FAQs

A: According to the FDA, SterilMed is considered the manufacturer of reprocessed devices. As such, we are as accountable as any manufacturer (including Original Equipment Manufacturers (OEMs)) for product safety, effectiveness, labeling claims, liability and warranty.

The FDA oversees and regulates the practice of reprocessing with significant oversight from Congress. Reprocessors must submit 510(k)s and receive clearance from the FDA. The FDA requires that devices are clean and sterile as well as safe and effective (substantially equivalent) for their intended use as the devices were when new. The FDA conducts inspections of reprocessors twice as frequently as device manufacturers. In other words, not only are the reprocessors considered to be the manufacturer of the device when they reprocess it, they must adhere to even stricter standards than the OEMs.

A: The most recent FDA inspection was on August 14, 2006. There were no observations or adverse actions resulting from the inspection. SterilMed has never received a FDA warning letter.

A: SterilMed is ISO 13485 certified and compliant with FDA's Quality System Requirements. The ISO 13485 standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services. SterilMed is audited by ISO on an annual basis and has an exemplary track record with this organization.

A: Reprocessing is effective, proven and safe.

Effective

• Generates over $150 million of cost savings each year for healthcare providers.
• Helps pay for indigent care and new life-saving technologies.
• Protects the environment — 2,000 tons of medical waste eliminated annually.

Proven

• Over 3,000 hospitals use reprocessed devices every day.
• AHA, AORN, CMS, JCAHO support it.
• Using reprocessed devices is a standard practice in 70% of U.S. hospitals.
• 80% of the US News and World Report's Best Cardiology Hospitals use reprocessed devices.
• 93% of the 2007 U.S. News' "Honor Roll" Hospitals use reprocessed devices.

Safe

• FDA-regulated reprocessors have shipped over 50 million devices with no evidence, from any source, of an increased risk to patient safety.
• Reprocessed devices have a defect-free rate of over 99.995%, based on the FDA's record of adverse events for reprocessed devices.
• 100% of reprocessed devices are inspected before shipment.

A: Keeping healthcare affordable is challenging when faced with increasing costs and decreasing reimbursements. Reprocessing SUDs is one way healthcare facilities can make a positive impact to their bottom line without sacrificing patient safety.

Typically, each device a facility reprocesses saves them 50 percent vs. the cost of buying the same device new. A facility's total savings associated with reprocessing will vary based on the size of the facility and the comprehensiveness and efficiency of their reprocessing program – the wider the range of devices reprocessed, the greater the savings they will achieve.

A: The decision to label a device as single use is at the discretion of the OEM and is not driven by the FDA. The decisions by the OEM to label a product as single use takes into account both product performance and financial considerations (increasing revenue).

A: The maximum number of times that any device will be reprocessed by SterilMed is five times. For devices that can be reprocessed five times, customers can get up to six uses of the device (one new and up to five reprocessing cycles). Validations for a handful of device types do not support the full five reprocessing cycles and are appropriately limited in the number of cycles that are permitted.

The actual number of times a device can be reprocessed is supported by successful validation testing and is dependent upon factors including device construction, material composition, and handling by the clinician. In order to maximize the number of reprocessing cycles, SterilMed uses proprietary collection tools, preliminary decontamination at the facility and leading edge technologies to clean devices.

A: SterilMed develops and provides validated processes, reviewed and cleared by the FDA, to ensure we provide a reprocessed product considered to be substantially equivalent to a new product. In order to be considered for reprocessing, we must ensure a reprocessed single-use device (SUD) is functional (after each clinical use and after the cleaning process), is clean (free of residual biomaterial and any residuals from the cleaning process) and is sterile.

Furthermore, the FDA review procedure evaluates all validated processes associated with reprocessing. These validation processes are designed to ensure that reprocessed devices are compatible with cleaning agents, remain biocompatible and maintain their material integrity.

SterilMed's state-of-the-art reprocessing technologies enable our company to supply over 8,000 different Class I and Class single-use devices in all OR departments as well as for the GI and EP/Cath labs.

A: SUDs which can't be cleaned, sterilized or ensured to be functionally equivalent to new devices are not reprocessed. As a current policy, we do not reprocess Class III implantable devices.

A: There is no difference in lead time between reprocessed and new devices. Once a customer has product in the reprocessing cycle, customers will receive a continuous flow of product back to their facility, similar to buying a new product.

A: After a device is used at the facility, it goes through the following steps to become a reprocessed device:

1. Collection at the facility – Devices targeted for reprocessing track through the facility's standard pathway for reusable devices and are pre-cleaned via the facility's standard techniques. The SterilMed OST managed pre-cleaning approach dramatically increases yield because devices are handled like reusable instruments, not like waste.
2. Pick-up and shipping to SterilMed – SterilMed utilizes customized shipping containers. Most SterilMed accounts have an on-site technician (OST) assigned to them to manage the collection of surgical devices throughout the facility. The OST consults with your department leaders on reprocessing best practices and facilitates material logistics. Devices are shipped weekly or bi-weekly based on collections.
3. Decontamination at SterilMed – Devices are received, logged in and labeled by account and department and sorted. The devices receive an enzymatic soak followed by manual cleaning as appropriate (e.g. brushing, scrubbing, flushing, etc.). SterilMed uses two primary enzymatic cleaning agents. One to target lipid-based debris and one for protein-based debris.
4. Ultrasonic cleaning – The devices are sent through a progressive ultrasonic cleaning process. A higher energy ultrasonic cleaning removes additional material. The customized high energy ultrasonic equipment is three to four times more powerful than what hospitals and surgery centers use. This cleaning is followed by a lower energy ultrasonic cleaning to deeply penetrate crevices, joints, lumens, blind holes and other areas that are inaccessible to other cleaning methods without damaging the device. The removal of contaminants is consistent and uniform, regardless of the complexity and the geometry of the substrates.
5. Other techniques are used when appropriate – Additional techniques are used such as: high pressure hydraulic flushing of lumens; vacuum desiccation; monitored scrubbing; computer numerical controlled sharpening (CNC) for shavers; and x-ray to determine number of remaining clips/staples in multi-clip appliers, linear staplers, etc.
   Orthopedic devices such as shaver and saw blades from any manufacturer are sharpened with proprietary computer numerical controlled (CNC) sharpening technology unique to SterilMed. The CNC sharpening platform is built with universal quick-change features that eliminates hours of set-up time associated with conventional manual sharpening equipment. Even complex geometries can be sharpened with a precision of +/- 0.005 of an inch which eliminates the human error associated with hand sharpening. This state-of-the-art automated technology produces sharpness that is substantially equivalent to original equipment manufacturer (OEM) devices.
6. 100% inspection is utilized across numerous stages in the process - Every single device is tested using customized and validated testing procedures. Functional tests are executed using specialized fixtures to confirm original specifications are met. Mechanical and electrical tests ensure proper sharpness, spring actuation, pressure (for seals), sensor function, insulation, diagnostic and imaging functionality.
7. Packaging and labeling – Reprocessing legislation (section 301 of MDUFMA) requires that all devices are either marked with the reprocessor's name or logo, a flag label, or otherwise bear a peel-away label that may be attached to the patient's chart. Devices are packaged in the appropriate customized packaging depending on device type to ensure product integrity when the facility receives the device. FDA required labeling components are included, such as: catalogue number, product name, description, etc.
8. Sterilization – SterilMed has partnered with Steris-Isomedix for all sterilization services. Steris-Isomedix employs a 100% ethylene oxide (EtO) sterilization process for the essential destruction of bacteria, viruses and spores. Steris-Isomedix is regulated by the FDA. A "Guarantee of Sterility" document is included in each shipment of product from SterilMed, based on the documentation and interpretation of mechanical, chemical and biological data from Steris.
9. Pack-out/shipping – The product is inspected a final time, packed out specifically to match customers and departments and shipped back to the facility. SterilMed's closed-loop supply chain ensures the maximum number of a facility's devices will be returned.

A: SterilMed develops and provides validated processes, reviewed and cleared by the FDA, to ensure we provide a reprocessed product considered to be substantially equivalent to a new product. Our processes are far more thorough and controlled than those performed in central sterile departments in hospitals. For example, each sterility cycle has biologic indicators which are verified sterilized before any product is released for shipment. Many central sterile departments use a tape which simply indicates the exposure to EtO gas with no certainty of sterility

A: SterilMed tracks the number of times a device has been reprocessed by placing a permanent mark or bar code on the device each time it has been reprocessed. If SterilMed receives a reprocessed device with the maximum number of marks, it will be rejected.

A: Only SterilMed guarantees that the same devices collected at your facility are returned to you. This ensures that our customers receive the benefits of their collection efforts. Once devices are received at SterilMed, they are received, logged in and labeled by facility and department and sorted. The product is then packed out specifically to match the customers and departments they came from and then shipped back to the facility of origin. This process ensures that each facility receives the same devices that were collected on their premises.

A: Managing inventory is easier if your reprocessed devices are returned on a regular schedule. That is why SterilMed employs a closed-loop collection and delivery supply chain approach. By returning the same devices collected at your facilities, SterilMed is able to return your devices in a timely manner on a predictable schedule automatically. Our Customer Service personnel work with accounts to assess current inventory management systems to make sure devices are consistently returned with no large fluctuations in timing of shipments or interruptions in order flow. To ensure maximum product flow back to your facilities with the least amount of lead time, it is our suggestion to initiate a standing PO.

A: The effectiveness of a reprocessing program is best measured by the amount of cost savings generated – typically measured in $/bed. Delivering the highest savings requires rigorous processes. SterilMed achieves this by offering: maximum device return, broadest device list, most consistent material flow and superior service.

Contact us today at (888) 541-0078 for more information.

A: A 510(k) is a pre-marketing notification made to the FDA to demonstrate that the device to be marketed is as safe and effective as (i.e. substantially equivalent to) a legally marketed device that is not subject to pre-market approval (PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims.

The legally marketed device to which equivalence is drawn is known as the "predicate" device and the 510(k) process and clearance is identical whether a device is a new device to the market or a reprocessed device. In other words, reprocessing companies such as SterilMed have to prove substantial equivalence to a predicate device and are seen as the manufacturer of the device.

A: SterilMed has never been involved in any lawsuit arising out of a patient injury or allegation of improper or negligent reprocessing of a medical product or device.

A recent analysis of FDA's MAUDE database concludes there is no evidence to suggest that reprocessed devices fail more often than original equipment. The Association of Medical Device Reprocessors (AMDR) analyzed data from 2000-2006 for the most-frequently reprocessed single-use devices, reprocessed devices have a 99.9997% adverse event free rate. For many products listed (i.e., cardiac stabilization devices, compression sleeves, burrs, blood pressure cuffs, pulse oximetry sensors, drill bits, external fixation devices, saw blades, etc.), the entire reprocessing industry has zero MDRs, as compared to dozens or even hundreds of events associated with OEM devices.

A: SterilMed is a medical manufacturer and therefore assumes the same liability as the original equipment manufacturer. 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. For a reprocessed medical device, SterilMed is considered by the FDA and our insurance carriers to be the device manufacturer for its next use.

A: SterilMed will warranty any device or equipment used in conjunction with a reprocessed device.

A: The Centers for Medicare and Medicaid Services (CMS) supports FDA's view that reprocessed devices are substantially equivalent to new so there is no change in reimbursement. There is no difference in reimbursement for a procedure using a reprocessed device versus a procedure that uses a new device.

Most insurance companies and Medicare use a diagnostic-base 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.

A: Only investigational devices require special patient consent. The FDA considers reprocessed devices as substantially equivalent to new devices and therefore no special consent form is required. General patient consent for a procedure covers the facility's prerogative to select devices as they see fit.