Medical Device Initiative

Letter From New Democrat Health Care Task Force to FDA on Unique Device Identification System

The three co-chairs of the New Democrat Health Care task Force – Reps. Allyson Schwartz, Kurt Schrader and Bill Owens – sent FDA a letter inquiring about the status of the agency’s final regulations to establish a unique device identifier (UDI) system and database.

Pew Comments on Draft Recommendations for Meaningful Use, Stage 3

The Pew Charitable Trusts submitted comments on preliminary recommendations regarding Stage 3 meaningful use objectives and standards for electronic health records (EHRs) to the Office of the National Coordinator for Health Information Technology. These comments follow remarks at recent meetings of the Health Information Technology (HIT) Policy Committee and HIT Standards Committee.

''Need to Know: Medical Devices''

The PBS program "Need to Know" devoted a portion of their March 22 program to discuss medical devices. Joining host Jeff Greenfield on the program was Pew's Dr. Josh Rising, project director of the medical devices initiative at The Pew Charitable Trusts.

''The Loophole That Keeps Precarious Medical Devices in Use''

The U.S. Food and Drug Administration announced last month that it will classify metal-on-metal hip implants as high-risk devices. That comes after the artificial joints were found to have failed at high rates, causing disability and meaning additional surgery for thousands of people. But hundreds of other potentially high-risk medical devices remain in use without what many consider to be adequate testing

Comments on the Health Information Technology Patient Safety Action and Surveillance Plan

In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology, Consumers Union, the National Women's Health Network, the National Research Center for Women and Families, the Trust for America's Health, and The Pew Charitable Trusts urge the ONC to promote adoption of the unique device identification (UDI) system for medical devices to improve the safety of medical care.

''Let The Sunshine In: CMS Releases Transparency Rule''

"After 15 months of delay, the Centers for Medicare & Medicaid Services has finally released the long-awaited Sunshine Act rule, which establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organizations."

Comments on Stage 3 of the the Meaningful Use of Health Information Technology

In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology and The Pew Charitable Trusts urge the ONC to incorporate medical device identifiers developed under the FDA’s unique device identification (UDI) system into both electronic health record (EHR) certification criteria and Stage 3 meaningful use (MU) objectives.

''Drug, Device Makers Anxiously Await U.S. Doctor-Payment Disclosure Rule''

''Drug and medical-device makers are bracing for a new U.S. rule that will require them to report physician-payment information to the government--a rule some companies and doctors fear will be overly broad and could mislead the public.''

Strengthening Our National System for Medical Device Postmarket Surveillance

The Medical Device Initiative submitted comments to the U.S. Food and Drug Administration concerning the FDA's National Medical Device Postmarket Surveillance Plan, "Strengthening Our National System for Medical Device Postmarket Surveillance."

''FDA Stakeholders Worry About Sequestration''

"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."

Expert Profile: Josh Rising

Josh Rising, Project Director, Medical Device Initiative

A Healthy Dose of Bipartisanship

Passed by Congress on June 26 and signed by President Obama on July 9, the FDA Safety and Innovation Act will increase inspections of foreign manufacturers that supply 80 percent of the ingredients in our pharmaceuticals, putting American companies on the same footing as their foreign competitors. In addition, it requires drug makers to hold their suppliers to high standards.

''Delays and Difficulties in Assessing Metal-on-Metal Hip Implants''

More than 500,000 U.S. patients have received metal-on-metal hip prostheses, most of which were implanted between 2003 and 2010. These prostheses entered the market through the 510(k) pathway at the Food and Drug Administration (FDA), whereby manufacturers need only demonstrate substantial equivalence to a device already on the market to gain approval. Unfortunately, there is now compelling evidence that these implants fail at a higher rate than hip prostheses made of other materials.

Pew Applauds Enactment of User Fee Legislation, Urges Its Swift Implementation

President Barack Obama today signed into law the Food and Drug Administration Safety and Innovation Act, which supports the U.S. Food and Drug Administration’s drug and device reviews and includes other measures to benefit patients.

''Drug, device reform gets bipartisan push''

"The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms."

''FDA Probing Safety of Metal-on-Metal Hip Implants''

"While thousands of Americans have benefited from hip replacements over the years, problems with metal-on-metal implants can lead to troubles requiring surgery to replace defective devices, experts say. Writing earlier this month in the New England Journal of Medicine, Pew's Joshua Rising and colleagues said that "there is now compelling evidence that these implants fail at a higher rate than hip prostheses made of other materials."

Pew Commends Congress for Passing FDA User Fee Legislation

The U.S. Senate today joined the House in passing Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the U.S. Food and Drug Administration’s drug and device reviews. The bill now goes to President Obama to be signed and implemented.

''FDA user fee bill gives agency new powers to inspect overseas prescription drug plants''

"A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the U.S. Senate."

Facilitating Medical Device Innovation: De Novo Reform

The de novo process as it exists now is not achieving its purpose of streamlining the path to move new devices onto the marketplace and has instead added unnecessary and time-consuming requirements.

Improving Medical Device Safety Through Better Surveillance

In 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.” By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues.

Pew's Allan Coukell Discusses FDA Reform Act of 2012

Allan Coukell, deputy director of the Medical Safety Project of the Pew Health Group, talked about drug safety on C-SPAN.

Pew Applauds Passage of Bipartisan User Fee Legislation by U.S. House of Representatives

The U.S. House of Representatives today passed bipartisan legislation to ensure that the U.S. Food and Drug Administration (FDA) has the funds it needs to approve products that improve health and protect consumers from unnecessary risks.

''Senate bill aims to increase drug import safety''

"U.S. regulators would inspect more drug manufacturing facilities in China, India and other foreign countries as part of legislation approved Thursday that aims to step up oversight of the nation's imported pharmaceutical supply."

Testimony before the Committee on Energy and Commerce Subcommittee on Health

U.S. House of Representatives PDF Download Since 1992, user fee agreements have given FDA significant and sustained resources that allow the agency to review new products quickly. In fact, preliminary findings of a study that Pew has funded show that FDA reviews new drugs faster than its cou

Testimony before the Senate Committee on Health, Education, Labor and Pensions

Allan Coukell, Director of Medical Programs, Pew Health Group: Chairman Harkin, Ranking Member Enzi, and members of this committee, thank you for the opportunity to testify about the importance of the user fee agreement legislation to patients.

Expert Profile: Allan Coukell

Allan Coukell, Deputy Director, Medical Programs

Allan Coukell

Allan Coukell oversees medical programs, including the Pew Prescription Project, the Drug Safety Project, the Antibiotics and Innovation Project, the Medical Device Safety project and the FDA Modernization Initiative, as well as other activities related to medical products and services.

Josh Rising

Dr. Josh Rising oversees the Medical Device Initiative, which seeks to facilitate innovation of certain new medical devices and to strengthen medical devices by improving the tracking of their safety once they are on the market.