties we're having with reimbursement, contracts and vendors," Phillips says. "If a hospital is going to reprocess successfully, it's important to educate the staff on the systems being put into place."

An in-service program should be designed to familiarize department supervisors and nurse managers with the program. They should have the opportunity to ask questions and become comfortable with the practice of reprocessing.

MONITOR AND REVIEW

The successful launch of an organization's medical device reprocessing program is just the beginning. Once a program is underway, upper management and the reuse committee must commit to evaluating participation and results. A quarterly review of the program provides an opportunity to express concerns, identify expectations and rate the performance of the facility and the reprocessing company.

For optimum results from a reprocessing program, some key questions to ask include:

  • Is staff doing everything it can to ensure as many devices as possible are collected?
  • What economic savings have we realized so far, and what are our potential savings?
  • Is there potential further savings with regard to collection rates and return to inventory?
  • Are we communicating effectively through in-service education and other tools?

Hospitals across the country are finding that reprocessing offers a patient-safe, economic alternative with a proven safety record. Medical devices represent one of the highest recurring expenses to hospitals after staffing. Reusing, rather than disposing of, these expensive devices translates into cost savings that can be reinvested in whatever providers may need to better serve their patients, be it more nurses, new technology or other initiatives.

Deborah Haley is implementation and utilization manager at Vanguard Medical Concepts, Inc., a national third-party reprocessing company based in Lakeland, Fla. She has held numerous positions in perioperative nursing, including staff educator and director.

Ask The Right Questions

The members of the Association of Medical Device Reprocessors (AMDR) work to ensure that their reprocessing practices meet all federal regulatory requirements and, most importantly, are safe and effective. The AMDR recognizes that significant differences exist among third-party reprocessors, so to maximize the benefits of third-party reprocessing, it encourages hospitals to ask the following questions before engaging the services of a third-party reprocessor:

  • Is the company registered with the FDA?
  • Does the company comply with applicable Quality System Regulation requirements?
  • Will the company permit you to visit its plant and review its quality manual?
  • Is sterilization performed by a commissioned and certified sterilization system, in accordance with ANSI/AAMI/ISO ST 11135 ST 1994?
  • Is the sterilization cycle re-qualified annually?
  • Are biological indicators used to monitor routine sterilization?
  • Are the sterilization systems routinely calibrated?
  • Is the residual sterilant level routinely tested?
  • Does the company have reprocessing procedures tailored to the specific types of medical devices you wish to have reprocessed and has the company validated these procedures?
  • Is the product functionality routinely tested?
  • Does the company track the number of uses per device?
  • Does the company comply with medical device reporting requirements?
  • Does the company have adequate liability insurance coverage?

Source: AMDR

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