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Articles from 1999 In October


Extruders Meet Many Needs



Machinery

Extruders Meet Many Needs

Series offers new benefits

Enhanced extruders bearing the Prodex name are available in screw sizes ranging from 2 to 10 in. Made by HPM Corp. (Mount Gilead, OH), the series includes the Prodex I extruder, which features 24:1 L/D, air-cooled bimetallic barrels with a choice of screws; the Prodex II, offering longer L/D ratios and available with either air or water barrel cooling and vented barrels; and the Prodex III, available with screw diameters up to 10 in. and barrel L/D ratios up to 50:1.

Prodex extruders are designed to offer processors several key benefits. These include high speeds (in some cases up to 800 rpm), excellent mixing and dispersion, fast changeovers and color changes, and the ability to maximize output and production rates.

All machines feature standard bimetallic barrels and are available with a choice of Double Wave or Triple Wave screws for optimal performance. The machines are also designed to produce higher outputs at lower temperatures than their predecessors.

For more information, call HPM Corp. at 419/946-0222.

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Materials

Composite Aimed at Bushings, Bearings

Lubricant compound a key ingredient

This composite material, developed specifically for high-load bushing and bearing applications, is the latest version of the XC-2 material developed by EGC Corp. (Houston). XC-2L is a carbon-fiber-reinforced composite with a special lubricant that, the supplier believes, makes it one of the few dry-running-capable materials on the market.

The material is designed to replace metal and other thermoplastics in bearing applications such as valves, pumps, and other industrial process equipment. By providing continuous lubrication, the material reduces the chance that critical equipment will seize or gall. And its PEEK matrix makes it highly resistant to most chemical processing fluids.

In comparative testing, XC-2L exhibited only half the wear of carbon at 12,000 PV against condition 1075 stainless steel 17-4 PH, according to the manufacturer. Under similar test conditions, the material's wear rate was 700 times lower than that of bronze, the company claims.

For more information, call EGC Corp. at 800/342-7677.

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Motion Control

Motion Controller Offers High Processing Speeds

Works with all motor types

A programmable motion controller, the PMAC2-PC Ultralite is a multiaxis device that can commutate and control all motor types (brush and brushless dc, ac vector, stepping, and switched reluctance) in precision velocity and position motion systems. Manufactured by Delta Tau Data Systems (Chatsworth, CA), the device offers high processing speeds and resolution capability of 40 MHz in the standard version and 60 and 80 MHz in the higher-speed optional versions. Servo update time is 18 microseconds per axis.

The motion controller is combined with the Macro fiber-optic ring network interface, which has a data rate of 125 Mb/sec. This high-speed network eliminates the need for the local-axis interface circuitry found in other members of the same family of motion controllers. (The name "Ultralite" is meant to signify the absence of these onboard axis interface circuits.)

As with other members of this product family, the PMAC2-PC Ultralite board may be installed as a stand-alone device, which will execute motion programs and completely control a machine's operation.

For more information, call Delta Tau Data Systems at 818/998-2095.

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Hardware Accessories

Couplings Tackle Challenging Applications

Some feature an automatic shutoff valve

Made of economical acetal, APC-series couplings are available with an automatic shutoff valve to eliminate wasteful or potentially dangerous spills during disconnection. The couplings, made by Colder Products Co. (St. Paul, MN), are designed for use in challenging fluid-handling applications, including cooling and lubricant lines, mild-chemical handling, laboratory tubing, and water filtration.

Offering a 1/4-in. nominal flow capacity, the couplings feature the CPC thumb latch, which provides simple, intuitive operation and an audible "click" to verify a secure, leak-free connection. APCD couplings, which offer the automatic shutoff valve, have a shrouded clip to protect against accidental disconnects.

All APC couplings include Buna-N O-rings, 316-stainless-steel valve springs, and integral fittings that are supposed to cut installation time and eliminate leak points. APC bodies come in NPT, BSPT pipe thread, and in-line styles with 1/4- or 3/8-in. hose barb, pipe thread, or compression terminations. Insert styles are available in hose barb, pipe thread, or compression terminations with elbow or in-line configurations.

For more information, call Colder Products Co. at 800/945-3814.


Copyright ©1999 Medical Product Manufacturing News

Las Vegas Show to Feature Advanced Packaging Technology



Las Vegas Show to Feature Advanced Packaging Technology

Billed as an exhibition of the most advanced packaging equipment and technology in the industry, Pack Expo Las Vegas 99 will be held October 18­20 at the Sands Expo and Convention Center in Las Vegas. The sponsor of the event, the Packaging Machinery Manufacturers Institute (PMMI), anticipates a show of record-setting size, with more than 600 exhibitors occupying over 300,000 sq ft of floor space.

More than 15,000 people are expected at Pack Expo Las Vegas 99, to be held October 18ן20.

Besides stopping at all those booths, attendees can drop in on Solutions 99, an interactive conference program featuring hot trends in packaging and processing. Sessions will feature experts speaking on various issues and offering advice on packaging and processing programs.

For more information, visit PMMI's Web site.


Study Predicts Surge in Demand for Oxygen Therapy Equipment

By 2005, the number of people who require home oxygen therapy is expected to grow from 1.3 million to 2.5 million, creating a lucrative business opportunity for companies that produce technologically advanced oxygen therapy equipment, according to a report by Frost & Sullivan, a Mountain View, CA, marketing consulting company that monitors the healthcare industry.

The report, entitled U.S. Oxygen Therapy Device Markets, evaluates industry segments such as concentrators, liquid-oxygen systems, compressed-gas systems, oxygen conservers, and regulators. Principal areas of research include identification of industry challenges, market engineering measurements, strategic recommendations, planning, and market monitoring.

The report is available for $2950. For more information, visit Frost & Sullivan's Web site.


RIM Material Passes the Drill for Dental Instrument

It was a cutting-edge product in search of a cutting-edge look.

Developed by the Midwest Dental Products Division of Dentsply International (Des Plaines, IL), the AirTouch cavity detection and treatment system cuts through material on the teeth with aluminum oxide particles delivered by pressurized air. When considering the housing for the AirTouch, designers at Dentsply Midwest decided that they wanted a material that could be formed into complex curves that would present a high-tech appearance. They also wanted a material with good structural properties, strength and impact resistance, and large-part capability.

The high-tech-looking housing of the AirTouch cavity detection and treatment system is made of the Prism CM-200 solid polyurethane RIM system from Bayer Corp.

Dentsply Midwest worked with Chicago design firm IDEO Product Development and molder Premold Corp. (Oconomowoc, WI) to find a housing material that was up to the job. "We worked with IDEO to find a replacement for sheet-metal and vacuum-formed parts," says Kenneth Schweitz, president of Premold Corp.

That replacement turned out to be the Prism CM-200 solid-polyurethane reaction injection molding (RIM) system from Bayer Corp. (Pittsburgh). "The combination of the Prism RIM system's attributes—its good structural properties, impact resistance, strength, and cosmetics—made it the material of choice for this application," says Schweitz. He adds that the Prism RIM system is easy to work with and resists the formation of shrink marks on the surface of the product.

What's more, the RIM process was more economical than the alternatives, Schweitz notes. "In one case, it was less expensive by a factor of 10 compared to injection molding, because of the complexity and size of the part. And compared to vacuum forming, the Prism system requires fewer secondary operations."

For more information on the Prism CM-200 RIM system, call 800/622-6004 or visit Bayer's Web site.


New Digital Hearing Aid Features Tiny Tantalum Capacitor

Tiny capacitors are critical components in one of the world's smallest digital hearing aids, a device so tiny that it can fit into the ear canal.

The Natura digital hearing aid from Sonic innovations Inc. (Salt Lake City) uses a proprietary digital signal processing technology with nine independent digital audio channels to process and amplify sound. This allows the Natura to be fine-tuned to compensate for hearing loss anywhere on the spectrum of sound frequencies.

Sonic innovations' tiny Natura hearing aid features a super-small circuit board with a TACmicrochip capacitor from AVX Corp.

One of the key components used in the design of the hearing aid's miniaturized circuit board is the TACmicrochip from AVX Corp. (Myrtle Beach, SC). This device, which provides high bulk energy storage, is the world's smallest surface-mount tantalum capacitor, according to AVX.

"There were tough challenges in implementing the Natura's revolutionary multichannel digital design," explains Bill Vierow, technical marketing manager for AVX. "The space constraints demanded an unprecedented degree of miniaturization in our components. We are pleased that our advanced technology hit the mark for such an important innovation in the medical field."

For more information about AVX products, call 843/946-0414 or visit the company's Web site.


Rapid Growth in Demand Seen for Minimally Invasive Cardiothoracic Surgery Products

Minimally invasive cardiothoracic surgery (MICS) products and procedures are rapidly penetrating the traditional cardiothoracic surgery market, according to a report from Medical Data International (MDI; Santa Ana, CA). The 394-page report, called U.S. Markets for Cardiovascular and Cardiothoracic Surgery Devices, predicts that the market for MICS products and services will reach an annual growth rate of almost 40% over the next few years.

The report analyzes markets for products used in open-heart and minimally invasive surgery. Major topics include prosthetic heart valves, prosthetic vascular grafts, and vascular and cardiac repair patches and fabrics. Also included: an overview of emerging diagnostic technologies related to cardiovascular disease management, market forecasts through the year 2003, and profiles of 24 major companies in the field.

The report is available for $3850. For more information, call MDI at 800/826-5759 or visit the company's Web site.


Business and Acquisition News

The board of directors of Baxter International Inc. (Deerfield, IL) has approved a plan to spin off the company's $1 billion cardiovascular business to Baxter shareholders on a tax-free basis. The spin-off will create a new publicly traded company headquartered in Irvine, CA. . . . Medical device maker Guidant Corp. (Indianapolis) has completed the sale of its general surgery business to United States Surgical (Norwalk, CT), a division of Tyco Healthcare Group LP. Financial terms were not disclosed. . . . Chicago firms First Chicago Equity Capital and Garrett Capital Advisors LLC announced that they will form a global cardiopulmonary products company by combining three acquisitions in that field. These are the assets of the cardiopulmonary products division of C.R. Bard Inc. (Murray Hill, NJ), certain assets of the cardiosurgery business of Minntech Corp. (Minneapolis), and Surgimedics Inc., a closely held company headquartered near Houston. . . . Thermedics Inc. (Woburn, MA), a manufacturer of implantable heart-assist devices and other biomedical products, has acquired the German medical products company Erich Jaeger GmbH for approximately $42 million. . . . Smith & Nephew Inc. (Memphis), a subsidiary of London-based worldwide healthcare group Smith & Nephew plc, has signed an agreement to acquire all of the outstanding shares of common stock of Exogen Inc. (Piscataway, NJ), a supplier of noninvasive ultrasound devices that accelerate the healing of bone fractures. The transaction values Exogen at approximately $68 million. . . . Plexus Corp. (Neenah, WI), which provides contract design, manufacturing, and testing services to the electronics industry, has completed its merger with SeaMED Corp. (Bothell, WA), a maker of electronic medical equipment. Under the merger agreement, SeaMED became a wholly owned subsidiary of Plexus. . . . Advanced Surface Technology Inc. (Billerica, MA), a producer of coatings and surface treatments for the medical industry, has announced an agreement to acquire the Plasma Science line of plasma products from BOC Coating Technology (Fairfield, CA). The acquisition allows AST to supply plasma systems to the medical market.



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Copyright ©1999 Medical Product Manufacturing News

A New Treatment Option for Women



A New Treatment Option for Women

Outsourcing was the key to developing the award-winning First Option treatment system

Sally Lane, Senior Editor

The statistics are alarming. Each year, more than 2.4 million American women suffer from menstrual disorders that compromise their health and quality of life. One such disorder, known as abnormal uterine bleeding (AUB), can lead to anemia and limit a woman's ability to work, exercise, or even leave her house.

Until recently, the only widely available and permanent treatment for AUB was hysterectomy, performed on 600,000 American women each year. Alternative options, such as drug therapy, dilation and curettage, and endometrial ablation (in which a laser, electrosurgical probe, or thermal balloon is used to remove the uterine lining) were proving more cost-effective and less invasive but were often less reliable.

A Promising Alternative

One promising option was endometrial cryoblation. In this procedure, a flexible, slender probe that generates freezing temperatures is inserted into the uterine cavity to destroy the endometrial lining. Although the treatment was promising, the accompanying technology was not. Existing devices were large, expensive, worked on high operating gas pressures, required refrigerant replenishment, and could not efficiently maintain low temperatures. These factors made the treatment cumbersome, inaccessible, and expensive.

John Dobak, MD, founder and chief technology officer at CryoGen Inc. (San Diego), was convinced this method could be improved upon. Dobak was inspired by an article in NASA Tech Briefs magazine. The article discussed the use of micro-miniature heat exchangers for achieving cryogenic temperatures in a catheter-based approach for cardiology applications. Dobak believed the same technology could be applied to endometrial cryoblation systems to create a more compact device that would effectively deliver the low temperatures needed.

CryoGen Inc. hired Bridge Design to create the console and treatment probe for the First Option system. A hideaway compartment houses the treatment probe when it's not in use.

Bridge Design went through numerous iterations before creating a graphic LCD with "soft menu" control keys that allow for self-explanatory control and solve international language problems with simple reprogramming.

The result was the First Option Uterine Cryoblation Therapy system, which garnered two design awards this year: a Medical Design Excellence Award, presented by MPMN's publisher, Canon Communications llc (Los Angeles), and an Industrial Design Excellence Award, presented by the Industrial Designer's Society of America (Great Falls, VA).

The First Option System

The First Option system consists of:

  • A cryoprobe that provides a recirculating conduit to the console and generates the freezing effect.
  • A disposable sterile control unit that provides a patient-contact interface and contains a heater that allows a physician to warm and disengage the cryoprobe from the frozen tissue. The unit also contains a thermocouple that registers the temperature at the tip and conveys the information to the console display.
  • A console that receives standard electrical power input and houses the compressor system, microprocessor, and user interface.

The procedure is typically performed in 15 minutes on an outpatient basis, under either local or general anesthetic. Patients can leave after a few hours of rest and usually return to normal activities the next day. The procedure costs $2000–$3500. By contrast, hysterectomy generally costs $11,000 and requires a three- to four-day hospital stay and up to a six-week recuperation period.

First Option uses a mixed refrigerant Joule-Thomson staged system developed by Dobak. The fluid mixture and linear oil-free compressor enabled the working pressure of the device to be reduced and allowed the mixture to circulate, eliminating the need for replenishment. The closed-cycle refrigerant gas system achieves probe surface temperatures of –90° to –110°C at working pressures of up to 400 psi. This system enabled designers to create a smaller, more portable, less expensive device. Because the proprietary refrigerants are recyclable, costly gas canister replacements and a refrigerant recovery system are eliminated, says Gene Reu, vice president of engineering for CryoGen.

A Collaborative Effort

Teamwork was the key to developing First Option. To develop a reasonable prototype in a short period of time, CryoGen engaged the design and development firm Bridge Design Inc. (San Francisco).

"We pursued outsourcing activities to speed the product development effort. We had a couple of key areas of the system that had to be developed, such as the console and user interface," Reu says.

"CryoGen needed a company that could understand all of the issues involved," says Bill Evans, Bridge president. "The fact that we are an ISO 9000 company was a factor as well. They really needed someone who was a team player."

For Bridge, the main challenge in designing the First Option console was the fact that designers basically had to start from scratch. "What you tend to see are products that are variations on existing products. That's a lot easier than the effort it takes to create a new platform technology. You're pretty much starting with a blank sheet of paper," Evans says.

To create the final product, Bridge assembled a cross-functional team including core scientists, the console team, safety experts, and manufacturing, marketing, and FDA representatives. To garner feedback, Bridge went through a six-month product-definition period that involved visiting doctors' offices with chipboard prototypes mounted on wheels, loaded with weights. Bridge also took along laptop computers loaded with a Shockwave-based simulation model of the user interface.

The feedback resulted in Bridge simplifying the interface by making the verbiage clearer and making the steps involved more logical, Evans says. (View interface model.)

The goal was to create an end product that was highly portable and easy to use yet attractive to enhance marketability. "We helped them get good looks into a product with high function to ease market acceptance of the new technology," Evans says.

The final product is 30 in. tall x 15 in. wide x 28 in. deep. Previous systems were the size of a refrigerator, Evans notes. First Option consists of recyclable materials, mainly plastics and aluminum. The external panels can be easily removed for service access, enabling critical maintenance of the compressor and umbilical probe line, which have to be field replaceable. Other internal systems are modularized for ease of service. The console conceals the treatment probe and cables in a pop-up compartment when not in use, and features a foldaway handle for easy maneuvering.

First Option is currently being produced in low to medium volume (hundreds per year) with a high unit cost because of its expensive core technology. The product, which has been in clinical trials since mid-1998, recently has been released to targeted reference sites, Reu says.

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Copyright ©1999 Medical Product Manufacturing News

Smooth Transitions



Smooth Transitions

New software applications are tackling issues of interoperability to increase sharing of design data.

David Bowen, Assistant Editor

SolidDesigner Version 7.0 Emphasizes Interactivity

One of the many challenges designers face in the development process is the need to incorporate ideas and changes from external sources such as customers, suppliers, and engineers while preserving the original design intent. SolidDesigner version 7.0, the latest release from CoCreate Software Inc. (Ft. Collins, CO), features several new additions that address this concern by improving interactivity while staying true to the intent of the design. The Dynamic Relations module now enables the designer to set up relative positioning rules for parts and assemblies in relation to faces, edges, and vertices. This variational feature functionality allows the user to set up geometrical design rules, while a system-based design-integrity feature provides constraints on modifications. After modifications are made, users can apply the rules defined in the relation set. To prevent surprises in a team-based environment, the system notifies users when a modification would break design intent.

Several types of relations can be set up, including value relations such as distance and angle, and logical relations such as parallel, perpendicular, coincident, tangent, fixed, and rigid. The reference elements for the relationships can be points, curves, or surfaces of any analytical type. Additionally, feature-recognition functionality automatically selects new features such as ribs or slots. The user can work on imported models with the same degree of ease in which he or she works on native models.

SolidDesigner Version 7.0 allows the designer to set up relative positioning rules for parts and assemblies.

Additional enhancements to Version 7.0 include adaptive meshing features within the Design Advisor module that enable designers to predict model behavior with finite element analysis, and a Sheet Advisor module that includes fold and unfold capabilities for progressive die design.

For more information, contact CoCreate Software Inc. at 970/206-8000.


InCADPlus Offers Seamless Data Translation Process

The data translation process has traditionally been a pitfall for accurate model analysis. This process, which involves saving a model in a neutral format from CAD and then uploading it into finite element analysis (FEA) software, often ends up with data being corrupted in the transition. InCADPlus, the newest offering from Algor Inc. (Pittsburgh), makes the analysis of CAD solid models easier by eschewing the traditional data translation process altogether. Developed as a cooperative effort between Algor and many of the leading CAD solid-modeling companies, InCADPlus can capture a CAD-created assembly or part geometry in coordination with the modelers' application programming interface, eliminating common data translation problems. Solid-modeling programs that contain this capability include Pro/Engineer, Solid Edge, Mechanical Desktop, and SolidWorks. This interoperability is taken one step further with Direct Memory Image Transfer technology, which allows models to be transferred over a network or on a disk if the CAD program and InCADPlus are on separate computers.

Within the CAD programs themselves, a menu selection window has been added to allow for their direct interface with InCADPlus. It also contains a solid-model interface that gives the user access to a suite of FEA capabilities within the CAD programs, including Algor's mechanical event simulation, linear and nonlinear stress, vibration, heat transfer, electrostatics, fluid flow, piping design, and composite materials modules. The meshing capability in particular gives the designer the ability to view the entire model before meshing to determine whether there are any defects, such as surface holes or self-intersecting surfaces.

InCADPlus can be accessed through a menu selection window that has been built into participating CAD programs.

For more information, contact Algor Inc. at 412/967-2700.


IronCAD Version 2.0 Provides 3-D Drag-and-Drop CAD Environment

The latest release from Visionary Design Systems (Santa Clara, CA) provides users with an intuitive drag-and-drop design approach, a design flow architecture that supports the process from concept through postproduction, wire-frame to photorealistic visualization, and interoperability with other CAD systems. While solid-modeling programs have generally applied a real or emulated Windows user interface to traditional mainframe or Unix modeling architectures, IronCAD version 2.0 is billed as the first PC-based solid-modeling software package built with a native Windows solid-modeling architecture. Its TriBall feature allows the user to precisely position any object according to translation, rotation, or any 3-D transformation. Dimension-driven modifications with or without dynamic 3-D constraints can be made to any feature, part, or assembly, including those features in the program's drag-and-drop catalog of stock, bends, lips, seams, hems, and punches.

IronCAD's design flow architecture uses modeling technology that maintains a focus on constraints and parametric relationships while allowing for dynamic 3-D manipulation. This means that models originally built using parametrics can undergo radical design changes without the need to rebuild the model. Casual users can design models without concerning themselves with constraints, parametrics, and feature trees, while power users can take advantage of them if they choose. The user's ability to effectively communicate the design to other members of the design team is further enhanced by IronCAD's visual design features. These features include automatic manipulation of rendering style; fully integrated, real-time texture, decal, and bump maps for representing design details; and effects such as 3-D animation, ray tracing, shadows, fogs, and gels.

IronCAD Version 2.0 provides users with an intuitive drag-and-drop design approach.

A variety of tools allow the user to import CAD data from other systems as static reference geometry, or modify them as if they were created natively. For example, 3-D surface data in IGES format can be converted into a solid and can be used to split or trim parts. In addition, polygonal formats such as VRML and STL can be imported, converted to solid with planar and curved surface fitting, and then used natively. And, automatic feature recognition can identify and create features on imported data.

For more information, contact Visionary Design Systems at 800/339-7304.

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Silicone-urethane copolymers



Resins and Compounds

Silicone-urethane copolymers

A company has developed a line of thermoplastic segmented silicone-urethane copolymers. PurSil and CarboSil copolymers exhibit the strength, flex life, processability, and abrasion resistance of urethanes and the biostability and biocompatibility of silicones. Additionally, silicone, fluorocarbon, hydrocarbon, polyethyleneoxide, sulfonate groups, and other materials can be covalently bonded to the polyurethane for specific applications. The Polymer Technology Group Inc., 2810 7th St., Berkeley, CA 94710.



Silicone elastomers

An implant-grade liquid silicone rubber system is designed to create elastomers for long-term implantation. The components, which come in separate containers, can be mixed in equal portions to create an elastomer for liquid injection molding or in a 10:1 ratio for casting. The system's advantages over peroxide-catalyzed systems include fast cure at elevated temperatures, no peroxide residue, and no volatile by-products. Custom formulations of radiopaque compounds or color master batches are available upon request. Applied Silicone Corp., 320 W. Stanley Ave., Ventura, CA 93001.



TPU resins

Thermoplastic polyurethane resins are biocompatible, sterilizable, and flexible. Uses for Texin resins include oxygen masks, medical tubing, postsurgical appliances, connectors, and radiopaque devices. Available in hardnesses from 75 Shore A to 70 Shore D, the plasticizer-free resins are chemical and abrasion resistant. They also exhibit high tensile and tear strength and have a low incidence of allergic reaction in applications in which there is contact with the body. Bayer Corp., 100 Bayer Rd., Pittsburgh, PA 15205-9741.



Stabilized compounds

A stabilizer formulation for vinyl compounds lessens the color shift and loss of strength caused by high heat, shear, and exposure to gamma rays during sterilization. In tests performed by the manufacturer, the formulation-treated compound took 46 minutes to degrade, compared with 29 minutes for the untreated compound. A 75 Shore A compound with the formulation exhibited 8–45% less change than its counterpart in a test of as-molded and aged test samples under two levels of gamma exposure. The stabilizer formulation will be incorporated into counterparts of existing grades of Apex vinyl compounds. Teknor Apex, 505 Central Ave., Pawtucket, RI 02861.



Phthalate-free compounds

Formulated with phthalate-free plasticizers, FDA-recognized specialty vinyl compounds are nontoxic, odorless, tasteless, and biocompatible. Superkleen compounds can be processed in the same manner as conventional vinyl molding and extrusion materials. They are radiation-stable, and range in durometer from 65 to 90 Shore A. AlphaGary Corp., 170 Pioneer Dr., Leominster, MA 01453.



Nylon compounds

With a flexural modulus rating of 100,000–250,000 psi, a series of flexible nylon compounds are dimensionally stable with minimal shrinkage after extrusion. The Fostalon 5000 series nylons are suitable for use in catheters, hubs, and shafts and are fully compatible with radiopaque fillers including barium, bismuth, and tungsten. The compounds are less susceptible to hydrolytic degradation than urethanes, can accept standard marking and imprinting inks, and can be processed on conventional forming equipment. Foster Corp., 329 Lake Rd., Dayville, CT 06241.



PVC compounds

A line of medical-grade PVC compounds includes nonphthalate formulations. The compounds are suitable for extrusion and injection molding and are available as clear, tinted, and opaque. Injection molding grades are used for drip chambers, respiratory masks, connectors, ports, and spikes. The formulations range in hardness from 55 to 110 Shore A and can undergo EtO, autoclave, and gamma radiation. Ellay Inc., 6900 E. Elm St., Commerce, CA 90040.



Polymers

High-performance elastomers are engineered for a wide spectrum of end uses, including molded and extruded technical goods. Kraton D polymers and compounds include styrene-butadiene-styrene and styrene-isoprene-styrene formulations and contain an unsaturated rubber midblock. Kraton G polymers and compounds contain a saturated midblock and include styrene ethylene/butylene styrene and styrene ethylene/propylene formulations. Shell Chemical Co., P.O. Box 2463, Houston, TX 77252-2463.



Medical resins

Autoclave-resistant medical resins are available for the medical industry. Among the products suitable for use in medical devices are Ecdel elastomers and Eastar and Eastar PETG copolyesters, which are clear and chemically resistant. Other products include Eastalloy polymer blends, which provide dimensional stability, low shrinkage rates, impact strength, and higher temperature resistance than amorphous copolyesters; Tenite and Tenite Hifor Clear cellulosics; Mxsten CM polymers; and Mxsten CV plastomers, which are reported to have better low-temperature sealability and higher stiffness than other plastomers. Eastman Chemical Co., P.O. Box 431, Kingsport, TN 37662-5280.



Acrylic-based multipolymer

A transparent, impact-modified, acrylic-based multipolymer compound is suitable for medical devices requiring maximum chemical resistance to lipids and PVC plasticizers. Applications include filter housings, luer locks, and IV connectors. Cyrolite CG-97 compound takes on a permanent blue-green tint after being irradiated, can be sterilized with EtO gas, and exhibits resistance to isopropanol. According to the manufacturer, the compound has better lipid resistance than lipid-resistant polycarbonate, along with enhanced initial light transmission and superior clarity after radiation. Cyro Industries, 100 Enterprise Dr., Rockaway, NJ 07866-5055.



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Copyright ©1999 Medical Product Manufacturing News

MPMN Cover Products

MPMN Cover Products

High-Contrast LCDs

Panelview Inc. (Beaverton, OR) offers a family of optically enhanced, thin-film-transistor LCDs suitable for high-ambient-lighting conditions and outdoor-sunlight-readable applications.




Positioning Stages

Available with ironless linear motors, Luge Ultra positioning stages from Bayside Motion Group (Port Washington, NY) are designed to provide high accuracy in medical applications.




Tungsten Microelectrodes

These needle-type microelectrodes from In Vivo Metric (Healdsburg, CA) are made of pure tungsten. An electrolytic process produces a highly polished micron-size tip for controlled penetration of single cells.




Copyright ©1999 Medical Product Manufacturing News

Machining equipment



Machining equipment

Turning machines

A single-spindle automatic turning machine is designed for applications requiring up to 13-mm-diam machining. With preliminary bar preparation, the DECO 2000 will also allow 16-mm diameters. Its software enables 50–100% faster computing speeds than previous models. The manufacturer has also introduced the MultiDECO 20/6 model, a multispindle offering 20-mm capacity with six spindles. It combines the flexibility of CNC with the speed of cam operation and is capable of managing 18 axes at one time. Tornos Technologies Corp., 70 Pocono Rd., Brookfield, CT 06804.


Centerless grinder

Fine grinding capacities from 0.020 to 2.000 in. diam make a centerless grinder suitable for both small and large shops. The Model 310 uses the same size wheels and work blades as the model that it is replacing, but incorporates many of the product improvements and features found on the manufacturer's larger-capacity machines. It uses a 12-in.-diam, 4-in.-wide grinding wheel and features hydrodynamic grinding spindle bearings. These are located at each end of the spindle to provide rigidity and thereby ensure good workpiece accuracy and surface finish, as well as a long life. Monza Corp., 532 Rte. 15, Sparta, NJ 07871.


CNC grinding machine

A CNC grinding machine is designed to automatically produce rotary burrs, end mills, router bits, drill bits, endodontic and surgical instruments, and other components for dental and medical applications. The compact (68 x 52 x 66½-in.) CNC 2005 grinds extremely complex part geometries in a variety of small diameters. It features five separate axes and a four-axis robot to pick and place blanks. According to the manufacturer, specific advantages of the machine include grinding accuracy, fast feed rates, and fast cycle times. Cutting Edge Technologies, P.O. Box 147, Bridgewater Corners, VT 05035.


Milling and engraving system

A CNC milling and engraving system provides high-speed machining of plastics, aluminum, and other nonferrous materials. The CAT3D was developed specifically for the electronics marketplace, including medical electronics manufacturing. Its applications include rapid prototyping, front panels and membrane subpanels, enclosures, 3-D mold making, and machining intricate parts. Features include a 60,000-rpm spindle, an automatic tool-change unit with electronic tool length measurement, and an integrated coolant system. A Z-height sensor measures and compensates for irregular surfaces. This prevents surface scratching while providing exact cutting depths for milling and engraving on contoured surfaces, 3-D shapes, and cavities. Datron Dynamics, Haines Rd., Mississauga, ON L4Y 1 Y6, Canada.


Die-sinking EDM

A die-sinking EDM uses Program Expert software systems and a numerical control capable of true multitasking. Program Expert automatically writes machine programs—from roughing to finishing—and selects the best technology for upcoming applications while the machine concurrently works on another project. Another software system, the Pilot Expert 3, is based on a novel method of spark analysis and provides unsupervised operation. It allows the system to continually self-adjust and avoid complications in the cut, which could cause increased machining time and dull the geometrical details of electrodes. Charmilles Technology Corp., 560 Bond St., Lincolnshire, IL 60069-4224.


Speed lathes

Speed lathes are typically used for burr removal, polishing, and gauging. The Model LT-2A lathe is an efficient, compact solution for machine shops that produce precision parts in high volume. It features a heavy-duty, heat-treated aluminum T-slotted base to accommodate jobs that require a tool holder or special fixture. Its 1/3-hp motor delivers 50% more torque than the model it replaces. Dimensions are 24 x 14 x 18 in., and the weight is 79 lb, allowing the unit to be easily moved to an end station for finishing jobs. The unit also features a heavy-duty foot switch and dynamic braking. It is equipped with instant forward and reverse, eliminating downtime. Microfine tension adjustment allows instant chucking and release of parts. Overbeck Machine Tools, 329 Ingalls St., Santa Cruz, CA 95060.


Programmable milling head

A five-axis programmable head attachment can be affixed to nearly any three-axis vertical or horizontal milling center to provide simultaneous five-axis machining and drilling capability economically. The heavy-duty solid-steel M5411 attachment uses the host machine's spindle drive and features precision Zerol bevel gears and Cone Drive worm gears for enhanced strength, accuracy, and long-lasting dependability. It can be installed in under 30 minutes and is compact enough to fit many small and midsized machines, measuring 8½ in. in diameter by 12 in. in length. The head offers a tilt range of ±90° and continuous 360° rotational capability. It runs with any five-axis-capable controller, five-axis-capable CAM software, and a five-axis Post Processor available through the manufacturer. Tri-Tech Precision Products Inc., 1577 Harmony Cir., Anaheim, CA 92807.


Stent cutter

Many factors, including the degree of automation, cutting speed, and the time needed to convert a design into a cutting program, contribute to throughput in stent cutting. A stent cutter designed to address these factors features automated tub indexing, software for quickly converting designs to cutting programs, Laser Process Manager software for documenting process conditions, and a control system (System 94W/PC) that is network-ready to transfer stent-cutting programs to the laser cutting system. The laser is a high-repetition-rate pulsed Nd:YAG. Training and service programs are provided by the manufacturer. GSI Lumonics, 105 Schneider Rd., Kanata, ON, K2K 1Y3, Canada.


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Copyright ©1999 Medical Product Manufacturing News

October MPMN'sFeatured Products & Services

October MPMN's
Featured Products & Services



Stainless-Steel Fingerstock

This stainless-steel fingerstock is designed to offer easy recyclability, good shielding performance and compression characteristics, and optimal finishes to reduce the chance of galvanic corrosion. The beryllium copper EMI-shielding gaskets are durable metal strips that are used to provide high shielding effectiveness in closure applications where extremely low closure forces are required. The gaskets are suitable for applications where closure force is applied parallel to the mating surface and the gasket is "wiped" rather than compressed. Tecknit, 129 Dermody St., Cranford, NJ 07016.


Coprocessor Board

The PC-430N is a high-speed ISA A/D-DSP coprocessor data acquisition board with two simultaneous sampling A/Ds. It is suitable for nonstop continuous fast Fourier transform processing, communications receiver signal collection to disk, or simultaneous graphics display of spectral data. A/D triggering uses a programmable timer-counter section, which controls the interval between A/D conversions and the interval between multisample A/D scans. The number of samples can be counted for repeating-array sampling. Datel Inc., 11 Cabot Blvd., Mansfield, MA 02048.


Display Monitor

This flat-panel display monitor is designed to be immune to the disruptive magnetic fields created by magnetic resonance imaging. Since ordinary cathode-ray tubes use an electron beam, strong magnetic fields render them inoperable even with the strongest magnetic shielding. This means that doctors normally have to view MRI images at a distance from the patient. But with the MRI/18 display, patients can be scanned before, during, and after surgery—and the doctor and his or her staff can view the images while standing next to the patient. Aydin Displays Inc., 700 Dresher Rd., Horsham, PA 19044.


Shielded Connectors

To minimize the risk of electromagnetic interference that has accompanied the increasing miniaturization of medical products, Pico-Nect ultraminiature SMT-type shielded connectors can be used with coaxial cables found in sophisticated equipment. According to the manufacturer, the low-profile connectors offer three advantages over other connection methods: faster connection, easier dismountability, and optimal electromagnetic protection. In medical ultrasound systems, the devices are used to connect coaxial cable to a probe. Axon Cable Inc., 1601 Feehanville Dr., Ste. 600, Mount Prospect, IL 60056.


Planetary Gearbox

This planetary gearbox offers integer ratios, low backlash, and up to a 10:1 ratio in a single stage. The IP57B is a NEMA size 23 gearbox that comes with five stock ratios from 5:1 to 100:1, nine standard ratios from 4:1 to 500:1, and 34 optional ratios from 3:1 to 1000:1. Typical operating life exceeds 5000 hours and can be extended beyond 10,000 hours with optional upgraded bearings. API Motion Inc., 45 Hazelwood Dr., Amherst, NY 14228.


Injection Molding Machines

Models in a line of BMC thermoset injection molding machines are rated at 100 to 850 tn clamp force. Based on the company's open-frame Prowler and Magna hydraulic injection molding machines, the line uses screw, barrel, and stuffer technology from Apex Plastic Technologies (South Elgin, IL). The machines are designed to process the full range of granular, sheet, bulk, vinyl ester, and thick molding compounds. Milacron Inc., Plastics Technologies Group, 4165 Halfacre Rd., Batavia, OH 45103.


Precision Orifice

This 0.0004-in. precision jewel orifice is now included in the company's standard line of orifice sizes. The hole is so small that it is invisible to the naked eye and must be machined using a superfine laser beam. Besides small size, the orifice offers zero porosity, high-temperature tolerance, and wear resistance. It is available with a filter and in a variety of custom or stock fittings and connector housings. Bird Precision, One Spruce St., P.O. Box 569, Waltham, MA 02254-0569.


Spray Valve

The 780S spray valve system uses low-volume, low-pressure air to apply silicones and other low- to medium-viscosity fluids without clogging, dripping, or overspraying. The system's neat, consistent coverage enhances product quality and appearance and minimizes waste, maintenance, and rework. A typical medical application is lubricating syringes before pistons are inserted. Only 4 in. long, the valve is simple to install and uses two separate air inputs to produce controlled spray patterns from 0.17 to 3.0 in. diam. EFD, 977 Waterman Ave., East Providence, RI 02914-1378.


Corrugated Tubing

Previously available from the supplier only through custom orders, corrugated tubing, or wire loom as it is commonly called, is now stocked for quick delivery. The corrugated tubing is suitable for use as a lightweight protective covering over wires or small tubes, or as an aesthetic feature. When the tubing is used as wire and cable sleeving in medical devices, where the ability to bend a protective cover or design element is a necessity, the corrugations provide flexibility that many straight-walled tubing materials cannot. NewAge Industries Inc., Plastics Technology Group, 2300 Maryland Rd., Willow Grove, PA 19090.



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An Excellence Adventure

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI October 1999 Column

EDITOR'S PAGE

Sponsored by MD&DI, the third annual Medical Design Excellence Awards will once again recognize outstanding achievements in medical device design and manufacturing.

Here's something you should do before this millennium ends. It's not a neglected New Year's resolution or some other oft-delayed self-improvement project. The few extra pounds can stay on. It's not expensive or painful. On the contrary, it can alleviate the burden of toiling in obscurity, extend the reach of your vision and commitment, help you gain recognition for your accomplishments, and sweeten the fruit of your labor.

Enter the 2000 Medical Design Excellence Awards (MDEA), sponsored by MD&DI and presented by Canon Communications.

As the premier awards program for the medical technology community, the global competition is open to companies or individuals involved in the design, engineering, manufacture, or distribution of finished medical devices or medical packaging. (Suppliers of materials, components, or services may submit a finished device on behalf of a product manufacturer with the manufacturer's written approval.) There are 10 categories: critical care and emergency medicine products; dental instruments, equipment, and supplies; finished packaging; general hospital devices and therapeutic products; implant and tissue-replacement products; in vitro diagnostics; over-the-counter self-care products; radiological and electromechanical devices; rehabilitation and assistive-technology products; and surgical equipment, instruments, and supplies. All products entered must be commercially available for purchase by December 20, 1999.

Entries will be evaluated by a panel of impartial, third-party jurors based on criteria that include engineering and design innovation, functional improvements, cost-effectiveness and other significant business benefits, aesthetics, and overall contribution to healthcare. The jurors will convene during the Medical Design & Manufacturing (MD&M) West show, January 18­20, 2000 in Anaheim, CA and choose four winners in each category. Following this selection, jurors will make a recommendation to Canon editorial staff for each category's "best-of-class" award. Category winners will be notified by mail before February 15 and announced to the press. They will be celebrated—and the winning products exhibited—at a reception and press conference on the show floor during MD&M East in New York City, to be held June 6­8 at the Jacob K. Javits Center. The "best-of-class" awards will also be presented at the show. For winning product designers and manufacturers, the presentation ceremony will thus take place before a true audience of one's peers—the MD&M attendees who are there for the express purpose of finding the resources that will enable them to build better medical devices.

Past award winners have commented on how gratifying it is for designers, engineers, and others on a development team—most of whom work out of the limelight—to be recognized for their contributions to a successful project. Those receiving awards in this year's third annual MDEA program will join a growing roster of the industry's most creative and enterprising product development professionals. The winning products will benefit from considerable publicity, including trade, news service, and commercial publication coverage in addition to features in MD&DI and other Canon magazines.

Entries must be received by December 20, 1999. To be considered for an award, contact the MDEA coordinator at 310/996-9434 or via e-mail at mdea@cancom.com. For an on-line entry form or more information about the program, visit the awards site .

Jon Katz

jon.katz@cancom.com


Copyright ©1999 Medical Device & Diagnostic Industry

Reprocessing Single-Use Devices: Why Does the Debate Continue?

When it can be validated that a device can be cleaned, tested, and reused without harm to the patient, the device should be reprocessed, a member of AMDR maintains.

The reprocessing of disposable or single-use devices is one of the fastest growing—and most discussed—areas in the healthcare industry today. The companies that manufacture such products are generally opposed to reprocessing, taking the position that these items have not been approved for multiple use. Recent discussions about reprocessing have tended to be conducted in vague generalities, and typically fail to focus on specific products. For example, is the item in question used or simply opened and unused? If a decision is made not to reprocess used balloon angioplasty catheters, does it automatically follow not to reprocess opened but unused products or noncritical items like stainless-steel drill bits and saw blades? Finally, any discussion and evaluation of reprocessing should identify exactly who is the reprocessor: a hospital, a third party, an FDA-registered commercial company, or a physician's office.

This article attempts to clarify some of the issues in the current debate over reprocessing. It also supports the proposition that a properly designed reprocessing program—carried out by either a hospital or a third-party reprocessor and in compliance with applicable FDA requirements—offers the healthcare provider an excellent way to maintain quality patient care while also achieving substantial cost savings.

WHAT DOES "SINGLE USE" MEAN?

There is a great misunderstanding of the term "single use" as it applies to reprocessing. Contrary to popular belief, the designation of a product as single use is at the sole discretion of the manufacturer. An operating room table or a laser could be labeled single use if the manufacturer so desired and the customer would buy it.

There are no published standards that differentiate quality, function, or length of useful life between reusable and single-use devices. FDA simply states that the institution or practitioner that reuses a single-use device should be able to demonstrate that the device can be adequately cleaned and sterilized, that the physical characteristics or quality of the device will not be adversely affected, and that the device remains safe and effective for the intended clinical use. These same criteria should be applied equally to reusable instruments that are reprocessed by a hospital.

It is not feasible to manufacture a surgical instrument that is perfect for one use and no more. Furthermore, it is difficult to define "one use." For example, are laparoscopic scissors to be used to make only one cut, or can they make 10 cuts, or perhaps 20? Obviously, instruments are employed differently in various medical procedures and situations. We do not hear of a single-use instrument wearing out just because one surgical procedure lasts longer than another. Many things affect the life of a surgical instrument. If a pair of scissors is only used once in a surgical case, has its entire useful life been exhausted? The answer, of course, depends on functionality—the same decision process that occurs regarding reusable instruments in the hospital today. If a disposable instrument is properly cleaned, tested, deemed functional, and properly repackaged and sterilized, it can and should be used again. The same proper handling, cleaning, inspection, and sterilization processes should be in place to determine whether any instrument—reusable or single use—will provide a successful medical result and the expected outcome.

WHAT IS REPROCESSING?

Reprocessing is standard practice in the United States today. As mentioned before, every surgical hospital reprocesses its supply of reusable surgical instruments through cleaning, inspection, and in-house sterilization. Whether a reusable instrument is reused or discarded depends on the hospital's inspection process prior to resterilization.

Certain reusable instruments are often provided to the hospital on loan from a manufacturer. Although such devices sometimes arrive at the hospital packaged and sterilized, more often than not these manufacturer-provided instruments are delivered nonsterile by the company representative in the trunk of his or her car—just in time for the hospital to sterilize them for use in the surgical procedure for which they have been requested. Very seldom are biological indicators (BIs) run to assure the sterility of such loaner instrument trays, even though the bioburden level is totally unknown. Is this practice considered safe? If the answer is "Yes," then why not reprocess and sterilize the single-use saw blade or drill bit as well?

If the inspection of a reusable instrument determines that it will not properly function for its intended use, it is either discarded or sent out for repair. The great majority of instrument repairs (such as sharpening) are done by companies other than the original manufacturer of the instrument. These instrument-repair companies may or may not be registered with FDA. All such repairs are undertaken to ensure the proper functionality of the instrument; if the process is right, the instrument will perform safely and effectively.

The reprocessing of both reusable and single-use medical devices is being done in hospitals today without the formal levels of regulation, protocol, or validation that FDA imposes on registered third-party commercial reprocessors. If adequate protocols and processes are applied, a proper determination can be made concerning the reuse of any instrument, regardless of whether someone chooses to call it reusable, disposable, or single use.

SHOULD ALL SINGLE-USE DEVICES BE REPROCESSED?

When reprocessing is discussed, there are usually no distinctions drawn concerning the risk of reuse of various devices. Reference is inevitably made to a small number of infections in 1984 that were traced to in-house reprocessing of hemodialyzer filters, and to the potential problems with the reuse of angioplasty catheters. Experts agree that scrutiny of hospital records since 1984 would find many other infections that could be traced to in-house reprocessing of reusable products. If sterility were the only criterion and cost was not an issue, few would disagree that all items should be reprocessed by FDA-registered companies using validated procedures. In reality, this is not feasible.

Given proper procedures, there should be no problems associated with reprocessing any product. However, as a practical position, there is often little reason to do so. Here again, it is important to be specific about the item in question.

For example, it is certainly appropriate to reprocess an opened but unused trocar and sheath with chamber. However, a used trocar with a chamber or valve is unlikely to be an acceptable product for reprocessing, even when handled by a third-party commercial company. The reason goes back to a basic tenet of sterilization: "If you can't clean it, you can't sterilize it." This principle should be applied to reusable instrumentation as well as to single-use devices. FDA has acknowledged this point and continues to seek compliance by manufacturers of reusable instrumentation in providing cleaning instructions for their products. In this regard, one driving force behind manufacturers' refusal to admit that their single-use devices can be used more than one time is the fact that it is quicker, less expensive, and easier to tell FDA and the hospital to simply throw away the product after one use. In addition, if a product can only be used once, the number of units sold in any given sales cycle will be greater, which translates into more profit for the manufacturer.

Although it is important to specify the product and the conditions of its use, there is no reason to single out implants or critical devices in the current context of the reprocessing debate. In fact, there seems to be a difference of opinion concerning the definition of a critical device. Thirty-plus years ago, Professor E. Spaulding suggested that devices be classified as critical, semicritical, or noncritical based on the risk of infection each presents. This level of risk, in turn, depends on the device's use and on the number of infection barriers it compromises during its use: the more barriers broken, the greater the need for sterility (i.e., the lower the quantity of bioload that can be tolerated).1 Over the years, this definition has been intermingled with FDA's classifications of critical and noncritical devices, which are based on three categories (Classes I, II, and III) that determine a product's level of regulation. FDA's classification of a noncritical device, for example, deals with the issue of failure—if the device fails, how life threatening would the situation become? Contrary to the degree of variance in the Spaulding classifications, most healthcare professionals expect that any product used within a sterile field be sterile. It is important to make clear in any discussion involving reprocessing that FDA's classification system is based on how the device functions, whereas the Spaulding system determines the required levels of disinfection to be used.

THIRD-PARTY REPROCESSING VERSUS IN-HOSPITAL REPROCESSING

There are major differences between reprocessing in the hospital and reprocessing by an FDA-registered reprocessor. The main distinction is that industry operates under far more stringent regulations than do hospitals. Because of major differences in the validation procedures used, a hospital might well choose to reprocess a certain product through an FDA-registered third-party reprocessor while declining to reprocess the same item within its own institution. If concern for patient safety is truly what is driving this debate, why has FDA not used its existing authority to regulate hospital reprocessing? This question can be answered two ways. First, a patient safety problem does not exist. Second, the manufacturers do not want to go against the wishes of their customers. If reprocessed products were causing major patient injuries or infections, the hospitals would have stopped the practice long ago. The end-user continues to be the best judge of quality.

FDA policy concerning third-party reprocessing continues to be unclear. In a letter dated October 1998 directly addressing the legal status of third-party reprocessing, Larry Spears, director of the Division of Enforcement III at FDA's Center for Devices and Radiological Health (CDRH), wrote that:

Third-party reprocessing of devices labeled for single use is lawful in the United States provided that the reprocessing firm complies fully with all regulatory requirements currently imposed on them. . . . Third-party reprocessors are subject to FDA inspection and enforcement actions will not be taken against them or their products unless FDA has determined that (1) the firm is out of compliance with current applicable regulatory requirements, or (2) the firm's products represent a danger to health.2

On July 9, 1999, Spears again addressed this issue when he wrote:

Third-party reprocessing of devices labeled for single use is unlawful unless those engaged in this practice comply with all regulatory requirements for manufacturers, including premarket notification requirements. However, FDA has exercised and will continue to exercise regulatory discretion for all premarket notification requirements, until a new FDA reprocessing position is adopted. The most significant regulatory requirement, at this time, is compliance with the newly developed Quality System regulation. That regulation requires appropriate manufacturing and quality assurance controls over all the firm's reprocessing operations including cleaning, disinfection, packaging, labeling, sterilization, distribution, etc. Third-party reprocessors are subject to FDA inspection and enforcement actions will not be taken against them or their products unless FDA has determined that 1) the firm is out of compliance with current applicable regulatory requirements (with regulatory discretion for all premarket notification requirements, until a new FDA reprocessing position is adopted), or 2) the firm's products represent a danger to health.3

So what is so different about these two letters? Clearly changing the phrase "is lawful in the United States provided that the reprocessing firm complies fully with all regulatory requirements currently imposed on them..." to "unlawful unless those engaged in this practice comply with all regulatory requirements..." is what is initially noticed. But the agency "will continue to exercise regulatory discretion for all premarket notification requirements" and will inspect and institute enforcement actions when necessary just as it has always done. But does premarket notification ensure a safe medical device? Why are there so many MDRs on new, nonreprocessed products? Operating room nurses across the country will confirm that new products fail every day right out of the package. It seems that the need for premarket notification and 510(k)s is the only argument that the original manufacturers can continue to make in light of the fact that many of their own customers have chosen to reprocess certain items. Could it be that FDA is receiving only one side of the story from the manufacturers and their lobbyists in Washington? As long as it was just hospitals reprocessing any device, it seems that there was no problem. But as soon as third-party reprocessors stepped on the playing field and began to gain acceptance as an industry, the manufacturers cried, "unlevel playing field."

Most infection-control practitioners understand that a validated process is one in which independent testing has determined that if the task is performed exactly the same way each and every time, the end result will be predictable and repeatable. Yet the same people consider it an acceptable practice to run more than one load a day in a sterilizer without testing each and every load with a BI. Or, perhaps more to the point, how many hospitals have policies requiring that the sterilization loads be held until the results of the BIs are confirmed? The generally accepted recommendation from groups such as the Association of Operating Room Nurses and the American Hospital Association is that BIs should be used at least weekly for all sterilizers, daily for steam sterilizers, and with every load for gas sterilizers.4 It is further recommended that any load containing implant products be biologically monitored.

FDA, however, holds third-party reprocessors to a much higher standard, namely the Current Good Manufacturing Practices (CGMPs). The revised CGMPs, set forth in the quality system regulation, were issued in October 1996 and became effective June 1, 1997. These requirements, as applied to the reprocessing of single-use items, would never allow a sterilization load to be released for use without confirmation of the sterility of the cycle, using the universally acceptable validation of SAL 10–6. And, with the exception of the 510(k)/PMA requirement, FDA's policy for reprocessors is the same as that applied to the original device manufacturers.

WHAT ARE THE BENEFITS OF REPROCESSING?

Everyone is feeling the pressures of the continuing rise in healthcare costs. Couple this with changes in reimbursement—such as reduced revenues under capitation—and healthcare providers face a major financial challenge. The question of how to reduce operating costs without compromising the standard of patient care is confronted daily by healthcare professionals at all levels. Personnel cuts, along with various materials management programs, have already been implemented by most institutions. Unfortunately, the changes have not produced all of the necessary savings, and it appears that the coming years will see further reductions in revenue and allowable patient billings. Reprocessing of selected disposable devices can potentially result in major savings.

Hospitals have long recognized that reprocessing devices labeled for single use makes sense. As described above, the single-use designation on a device is often entirely arbitrary; in many cases, devices that now carry a single-use label previously were reusable or currently have a reusable counterpart. Thus, when it can be scientifically proven and validated that a device can be cleaned, functionally tested, repackaged and sterilized, and used again without harm to the patient, the device can and should be reprocessed. Not to do so wastes precious healthcare resources and needlessly exacerbates the country's environmental waste disposal problem.5

OPPOSING VIEWPOINTS

Manufacturers have discouraged reprocessing by giving away expensive capital equipment if the hospital will commit to purchasing a certain amount of disposables. Sometimes, by simply adding plastic to a reusable product, the manufacturer produces a new single-use product that cannot be autoclaved, which is the most popular form of in-hospital sterilization. Some manufacturers, however, have also provided hospitals with guidelines for the resterilization of opened but unused disposable products.

Most manufacturers have stated that they will not stand behind a single-use product should the hospital choose to reprocess and reuse it. This is only fair, since manufacturers cannot inspect a product prior to its reuse and do not have the responsibility for repackaging and sterilization. The manufacturer would retain responsibility for any defects in original materials and workmanship, but the hospital would accept responsibility for the functionality and sterility of the reprocessed product. The same conditions would apply if the hospital were to select a third-party commercial reprocessor, although most third-party reprocessors provide liability coverage for the hospital.

The Association of Medical Device Reprocessors (AMDR) was established in 1997 to provide a viewpoint counter to that of device manufacturers. The group represents the legal and regulatory interests of third-party reprocessors of medical devices labeled for single use, and is dedicated to educating consumers and the healthcare community regarding the safety, legality, and benefits of third-party reprocessing. According to the organization, medial device reprocessing has an excellent safety record. In the 12 years since the third-party reprocessing industry emerged, millions of devices have been reprocessed with few problems. In fact, based on available evidence, including MDRs, the safety record of reprocessed devices is at least as good—or better than—the safety record of new devices. Indeed, there are numerous, well-documented cases of non-reprocessed medical devices causing patient injury or death. AMDR member companies are careful to adhere to established, validated protocols. Far from maintaining that every device should be reprocessed, the group recommends reprocessing only when it can be scientifically proven and validated that a device can be cleaned, packaged, and sterilized without impairing its functionality.

CONCLUSION

The reprocessing of selected single-use items can be a viable cost-reduction program when performed under proper guidelines. There is no evidence that such programs in any way diminish patient-care standards. In fact, an effective reprocessing program may actually improve patient care if the associated cost reduction helps maintain adequate hospital staffing levels.

Every product, disposable or reusable, has a functional life, which cannot be precisely determined. Expensive reusable items have been known to break on first use, whereas single-use devices have often proved useful for many successive procedures. Functionality is the key: if a product can be economically reprocessed with validated protocols and deemed to be functional, there is no reason to discard that product after one use.

Our nation is in the midst of a healthcare crisis that shows no sign of resolving itself any time soon. Government agencies, hospitals, healthcare professionals, patients, and manufacturers must all become part of the solution. A prudent program of reprocessing saves money, jobs, and the environment—without changing the standard of patient care.

REFERENCES

1. VW Greene, "Disinfection and Sterilization of Disposable Devices/Equipment," in Chemical Germicides in Health Care: International Symposium, ed. William A. Rutala, (Washington, DC: Association of Professionals in Infection Control and Epidemiology, 1994).

2. Letter from Larry Spears, director, Division of Enforcement III, Office of Compliance, CDRH, FDA, to Stephen Terman, Esq. (October 19, 1998).

3. Letter from Larry Spears, director, Division of Enforcement III, Office of Compliance, CDRH, FDA, to Stephen Terman, Esq. (July 9, 1999).

4. Association for the Advancement of Medical Instrumentation ST 19, 1985.

5. Nancy J Perry, "Undercover in a Hospital," Money (December 1994), 142.

William B. Stoermer Jr. is executive vice president of Alliance Medical Corp. (Phoenix), and has a long history in the healthcare industry, including positions with original equipment manufacturers, as a hospital administrator, and currently with a reprocessing company. Alliance Medical Corp. is a founding member of the Association of Medical Device Reprocessors (AMDR).


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Copyright ©1999 Medical Device & Diagnostic Industry