It is the recognition of every soldier as a first responder that has helped drive the latest addition to the Army’s training arena, the Medical Simulation Training Center (MSTC).

“I think what you see is that the Army, with its experience in the contemporary operating environment, in theater, has once again learned the lesson that every soldier out there is first a rifleman, with all of the other skills supporting that effort,” observes Lt. Col. Scott Pulford, U.S. Army product manager Ground Combat Tactical Trainers (PM GCTT) within the Program Executive Office for Simulation, Training & Instrumentation (PEO STRI). “But right behind that, almost in parallel with being a rifleman, we’re finding that every soldier will also be a first responder and have that critical lifesaving skill set necessary to be able to perform buddy aid. Whether it’s that 91 Whiskey-Army medic-assigned to the squad or platoon or the guy that just happens to be riding shotgun in that Humvee, he is going to be the first one on the scene.”

The MSTC initiative standardizes the medical training needed to give soldiers the skills to save wounded soldiers in combat. MSTCs teach both medics and nonmedical personnel to be a soldier first and a medic second and will be used for both combat medical advanced skills training and combat life-saver (CLS) training. The new training centers provide realistic wartime training to ensure that in the very distracting situation of war, they will be able to perform their duties both as a soldier and a medic/CLS. Some even have medical obstacle courses for soldiers where the sights and sounds of war are present and instructors place stress on the soldier in the training.

According to Debra Marsden, MSTC project director in PM GCTT, the origins of MSTC go back to 2004 and a visit made by the vice chief of staff of the Army to Fort Campbell, Ky.

“He talked to some of the soldiers there who had just returned from Operation Iraqi Freedom, a couple of them amputees,” Marsden explained. “They basically attributed their lives to the training that the combat medics and some of the nonmedical personnel had received on the medical simulators. And with that, Gen. Cody put out the directive that he wanted a patient simulator at every camp, post and station,” she added.

That tasking went to Army Medical Command where the MSTC concept took shape. In addition to the medical simulators, the new training centers include an array of sensory devices designed to simulate a combat environment.

The MSTC fielding plan is based on high densities of the Army medic populations as well as force projection platform and deployment rotation considerations. The program currently calls for 19 sites to be operating by the summer of 2007, including a deployable package recently approved for Afghanistan.

Of those 19, the first six priority one sites include a Kuwait suite and a deployable package that is currently in Balad. Formal ribbon-cutting ceremonies were held on the first MSTC site, located at Fort Lewis, Wash., in May of this year.

“Fort Lewis was the first one to stand up and they have training lanes outdoors where they have actually instituted a sound system that has some combat sounds,” Marsden said. “They have burning vehicles. They have a crashed helicopter. They have an obstacle course that the soldiers have to run through, using a weighted mannequin as a patient simulator. So it’s pretty much real life: first getting the wounded soldiers out of harm’s way, triaging to determine the casualty levels and then treating those soldiers as well. It’s kind of a tri-level training.”

According to Shannon Swain, military analyst at PEO STRI, the Army has been teaching combat lifesaving “almost since the beginning of time. Units were doing it, but it was not standardized. Often the medics did the training just to build rapport with their units. But this puts it out in a standardized environment with a lot more added to it.

“Before MSTC, many times the CLS would be taught in a clinical environment: a lab, a room, or something,” Swain added. “Now, with MSTC, they are putting it into a combat situation where you have the noises, sounds, smells and look of combat, with real bleed and breathe simulators. And they have to go through these environments and perform their tasks under physically and mentally stressful conditions, so it validates their skills before they go downrange.”

“The training has been going on but the standardization of it, the continuous update of the techniques and procedures, hasn’t been there,” noted Pulford. “And I guess in some cases it was ‘haves’ and ‘have nots’ There were different installations that had a more robust capability. We’ve seen that as we’ve gone out to do our site surveys for these first 18 sites; some have a pretty established capability with facilities already in place while others have a much more ‘backyard/ hip-pocket’ training approach.

“Every day there are new lifesaving skills, techniques and procedures that the medical community both here in the States and over in theater are learning new ways to keep our soldiers alive,” Pulford continued. “And the medical community has the challenge of how to export all that knowledge. If the soldier is only going to get a limited amount of time in theater before he crosses over into harm’s way, and the last time he got a real good dose of lifesaver training may have been six months before that, how do we teach him all of the latest and greatest techniques, technologies and procedures that he is going to see once he gets on the ground in theater? For the medical training community, this creates a standardized, efficient, rapidly ‘updateable’ way of getting that information and those skills out to everybody as quickly as possible. By the time that all 18 or 19 of these sites are up and operational, it will almost be like having a direct phone link to the field. As soon as the schoolhouse sees a new technique or new technology, they can get the word out to all 18 of those sites and really impact everyone who is in the ramp-up ready to deploy.”

With 0.35 [micro]m high-voltage CMOS process, H35, chip fabrication service allows for integration of 3.3, 5, 20, 50, and 120 V devices on single chip without any process changes. Process matches BCD performance and chip sizes, while modularity permits 100% reuse of low-voltage CMOS design IP. Produced in 8 in wafer fabrication, H35 offers fully scalable 120 V NMOS and PMOS devices and floating logic libraries.

Unterpremstaetten, Austria (May 9, 2006) - austriamicrosystems’ Full Service Foundry business unit announced today at the Fabless Semiconductor Association (FSA) Supplier Expo in Munich the offering of its leading edge 0.35[micro]m High-Voltage CMOS technology H35 with an additional set of 120V NMOS and PMOS devices. The new extension allows the integration of 3.3V, 5V, 20V, 50V and 120V devices on a single chip without any process changes.

H35 is the first purely CMOS based High-Voltage process that matches BCD performance and chip sizes at much lower process complexity. It is based on the 0.35[micro]m CMOS process transferred from TSMC. Rigorous modularity permits 100% reuse of low voltage CMOS design IP. H35 offers fully scalable High-Voltage NMOS and PMOS devices, floating logic libraries as well as a best-in-class power-on resistance. This makes the High-Voltage CMOS technology a competitive solution for fabless design houses and IDMs in fields such as power management products, display drivers, broadband and wireless applications, modems, sensors, capacitive actuators, printer and MEMS driver ICs.

For its fully automotive and medical qualified process, austriamicrosystems delivers its industry benchmark design environment (”HIT-Kit”), which comes complete with IO libraries, special utilities optimized for High-Voltage CMOS product design and excellent characterized circuit simulation models. New High-Voltage designs utilizing the 120V devices can already be started in the H35 50V process option, which is available for volume production today. All 50V devices and blocks can be reused without any layout modifications in the 120V option. Engineering runs supporting the 120V process option are already offered to dedicated customers, volume production will be available by end of 2006.

“The new 0.35[micro]m High-Voltage CMOS process is the 5th generation of the continuously improved High-Voltage technologies from our company and is produced in austriamicrosystems state-of-the-art 8-inch wafer fabrication. As only two mask level adders on top of CMOS are required it also makes H35 the process with the lowest complexity in the market. All of this makes H35 the optimum choice for achieving smallest possible die sizes at very competitive cost for a voltage range from 20V to 120V”, states Peter Gasteiner, Senior Vice President and General Manager of austriamicrosystems’ business unit Full Service Foundry.

About austriamicrosystems

austriamicrosystems’ business unit Full Service Foundry has successfully positioned itself in the analog/mixed-signal foundry market offering well-established RF CMOS, High-Voltage CMOS, BiCMOS and SiGe-BiCMOS processes. With superior support during the design phase, with high-end tools and experienced engineers, austriamicrosystems succeeds to be an attractive analog foundry partner especially for fabless design houses.

Designing and manufacturing a medical device incorporates many of the same methods and processes as designing and building a car, except for one big difference: the U.S. Food and Drug Administration (FDA). Something as simple as a basic wooden tongue depressor or as complex as a programmable pacemaker with microchip technology are both considered medical devices by the FDA, the government arm that regulates the design, manufacture, packaging, and safety of medical devices. Lab equipment, test kits, and radiation-emitting products such as ultrasound, x-ray, and laser machinery also fall under the FDA’s regulated medical devices.

The medical device industry encompasses a wide variety of products and technologies, from hand tools and implantable screws, to computer-controlled surgical machines and artificial organs. According to Forrester Research, the U.S. is the world’s largest medical device market, valued at $43 billion. The industry is expected to grow at a rate of 9 percent per year through 2004. The development of more innovative medical devices in areas such as orthopedic implants, cardiovascular treatment, and surgical equipment continues to increase.

To account for the diverse design, manufacturing, and control procedures used to make such devices, the FDA has compiled Current Good Manufacturing Practice (CGMP) requirements that help manufacturers comply with FDA regulations. These CGMP regulations ultimately protect patients and users of medical devices from purchasing ineffective or dangerous products.

So how far into the design and production of a medical device should a manufacturer go before worrying about FDA compliance? According to the FDA, they must think about compliance at the very beginning, before the product is even designed. The FDA’s Center for Devices and Radiological Health (CDRH) - responsible for the regulation of medical devices and ionizing and non-ionizing radiation– emitting electronic products - has issued CGMP requirements for design controls that guide manufacturers from the very first drawing they make of a new device.

Design controls are a set of procedures incorporated into the design and development process that cover the life of the medical device, from design to production, distribution, maintenance, and obsolescence of the device. The design controls apply to all changes to the device or the manufacturing process, including those that occur long after a device has been introduced to the market. They include everything from the initial design input and review, to verification and validation of the design, to design changes and a history file of those changes. Once the device is designed, the FDA has further regulations covering clinical evaluation, manufacturing, packaging, labeling, and post-market surveillance of the device.

Sound mind-boggling? The FDA, and some commercially available software packages, can help medical device manufacturers get started.

Reducing the Risk

While the FDA is the best place to go for exact information on compliance with their regulations, there are a number of commercially available software packages that can help medical device manufacturers streamline their processes, reporting, and quality procedures to ensure compliance with CGMP standards.

NetRegulus is a provider of product quality intelligence software and services for FDA-regulated medical product manufacturers. Based in Oakbrook Terrace, IL, NetRegulus offers their PQIntelligence(TM) software, an enterprise-wide, Web-enabled data management package that lets users track products and product-related information from initial bench testing all the way through to product phase-out. It automates, organizes, and manages clinical, regulatory, and product data. It also provides tools to track marketing trends, file on-time regulatory reports, handle postmarket surveillance, manage clinical and scientific studies, and manage quality audits, field actions, and recalls.

Pilgrim Software (Tampa, FL) offers the Quality & Manufacturing Integrated System (Q&MIS(R)) suite of software that helps manufacturers analyze their manufacturing process, recognize trends and measure quality, and meet FDA guidelines. Also an enterprise-wide application, the Web-based product allows users to integrate audits, calibration management, document control issues, supplier quality management, preventive maintenance operations, internal process controls, and training processes into one approach. These different functions also can work as standalone applications.

Other companies, such as EduNeer- ing, provide online compliance education and risk management solutions for FDA compliance. In 1999, EduNeer- ing entered into a Cooperative Research & Development Agreement (CRADA) with the FDA to jointly develop online training programs and courses, which will ensure that everyone in industry and government has access to the same tools and core knowledge, enhancing compliance efforts by regulated manufacturers.

Earlier this year, Able Software received clearance from the FDA to market its 3D-DOCTOR software for medical imaging applications. 3D-DOCTOR is also a rendering and measurement software for computer tomography (CT), magnetic resonance imaging (MRI), microscopy, and other volumetric images. It creates 3D surface models from cross-section images in real time on a standard PC, letting doctors perform 3D visualizations of CT/MRI images. In effect, the software creates CAD models from medical images.

Designed to meet demand for music and photo storage, 2 GB miniSD Memory Card is suited for mobile phones with megapixel cameras and music player functions, and is able to store up to 35 hours of music. Card offers max writing speed of 5 MB/s and includes CPRM advanced copyright protection function. Unit’s primary application is mobile devices with miniSD slots, but it can also be used in standard SD slot with adapter.
High Capacity miniSD Card to Be Marketed Worldwide to Meet Growing Demand for Music and Photo Storage in Mobile Devices

IRVINE, Calif., and TOKYO, May 24 / — Toshiba America Electronic Components, Inc., (TAEC)* and its parent, Toshiba Corporation, today announced an expanded line-up of large capacity miniSD Memory Cards with the introduction of a 2-gigabyte (GB)(1) capacity card. The miniSD Card is much smaller than a standard SD Memory Card but delivers increasingly large capacity. Its primary application is in mobile devices with miniSD slots, but it can also be used in standard SD slots with an adapter.

“As mobile phones increasingly offer high-resolution cameras and support for digital music, demand is growing for a small, versatile, high capacity storage device for images and music. For the growing percentage of cell phones equipped with a miniSD Card slot, Toshiba’s new 2GB card addresses these requirements,” said Brian Kumagai, business development manager, NAND Flash, for TAEC.

With the addition of the new 2GB miniSD Card, Toshiba will expand a product line-up that already extends up to 1GB.

Key Features

1. The 2GB storage capacity is ideal for mobile phones with megapixel cameras and music player functions(2) and is able to store up to 35 hours of music(3).

2. Maximum writing speed of approx. 5MB/s(4)

3. Adopts CPRM(5) advanced copyright protection function

Specifications

Name of Product: 2GB miniSD Memory Card

Maximum Write Speed: 5MB/second

Compatible Interface: SD Memory Card standard compatible

Power Supply Voltage: 2.7 - 3.6V

Compatible Standard: SD Memory Card standard compatible

Exterior Dimensions: 20.0mm(W)-21.5mm(L)-1.4mm(T)

Weight Approx.: 1g

Pricing and Availability

The Toshiba 2GB miniSD Memory Card will be available in June 2006 priced at $109.99.

SD Memory Card

The SD Memory Card is a revolutionary Flash memory storage device designed to meet the converging security, capacity, ergonomic and performance requirements of emerging audio, video, data and multimedia consumer electronics markets. The SD Memory Card was jointly developed by Toshiba Corporation, SanDisk Corporation and Matsushita Electric Industrial Co. Ltd. (best known for its Panasonic brand name products). The SD Memory Card includes key enhancements over existing Flash cards including cryptographic security, protection of copyrighted data, high-data transfer rate for fast copy/download and high storage capacity. TAEC currently offers a wide selection of SD Memory Cards with storage capacities of, 512MB(6), 1GB and 2GB in the standard (blue) product family, and a higher performance (white) family of cards in, 512MB and 1GB capacities. The Toshiba SD Memory card line-up also includes miniSD in capacities ranging from 512MB to the new 2GB card. As the world of SD expands, SD Memory remains the global standard for compact, portable memory.

NAND Flash Background

As a recognized pioneer in flash technology, Toshiba was a principal innovator of NAND- and NOR-type Flash technology in the 1980’s. Toshiba maintains leadership in Flash technology today, with a complete line of NAND memory in densities from 64 megabit(7) (Mb) to 16Gb(8) to meet various application requirements. NAND Flash has become one of the leading technologies for solid-state storage applications because of its high-speed programming capability, high-speed erasing, and low cost. The sequential nature (serial access) of NAND-based Flash memory provides notable advantages for these block-oriented data storage applications. Toshiba’s NAND Flash memory products are optimized for general solid-state storage, image file storage and audio for applications such as solid state disk drives, digital cameras, audio appliances, set-top boxes and industrial storage.

Intel took another step toward developing its nascent digital healthcare business when it announced a consortium of 22 healthcare and technology companies that will set technology standards for home healthcare monitoring devices. The consortium includes companies in the medical technology industry, such as General Electric, Medtronic and Philips Medical Systems; large technology players Intel and Cisco Systems; consumer electronics giants Samsung, Panasonic and Motorola; and healthcare providers such as Kaiser Permanente and Partners Healthcare, a system of hospitals and doctors based in Boston.

The consortium, called Continua Health Alliance, will develop a set of guidelines and choose technology standards to be used in a host of devices that both sick and healthy people and their healthcare providers will be able to use to monitor patients’ status from home. The aim is to provide better preventive medical care and reduce unnecessary visits to the doctor and to emergency rooms. The group plans to develop devices to serve several segments of the population: the 1 billion adults worldwide who are considered obese, the 860 million people with chronic disease and the growing elderly population. The goal is to feed data from weight scales, blood pressure monitoring devices and, for the elderly, sensors in the home, to a network that will allow healthcare providers and remote family members to monitor a person’s condition.

On the surface, predictive modeling might not light up the sky the way wireless devices or voice recognition systems do. But make no mistake: Its impact is so far-reaching that soon it will influence and possibly direct the healthcare services many of us receive.

Disease management (DM), with its predictive modeling corollary, have of late come under increased scrutiny. The DM concept, of course, made perfect sense in the beginning: Manage those patients with chronic, high-cost conditions to avert admissions or emergency episodes and. hence, reduce costs. But how does a health plan with 500,000 members actively influence 10 percent of its membership with diabetes, congestive heart failure and asthma in such a way that the intervention moderates behavior that, in turn, moderates costs? That’s 50,000 people and a lot of intervention. How much smarter might it be to predict who could be in the high-risk population years before they get there, and modify their behavior now?

The advent of more sophisticated predictive modeling technology has turned attention to high-risk health plan members who aren’t yet high-cost patients, but soon will be without effective intervention and lifestyle changes. These may be patients in the early throes of utilization, as well as consumers who aren’t yet active utilizers. Experts postulate that 2 percent of a health plan’s membership may be at very high risk and may, eventually, drive 70, 80 or even 90 percent of the health plan’s expenses. Those numbers alone make it a problem worthy of the IT microscope.

Artificial Intelligence

HealthSCOPE Benefits Inc. (HSB), headquartered in Little Rock, Ark., is a full-service health management and claims administration company–a third party administrator. It provides administration, claims and support services to self-funded employers. Its 250 employees manage more than $400 million in annual healthcare expenses, servicing about 140,000 members.

As part of a suite of medical management services that includes disease management and case management, HSB also offers High Impact, a predictive modeling-based program that proactively identifies tomorrow’s high-risk. high-cost patients. Today, about 40 percent of HSB’s total membership is eligible for the High Impact program.

The technology foundation of High Impact is Risk Navigator Clinical, a forecasting tool from Orlando, Fla.-based MEDai (Medical Artificial Intelligence). The technology foundation of Risk Navigator Clinical is MITCH (Multiple Intelligent Tasking Computer Heuristics), a prediction engine that allows health plans and TPAs to not only predict which members are tomorrow’s high-cost patients, even if they are not now heavy utilizers, but also to predict which individuals in the high-risk population are likely to respond to intervention.

MEDai CEO and co-founder Steve Epstein says the technology is third-generation. It started with rules-based systems, he says, then progressed to groupers, and now systems are heuristic. They have become “smart.”

“It’s a tremendous advantage,” says Epstein, “for a health plan to take subsets of a populations and say ‘Five years down the road, if you continue your current lifestyle, you run an 80 percent chance of developing heart disease or lung disease. Here is what you can do now to prevent that.’ It’s an even greater advantage for the health plan to be able to predict which members are likely to respond to its intervention.”

Juggling Data

To forecast risk, MITCH uses a varied collection of administrative data–encounter claims, pharmacy claims, lab data and membership files–as well as survey or evaluative data such as health risk assessments. With earlier renditions of predictive modeling programs, accurate predictions couldn’t be generated if some of the data were weak or missing but no longer.

MITCH’s mission is to spot high risk from miles away. Being able to deal with linear and nonlinear data, “MITCH can compare a consumer sitting at home, with no prior hospital admissions or ER episodes, to his neighbors with similar backgrounds, ages, zip codes and insurance coverage, and can generate an accurate prediction,” says Epstein.

Equally important, he says, is the system’s ability to identify the drivers. “It’s not enough to identify the risks,” he continues. “Care management programs must know the drivers of risk. Is it a drug, a lab value, or something in the patient’s history at the foundation of his risk score?”

Modeling with artificial intelligence (AI) also makes crystal clear the difference in value of healthcare dollars spent. In their article, “Predictive Modeling in Health Plans,” authors Randy Axelrod and David Vogel cite as an example two health plan members that each generate $3,000 of service utilization in a plan year. One member generates those costs in a single episode of hospital treatment; the other, through months of prescription utilization. While the dollar amounts might render similar financial profiles, AI-based predictive modeling would manifest dramatically different risk forecasts for those patients.

When it comes to cases, trays and other enclosures for medical devices and emergency equipment, off-the-shelf products and those made from plastics may not be the best solutions. Before ordering or designing your next medical case or system, it could pay major dividends to consider the questions that many experts ask themselves.

Providing unfailing protection for medical devices and equipment–a function often performed by cases and other enclosures–is not to be taken for granted. While there is no shortage of medical case fabricators and other suppliers, selecting the right case–whether carrying case, instrument housing, sterilization container or other equipment enclosure–can be vital to the successful care of patients and accident victims.

Because medical cases are often subjected to the stresses of harsh environments, such as chemical or autoclave sterilization, rugged use and atmospheric pressure, or carry devices that will benefit from special design features, it behooves medical equipment suppliers and practitioners to be highly selective when specifying case application requirements.

“Many people in the medical community feel that cases, trays and other equipment enclosures are more or less standard items,” says Don Saak, Business Development Director for Zero Manufacturing, of North Salt Lake, UT. “The fact is that custom cases are not only practical, but are often critical for the protection, performance and efficient use of the equipment they contain.”

Saak notes that Zero Manufacturing has for many years built custom-designed products for aerospace, military and electronics, in addition to medical applications. “The standards of quality and functionality in these fields are benchmarks throughout the world,” he says. “The cases used to house or transport medical appliances, surgical tools and other devices can benefit directly from the materials and engineering advancements developed for the aerospace and electronics industries.”

What criteria should manufacturers and users of medical equipment consider in the specification of cases for their products? While that depends on specific applications and the sensitivity of case contents, Saak identifies five “rules of the road” for specifying medical cases:

1. Choose appropriate case materials

The materials from which cases are fabricated have a direct bearing on protection of the case contents and durability of the case itself.

Essentially, the choice of case materials is between metal and plastic. Metal cases are usually constructed of aluminum or aluminum alloys, and are typically either deep drawn or welded. Plastics, ranging from standard compositions to space age composites, are commonly vacuum formed, thermoformed, rotationally molded, blow molded or injection molded.

Metal cases are well known for their protective attributes. They offer high resistance to impact, can be sealed tightly, and can withstand extreme temperatures and can be made fireproof. “If an aluminum case is subjected to high impact, the shock will be absorbed by the entire case,” explains Saak. “We’ve received letters from customers that told how their metal cases withstood the impact of auto accidents and buildings collapsing. These cases may be dented, but they will take a beating or go through a fire and still protect tire contents.”

Plastic cases can also offer a good seal and, depending on composition, substantial resistance to impact. When plastic cases “give,” they tend to crush or crack. While metal cases are not crush- or crack-proof, they will usually sustain a wider range of extreme heat or cold. Aluminum becomes harder in extreme cold, whereas plastic becomes brittle. Aluminum dissipates heat, whereas plastics can deform or melt when subjected to extreme heat, exposing contents to shock and perhaps functional damage.

Sometimes overlooked, case materials can affect the hygiene of contents that undergo sterilization. “The materials that make up the plastic case could out-gas during some chemical sterilization processes,” Saak explains. “While this is not a common problem, it is one that could cause contamination of items such as surgical instruments or implants that are being sterilized.” Also, many plastics are weakened during autoclave sterilization, and may have a much shorter lifespan than their metal counterparts. One-piece deep drawn metal cases also offer the advantage of having no seams or welds, so there are fewer “hiding places” for bacteria and other foreign matter.

In some cases, applications require shielding from EMI/RF (electromagnetic interference/radio frequency interference), which will affect choice of materials. “We have a lot of experience in this with aerospace and military cases,” Saak says. “We know that aluminum provides a natural EMI/RFI shield, which will prevent stray emissions from affecting instruments inside or even outside one of our cases.” Plastic must be coated or impregnated with shielding materials.

* Adding decorative designs or stickers to medical devices before a procedure significantly reduces aversion, fear, and anxiety, and may be especially useful for needle-phobic patients (A).

Needle phobia–fear of needles, syringes, intravenous therapy, and medical devices–can seriously compromise medical care. (1-7) We hypothesized that a novel cognitive therapy consisting of simple designs and decorations on needles and other medical devices would reduce needle phobia. Fear, aversion, and anxiety decreased significantly–as measured by validated visual analogue reaction scales–when patients were exposed to decorated devices.

* Materials and methods Subjects

This was a randomized controlled trial approved by the Institutional Review Board (IRB). Sixty patients were recruited from outpatient clinics: 67% female, 33% male, 100% outpatients, 41% pediatric patients, and 59% adults–representing the typical mix of subjects in a family practice clinic. The mean age of the patients was 32 [+ or -] 21 years (range, 3 years to 65 years).

After informed consent, the subjects were randomly exposed to 8 different designs of winged needles and 6 different designs of syringes fitted with a needle. Smaller subsets of subjects were exposed to different designs of intravenous (IV) bags and scalpels.
Advertisement

Stress-reducing needles and syringes

Stress-reducing syringes were created by taking conventional 10-mL syringes (10-mL Luer-Lok BD syringe, ref 309604, Becton Dickinson, Franklin Lakes, NJ) and decorating them so that the markings of the barrel could still be seen (FIGURE 1). Stress-reducing winged catheters (21 G 3/4 X 12-inch 367281 Vacutainer brand Safety-Lok Blood Collection Set; Becton Dickinson, Franklin Lakes, NJ) were created by decorating the wings in a symmetrical manner (FIGURE 2). Similarly, different designs of IV bag (FIGURE 3) and scalpel were used.

[FIGURE 1-3 OMITTED]

Outcome measures

For each group of devices, the presentation of individual devices to each subject was randomized to eliminate the possibility of a consistent bias. Emotional responses to the medical devices were determined with the validated visual analogue reaction scales where 0 is lowest response and 10 is the strongest. (8-11) These included the Visual Analogue Anxiety Scale (VAAS), Visual Analogue Fear Scale (VAFS), and Visual Analogue Aversion Scale (VAS). Significant needle phobia was defined as an aversion, fear, or anxiety score of greater than or equal to 5.

Statistical analysis

Primary analyses consisted of comparing the responses to the stress-reducing devices as a class with the conventional devices as a class. These paired data were compared with the paired 2-tailed t-test. To determine whether these responses were class-specific or design-specific, the results for each individual device were then compared with a matched control, design by design, again with the paired 2-tailed t-test. Corrections were made for multiple comparisons.

* Results

Patients experienced markedly more aversion to (dislike of) conventional syringes (VAAS score: 5.88 [+ or -] 3.61 vs stress-reducing syringes VAAS score: 1.21 [+ or -] 1.64; P<.001); they also had greater fear (conventional VAFS score: 4.68 [+ or -] 2.8 vs stress-reducing VAFS score: 2.19 [+ or -] 2.8, P<.001) and anxiety (conventional VAS score: 4.54 [+ or -] 3.68 vs stress-reducing VAS score: 2.21 [+ or -] 2.84, P<.001) (TABLE). This corresponds to a mean 79% decrease in aversion scores, 53% reduction in fear scores, and 51% decrease in anxiety scores with the stress-reducing syringes. Ninety-five percent of subjects preferred the stress-reducing syringes to the conventional syringes; 98% of subjects felt that stress-reducing syringes should be available for children; 72% felt that the stress-reducing syringes should also be available for adults.

The syringes most favored were those with musical notes (56%), flowers (18%), and smiley faces (12%). Each of these designs had lower scores in the 3 domains (fear, aversion, and anxiety) compared with the conventional device (P<.01), indicating that the reduction in stress measures was a class effect, rather than a specific effect of the individual design.

Significant needle phobia is defined as aversion, fear, or anxiety scores [greater than or equal to] 5. Using this definition, 80% of subjects experienced moderate to severe aversion, 63% suffered moderate to severe fear, and 62% experienced moderate to severe anxiety on exposure to conventional syringes. This corresponded to mean aversion, fear, and anxiety scores of 7.18 [+ or -] 1.92, 6.98 [+ or -] 2.16, and 6.78 [+ or -] 2.44, respectively. In subjects with significant needle phobia, stress-reducing syringes reduced aversion scores by 81% (P<.001), fear scores by 56% (P<.001), and anxiety by 47% (P<.001). Stress-reducing syringes had a positive response rate of 98% for reducing aversion, 87% in reducing fear, and 74% in reducing anxiety.

A two-part series on the reprocessing of medical devices that appeared in the Washington Post (Dec. 11 and 12,2005) has focused attention on a particular patient safety issue: the reuse of devices labeled for single use. The Post claimed that a growing number of U.S. hospitals are ignoring the warnings of manufacturers by reusing medical devices designated for one-time use because the cost savings are significant. Consequently, patient safety is being compromised.

According to the Association of Medical Device Reprocessors, the savings axe indeed significant: On average, hospitals can save as much as 50 percent by reprocessing, as opposed to purchasing new devices. Some dramatic examples, cited by the Post, include cardiac catheters ($279 new, $58 reprocessed); blades used in orthopedic surgery ($30 new, $14 reprocessed); and deep-vein thrombosis compression sleeves ($124 new, $11 reprocessed).

Reprocessing has other impacts, as well. The AMDR noted that its members reduced hospital waste by 935 tons in 2004, the first year such numbers were tabulated.
Advertisement

Nevertheless, there are some disturbing facts surrounding the reuse of single-use devices. Hospitals are not required to tell patients that reconditioned devices may be used in surgery. And federal records and interviews show that single-use devices have malfunctioned during reuse, although the AMDR claims that there are many more examples of failure of original devices than of those that have been reprocessed.

The Food and Drug Administration has oversight over the reprocessing industry. Although it has always conducted periodic inspections of reprocessors’ facilities and required them to follow good manufacturing practices, the agency requested a review of the practice of single-use device reprocessing in 1999. According to the resulting report, Single-Use Devices: Little Available Evidence of Harm from Reuse, But Oversight Warranted, issued by the General Accounting Office in June 2000, “FDA’s regulation of SUD reprocessing … has been inconsistent.”

To address this concern, the agency instituted a new regulatory framework in 2002 with the passage of the Medical Device User Fee and Modernization Act, which amends the Federal Food, Drug, and Cosmetic Act. Among the act’s significant provisions were new regulatory requirements for reprocessed single-use devices, including requiring reprocessors to submit data validating that their work produces safe devices.

However, following the Washington Post series on the reprocessing industry, Rep. Rosa DeLauro (D-Conn.), the ranking Democrat on the House Appropriations Committee subcommittee that oversees the FDA, called for more rigorous federal oversight of reused medical devices deemed for one-time use. In a Dec. 12, 2005, press release, DeLauro acknowledged that the FDA has made progress in monitoring the industry, but expressed concerns about the FDA’s role. “As the Post series demonstrated, what medical providers save in costs with reprocessing medical devices, they lose in patient safety,” wrote DeLauro. Rigorous oversight of reprocessing is needed.” DeLauro is especially concerned about the fact that the FDA allows physicians to voluntarily report problems with faulty medical devices, and does not require medical facilities to report device malfunctions.

Is your hospital paying for expensive new medical devices that vendors convince physicians to try out? Here are two simple ways to curtail these unexpected costs:

* Add a term to your supplier contracts that says something like this: “New technology that has not been added to the existing contract before delivery is not authorized for purchase.” This politely informs suppliers that they risk nonpayment by introducing new technology without agreed-upon deliberations.

* Institute hospital procedures to back up this contract term. Require purchasing staff to seek executive authorization before issuing purchase orders for medical devices that are not matched back to a contract. Also, establish a committee to rationalize purchase of new products.