Medical Device Reprocessing

Medical Device Reprocessing
Is It Good for Your Organization?

By Don Selvey

Here's a fact that may surprise you: if just 1 or 2% of all the disposable medical devices used in the US today were reprocessed, the healthcare industry would save a billion dollars every year. That billion dollars could be devoted to patient care, research, bringing new treatments to the bedside, and making healthcare more affordable.

What exactly is reprocessing? The American Society for Healthcare Central Service Professionals (ASHCSP) says it includes all operations performed to render a used reusable or single-use device patient-ready or to allow an unused product that has been opened to be made patient-ready. There are two ways to reprocess: creating an in-house program or relying on a third-party reprocessor.

Whether a healthcare organization reprocesses in-house or through a third party, a medical device cannot be reprocessed successfully unless it can be cleaned, sterilized, and, when applicable, function tested.

In this context, "clean" means removal of visible contaminants and environmental debris (including microscopic particles of tissue, body waste, body fluids, dirt, and dust). Function testing verifies that a device will perform as intended. "Sterilized" in the context of reprocessing means a sterility assurance level of 10^-6, or a theoretical one in a million chance that an organism could survive. This meets domestic and international sterilization standards.

A June 2000 General Accounting Office study, Single-Use Medical Devices--Little Available Evidence of Harm From Reuse, but Oversight Warranted, says hospitals that reprocess report annual savings up to $1 million for electrophysiology catheters alone. A device labeled for single use that is reprocessed just once by a third party typically saves a hospital 50% of the original cost of the item. Hospitals that reprocess in-house have claimed even greater savings.

Another benefit of reprocessing--reducing the amount of medical waste a facility generates--can also produce significant cost savings. For example, a multi-hospital system estimates that in a year they not only saved $300,000 by reprocessing compression sleeves, but also eliminated six tons of medical waste that would have been shipped to a landfill.

Why isn't every hospital reprocessing?

If reprocessing is so economical, why isn't every hospital and surgery center in the nation doing it? The answer lies in misunderstandings about the integrity and safety of single-use medical devices after reprocessing. Some healthcare personnel have voiced concerns that patients may be harmed by this practice. What many healthcare professionals aren't aware of is how thorough, painstakingly precise, and rigidly monitored a successful reprocessing program is. Many also may not realize that labeling a device "single-use" is sometimes simply a marketing strategy on the part of the original equipment manufacturer, since the identical or nearly identical device may have been manufactured previously as a reusable device. In addition, in other developed countries, some of these devices are not labeled as single-use.

Most reassuring of all, in August 2000, the Food and Drug Administration (FDA) issued a Guidance Document, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, which requires hospital and third-party reprocessors to undergo the same scrutiny as medical device manufacturers. Before the Guidance Document was issued, hospitals weren't required to abide by the same regulations as manufacturers.

Now, however, all reprocessing operations must abide by the same standards as an original equipment manufacturer. Most notably, this entails fulfilling seven basic requirements. They are:

• Facility registration and device listing with the FDA. The FDA requires that any organization engaged in reprocessing must register initially and annually thereafter with the FDA and provide the Agency with a comprehensive list of all the medical devices they reprocess.
• Medical device reporting (MDR). All manufacturers, including hospital and third-party reprocessors, must comply with Manufacturer Reporting Requirements and report all patient injuries related to device failures and malfunctions. Previously, hospital reprocessors were subject to less stringent reporting requirements.
• Device tracking. The FDA can issue a tracking order for specific devices--usually implants. When this occurs, a reprocessor must be able to identify all patients implanted with the tracked device.
• Corrections and removals. Reprocessors must have a formal procedure for recalling or correcting defective products.
• Quality system regulation (QSR). All reprocessors must establish and maintain a comprehensive quality system for all aspects of their operation.
• Labeling. Third-party and hospital reprocessors must now comply with the same labeling regulations as manufacturers.
• Premarket Submissions. The level of pre-market submission is based on the FDA's classification of a device.
  -- Class I devices may be exempt from a premarket submission.
  -- Class II devices require reprocessors to submit a premarket notification [510(k)] within a year.
  -- Class III devices require reprocessors to submit a premarket approval application (PMA) within six months.

Hospitals must comply with the timeframes for submitting premarket submissions, but they have a 12-month grace period (until August, 2001) to comply with all other provisions in the FDA-issued Guidance Document. Third-party reprocessors are subject to immediate enforcement of all provisions.

Many hospitals, especially in view of the new FDA Guidance Document, have no interest in on-site reprocessing because they don't want to function under the constraints of strict governmental oversight. Many hospital and surgery center representatives also recognize that under the FDA guidelines, an in-house facility can be prohibitively expensive to establish and maintain. That's because reprocessing is now enormously labor- and resource-intensive and requires highly trained experts to ensure that the facility complies with the FDA regulations. Yet the demonstrated ultimate cost savings, along with assurances of patient safety and effectiveness, make reprocessing an important consideration for healthcare institutions. To whom do they turn?

They can turn to a third-party reprocessor that belongs to the Association of Medical Device Reprocessors (AMDR), a trade association representing approximately 80% of the non-hospital reprocessing done in the US. AMDR's Web site defines a "third-party reprocessor" as an entity that, at the request of a customer, inspects, cleans, functionally tests, packages, and sterilizes medical devices labeled for single-use in such a manner that the quality, physical characteristics, and performance functions of the device are not significantly affected and the device remains safe and effective for its appropriate clinical use." Third-party reprocessors return reprocessed devices to the facility that requested the service, minus those devices that have been rejected. Devices are rejected when they cannot perform as intended.

Which devices are best for reprocessing?

The FDA classifies single-use medical devices according to the level and type of control needed to ensure that the devices are safe and effective. Class I devices need the fewest controls; Class II devices require "special controls." Class III is the most stringent regulatory category and medical devices that fall under this category require a premarket approval. Class I and Class II devices are the best candidates for reprocessing, with some notable exceptions. These exceptions include products that have true single-use applications, such as wood tongue depressors, examination gloves and fiberoptics. Orthopedics Today estimates that "at least 8% of the [single-use medical device] market consists of devices that may be reused if properly reprocessed, sterilized and repackaged." Alliance Medical Corporation, a medical device reprocessor, contends that only between 1 and 2% of disposable medical devices can be safely reprocessed. However, other reprocessors may not agree.

Devices that Alliance reprocesses fall into the following general categories:

• Open/unused devices and suture
• E.P. catheters
• DVT compression sleeves
• Orthopedic tools
• Laparoscopics
• GI biopsy forceps

Reprocessable Class I devices include:

• Orthopedic chisels
• Surgical curettes
• Surgical gouges
• General use surgical scissors
• Non-electric biopsy forceps
• Orthopedic knives
• Orthopedic saw blades
• Chisels
• Rasps

Between 65 and 75% of all single-use medical devices are identified as Class II. Class II single-use devices that can be reprocessed include:

• Non-ported trocars for endoscopic procedures
• Sequential compression devices (compression sleeves)
• Most laparoscopic instruments, including: scissors, clamps, dissecters and graspers
• Recording and diagnostic EP catheters
• Drills and burrs
• Flexible snares

Because Class III, single-use medical devices pose greater risk to the patient and now require pre-market approvals (PMA), they are generally not reprocessed. Such Class III devices include:

• Transluminal coronary angioplasty catheters
• Percutaneous and conduction tissue ablation electrodes
• Implanted infusion pumps

How third-party reprocessing works

Each third-party reprocessing organization works a little differently. At Alliance Medical Corporation, when a shipment arrives, staff in receiving follow standard precautions requirements and transfer the devices from their shipping container(s) into bins used for work in progress. Using OneWorld^®, a sophisticated Enterprise Resource Management software package designed by J.D. Edwards, Alliance controls all product flow. Staff assign a unique sales order number that includes a code to identify how the order should be processed. If the order contains any compression sleeves, they are examined for signs of body waste or blood. If found, the sleeves are immediately rejected. Bins are then placed in a staging area.

Devices from various hospitals and surgery centers are never intermingled. The devices a hospital sends to Alliance are always the exact devices returned to that hospital, minus those that have been rejected--unless the client asks that the rejected devices be returned. At any point in the process, a technician has the authority to reject a device. The company sends a report to the hospital or surgery center that explains the reasons for the rejection. Alliance assumes responsibility for the device's disposal and clients are not charged for rejects.

Next, the bins are placed on racks and transported to the initial clean area where a technician receives it. All technicians who come in contact with the bins' contents must be protected from any hazards those devices might pose, so personnel follow standard precautions and wear personal protective equipment (a "bunny" suit) that includes gloves, face masks, shields, hair, and shoe coverings. At the beginning of the process, people are protected from the product. By the end of the process, this axiom is flipped: the product requires protection from people.

Once a batch of devices arrives in initial clean, a technician completes a sorting operation and reviews and adds details to the order record that originated in Receiving. This document travels along with the devices at every stage. In this phase, the technician examines each device for any obvious defect that could cause it to be rejected. If no defect is found, the device moves on to the next step. Sometimes hospitals send devices that the company doesn't reprocess. In those cases, the devices are automatically rejected. As another precaution, the technician consults customer-originated lists to make certain devices being examined are not among those that a customer does not want reprocessed.

After the examination is complete, devices with difficult-to-clean features, such as jaws, hinges, channels or grooves, are gently cleaned in a compressed air microcleaner that uses sodium carbonate, a very mild abrasive. Microcleaning removes any additional material that may be clinging to parts of the device. Each device is cleaned and examined individually. This part of the process takes about 12 minutes for each device.

After the microcleaning (or when devices do not require this step), all devices are soaked in an enzymatic cleaner for at least two hours. The company doesn't use any cleaner containing glutaraldehyde.

After the enzymatic cleaner immersion, each device is comprehensively cleaned in a three-compartment sink. If the device is a laparoscopic or biopsy instrument, it receives a cleaning in a specially designed lumen cleaner. The sheathing is stripped from laparoscopic instruments to ensure cleanliness of the essential device and replaced later with the same material used by the manufacturer. The sinks and lumen cleaners used were designed by company engineers.

All other devices are cleaned again with a different type of enzymatic cleaner formulated for either metal or plastic. All devices then go through a clean rinse, and afterward, they soak in a disinfectant for at least 20 minutes. Each device is custom-cleaned according to device specific protocols. A laparoscopic instrument, for example, is typically cleaned in 30 minutes. But the cleaning cycle time for a biopsy instrument is about eight hours.

After the cleaning process, compressed filtered air is used for drying each device.

The initial cleaning process is different for compression sleeves, which aren't immersed in cleaning solutions because this would degrade the materials used in the device. Instead, technicians use a variety of cleaning instruments to clean away any spots, stains or lint. Technicians track the number of times a compression sleeve goes through reprocessing. After cleaning, trained technicians minutely inspect the devices under a microscope. If any remaining debris can't be removed during recleaning, or if there is an obvious defect, the device is rejected.

All devices are transferred to Processing after cleaning through pressurized airlocks, which ensure that the flow of air moves from Processing into Initial Clean, instead of vice versa. Airlocks are located throughout the facility to help prevent cross-contamination and to ensure the proper flow of products.

The first step in Processing is log-in, where a detailed listing and description of received devices is added to the computerized order record. At log-in, the manufacturer of the device is identified and precise identifying numbers pertaining to each device are recorded. When compression sleeves, for example, are noted in receiving, the order record might indicate only that 100 compression sleeves were received. At log-in, those same compression sleeves are identified by manufacturer and model.

At this stage, the company will soon use a non-destructive laser to etch a unique two-dimensional bar code onto most devices, allowing instant retrieval of detailed information about a particular device, including how many times it's been reprocessed. Laser etching expedites logging, tracking, and facilitates product flow.

After log-in comes restoration for those devices that require it and function testing. For example, devices with cutting features are sent to a sharpening station. Using precise instrumentation and delicate handiwork, the technician restores each device to its original condition. Viewing the device under 10 power magnification, the technician sharpens each tooth or blade of the device and makes sure that proper cutting angles are reinstated. Burrs are removed. Other features of a device are restored at this stage, such as sheathing on scissors removed during cleaning.

Function testing is next. Devices that can be functionally tested are forwarded to a technician who determines whether the device can perform as it's expected to perform. This phase can include functional confirmation using custom-designed equipment, cut tests where applicable and other function tests that duplicate the rigorous approach taken by original equipment manufacturers prior to releasing a product to market.

Compression sleeves are function-tested with a pressure decay machine, which determines whether the sleeves hold their pressure during inflation and that they deflate properly. Once the compression sleeves are function tested, they are sent to another area in Processing to be folded. Parallel Initial Clean and Processing operations exist for electrophysiology catheters, because these devices are required to be non-pyrogenic. EP catheters have their own cleaning, testing and final rinse areas, to ensure that each device does not exceed the limit of 20 endotoxin units per device.

After function-testing has been performed on all devices, they go through a "final clean" operation, where they are processed with heated, reverse osmosis/deionized water. This so-called "hungry water" gently cleans by attracting dirt to water molecules, eliminating any particulates that remain on a device.

Many clinicians have asked how many times a device can be reprocessed. There are no specific numbers; it depends on how the device has been used and whether it can pass stringent inspections and testing. If it can, then the device can be used safely one more time.

The packaging and sterilization stages

After the final clean, each device is transferred for packaging to one of two packaging areas designed as Class 10,000 clean rooms--where air circulates at more than twice the rate of most operating rooms. In the pre-packaging area the device might be mounted on chipboard to hold it in place, or, if it's a sharp, secured with tip protectors.

In packaging, each product is placed into a Tyvek ^® mylar pouch. A chemical indicator strip is placed into each pouch, which, when it changes color, indicates sterilization has occurred. Some devices are double pouched to accommodate the needs of individual facilities.

Device packages are then bar-sealed with calibrated and validated machinery, labeled and loaded onto a stainless steel tray in preparation for sterilization. Ten biological indicators inside syringes are inserted into each load. The biological indicator used is Bacillus subtilis var. niger, the industry's recognized challenge organism for confirming EO sterilization. If the sterilization process can kill this organism, the load has met the domestic and international standards for sterility of 10^-6.With EP catheters, in addition to the bacillus subtilis, limulus amoebocyte lysate (LAL) is used as another biological indicator of pyrogenicity.

Each load of product is placed into one of three sterilization chambers. Each cycle lasts approximately 10.5 hours and uses about one half-pound of EO. Alliance operates Joslyn sterilizers, which have some unique features including a preconditioning process that efficiently removes air and humidifies the breathing spaces in complex devices such as lumens, making EO penetration faster and more predictable. The sterilizers also use a patented detoxification process that removes residual sterilant from materials faster and more predictably than aeration.

After the cycle has been completed--to verify that sterilization has been successful--the biological indicators are removed and sent to an independent testing facility. This facility determines whether all of the organisms have been killed. During that time, product release technicians inspect every package for seal integrity, intact and correct labels, foreign matter, and that the sterilizer strip has turned. Products are then logged out and boxed for transport, but remain in quarantine for 72 hours until the independent lab has verified that sterilization has been successful. Only then are devices returned to the hospital or surgery center client. EP catheters, placed in white, sodium-bleached, sulfate boxes, are sent via overnight delivery. All other devices are sent via ground or air transport through UPS.

How does a third-party reprocessor determine which devices can be reprocessed most effectively? Those decisions are made by Alliance's Engineering Department. There, a staff of trained and experienced biomedical engineers review original equipment manufacturer documentation on all devices under consideration for reprocessing. Relying on a scientifically sound approach, they reverse-engineer nearly all devices to understand completely how they work and perform a battery of tests to determine at what point a device may not function safely one more time. For example, exhaustive testing on soft tissue ablators allowed engineers to determine the minimum measurement for an electrode that would guarantee that it would operate as intended when used by a surgeon.

These extensive review and testing procedures lead engineers to develop device-specific protocols for cleaning, function testing and sterilizing every device that's given the go-ahead for reprocessing. Alliance also validates all cleaning, packaging and sterilization procedures at least annually, or whenever a procedure is changed.

Conclusion

Healthcare industry experts are recognizing the value, safety, and effectiveness of single-use medical device reprocessing. The American Hospital Association supports limited and regulated reprocessing. In a letter to its members, the American Society for Healthcare Central Service Professionals notes that "tens of millions of devices have been reprocessed over the years safely and effectively."

The FDA, which has faced pressure from original equipment manufacturers to ban reprocessing, instead has issued a Guidance Document that establishes strict regulation of every organization that chooses to perform single-use medical device reprocessing, including hospitals. For hospitals that have been doing in-house reprocessing or even thinking about in-house reprocessing, the FDA Guidance Document means additional economic and regulatory burdens. But many in the third-party reprocessing industry welcome the Guidance Document as another tool to guarantee that reprocessing is safe and provides value.

When a hospital or surgery center decides to use a third-party reprocessor, it:

• Saves up to hundreds of thousands of dollars each year--depending on the size of the organization--in the cost of disposable medical devices;
• Follows a national trend toward outsourcing many non-clinical functions;
• Avoids FDA involvement in the hospital's central supply, processing, and distribution department;
• Reduces waste and demonstrates that it is concerned about sound management of resources as well as the future of the environment;
• Understands that the third-party reprocessor assumes liability for the performance and safety of each device reprocessed;
• Assures its community that the reprocessed disposable medical devices the hospital or surgery center uses are as clean, functional, and sterile as when the devices came from the original manufacturer.

The FDA Guidance Document, the support of major healthcare advocacy organizations, and the industry's own strict standards have helped to intensify the bright light of respectability for third-party reprocessing.

Don Selvey is Vice President of Regulatory Affairs and Quality Assurance at Alliance Medical Corporation in Phoenix, Ariz.