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By Deborah Haley, RN, CNOR, MBA
Few headlines regarding the healthcare industry today offer good news, itseems. Across the country, hospitals are struggling to deal with dwindlingreimbursements, budget shortfalls and the nursing shortage. Finding programsthat will deliver maximum savings to a facility's bottom line is more importantthan ever.
Medical device reprocessing is helping to meet that need. Each year, thehealthcare industry discards millions of dollars in otherwise functional medicaldevices after a single use. Reprocessing offers a safe, scientific alternativethat can help medical facilities realize as much as a 50 percent savings overthe purchase price of new medical devices without affecting the quality ofpatient care.
In late 2000, new regulations by the Food and Drug Administration (FDA)forced drastic changes for hospitals that reprocess single-use medical devicesin-house. The FDA guidance calls for hospitals and third-party reprocessors toadhere to the same premarket submission requirements as device manufacturers.For every device a facility wants to reprocess, it now must demonstrate thesafety and effectiveness of that device.
Since then, hospitals have had to decide whether to continue in-housereprocessing of devices labeled for a single use (SUDs). Most have concludedthat they lack the resources to meet the premarket requirements and have begunoutsourcing to third-party companies to safely reprocess their SUDs.1As a result, the reprocessing industry is experiencing significant growth andhospitals that outsource are seeing considerable cost savings while stillproviding safe, quality patient care.
CHOOSING A REPROCESSOR
Some hospitals may choose to continue in-house reprocessing. However, thosethat do must register with the FDA and follow premarket submission requirementsto show the efficacy and safety of each SUD it is reprocessing. The FDA istaking steps to ensure that hospitals comply with the new guidance. In July2002, the FDA issued a warning letter to a Tucson, Ariz. hospital for continuingto reprocess SUDs without meeting the requirements.2
The decision to outsource reprocessing should involve stakeholders from allareas of the hospital, including the operating room, infection control, riskmanagement and administration. Once the votes are in and the decision made, theimportant question for hospital executives is: How do we maximize savings forour hospital?
First, a hospital must perform due diligence in choosing a third-partyreprocessor. From the regulatory standpoint, reprocessors must comply with ahost of requirements, the most significant of which is the FDA's Quality SystemRegulation (QSR) that controls all manufacturing processes, including cleaning,disinfection, packaging, labeling, sterilization and distribution. QSRrequirements apply to both third-party reprocessors and device manufacturers.
Not all reprocessing companies are the same, however. Hospitals should lookfor service and quality that go beyond FDA compliance. The Association forMedical Device Reprocessors (AMDR), the trade group to which the three largestreprocessing companies belong, recommends that hospitals ask a range ofquestions before choosing a reprocessor. (See accompanying sidebar)
ROAD MAP TO SUCCESS
If a hospital is to maximize savings and reduce the amount of medical wastedestined for the landfill, it's important to have a plan in place forimplementing a reprocessing program. An implementation plan serves as a road mapto success and can help shorten the learning curve typically associated with thelaunch 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 clearlycommunicated to ensure that the program is embraced and supported at all levelsof the organization.
"If you don't have the key people and departments on board and ready tobegin, a program can falter and founder," said David Phillips, nursemanager of surgical services at Horton Medical Center in New York."Reprocessing represents an opportunity for hospitals to see significantcost savings. But you have to have hospital executives on board as well asrepresentatives from materials management, financial management, senior-levelmanagement for managed care and department heads from areas where reprocessingwill take place."
Partnering with a third-party company to launch and maintain a reuse programcan benefit the hospital in the short term and in the long run. The company canserve as a ready resource to help key hospital personnel anticipate challenges,answer questions and fine-tune details. Company representatives should functionas liaisons in various areas, including device collection, in-service trainingand utilization review to deliver maximum savings.
An effective implementation program guides an organization through theplanning, execution and management phases of a reprocessing program. Key stepsinclude 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. Frombenchmarking and usage data, the reprocessor should be able to provide valuableinformation about how well various hospital departments are complying with theprogram. A facility also can use the information to determine its cost savingsand pinpoint areas where savings opportunities remain.
To be effective, the reprocessing steering committee should include seniormanagers from operations, the operating room and infection control. In addition,representatives from administration, central supply, the cath lab, the endoscopylab, materials management, nursing, the medical staff and risk management shouldbe included. A representative from the reprocessing company also should serve onthe committee. The panel's role is to guide the program, review and analyzecompliance, and identify areas for improvement. The chairperson shouldunderstand the financial benefits and function as the "champion" ofthe program within the organization.
PARTICIPATION IS CRITICAL
If a facility is to achieve maximum economic and environmental benefits fromreprocessing, participation across departments is critical. By providing cleardirection to department heads, the reuse committee can drive home the importanceof consistent collection of devices to be returned to the reprocessing company.
A reprocessing in-service and department orientation should be establishedfor each department, with specific staff training on proper collection of eachtype of device to be reprocessed. In turn, staff must follow through byconsistently placing devices in collection containers. Selecting the appropriatetype and quantity of containers and locating them strategically and convenientlythroughout the facility will result in the highest collection rates.
In addition, the hospital should take steps to ensure reprocessed devices arereturned to inventory and chosen first off the shelves. One person - be it amaterials management inventory clerk or an operating room inventory clerk -should be responsible for return and restocking of reprocessed devices. Thereprocessor should be able to supply reports to the hospital showing howefficiently the facility is collecting and returning devices for reprocessing.
It is important to know what type of tracking information the reprocessingcompany can provide. A reprocessor that has cleaned, tested and sterilizedmillions of devices -- and tracked those devices by using unique identificationnumbers -- can show the durability of the devices that a hospital is using. Inturn, that information may give a hospital insight on which manufacturers fromwhich to buy.
IMPORTANCE OF COMMUNICATION
Communicating the benefits of a reprocessing program helps to educate staffand eliminate concerns based on perception rather than fact. At the program'slaunch, the steering committee should meet with surgeons, department heads andnurse managers to convey the goals and objectives of the program. Theorganization's board of directors and medical staff should be notified by letteror with a presentation.
The committee also should meet with the staff education and nursingdepartments to determine the schedule and content of an in-service trainingprogram. It's a good idea to prominently post notices about the reprocessingprogram and display any other materials that promote the program and encourageparticipation.
"Reprocessing is another avenue for a hospital to combat the financialdifficulties we're having with reimbursement, contracts and vendors,"Phillips says. "If a hospital is going to reprocess successfully, it'simportant to educate the staff on the systems being put into place."
An in-service program should be designed to familiarize departmentsupervisors and nurse managers with the program. They should have theopportunity to ask questions and become comfortable with the practice ofreprocessing.
MONITOR AND REVIEW
The successful launch of an organization's medical device reprocessingprogram is just the beginning. Once a program is underway, upper management andthe reuse committee must commit to evaluating participation and results. Aquarterly review of the program provides an opportunity to express concerns,identify expectations and rate the performance of the facility and thereprocessing company.
For optimum results from a reprocessing program, some key questions to askinclude:
Hospitals across the country are finding that reprocessing offers apatient-safe, economic alternative with a proven safety record. Medical devicesrepresent one of the highest recurring expenses to hospitals after staffing.Reusing, rather than disposing of, these expensive devices translates into costsavings that can be reinvested in whatever providers may need to better servetheir patients, be it more nurses, new technology or other initiatives.
Deborah Haley is implementation and utilization manager at VanguardMedical Concepts, Inc., a national third-party reprocessing company based inLakeland, 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: