Medical Device Conservation The Science and Safety of Medical Device Reprocessing Think Green help save our planet!
Session Description The session describes the history, science and safety of medical device conservation (reprocessing). With strict FDA regulatory and manufacturing quality processes, the reprocessing of medical devices labeled for "single use" has been established as a standard practice in United States hospitals. And why it is imperative that every hospital associate embrace our reprocessing program and understand how their actions related to our reprocessing program impacts our ability to maintain safe, quality healthcare while conserving valuable resources.
Session Overview Reprocessing Definition Background Benefits Endorsements Widely accepted Government oversight and regulation FDA process validation Quality controlled process Vendor Disruption tactics Frequently asked questions Summary
Reprocessing Terminology OEM Original Equipment Manufacture SUD Stands for Single use device Hospitals recognized that the "single use" label was often motivated by economic objectives, rather than patient safety concerns. Reprocessing A FDA approved manufacturing process for SUD that upon completion the device remains substantially equivalent to its predicate device.
What is the definition of reprocessing Reprocessing is an FDA regulated manufacturing process by which medical devices labeled as single use, are cleaned, refurbished, tested and sterilized; making the device safe for reuse. Unlike sterilization which is the procedure of making some object free of live bacteria or other microorganisms (usually by heat or chemical means) Before a third party reprocessor can safely reprocess a medical device, the device must be cleared by the FDA through a scientific validation process called a 510K. A 510k is the compellation of comprehensive scientific and engineering test data that confirms the device is equivalent to a new device following the reprocessing process. The tests include: Functional and biocompatibility Mechanical, electrical and reliability testing Material and physical testing Sterilization
Reprocessing Background The reprocessing of medical devices labeled for "single use" has been standard practice in United States hospitals for over 20 years. Medical device reprocessing emerged when original equipment manufacturers (OEMs) began to change the labels on certain devices from "reusable" to "single use," without making significant structural changes in the devices. Historically, the majority of reprocessing had been conducted in the hospitals central sterile centers.
Reprocessing Back ground The decision to label a device as single use or reusable rests with the manufacturer, not the FDA. However, for a manufacturer to label a device as reusable, it must provide data demonstrating to the FDA s satisfaction that the device can be cleaned and sterilized without impairing its function. Therefore manufactures must label the device single use because the manufacture chooses not to conduct the studies needed to demonstrate that the device can be labeled reusable.
The benefits of Reprocessing There is something for everyone Reduces Supply Chain costs (on average 50% less than new) Allows physician s to use their preferred product/s without sacrificing clinical outcomes Prepares physicians for outcome/cost profiling Provides resources to other important competing priorities Indigent care New technology Community outreach programs Supporting charitable organizations
Reprocessing devices will divert more than 27 tons of waste from landfills over the next 3 years. A September 2008 article in Materials Management in Health Care magazine notes "for Banner Health, Phoenix, reprocessing medical devices isn t just a cost-saver, it's an Earth-saver." The article highlights the fact that "American health care facilities send 4 billion pounds of waste to landfills and commercial incinerators," and that health care is the second largest contributor to landfill space after the food service industry." According to the article, Banner officials predict that by using reprocessed devices they will divert more than 27 tons of waste from landfills over the next 3 years. AMDR - Medical Device Reprocessing in the News www.amdr.org 2009
Many leading professional organizations now endorse reprocessing AORN Reprocessing is recommended if the manufacture provides instructions, or if the reprocessor can demonstrate and document that the effectiveness and integrity of the medical device is not compromised American Hospital Association The safety record of many reprocessed SUD is as good or better than that of new devices American College Of Cardiology Reprocessing is a safe practice that hospitals and physicians have relied on for more than two decades. A significant body of peer reviewed literature demonstrates that certain devices labeled SUD can be safely and effectively reprocessed, including EP catheters JCAHO Joint Commission on Accreditation of Health Organizations removed the standard that prohibited reprocessing disposable medical devices in 1995. AAMI AAOS ACC ADDM AHA AHRMM AMDR AORN APIC ASGE ASHCSP CDC ECRI FDA HCFA (CMS) IAHCSMM JCAHO HASPE
Widely Accepted Over 70% of all hospitals currently reprocess 13 of 14 US News & World Report 2006 Top U.S. Hospitals All of US News & World Report Top 20 Teaching Hospitals 73% US News Top Orthopedic Hospitals 82% US News Top Heart Hospitals
FDA report concludes Reprocessing is safe! The GAO reported in 2000 and then again in 2008 - Reprocessing does not pose an elevated health risk. In a post market surveillance of 350 hospitals conducted by the FDA on reprocessing; There were no reported increase in infections rates using reprocessed SUD s There were no reported concerns with mechanical related problems as compared to new dev ices In a report to the Committee on Government Reform the FDA concluded Reprocessing is Safe!
Science based cleaning and testing approach All reprocessed devices must meet these requirements: Original functionality specifications FDA s cleaning requirements FDA s sterility requirements Reprocessors must comply with: FDA 510(k) clearances and Quality System Requirements ISO 13485 quality assurance system; same as OEM s The FDA believes that reprocessed SUDs are as safe and effective as a new devices A number of the new requirements for SUD reprocessors exceed the requirements for original manufacturers. - Dr. Daniel Schultz, Director, Center for Devices and Radiological Health, FDA
Point of Use Collection Options Device are collected at the facility and then transported to an approved FDA third party reprocessor Several different types of point of use collections containers will be used to collect devices for reprocessing. Your manager will direct you to the location of the collection container for your area. Always place devices into the collection container. Do not inhibit the collection process by leaving any item on top of the collection container.
Reprocessing Cleaning Approach Devices are cleaned in consistent stages: Microblasting Manual cleaning Ultrasonic cleansing Disinfection Specialized cleaning Lumen cleaners, etc Similar to the quality approach used by pharmaceutical companies, SterilMed validates its cleaning process by measuring the level of bioburden at the molecular level These processes far exceed typical hospital practices for cleaning re-usable instruments.
Many devices are refurbished Sharps: computer-controlled equipment resharpens shavers and blades. Eliminates variability of manual sharpening Only reliable way to sharpen complex edges Trocars: sharpen bladed models Pulse oximeters: replace all patient contact materials Catheters: improve tip joint bond integrity on some models
100% of reprocessed devices are inspected Confirms that devices: Meet cleaning requirements Are free of visual defects Conforms to specifications Original equipment manufacturers test only a fraction of new devices in each individual lot Microscopic examination
Devices are functionally tested Specialized processes used to confirm original specs are met Mechanical Tests Sharpness Bladed devices Spring actuation Clip appliers, trocars Pressure test of seals Trocars, sleeves Electrical Sensor function All catheters, pulse ox Insulation All electrical devices Image AcuNav catheter Diagnostics Pulse ox
Packaging for Ease of Use Similar packaging to the manufacturer is used when possible Store the same as new devices Pull reprocessed devices first Easy to manage inventory Specifically designed for individual products, including: EP catheters - boxed tray packs and hanging peel pouches Ultrasonic scalpels - Custom designed tray packs Pulse oximeter sensors - easy to select model with color-coded packages
Final Step - Sterilization 100% EO sterilization Devices are sterilized using Ethylene Oxide (EO) system Biological indicators are included in every load and checked to confirm sterilization. No devices are released until BI s indicate proper kill. Scan package into tracking system to verify order completion Inspect packaging for integrity
Quality Monitoring and Reporting Quality Reporting Adverse event free rate (MAUDE) better than 99.9997% Zero patient injury claims Superior FDA audit record I wish we had this kind of technology in our sterile processing department - SPD Manager after visiting a reprocessing facility
The number of device categories cleared for reprocessing will continually increase. The device categories currently approved include: DVT Sleeves Pulse Oximeters Biopsy forceps Laparoscopic instruments Trocars Harmonic scalpels Staplers and clip appliers Tourniquet cuffs Arthroscopic shavers Arthroscopic probes Burrs, bits and blades External fixators Phaco tips Open/Unused devices
FAQ s How are reprocessed devices marked for tracking purposes? (A) A Reprocessor tracks the number of times a device has been reprocessed by placing a permanent mark on the device each time it has been reprocessed. On catheters, a bar code may be applied to the device, which will provide data for each reprocessing. In addition, a Reprocessor must place their initials on every device. How many times can a device be reprocessed? (A) The actual number of times that a device can be reprocessed is dependent upon a number of factors: device construction, material composition, handling by the clinician and the FDA s 510K clearance. Do I need patient consent to use reprocessed SUDs? (A) No additional patient consent is necessary when using reprocessed devices. Unlike investigational devices that require special patient consent, FDA considers reprocessed devices as substantially equivalent to a new device. Therefore, no special consent form is required. At the local level, hospitals drive the decision to use any approved/cleared products including reprocessed devices as part of their best practices. General patient consent for a procedure covers the hospital s prerogative to select devices as they see fit.
FAQ s How do you sterilize SUDs at the end of reprocessing? (A) Most medical device manufactures and Rporcessors partner with Steris-Isomedix for all sterilization services. Steris delivers state-of-the-art services as part of a complete program that emphasizes exceptional process quality control. Steris-Isomedix employs a 100% ethylene oxide (EtO) sterilization process for the essential destruction of bacteria, viruses, spores, etc. Steris-Isomedix is regulated by the FDA and differs in intensity from EtO sterilization performed in hospitals. Does a Reprocessor guarantee its reprocessed devices and services? (A) A Reprocessor warrants that it will comply with all laws and regulations applicable to its services, including but not limited to FDA and HIPAA, and that reprocessed products will meet all FDA requirements and be fit for their intended purpose. How does a reprocessor handle a recall issued by the original equipment manufacturer (OEM) recalls? (A) A Reprocessor must be vigilant in tracking product recalls by the original equipment manufacturers (OEMs). The FDA automatically e-mails us to alert us to recalls and our Director of Quality Assurance/Regulatory Affairs receives a bi-monthly newsletter listing current OEM recalls. Customers also alert us to OEM product recalls. It is important to note that many recalls by original equipment manufacturers are due to compromised packaging or issues associated with sterilization. A reprocessor performs both packaging and sterilization so in those recall scenarios, it may be deemed unnecessary to retrieve the product. However, since a Reprocessor odes not track OEM lot numbers, any lot number specific recall by the OEM would require SterilMed to retrieve all reprocessed devices of that type to ensure compliance.
FAQ s Will reprocessed devices get reimbursed inpatient? (A) For inpatient procedures, Medicare like most insurance companies uses a diagnosisbased payment system, providing a fixed reimbursement amount for the hospitals according to patient diagnosis. The hospitals then utilize procedures and equipment they deem as best practices within that reimbursement framework including approved reprocessed medical devices. For private pay/private insurance patients (roughly 10% of total hospital patients), there may be an adjustment of line item charges. In other words, in order to reflect the lower acquisition cost associated with reprocessed devices, the hospital would bill the patient (and insurance company, if applicable) for the actual cost of the item. Will reprocessed devices get reimbursed outpatient? (A) The Centers for Medicare and Medicaid Services (CMS), formerly known as the Health Care Financing Administration (HCFA) states that, since the FDA sees a reprocessed device as a substantially equivalent device, Medicare will provide payment for devices used in outpatient procedures. For private pay/private insurance patients (roughly 10% of total hospital patients), there may be an adjustment of line item charges. In other words, in order to reflect the lower acquisition cost associated with reprocessed devices, the hospital would bill the patient (and insurance company, if applicable) for the actual cost of the item.
FAQ s What kind of product liability insurance does a Reprocessor have? (A) A physician is not subject to increased risk of liability if a reprocessed device causes patient injury. The reasons are as follows: Physicians contractually protected A Reprocessor contractually agrees to indemnify and hold harmless a medical facility, physicians and clinicians against claims and liabilities arising out of a Reprocessors negligence or breach of warranty. A Reprocessor warrants that the reprocessed device is fit for its intended purpose. This indemnity and hold harmless obligation shall not apply to damages arising out of misuse of medical devices (including off-label use) reprocessed by a Reprocessor. A Reprocessor, not the hospital, is liable for patient injuries due to medical device failure - If a patient injury occurs due to the failure of a medical device, the device manufacturer and not the physician is held liable unless physician negligence is involved. Once a device is reprocessed, a Reprocessor is considered by the FDA and our insurance carriers to be the device manufacturer for its next use.
Summary Reprocessing is FDA regulated The FDA has concluded that reprocessed device are save as new devices. Post market surveillance by the FDA of over 300 accounts found: No evidence of an increase in infection rate with reprocessed products No evidence of a decline in clinical outcomes Reprocessed devices do not fail more often than similar new devices Reprocessing is better for the environment savings million s of pounds of medical waste from our landfills. Reprocessing is supported by AHA, AORN, CMS, JCAHO, and multiple other professional and regulatory organizations Reprocessing is widely accepted 70% of all hospitals reprocess and 93% of US News Best Hospitals Reprocessing is an important part of our facilities approach toward conserving valuable resources and reducing our impact on the environment.