Reuse of single-use devices
More on EPP-green
Summary of issues relating to reuse
The practice of reprocessing single-use devices (SUDs) for reuse began in hospitals in the late 1970's. Approval of the practice of reusing hemodialyzers in the early 1980s by the US Public Health Service led the way for current activity.
Reusable items are those for which the original equipment manufacturer (OEM) provides guidance on the reuse of an item. Disposable items are those labeled by the OEM as single-use only. In the past, single-use devices considered for reprocessing included “outdated” items, based on an arbitrary date-related indicator of sterility. With the current practice of using an event-related sterility indicator (e.g., package damaged or not intact), there are only two categories of single-use items that require consideration for reprocessing:
- Open and unused.
- Open and used.
Different processes are required accordingly:
- Reprocessing, repackaging, and resterilizing are required for all items open and unused.
- Cleaning, functional testing, packaging, and sterilization are required for all items that are open and used.
The US Government Accounting Office (GAO) issued a report to Congress in June 2008 entitled: "Reprocessed Single-Use Medical Devices:FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk" This report notes that FDA has analyzed its data on reported adverse events related to reprocessed SUDs and has concluded that there are no patterns that point to these devices creating such risks. After reviewing FDA's processes for monitoring and investigating its adverse event data, [GAO] found no reason to question FDA's analysis.
Extent of reprocessing of SUDs and current trends
Historically, most items in the hospitals were designated as reusable and were reprocessed and reused. The use of disposables became popular because of convenience and reducing the risk of cross contamination. However, as the cost of waste disposal increased, hospitals looked for opportunities to reduce waste. They attempted to return to the use of reusable items and began to reprocess certain items.
A 1998 survey of OR managers indicated that over a four year period the reuse of single-use devices almost doubled. Approximately 60 percent of the managers surveyed reported the reuse of selected single-used items, and 40 percent reported the reuse of items opened and not used. The increase in reuse of single-use items raised questions about patient safety, informed consent, and the need for equitable regulation of the original equipment manufacturer and the reprocessors. These event sprompted the FDA to investigate reuse and issue guidance for all entities that were involved in reuse of single-use items, including hospitals and third party reprocessors.
An FDA survey of hospitals conducted in February 2002, found that 24 percent of hospitals were using at least one type of reprocessed SUD and the majority of them used "third parties" to reprocess their SUDs. The most commonly reprocessed SUDs and percent of hospitals reprocessing these devices in 2002 were:
- Sequential compression device (SCD) sleeves (15.8 percent of hospitals)
- Drill bits, saws, blades, or burrs (7.3 percent)
- Biopsy forceps, snares (6.2 percent)
- Endoscopic/laparoscopic scissors, graspers, dissectors, or clamps (6.1 percent)
- Electrophysiology (EP) diagnostic catheters (3.9 percent)
In-house reprocessing of open but unused SUDs is not currently regulated by the FDA. According to a 2002 AHA Survey, approximately 25 percent of hospitals were reprocessing some or all of open but unused SUDs and 75 percent were discarding them. Of those that reprocess, nearly half sent items to a third party reprocessor.
Following the FDA guidance issued in August, 2000, hospitals have moved their reprocessing of SUDs from "in-house" to third-party reprocessing companies.
The FDA policy on instrument reuse from 1987 states that the reuse decision belongs to the hospital and the practitioner. The reuse decision was to be based on whether the instrument could be adequately cleaned and sterilized, whether it would not be adversely affected in terms of quality, and whether it remained safe and effective for its intended use. In a 1998 letter the FDA commented on the absence of evidence of adverse patient outcomes related to the reuse of single-use devices. The agency said it would continue to rely on post market requirements including Good Manufacturing Practice (GMP), medical device reporting, registration with the FDA, and labeling requirements. The FDA also stated it would continue to inspect reprocessing facilities with follow up regulatory action being taken as appropriate. Submission of data on adverse outcomes was encouraged along with the evaluation of the effects of cleaning on device performance and material composition.
In February, 2000 the FDA released the draft document "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme" and in August 14, 2000 release a guidance document, "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals." These publications followed a period of intense discussion between the FDA and stakeholders, and created opportunities for all parties to provide information to the FDA. The FDA proposed a risk-based categorization that was intended to assure that specific requirements for reuse of single-use devices were based on the degree of risk considering the complexity of the devices and the possible risk to the patient associated with reuse.
In the August 14, 2000 guidance document, the FDA re-examined its policy on the issue of reuse of medical devices labeled for single-use with the primary goal of protecting the health of the public by assuring that the practice of reprocessing and reusing single-use devices (SUDs) is safe and effective and based on good science. Subsequent documents have been published by the FDA in 2003 and 2005 to provide guidance for the industry and FDA staff to supplement and clarify related guidance and regulations and are available at the FDA Reuse Web site. Since these 2000 guidance documents were issued, hospitals have transferred their in-house reprocessing to third-party reprocessors.
A listing of the current FDA documents related to reuse of SUDS is provided in the section of this web site on Key Documents and includes data submission.
The FDA guidance equitably applies existing regulations to original equipment manufacturers (OEMs), third parties, and hospitals to minimize risks associated with reprocessed SUDs. All entities that reprocess SUDs are required to obtain approval from FDA (e.g., registration requirements and for each device, submission of either a 510(k) application or PMA [premarket approval]). The specific FDA requirements for the regulation of devices are based on 1) the criticality of the device (critical, semicritical, or noncritical) and 2) the risk category/class of the device according the FDA's Risk Prioritization Scheme (definitions below).
- Critical reprocessed SUD: intended to contact normally sterile tissue or body spaces during use.
- Semicritical reprocessed SUD: intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.
- Noncritical reprocessed SUD: intended to make topical contact and not penetrate intact skin.
FDA Risk Categories:
- = Low risk according to Risk Prioritization Scheme (RPS)
- = Moderate risk according to RPS
- = High risk according to RPS
3* = High risk due to neurological use
Additional FDA Requirements
In October 2002, the FDA's Medical Device User Fee and Modernization Act (MDUFMA) was signed into law. It imposed a number of additional requirements to further regulate the reuse of SUDs. MDUFMA required FDA to review the critical and semicritical reprocessed SUDS that were previously exempt from premarket notification requirements and determine which of these devices now required premarket approval (PMA).
Additional validation data required
Under MDUFMA, SUD reprocessors were also required to submit:
- Additional supporting documentation for certain devices that were currently being marketed and had already received 510 (k) clearance for them to continue to be legally marketed; and
- Submission of additional validation data with certain new 510(k) submissions.
The additional validation data include cleaning and sterilization data and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate (i.e., original) device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification.
Status of reprocessed devices
The FDA has provided a special Web site with detailed information on the status of individual reprocessed devices based on the requirements of MDUFMA for additional validation data.
This FDA information includes three on-line lists:
- No Longer Legally Marketed Devices
- Legally Available Devices
- Complete List (Excel file, .xls)
The lists include the status of all devices that required supplemental validation submission (SVS) data with details on the vendor, and the SUDs (e.g., model, size, length, color). These product lists are vendor-specific and product-specific. FDA has announced that it will update these lists as new information becomes available. For questions about a specific device, contact the reprocessing company or the Premarket Review Staff (510(k)) at FDA at 301-594-1190.
Additional regulations were imposed by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), which amended sections of MDUFMA. As of August 1, 2006 for all reprocessed SUDs, the reprocessor must be identified through a mark on the device or attachment (e.g., detachable label).
Adverse event reporting
MDUFMA also required FDA to modify the mandatory and voluntary MedWatch forms to include boxes indicating whether a device was a reprocessed "single-use" device and the name of the reprocessor. FDA revised the forms in February of 2004 (For additional information and copies of the forms, see Recalls and product notifications).
Third party reprocessors
The Association of Medical Device Reprocessors (AMDR) is a trade-based association representing companies that are third-party reprocessors of single-use medical devices. Membership in this organization is voluntary. It is estimated that AMDR members perform the majority of the third party reprocessing done in the United States. Members of the AMDR agree to be registered with the FDA and comply with all FDA regulations including the "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals." Members must maintain a minimum of $5 million in liability coverage (range $10 – 50 million) and comply with all standards from the Association for the Advancement of Medical Instrumentation (AAMI), the American Hospital Association (AHA), the Association of Operating Room Nurses (AORN), and the Centers for Disease Control and Prevention (CDC), state-licensing boards, and pertinent legislation. See Contracted Suppliers.
Formation of a reuse committee
The decision to reprocess SUDS must be made by each healthcare facility hospital. A multi-departmental reprocessing team should be established to gather relevant information and investigate the feasibility of reuse of SUDs. Membership on this committee or team might include staff from materials management, risk management, infection control, clinical/patient care, safety, administration, legal, and public relations. There are a number of issues to consider in making a decision to reuse SUDs. These might include a review of current regulatory requirements, selection of SUDs to consider for reuse, review of case-studies of hospitals with successful reuse programs, and site visits of other hospitals or third party reprocessors.
Considerations in the decision making process
Some of the considerations in the decision making process will include:
- Top-level administration should fully support reuse of SUDs and drive the implementation.
- Consider which reprocessing method (sterilization or high-level disinfection) is most appropriate for each category of device.
- Staff education is needed to explain the science and regulatory oversight associated with reuse of SUDs.
- Cost savings opportunities will be based on a number of factors, including
- staff compliance.
- range and type of devices selected by the hospital.
- cost of the devices to be reprocessed.
- pace of implementation (Note: this pace should be individualized based on the needs of your organization to ensure the greatest compliance with the initiative.)
- number of cycle turns (number of times a specific device can be reused) (Note: Factors that impact cycle turns are the reprocessing method, durability of the manufacturer's device, and the staff handling of the device.)
- Cost savings estimates can be validated with face-to-face discussions with potential reprocessing vendors. The ongoing review of the actual results will help determine where to set budget goals for each department and overall for the hospital.
Selection of a third party reprocessor
The selection of a third party reprocessor is dependent upon some key issues. They include:
- Safety – All reprocessors are required to be compliant with all FDA requirements as outlined in their August 2000 guidance document, including the Quality System Requirements (QSR). FDA inspection reports may also be reviewed.
- Selection – the broader the range of devices and the method of reprocessing utilized for the devices will yield the greatest savings.
- Support – The method for collecting devices at the hospital should be flexible, efficient and user-friendly. Other considerations include type of and frequency of on-site support, reporting capabilities (e.g. types of quality reports, certificate of liability insurance, and device tracking capability.
The Association of Medical Device Reprocessors has outlined a number of factors for health care facilities to consider before engaging the services of a third-party reprocessor. These include:
- Is the company registered with 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 requalified 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?
Download a white paper summary of reprocessing decision issues (.doc) (47 KB). For other guidance documents for selecting a third party processor, see Key Documents.
If a decision is made to move forward with reuse of SUDs, specific internal policies and procedures will need to be developed to assure successful implementation. This will include the establishment of a protocol and method for performing preliminary decontamination on-site using the hospital's protocol for cleaning reusable equipment.
Reporting of adverse events and liability
If serious patient injury, adverse event or death arises that may be associated with any medical device (new or reprocessed SUD), the event must be reported to the FDA on the MedWatch Reporting Form 3500A as part of the mandatory reporting requirements of the Safe Medical Device Act. Modification of MedWatch forms now includes a category for reprocessed SUDs and the name of the third party reprocessor.
Also, any party may be liable (user facility, original equipment manfacturer, third party reprocessor) depending on the cause of the event, e.g., user error, improper use of the device, device design, device/manufacturing defects or device failure.
The primary consideration should be if the third party reprocessor complies with all the current FDA requirements, to assure that the device is safe for reuse.
CMS has indicated that if SUDs are reprocessed according to the FDA guidance document, reprocessed devices are approved for reimbursement exactly like new devices for both inpatient and outpatients.
Premier has considered the recent FDA changes and provides the following position statement to assist hospitals in understanding Premier's position.
Premier understands that some members have policies that call for the reprocessing of certain medical devices that are labeled as single-use devices (SUDs) by the device manufacturers. Decisions regarding reuse of single use medical devices are solely the decision of the member healthcare facility. Premier recognizes the implementation and enforcement of new FDA requirements on reuse of SUDs that apply existing regulations equally to original equipment manufacturers, third party reprocessors, and hospitals, in an effort to reduce risks associated with reuse. To any extent that a Premier member's policies regarding the reuse of SUDs result in a conflict with that member's commitment to Premier group purchasing policies, Premier will use commercially reasonable efforts to help resolve such conflicts.