Medical Device Reprocessing

Medical Device Reprocessing
Is It Good for Your Organization?

By Don Selvey

Here'sa fact that may surprise you: if just 1 or 2% of all the disposable medicaldevices used in the US today were reprocessed, the healthcare industry wouldsave a billion dollars every year. That billion dollars could be devotedto patient care, research, bringing new treatments to the bedside, and makinghealthcare more affordable.

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

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

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

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

Another benefit of reprocessing--reducing the amount of medical waste afacility generates--can also produce significant cost savings. For example, amulti-hospital system estimates that in a year they not only saved $300,000 byreprocessing compression sleeves, but also eliminated six tons of medical wastethat 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 centerin the nation doing it? The answer lies in misunderstandings about the integrityand safety of single-use medical devices after reprocessing. Some healthcarepersonnel 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 programis. Many also may not realize that labeling a device "single-use" issometimes simply a marketing strategy on the part of the original equipmentmanufacturer, since the identical or nearly identical device may have beenmanufactured previously as a reusable device. In addition, in other developedcountries, 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-UseDevices Reprocessed by Third Parties and Hospitals, which requires hospitaland third-party reprocessors to undergo the same scrutiny as medical devicemanufacturers. Before the Guidance Document was issued, hospitals weren'trequired to abide by the same regulations as manufacturers.

Now, however, all reprocessing operations must abide by the same standards asan original equipment manufacturer. Most notably, this entails fulfilling sevenbasic 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 premarketsubmissions, but they have a 12-month grace period (until August, 2001) tocomply 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 nointerest in on-site reprocessing because they don't want to function under theconstraints of strict governmental oversight. Many hospital and surgery centerrepresentatives also recognize that under the FDA guidelines, an in-housefacility can be prohibitively expensive to establish and maintain. That'sbecause reprocessing is now enormously labor- and resource-intensive andrequires highly trained experts to ensure that the facility complies with theFDA regulations. Yet the demonstrated ultimate cost savings, along withassurances of patient safety and effectiveness, make reprocessing an importantconsideration for healthcare institutions. To whom do they turn?

They can turn to a third-party reprocessor that belongs to the Association ofMedical Device Reprocessors (AMDR), a trade association representingapproximately 80% of the non-hospital reprocessing done in the US. AMDR's Website defines a "third-party reprocessor" as an entity that, at therequest of a customer, inspects, cleans, functionally tests, packages, andsterilizes medical devices labeled for single-use in such a manner that thequality, physical characteristics, and performance functions of the device arenot significantly affected and the device remains safe and effective for itsappropriate clinical use." Third-party reprocessors return reprocesseddevices to the facility that requested the service, minus those devices thathave 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 typeof control needed to ensure that the devices are safe and effective. Class Idevices need the fewest controls; Class II devices require "specialcontrols." Class III is the most stringent regulatory category and medicaldevices that fall under this category require a premarket approval. Class I andClass II devices are the best candidates for reprocessing, with some notableexceptions. These exceptions include products that have true single-useapplications, such as wood tongue depressors, examination gloves and fiberoptics.Orthopedics Today estimates that "at least 8% of the [single-usemedical device] market consists of devices that may be reused if properlyreprocessed, sterilized and repackaged." Alliance Medical Corporation, amedical device reprocessor, contends that only between 1 and 2% of disposablemedical devices can be safely reprocessed. However, other reprocessors may notagree.

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 ClassII. 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 thepatient and now require pre-market approvals (PMA), they are generally notreprocessed. 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. AtAlliance Medical Corporation, when a shipment arrives, staff in receiving followstandard precautions requirements and transfer the devices from their shippingcontainer(s) into bins used for work in progress. Using OneWorld^®, asophisticated Enterprise Resource Management software package designed by J.D.Edwards, Alliance controls all product flow. Staff assign a unique sales ordernumber that includes a code to identify how the order should be processed. Ifthe order contains any compression sleeves, they are examined for signs of bodywaste or blood. If found, the sleeves are immediately rejected. Bins are thenplaced 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 returnedto that hospital, minus those that have been rejected--unless the client asksthat the rejected devices be returned. At any point in the process, a technicianhas the authority to reject a device. The company sends a report to the hospitalor surgery center that explains the reasons for the rejection. Alliance assumesresponsibility for the device's disposal and clients are not charged forrejects.

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

Once a batch of devices arrives in initial clean, a technician completes asorting operation and reviews and adds details to the order record thatoriginated in Receiving. This document travels along with the devices at everystage. In this phase, the technician examines each device for any obvious defectthat could cause it to be rejected. If no defect is found, the device moves onto the next step. Sometimes hospitals send devices that the company doesn'treprocess. In those cases, the devices are automatically rejected. As anotherprecaution, the technician consults customer-originated lists to make certaindevices being examined are not among those that a customer does not wantreprocessed.

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

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

After the enzymatic cleaner immersion, each device is comprehensively cleanedin a three-compartment sink. If the device is a laparoscopic or biopsyinstrument, it receives a cleaning in a specially designed lumen cleaner. Thesheathing is stripped from laparoscopic instruments to ensure cleanliness of theessential device and replaced later with the same material used by themanufacturer. The sinks and lumen cleaners used were designed by companyengineers.

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

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

The initial cleaning process is different for compression sleeves, whicharen't immersed in cleaning solutions because this would degrade the materialsused in the device. Instead, technicians use a variety of cleaning instrumentsto clean away any spots, stains or lint. Technicians track the number of times acompression sleeve goes through reprocessing. After cleaning, trainedtechnicians minutely inspect the devices under a microscope. If any remainingdebris can't be removed during recleaning, or if there is an obvious defect, thedevice is rejected.

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

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

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

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

Function testing is next. Devices that can be functionally tested areforwarded to a technician who determines whether the device can perform as it'sexpected to perform. This phase can include functional confirmation usingcustom-designed equipment, cut tests where applicable and other function teststhat duplicate the rigorous approach taken by original equipment manufacturersprior to releasing a product to market.

Compression sleeves are function-tested with a pressure decay machine, whichdetermines whether the sleeves hold their pressure during inflation and thatthey deflate properly. Once the compression sleeves are function tested, theyare sent to another area in Processing to be folded. Parallel Initial Clean andProcessing operations exist for electrophysiology catheters, because thesedevices 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 thelimit 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, reverseosmosis/deionized water. This so-called "hungry water" gently cleansby attracting dirt to water molecules, eliminating any particulates that remainon a device.

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

The packaging and sterilization stages

After the final clean, each device is transferred for packaging to one of twopackaging areas designed as Class 10,000 clean rooms--where air circulates atmore than twice the rate of most operating rooms. In the pre-packaging area thedevice 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 changescolor, indicates sterilization has occurred. Some devices are double pouched toaccommodate 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. Thebiological indicator used is Bacillus subtilis var. niger, theindustry's recognized challenge organism for confirming EO sterilization. If thesterilization process can kill this organism, the load has met the domestic andinternational standards for sterility of 10^-6.With EP catheters, inaddition to the bacillus subtilis, limulus amoebocyte lysate (LAL) isused as another biological indicator of pyrogenicity.

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

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

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

These extensive review and testing procedures lead engineers to developdevice-specific protocols for cleaning, function testing and sterilizing everydevice that's given the go-ahead for reprocessing. Alliance also validates allcleaning, packaging and sterilization procedures at least annually, or whenevera procedure is changed.

Conclusion

Healthcare industry experts are recognizing the value, safety, andeffectiveness of single-use medical device reprocessing. The American HospitalAssociation supports limited and regulated reprocessing. In a letter to itsmembers, the American Society for Healthcare Central Service Professionals notesthat "tens of millions of devices have been reprocessed over the yearssafely and effectively."

The FDA, which has faced pressure from original equipment manufacturers toban reprocessing, instead has issued a Guidance Document that establishes strictregulation of every organization that chooses to perform single-use medicaldevice reprocessing, including hospitals. For hospitals that have been doingin-house reprocessing or even thinking about in-house reprocessing, the FDAGuidance Document means additional economic and regulatory burdens. But many inthe third-party reprocessing industry welcome the Guidance Document as anothertool 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 advocacyorganizations, and the industry's own strict standards have helped to intensifythe bright light of respectability for third-party reprocessing.

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

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