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Shuren is "Acting" No More, Named CDRH Chief

After months of the word “acting” in front of his title, the U.S. Food and Drug Administration (FDA) has named Jeffrey Shuren, M.D., as permanent director of the Center for Devices and Radiological Health (CDRH). FDA Commissioner Margaret Hamburg, M.D., appointed Shuren to the job on a permanent basis on Jan. 20.

In recent years, the device division of the agency has been widely criticized by lawmakers, industry watchdog groups and consumers for controversial approvals and review practices, as well as for being too cozy with device makers.

Shuren had served as acting head of the unit since CDRH’s former director, Daniel Schultz, was pressured to resign in August 2009 after more than 15 years with the agency. Shuren has held various positions with the FDA since 1998, including associate commissioner for policy and planning. In a previous job, he oversaw development of Medicare’s national coverage decisions for medicine and non-implantable devices.

Notably, the Institute of Medicine currently is evaluating—in a $1.3 million project due to be completed in 2011—CDRH’s 510(k) approval process. The agency also has undertaken an internal review. Hamburg has made no secret of her intent to shake things up within the agency and clean house at CDRH. The device unit's priorities for 2010 will include strengthening product reviews and increasing transparency about decision-making, according to documents posted on the FDA’s Web site.

In a statement released by the Advanced Medical Technology Association (AdvaMed), Steve Ubl, president and CEO, said the trade group looks forward to working with Shuren and said he has shown “effective leadership skills” and has clearly established his goals for regulatory approvals, adapting to changing technology and resolving internal disputes.

“As one of the key negotiators during the reauthorization of the Medical Device User Fee Act, Dr. Shuren demonstrated he understands the unique needs of the medical technology industry,” Ubl said. “His more than 10 years experience at FDA, in various high-level policy and planning positions within the commissioner’s office, will serve him well as he takes control of an organization that oversees such a wide range of life-saving and life-enhancing products.”

FDA Opens Mexico Office


As part of its continuing effort to bolster its food and medical product safety and work with regulatory counterparts overseas, the U.S. Food and Drug Administration (FDA) recently opened an office in Mexico City. It is the agency’s third post in Latin America and its tenth international post in the past 13 months.

“The opening of this office represents an important step as we redesign our product safety strategy,” said FDA Commissioner Margaret Hamburg, M.D. “We, like our partners in the Mexican government, realize that prevention is the key. For example, more than a third of the fresh fruits and vegetables we eat come from Mexico, as do a large amount of our medical devices. Having FDA experts located permanently there will be mutually beneficial to both our countries and respective citizens.”

Staff assigned to the Mexico City post will work with their counterparts in the Mexican government to harmonize regulations and guidance standards and to work on other collaborative initiatives, according to the FDA. Collaboration will include sharing information on regulatory systems, as well as joint workshops on the safety of food and medical products.

FDA staff also will offer collaboration on the use of the latest laboratory techniques, foster other collaborative initiatives to ensure the safety of food and medical products marketed in the two countries, and be a “portal” to the FDA for counterpart Mexican agencies and the U.S.-export industry in Mexico.

According to Murray Lumpkin, M.D., the FDA’s deputy commissioner for International Programs, FDA staff also will work with industry in Mexico. “Experts in Mexico City will work closely with local industries that ship food and medical products to the United States to improve their understanding of U.S. safety and product quality expectations,” he said. “Their activities will include providing technical advice and working with government agencies and the private sector to develop certification programs.”

To date, the FDA has opened 10 international posts, including posts in China, India, Europe, and Latin America, along with its U.S.-based staff. The other posts in Latin America are located in Santiago, Chile, and at the FDA’s Latin America Office headquarters in San José, Costa Rica.

Symmetry Shutters Plant, Restructures



Symmetry Medical Inc. will close its plant in Auburn, Maine, and consolidate its operations into other facilities as part of a broader restructuring program. The consolidation is slated to be complete by the middle of 2010, and the company did not release any information on how many employees would be affected. The consolidation will include the transfer of current production capacity, including equipment and machinery.

Company execs said the move would better position the company for the anticipated recovery of the orthopedic sector.

With this move, the Warsaw, Ind.-based manufacturer of orthopedic implants, instruments and cases hopes to streamline its business and reduce costs. The restructuring, once complete, is expected to generate annual cost savings of approximately $3.4 million. The total one-time cost of the plan will be $2.4 million to $2.8 million, according to Symmetry.

“These decisions are difficult under any circumstances, and we recognize the personal impact they have on those dedicated employees who have made contributions to the success of our business,” said Brian Moore, president and CEO of Symmetry. “We are committed to treating them fairly and with respect throughout this process.”

Symmetry has facilities throughout the United States and Europe, in addition to a plant in Malaysia.

Stryker Buys Medical Device Reprocessing Firm



Stryker Corp. has acquired Ascent Healthcare Solutions, a reprocessor and remanufacturer of medical devices, for $525 million in cash, according to the Kalamazoo, Mich., firm.

Ascent, which was formed through the 2005 merger of Vanguard Medical Concepts and Alliance Medical Corp., is based in Phoenix, Ariz., and employs 900. It will become a division of Stryker operating under the MedSurg group of businesses and will keep

its name: Ascent Healthcare Solutions. Ascent has two reprocessing facilities, in Phoenix and Lakeland, Fla. Ascent’s revenue in 2008 was more than $100 million. It provides services to 1,800 hospitals.

“With Ascent as part of Stryker, we will also help divert thousands of pounds of medical waste from landfills while simultaneously redirecting substantial financial resources to patient care quality initiatives,” said Stephen P. MacMillan, CEO of Stryker.

In Ascent, Stryker gains a business for repurposing used medical devices, which can save hospitals money while cutting down on waste. Ascent offers products in 35 different medical device categories including cardiovascular and orthopedic products.

The deal represents the second-largest acquisition ever for Stryker, following the $1.65 billion purchase of orthopedic device maker Howmedica from Pfizer, Inc. in 1998, and the biggest purchase during MacMillan’s tenure. He has been CEO for about five years. Stryker has long talked about using some of its big cash stockpile on purchases, but hadn’t spent much prior to this deal. The company has been careful not to overpay and has also been wary of smaller companies that appear to partially generate rapid growth through sales and marketing practices that don’t comply with Stryker’s, MacMillan said in a recent interview.

Reprocessing has been a controversial practice. Many medical device companies claim that reprocessing of single-use devices (SUDs) is an unsafe practice. The U.S. Food and Drug Administration (FDA), however, has been very stringent about reprocessing practices and holds reprocessors to the same standards as OEMs. Types of reprocessed devices range from compression sleeves used externally to maintain circulation during and after surgery to invasive devices used to lift and stabilize the heart during open-heart surgery.

In late 2005 a series of articles in The Washington Post called the practice into question and explored the patient safety issue. 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 and that, consequently, patient safety is being compromised.

In 2008, the Government Accountability Office (GAO) released a report on reprocessed single use devices. According to the GAO, there isn’t enough data to support that the process is unsafe.

“While FDA has made changes to its data collection process regarding reprocessed SUD-related adverse events, the data are not suitable for a rigorous comparison of the safety of reprocessed SUDs compared to similar original SUDs. For such a comparison to be definitive, FDA would have to collect additional data that would identify the type of device and adverse event, the number of original and reprocessed SUDs of that type in use, the number of times each reprocessed SUD was used, and the rate of adverse events associated with the original devices,” according to the report. “With regard to safety-related data outside of FDA, the limited number of peer-reviewed studies related to reprocessing published since 2000 was insufficient to support a comprehensive conclusion on the relative safety of reprocessed SUDs. FDA officials have concluded that the cost of conducting rigorous testing would not be an efficient use of resources, especially given that the available data, while limited, do not indicate that reprocessed SUDs present an elevated health risk. FDA has analyzed its data on reported adverse events related to reprocessed SUDs and has concluded that there are no patterns that point to these devices creating such risks. After reviewing FDA’s processes for monitoring and investigating its adverse event data, we found no reason to question FDA’s analysis.”

In response to some of the possible criticism of the process, MacMillan said: “Conducted in accordance with [FDA] regulations, reprocessing and remanufacturing is one of the most impactful programs in use at hospitals, allowing for significant cost savings to the healthcare system.”

Medical Device Industry Responds to Haiti



Responding to the devastating earthquake that hit the Caribbean nation of Haiti on Jan. 12—the most severe to strike the country in 200 years—the medical device industry has proven that its charitable

From right, trauma surgeon Dr. Andrew Tang, anesthesiologist Karen Embrey, and surgical ICU nurse Claudel Thamas, born in Haiti, board a shuttle bus with medical supplies as doctors and other medical personnel from the Keck School of Medicine at the University of Southern California and nurses from Los Angeles County-USC Medical Center prepare to leave for Haiti on Jan. 16. Photo courtesy of Associated Press/Reed Saxon.
side is stronger than a 7 on the Richter scale. Medtech firms have been quick to support relief efforts, donating millions worth of dollars in aid and much-needed medical supplies.

“There are still thousands of patients with major fractures, major wounds, that have not been treated yet,” said Dr. Eduardo de Marchena, a University of Miami cardiologist who oversaw a tent hospital near the airport where hundreds of severely injured people were being tended, told The New York Times. “There are people, many people, who are going to die unless they’re treated.”

Partners in Health, an organization that has been providing health care in Haiti for two decades, estimated that 20,000 Haitians were dying daily from lack of surgery. But that figure was not backed up by other aid organizations in Haiti and appeared to be much higher than other estimates of the continuing death toll from injuries.

Some of the medical device firms donating money and supplies, include:

Abbott Laboratories, of Chicago, Ill., has donated a total of $2.5 million in cash, pharmaceuticals and nutritional products.

Becton, Dickinson & Co. has donated $550,000 in cash and matching employee contributions and plans to ship another $500,000 in medical equipment, including needles, syringes, IV catheters and blood collection tubes. The Franklin Lakes, N.J.-based firm will split $250,000 between the American Red Cross and the U.S. Fund for UNICEF.

Another $250,000 will go to Partners in Health, AmeriCares, the Catholic Medical Mission Board, Direct Relief International, Heart to Heart International, Project HOPE and Save the Children.

CareFusion, based in San Diego, Calif., has donated 100 CareFusion ventilators and 200 infusion pumps. Additionally, the company has purchased and will donate 100,000 bottles of silver dihydrogen citrate, a water purification product that can purify and make drinkable up to 20 million gallons of water. CareFusion’s donation is valued at approximately $3.1 million.

DePuy Orthopaedics and Spine contributed a supply of trauma-related orthopedic products and instruments. Johnson & Johnson (DePuy’s parent company) partners airlifted disaster relief modules into Haiti that included large quantities of consumer, pharmaceutical, and medical devices and diagnostic products. Sixty pallets of first aid and consumer hygiene kits also were shipped. Antibiotics and pain medications have been donated for use in acute care. Specialized medical devices to assist with traumatic limb injuries are being provided to qualified surgical teams.

Hanger Orthopedic Group, in Bethesda, Md., and its philanthropic organization The Hanger Ivan R. Sabel Foundation has provided $250,000 in funding and orthopedic devices. A direct cash donation of $25,000 and a contribution of $225,000 in orthopedic devices, including neck and back braces, limb immobilizers, fracture boots, wrist splints, and cervical collars, will be donated to two charitable organizations currently providing care in Haiti—Physicians for Peace and Project HOPE.

Kinetic Concepts Inc., of San Antonio, Texas, has contributed more than $2 million worth of advanced wound care products, collaborating with the Surgical Implant Generation Network and Project Medishare to distribute the products. KCI also is developing a program to match donations made by its employees.

• Minneapolis, Minn.-based Medtronic Inc. pledged $1 million through the Medtronic Foundation. Contributions could exceed $1.25 million with product and employee donations. The foundation will match employee donations up to $250,000, with matching funds directed to Partners in Health. An additional $750,000 in grants will be directed to the rebuilding of healthcare infrastructure. The foundation currently is assessing potential nonprofit partners to lead those efforts. Employees worldwide also are offered five days of paid leave to assist in recovery efforts.

Smith & Nephew, with U.S. headquarters in Memphis, Tenn., has donated more than $2 million in implants and surgical instruments to treat bone fractures. Supplies are being distributed by Hope Force International.




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