Judging from the claims about the pads, you'd think they were medical devices, but they are not regulated as such. FDA spokeswoman Rita Chappelle said she could not disclose the details of the investigation, but noted that the agency often opens cases because of suspicion about whether a firm has violated rules on making false and misleading claims. Doctors interviewed for the AP story are skeptical about the pads' claims because the skin only excretes water and salt, not toxins. They also questioned the vagueness of the ingredient list onÂ the KinokiÂ Web site. One indicator that the product may not be legitimate: If you do a Google search for "Kinoki Foot Pads," you get several sites charging that the pads are a scam before you get to the actual Kinoki site. Â
Members of a Senate appropriations subcommittee yesterday declared that FDA needs a significant increase in funding in order to accomplish its mission, and asked FDA Commissioner Andrew von Eschenbach to estimate how much of an increase the agency could absorb without logistical problems, reports the New York Times. After the Senate passed a resolution calling for a 20% increase in FDA's budget, von Eschenbach said the agency would have trouble absorbing that much of an increase in one year. So Sens. Herb Kohl (D-WI) and Robert Bennett (R-UT) asked him to estimate how much the agency could absorb in one year. He said he would be happy to present them with a series of options at a later date. He also said he wants to hire about 700 people next year, but would not be able to do so if President Bush's budget proposal were adopted unchanged. The commissioner sounded more optimistic about the agency's ability to accomplish his mission than he had previously, however. In a speech last month, he said that FDA may fail in its mission because of funding. Yesterday, he said that FDA remains the gold standard of food, drug, and device regulation, but that it must change if it wants to maintain that level.
For decades, the healthcare industry has tried to stay a step or two ahead of antibiotic-resistant bacteria by monitoring hospital environments and the usage of medical devices. In recent years, however, bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), also known as the Superbug, have demonstrated increased strength, the number of hospital-associated infections has continued to rise, and the occurrence of potentially harmful accidents like misconnecting IV components has proven that human error is not only to be expected, it is inevitable. While hospitals and healthcare providers try to curb these incidents in their own ways, OEMs are feeling more pressure to help prevent such problems from occurring at the device level.
Taking the Safety Initiative
Designed to eliminate potential misconnections with luer fittings, Colder's SRC connector is made from medical-grade, animal-free polypropylene.
The Superbug can be carried by a person, even if they aren't infected with the bacteria, or on equipment such as a catheter. It can be easily spread in a hospital where people are in proximity to each other and many patients have weakened immune systems, making them more susceptible to infection. The prevalence of the Superbug has created a demand for products that help prevent the spread of bacteria or reduce the chance of infection. "Many manufacturers are looking at adding an antimicrobial offering," says Kerry Edgar, vice president of marketing at Medegen Inc. (Ontario, CA; www.medegen.com). "With the Joint Commission [National] Patient Safety initiatives asking hospitals to reduce hospital-acquired infections. . .antimicrobial devices will begin to play a bigger role in IV products."
The Joint Commission's National Patient Safety Goals for 2008 do not instruct medical device manufacturers to use antimicrobial components; goal 7 simply states that healthcare organizations need to "reduce the risk of healthcare-associated infections." Part 7B, however, requires healthcare organizations to "manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a healthcare-associated infection."
MRSA enters the body through a wound or even a puncture in a patient's skin made by an IV line or catheter. By incorporating antimicrobial materials and additives in device designs, OEMs could help to eliminate their devices as potential sources of infection. Responding to the risks of hospital-associated infections, Elcam Medical Inc. (Hackensack, NJ; www.elcam-medical.com) has released an antimicrobial stopcock. Designed as an improvement on the supplier's earlier attempts to prevent contamination of IV lines, the B-Stop is made using raw material that has been impregnated with silver ions to reduce bacteria colonization on the device.
Previously the company has offered a closed, swabbable stopcock and a stopcock featuring a flow channel that automatically flushes the side port along the flow line to eliminate residual volume and to minimize potential infection. Elcam conducted in vitro tests using various yeasts and bacteria, including MRSA, to demonstrate the efficacy of the B-Stop. Results showed that the product can reduce at least 2 log of inoculated bacteria, and, in some cases, can achieve a 3-log kill, which is more than 99.9%.
Cleanliness Is Next to User-Friendliness
Though component designers and engineers can't control the environment in which their products are used, manufacturers can try to prevent a device from being misused or mishandled by creating handling instructions that support the design of the product. For example, Medegen designed its needleless luer-activated device that is used on access ports to look like a blue target.
The B-Stop antimicrobial stopcock from Elcam is made from raw material impregnated with silver ions to reduce bacterial colonization on the device.
"During education of the clinical customer we remind them to look for the blue target when attaching an IV administration syringe or set," says Edgar. The blue target on the Tru-Swab port is supposed to help users remember that the port is IV related so that no other device will be connected to it. "We also remind them to follow the three Ds: disinfect it, double-check it, and dry it," says Edgar, referring to the manufacturer's instructions to disinfect the port, check it by tracing the line back to the medication to verify it is correct, and then wait for the disinfectant to dry before accessing the port to ensure maximum kill rate.
With both liability issues and regulatory factors to consider, OEMs continue to closely examine the connections they are using in IV products and how to make them safer, according to Jim Brown, medical business unit manager at Colder Products Co. (St. Paul, MN; www.colder.com). Engineers have to imagine all the potential misuses of a product at the design stage in order to make the safest possible product.
"The same concerns that are driving changes in components used in devices [in hospitals] are also affecting products used in home healthcare," says Jim Pisula, vice president of marketing for Value Plastics (Fort Collins, CO; www.valueplastics.com). "When you're designing equipment that will be used by nonprofessionals, you have to place a premium on making the designs easy to understand, friendly to patients, and durable," he adds. Brown concurs, naming misconnections as a concern for hospitals and home-healthcare applications but noting that, "ease-of-use is a bigger concern for home-healthcare applications because the user generally is less trained and [his or her] dexterity may be an issue compared with [that of a hospital professional]." Pisula also adds that more emphasis is being put on connectors earlier in the design cycle than in recent years because connectors carry significant weight in terms of customer preference and loyalty, as well as device function.
BSE, the Other Problem Pathogen
A few years ago, research showed--and FDA warned--that DEHP, a chemical used to soften PVC, could leach into the contents of an IV bag and cause harm to the patient. So OEMs began using DEHP-free materials. Similarly, connector suppliers are now noticing--and responding to--an increasing demand for and interest in animal-free materials. Bovine spongiform encephalopathy (BSE), also known as mad cow disease, is a progressive neurological disorder that can be transmitted to humans. Healthcare agencies worldwide have been recommending approaches to reducing the risk of spreading BSE to humans. One suggestion is to document that products containing animal derivatives only use materials from BSE-free countries.
Value Plastics offers its fittings and connectors in animal-free polypropylene. Because the material does not include any animal derivatives, customers are spared any BSE-related paperwork. "For years we have offered components in several animal-free materials, but the interest is greatest in animal-free polypropylene, a relatively recent addition to the medical polymer lineup," says Pisula. Brown has also noticed this trend, as well as increased interest in materials that have less potential impact on the media they handle.
Fortunately for OEMs, suppliers are equipped to offer a variety of high-performance materials to meet application and design requirements. "Device makers don't need to make a choice between patient safety and cost-effectiveness," Pisula says. "They just need to talk with their suppliers and bring them into the design process [early] to maximize their options. The result is better solutions for device makers and patient care."
HHS Secretary Mike Leavitt said FDA plans to open an office in China to better get a handle on contaminated medical devices, drugs, foods, and other products being exported from that country, the Associated Press reports. The agency expects to begin work there next month, with the official office opening coming in October. This signifies a change in strategy for the agency, which had been trying to detect unsafe products during customs. That's no longer feasible, Leavitt said, because it is impossible to inspect all of the massive numbers of imported products. So now, he said, FDA's strategy will be to work with Chinese regulators to "build safety into the products." Similar arrangements with India and some Central American countries could come soon. The FDA office in China will be headed by Christopher Hickey, director of the HHS Asia/Pacific office.
Michael Gauthier, president, Gauthier Biomedical, Grafton, WI.
When selecting vendors for design, development, and prototyping, OEMs have a lot to consider. Although all projects are different, here are some key attributes that OEMs should assess each time they search for a vendor:
Credentials. Qualifications vary drastically among vendors who service the medical OEM community. Start with the basics by checking to see whether the vendor has ISO certification in place; ISO 13485 certification is usually preferable for the medical device industry.
Capabilities. If you plan to use the same vendor from rapid prototyping to clinical build, you may want to find out about its capabilities and capacity. Usually a simple site visit can identify a vendor’s potential. Check that the company has space for more equipment, and if it has plans to expand.
Communication. Because the collaboration process is so critical to good product development, it’s helpful to have the ability to quickly and easily share design ideas. Check to see if the vendor uses the latest in 3-D solid-modeling software to verify the form, fit, and function of devices, and make sure that it is able to offer full photorealistic renderings of concepts for your review.
Experience. An experienced vendor is often capable of designing procedure-specific instrumentation. Look for a vendor that can bring multiple options to the table. Experience will enable a vendor to steer OEMs around design pitfalls and may have a variety of proprietary products that allow it to provide unique service features that others can’t.
Patented Technology Enables Prototyping of Microstructures
Rapid prototyping of microdevices is accomplished with a patented technology that enables the patterning and miniaturization of designs down to 3 µm—without a photomask. Stents, catheters, and implantable devices can be prototyped using this technology, which allows for the patterning of many shapes, surfaces, and materials. In addition to prototyping services, the company provides its equipment to firms and researchers.
Intelligent Micro Patterning LLC, St. Petersburg, FL
Company Specializes in Electronic Device Development
Providing electronic device and software development services to medical companies, a firm specializes in designing products with embedded systems, including drug-delivery, respiratory, and imaging devices. The company can manage product development from concept through manufacturing, or it can work in tandem with an OEM’s development team to design an electronic subsystem to meet a project’s requirements. Analog and digital circuitry, microcontroller hardware and firmware, and human interface design are available.
Sunrise Labs Inc., Auburn, NH
Company Has Designed More Than 2000 Medical Balloons
A designer and manufacturer of medical balloons, finished products, and related equipment has developed more than 2000 balloon designs, according to the company. The firm can support proprietary product design, or build a prototype based on customer specifications. Whether in the prototyping or production stage, balloon sizes can range from 0.5 to 50 mm in diameter and up to 250 mm in length, with wall thicknesses as thin as 0.0002 in. Potential materials include nylon, Pebax, polyurethane, and PTE, and materials testing and analysis is offered using differential scanning calorimetry, dynamic mechanical analysis, and extensional testing. Balloon and catheter prototyping can be scaled up to full manufacturing in multiple cleanrooms.
Interface Associates, Laguna Niguel, CA
Orthopedic Instrumentation Provider Can Develop Prototypes in Two Days
Prototyping is part of a firm’s full-service orthopedic manufacturing offerings. Depending on a project’s complexity, prototypes can be developed in as few as two days, according to the service provider. The company can modify existing products or develop new products based on customer designs. Each prototype is machined, fabricated, finished, and quality tested based on standard production processes to ensure manufacturability. A feature on the company’s redesigned Web site allows customers to design a virtual product from scratch, which company engineers can then use to build a prototype.
Gauthier Biomedical, Grafton, WI
Product Design Process Incorporates Lean Manufacturing Practices
A company designs and develops wound-care, diagnostic, drug-delivery, and other medical devices made employing various laminating, die-cutting, and dispensing techniques. For each project, the company holds a product and process preparation (3P) event, a lean manufacturing practice whereby engineers, quality personnel, production operators, and subject matter experts convene to develop several alternative product designs and process steps to meet a customer’s needs. Then the team evaluates each alternative against budget and manufacturing criteria. The 3P event is suited for complex projects with tight deadlines.
Tapemark, West St. Paul, MN
NEED TO KNOW
Acro Associates Inc. (Concord, CA; www.acroassociates.com), a provider of fluid control systems, has completed a year-long infrastructure expansion project. Along with achieving ISO 9001:2000 certification and launching a new Web site, the company added equipment and several thousand square feet to its facility. . . . Fanuc Robotics America Inc. (Rochester Hills, MI; www.fanucrobotics.com) has launched a program to certify instructors at high schools, community colleges, and universities to train students how to program robots. Eligible schools participating in the Certified Education Robot Training program can purchase an industrial robot and tooling package. . . . Nearly doubling the size of its large-part molding facility in Inman, SC, Mack Molding (Arlington, VT; www.mack.com) is adding 18,000 sq ft of floor space. The expansion also includes the acquisition this month of two megapresses—2600 and 400 tn—each with seven-axis robots, and the creation of 30 to 45 jobs in the next three years. . . . Celebrating its 10th anniversary, Trotec Laser Inc. (Ypsilanti, MI; www.trotec.net) is holding a year-long contest giving entrants the chance to win a Speedy 100 CO2 laser engraving machine. Enter to win the machine, which will be awarded in September, by visiting the company’s exhibits at upcoming trade shows.
NEED TO KNOW
Hiemstra's cleanroom supports the manufacture and assembly of such products as surgical tools and catheter-based drug-delivery systems.
On the heels of receiving ISO 13485 certification for its contract design quality system, Hiemstra Product Development LLC (San Francisco; www.hiemstra.com) has been granted state approval to manufacture Class I–III devices in its cleanroom. A firm can receive approval from the Food and Drug Branch (FDB) of the California Department of Health Services Division of Food, Drug, and Radiation Safety following an audit of a facility and its design and GMP systems. Because of the FDB approval, Hiemstra can now assist customers from the development stages of a product through first-in-man studies, ongoing clinical trials, and low- to medium-volume production during early ramp-up.
Early involvement in the process can be critical, given the complexity of product development and regulatory approval, says Hiemstra marketing consultant Nina Binetti. “We are seeing an increased interest to integrate our industrial design group up front in the product development process for better usability and value-added design elements,” she says. “We definitely see industrial design becoming [a bigger] part of the process. With our FDB approval, ISO certification, and quality management system, all of our processes are now interconnected to provide the highest-quality outputs in the most efficient manner.”
The company’s 750-sq ft, Class 10,000 cleanroom is equipped to handle manufacturing runs of a few hundred up to 30,000 units. The cleanroom will enable the company to expand its existing capabilities, working with such products as implants, surgical tools, power supplies and enclosures, and drug-delivery systems. In addition to offering manufacturing support for these types of products, the company also is expanding its design and development programs to service the growing market of combination products. “New combination products are providing effective treatment options where traditional options have previously failed. We see a growing pipeline of novel combination products in the areas of nano- and biotechnology, regenerative medicine, and orthopedics, in particular,” says Binetti.
With the number and variety of medical products continuing to increase, Binetti suggests there is a need for greater understanding of the regulatory approval process. “Regulatory requirements are continuously changing,” Binetti says. “Pathways that were successful for a device in the past may not hold today. Hiemstra can help customers find the most efficient regulatory process.”
NEED TO KNOW
A molded sample containing a silane-based antimicrobial concentrate (right) as compared with two samples containing silver-based antimicrobials (left).
RTP Co. (Winona, MN, www.rtpcompany.com), a supplier of specialty thermoplastic compounds, has entered into an exclusive sales and manufacturing agreement with Biosafe Inc. (Pittsburgh; www.biosafeinc.com) to use its silane-based antimicrobial technology in RTP’s line of antimicrobial products. The silane-based concentrate can be used as an additive in compounds for a variety of extrusion and injection molding processes.
The technology is faster acting than silver-based additives in rendering plastics antimicrobial and does not cause discoloration, according to Jean Sirois, general manager of RTP. “The active ingredient in these antimicrobial masterbatches only needs to be at a 0.25–0.5% loading in the final product to be effective, making it much more efficient than traditional antimicrobials such as silver or triclosan,” she says. “Unlike silver, silane-based antimicrobials improve color and do not compromise optical properties when used with high-clarity resins.”
Safety is another possible benefit of the antimicrobial technology. “These masterbatches work by physically puncturing and rupturing the cell wall to inhibit microbial growth,” says David Dodds, market manager at RTP. “Conventional antimicrobials kill by leaching into the cell, where they are metabolized and interfere with critical life processes, which can cause microorganisms to become resistant.” Silane-based products avoid this problem, Dodds asserts, noting that they have been used for next-to-skin and next-to-wound applications for decades and have proven effective against a broad range of microbes. The silane-based products contain no volatile organic compounds, heavy metals, arsenic, or polychlorinated phenols. Typical additive levels are between 2 and 3% to impart the desired effect into the host polymer.
The additives are used at the normal processing temperature of the polymer, and are available for use with PUR, PBT, PET, POM, PC, PA, PVC, TPE, and other resin systems. PE, PP, and ABS may also be suitable for the additives, but testing and trials are still under way to improve performance in these polymers, according to Sirois.
Applications for the silane-based masterbatch products include injection-molded items and catheters, as well as extruded sheet, films, profiles, and fiber.