Reprocess Approved Single-Use Devices
All PIM content was independently developed and reviewed to be vendor-, product-, and service provider-neutral.
Single-use medical device (SUD) reprocessing and remanufacturing can be the cornerstone of your environmental initiative by saving costs and reducing waste. FDA-approved third-party manufacturers can provide advanced services that more responsibly use resources, deliver supply-cost savings, and lessen the impact on the environment.
Project Talking Points
- Healthcare organizations increasingly recognize that third party reprocessing of medical devices labeled “single use device” or SUD is a safe and effective process that can help redirect valuable financial resources back into patient care.
- Most Original Equipment Manufacturer (OEM)-designated single use devices are disposed of as bio-hazardous waste, which further increases the cost of disposal and uses more resources for processing.
- Reprocessing SUDs is a strategy that saves money and significantly reduces the volume of regulated medical waste generated by the facility, and is now common practice in many operating rooms and healthcare institutions.
- The Joint Commission (TJC) states that reprocessing of SUDs should be done by Third Parties. As per TJC standards it is not acceptable that hospitals reprocess SUDs.
Triple Bottom Line Benefits
- Cost benefits– Reprocessing and purchasing SUDs is much less expensive (up to 50% savings) when compared to purchasing OEM products. There are also significant savings associated with reducing waste management costs. Depending on the size of your hospital/system, organizations can save up to millions of dollars annually by reprocessing SUDs. According to a Healthier Hospitals Initiative (HHI) case study, in 2011 Hospital Corporation of America (HCA) saved $21,700,000 by reprocessing SUDs.
- Environmental benefits – Reprocessing saves energy, material resources and landfill space. According to an HHI case study, in 2011 HCA diverted 728,000 pounds of medical waste from entering the landfills.
- Health and safety benefits – By freeing resources from supply costs saved by reprocessing SUDs, hospitals can redirect these monies to initiatives that impact patient care directly, such as hiring more nurses, investing in new technology, or serving more patients.
- Quality and outcomes - Metrics are in development. If you have suggestions, please contact us or participate in the discussion below.
The Association of Medical Device Reprocessors (AMDR) suggests hospitals ask the following questions when evaluating a third-party reprocessor:
General FDA Requirements:
- Is the company registered with FDA and can the company provide evidence of such FDA-registration?
- Does the company have a reputable FDA inspection record?
- Has the company listed its products with FDA and can the company share a listing of its product offerings?
- Does the company comply with FDA’s Quality System Regulation (QSR) requirements for medical device manufacturers?
- Does the company comply with FDA’s Medical Device Reporting requirements for medical device manufacturers?
- 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?
- Does the reprocessor have in place validated cleaning procedures?
- Is product functionality routinely tested?
- Does the company track the number of uses per device?
- Does the company recycle the raw materials from a device when it is no longer capable or eligible to be reprocessed?
- Does the company have adequate liability insurance coverage?
- Will the company permit you to visit its plant and review its quality manual?
- How will the company partner with you and your staff to integrate a reprocessing program into your established supply, storage and usage patterns?
- Is the collection program designed to ensure optimal compliance?
- Does the reprocessing partner support your efforts with regular business reviews, tracking programs and educational services that maximize staff participation?
- Assess and select FDA-approved single use device reprocessors in the market place. They have a lot of experience with implementation and can help with all aspects of this implementation plan. Use the Association of Medical Device Reprocessors http://www.amdr.org/ (AMDR) to guide the selection process. AMDR is a trade association for third-party reprocessors whose members account for approximately 95 percent of the third-party reprocessing done in the United States.
- Form a multidisciplinary task force at the department and hospital level. Stakeholders include all impacted clinical groups, supply chain managers and key “value analysis” members, OR managers, CSR managers, sustainability coordinator, OR Environmental Services, and Shipping/Recieving. Stakeholders may vary depending upon implementation vs. ongoing management issues.
- Determine your metrics for success, and develop a plan throughout the sourcing and early implementation plases for how you will continuously collect that data, and who will recieve it on a regular basis,
- Introduce devices to be reprocessed and implement the program with a “phase-in” approach, then broaden the scope with success. Start with non-invasive items. Your preferred vendor can also help you decide where to start and what to phase in at various points. A wide-range of SUDs are commonly reprocessed, from cardiovascular and orthopedic devices to general surgery accessories. The following list provides a sampling of SUDs that may safely be reprocessed; a complete list is available on http://www.amdr.org/
- Arthroscopic shavers
- Biopsy forceps
- Blood pressure cuffs
- Clamps and dissectors
- Compression sleeves (DVT)
- External fixation devices
- Electrophysiology catheters
- Harmonic Scalpel
- Laparoscopic scissors and forceps
- Orthopedic drill bits and burrs
- Phaco tips
- Pneumatic tourniquet cuffs
- Pulse oximeter sensors
- Scissors and staplers
- Soft tissue ablators
- Unused items
- Prepare an FAQ sheet and coach the team with answers to barriers that might arise. Clinicians and staff members may resist implementation with concerns over quality and safety, compliance and reporting in addition to having a preference for and strong opinions about certain items. The key to addressing these concerns is to provide administrative support and education about the environmental and cost saving benefits as well as the program’s strict adherence to FDA regulation.
- Plan a stakeholder group visit to the reprocessor plant and a facility that has successfully implemented programs.
- Searching for success or failure rate data will present numerous outcomes and case studies, but the practice is trending to best practices. AMDR is a good initial source, but your experience will also help others, so publicize wins and challenges associated with implementation such as environmental performance (reducing waste to landfill) and staff satisfaction and cost performance (savings). Be sure to measure and record savings associated with the program for reporting purposes.
- Implementation and ongoing management strategies include designating a clinical and/or initiative champion in the OR – a go to person for questions and problems. The Champion may also be responsible for tracking collection of used products and restocking of reprocessed products. – clarify all roles.
- Communicate criteria for open but unused products. Will it be used as a stand-alone item when returned? Is it a product line still in use? Is it the only item of a multi-item set, can it be used as a stand-alone product?
- Establish a regular routine for placing collection containers and sending them out in prepaid shipping boxes (consider assigning this Responsibility to an individual or select team).
- Collaborate with staff to agree on process for where reprocessed items are placed on the supply carts for first use (not doing this is a common barrier to realizing projected savings).
- Regularly review quarterly reports from reprocessor and purchasing/invoicing to understand and communicate savings and quality control monitoring.
- Continuously assess and be aware of changes in single use devices by the OEMs. The supply chain contracting process provides a good opportunity to better manage your relationship with the OEMs about your sustainability commitment and preference to reprocess.
- Place collection policies for reprocessed products in department manuals.
Regulations, Codes and Standards, Policies
- 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 semi-critical reprocessed SUDs that were previously exempt from premarket notification requirements and determine which of these devices now required premarket approval (PMA).
- Find more information and sign up for email updates from the FDA here.
- Before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers, including:
- Reprocessing firms must register and meet FDA requirements.
- Submit documents for premarket notification or approval.
- List all products.
- Submit adverse event reports.
- Track devices whose failure could have serious outcomes.
- Correct or remove from the market unsafe devices.
- Meet manufacturer and label requirements.
- The third-party reprocessing industry is subject to a stringent, comprehensive regulatory scheme. Reprocessors are, in many cases, required to include in their premarket submissions to the FDA; a whole category of data that OEMs are not required to submit. Specifically, reprocessors are required to include validation data regarding cleaning, sterilization, and functional performance to show that the reprocessed device will remain “substantially equivalent” to the original device.
- For a full description of the 2000 FDA guidance on reprocessing as well as subsequent FDA guidance on cleaning, functional testing, sterilization and data requirements, see FDA Guidance Docs.
- FDA’s Guidance Document – Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals.
- FDA’s Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices – Guidance for Industry and FDA Staff.
Cross References: GGHC
GGHC Operations v2.2 2008 Revision, Waste Management, Credit 2.1, Regulated Medical Waste Reduction: <10% Total Waste Stream, 1 point.
If you have any information or resources to contribute, please contact us or participate in the discussion below.
- AHRMM 31-page slide presentation, “SUD reprocessing – the new frontier in supply cost management.”
- Single-Use Device Reprocessing: Balancing Cost Savings, Patient Safety, an article from Health Leaders Media.
- Research, literature, presentations, and other resources to substantiate implementing SUD reprocessing within your organization from Practice Greenhealth.
Supply Chain, Waste
- Medical Products
- Source Reduction
- Waste and Recycling
- Waste Reduction
- All departments
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