Navigation Links
Analysis calls for medical device information to better serve patients and doctors
Date:1/31/2008

The approval process for medical devices does not involve the same rigorous review used for pharmaceuticals, and this needs to change in order to improve health outcomes, say researchers from the University of California, San Francisco.

The UCSF team analyzes the problem and proposes steps toward a solution in a Perspectives article in the January 2008 issue of the Journal of General Internal Medicine devoted entirely to medical devices. UCSF researchers Mitchell D. Feldman, MD, MPhil, and Jeffrey A. Tice, MD, edited the issue.

The team concludes that after a device achieves Food and Drug Administration (FDA) approval, a technology assessment by an independent organization can help identify medical devices that are truly beneficial and safe. The researchers also suggest that this assessment follow an evidence-based approach to information-gathering that includes data on the devices success in clinical application. This type of data would be valuable for increasing health professionals awareness of the potential promise and pitfalls of new technology, the team writes.

These days, patients are asking their doctors for the newest technologies from genetic tests to specific radiation treatments, and many physicians dont know where to turn for the latest evidence-based information, said Feldman, professor of medicine at UCSF and corresponding author of the study. Sometimes, the only information out there is what the manufacturer provides.

The UCSF analysis evaluated the federal review process, the method by which devices come to market, how the scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technologys medical benefit to patients.

Out of the thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the kind of scrutiny required for new drugs, according to information cited in the report. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Plus, the agency relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients, the report states.

FDA approval should be the start of the process toward clinical application, not the end, Feldman said. Physicians and patients just arent aware of the limitations of the FDA process of initial assessment and oversight of new medical technologies. Assessments by objective entities are a necessary addition to FDA approval - so that deficiencies in clinical evidence, and patient safety issues that may arise after approval, are recognized before widespread adoption into clinical practice.

The purpose of independent review organizations is to provide transparent, objective evaluations of new medical devices and to inform the public, physicians and policy makers, Feldman said. Some, like the California Technology Assessment Forum (CTAF), which is profiled in the Perspectives article as a case study, have meetings open to the public and populate their review board with experts in medicine, representatives from medical professional societies, technology manufacturers, policy makers and insurance providers, among others. CTAF selects devices for review based on their impact and the availability of relevant clinical data.

The UCSF Division of General Internal Medicine currently subcontracts with CTAF to provide technology assessments.

In order to be considered in an assessment, CTAF requires that information already be published or accepted by a peer-reviewed journal. This encourages companies to make their trial results available to the public, said Tice, attending physician in the Division of General Internal Medicine at UCSF and co-author of the study. CTAF also requires improvements in patient-oriented outcomes, not surrogate markers. For example, we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size.

Topics can be brought to the boards attention by all potential stakeholders, including health plans, industry, professional societies and consumer groups. Once findings are presented, the technologys manufacturer has the opportunity to give testimony, and eventually the board makes recommendations based on the body of information presented.

We cover it all, from evaluating technologies used in genetic testing, radiation treatment for prostate cancer, digital mammography, computerized prosthetics and pre-natal screening to Positron Emission Tomography scans, Tice said.

Eventually, the authors suggest, independent review boards should summarize their findings into uncomplicated take-home messages that patients can easily find on their own.


'/>"/>

Contact: Lauren Hammit
lhammit@pubaff.ucsf.edu
415-476-2557
University of California - San Francisco
Source:Eurekalert

Related biology news :

1. More comprehensive analysis of Klamath River basin needed to aid decision makers
2. Human clones: New U.N. analysis lays out worlds choices
3. Powerful integration of lipid metabolic profiling with gene expression analysis
4. Tumor genome analysis unveils new insights into lung cancer
5. Analysis of breast and colon cancer genes finds many areas of differences between tumors
6. Interacting protein theory awaits test from new neutron analysis tools
7. DNA analysis shows true dispersal of protozoa
8. Ginkgo SRMs: Tools for product analysis/quality
9. Island monkeys do not recognize big cat calls
10. UC Davis bird-flu expert calls for changes in early-warning system
11. Rice University expert calls for coordination in nanotechnology research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2016)... RATON, Florida , March 29, 2016 ... or the "Company") LegacyXChange "LEGX" and SelectaDNA/CSI Protect are ... DNA in ink used in a variety of writing ... theft. Buyers of originally created collectibles from athletes on ... through forensic analysis of the DNA. ...
(Date:3/18/2016)... --> --> Competitive Landscape Analysis ... Physical infrastructure and Perimeter Surveillance & Detection Systems ... and the continuing migration crisis in the Middle ... led visiongain to publish this unique report, which is crucial ... & security companies in the border security market and the ...
(Date:3/14/2016)... HANOVER , Allemagne, March 14, 2016 /PRNewswire/ ... http://www.apimages.com ) - --> - ... ) - --> ... les solutions biométriques, fournit de nouveaux lecteurs d,empreintes ... lecteur LF10 de DERMALOG sera utilisé pour produire ...
Breaking Biology News(10 mins):
(Date:5/18/2016)... ... May 18, 2016 , ... Tech Coast Angels (TCA) today announced ... Therapeutics at the annual ACA Summit last week in Philadelphia. , The ... ACA’s member angel groups. It is the highest honor available for an early-stage company ...
(Date:5/18/2016)... ... May 18, 2016 , ... STACS DNA Inc., the sample tracking software ... report sexual assault kit processing to help them save time and reduce errors. , ... kits to be processed and victims informed of results. Due to a previous lack ...
(Date:5/18/2016)... ... May 18, 2016 , ... Ryan Benton was diagnosed with ... in the late teens to early twenties. DMD is a relatively common progressive genetic ... age of 22, Benton’s condition was critical. He met with the founder of the ...
(Date:5/17/2016)... ... May 17, 2016 , ... ... a healthcare consultancy based in Saudi Arabia, have formed a partnership to bring ... providers in the Kingdom of Saudi Arabia (KSA). , The partnership addresses ...
Breaking Biology Technology: