Navigation Links
A call to prevent unsafe high-risk medical devices from reaching the marketplace
Date:1/22/2013

t surgeries.

"Some patients' mobility will decline to the point of needing walkers or wheelchairs to get around and other serious events up to and including death can occur from subsequent operations," Redberg said. "And that's just for the metal-on-metal implants."

An Obscure Loophole

These high-risk metal-on-metal devices avoid going through clinical trials because of FDA loopholes in the 510(k) clearance, which allow them into the marketplace by claiming "substantial equivalence," which means they are similar to already approved devices or "predicate devices."

"All you have to do is show that your device is substantially similar to a number of other devices," Redberg said. "And some of those devices which were originally approved have been recalled or pulled off the market, but their original approval was still allowed for those 'predicate devices' that claimed 'substantial equivalence.'"

Even voluntarily recalled devices can serve as predicates under the 510(k) clearance as long as the FDA did not require their removal from the market or a court did not find they were misbranded or misrepresented in any way.

"High-risk medical devices should go through randomized clinical trials done in people so we can assure patients they are safe and effective," Redberg said. "Even the more stringent pre-market approval (PMA) process doesn't always mean that you actually have gone through randomized clinical trials, so we have to make sure these devices not only go through pre-market approval but randomized clinical trials as well."

Questions to Ask

For patients who are in the process of undergoing a medical procedure, Redberg suggests they stay informed and ask many questions.

"Just like for any kind of procedure, I would ask, 'Are there scientific data that show this procedure or device is going to help me?'" Redberg said. "'Has it been studied in clinical trials? Has it been studi
'/>"/>

Contact: Leland Kim
leland.kim@ucsf.edu
415-502-6397
University of California - San Francisco
Source:Eurekalert  

Page: 1 2 3

Related biology news :

1. Preventing home invasions means fighting side-by-side for coral-dwelling crabs and shrimp
2. Commonly used diabetes drug may help to prevent primary liver cancer
3. New discovery may lead to effective prevention and treatment of graft-versus-host dsease
4. How many calories does it take to reach childhood obesity prevention goals?
5. Gut microbiota transplantation may prevent development of diabetes and fatty liver disease
6. New product to replace fishmeal could help prevent global food shortage
7. Clinical trials for Alzheimers disease preventative drug to begin early 2013
8. Preventice Expands Options for Wireless Patient Monitoring with Qualcomm Life
9. New paints prevent fouling of ships hulls
10. IOC recognizes University of Calgary Sports Injury Research Prevention Centre
11. Preventing the immune system from going haywire during sepsis
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
A call to prevent unsafe high-risk medical devices from reaching the marketplace
(Date:7/11/2014)... creating a new professorship in tissue engineering to ... Molecular Engineering and the Marine Biological Laboratory, supported ... and Eugene Bell Foundation., The Eugene Bell Professorship ... for Molecular Engineering. That endowed chair holder also ... Eugene Bell Center for Regenerative Biology and Tissue ...
(Date:7/11/2014)... Cell scientists have set a "mouse TRAP" to capture ... a recent study published in the Journal of ... a technique called TRAP to extract cellular and genetic ... by scientists at the Rockefeller Institute for Medical Research ... the protein-making machinery, or ribosomes, of the cell type ...
(Date:7/11/2014)... from The Chinese University of Hong Kong, BGI and ... linked to salt tolerance, with implication for improving this ... published online in Nature Communications provides an ... improvement. , Soybean is an important crop for the ... have less genetic diversities than their wild counterparts. Among ...
Breaking Biology News(10 mins):New professorship in tissue engineering links molecular engineering, marine biology 2BGI reports a novel gene for salt tolerance found in wild soybean 2
... our pleasure to welcome you to the SIBs 10th ... Switzerland. Amongst them, we are particularly happy to welcome ... will take place on Wednesday, 24th September at the ... heart of science Wednesday, 24 September ...
... know it,s good for you in other ways, but ... lung disease? It just might. According to recent ... lung concentrations of NRF2-dependent antioxidants, key components of the ... the severity of chronic obstructive pulmonary disease (COPD) in ...
... ships, that can sail throughout the body via the ... system and ferry their cargo of anti-cancer drugs and ... undetected. In a forthcoming issue of the Germany-based ... San Diego, UC Santa Barbara and MIT report that ...
Cached Biology News:COPD? Eat your veggies 2Researchers develop nano-sized 'cargo ships' to target and destroy tumors 2Researchers develop nano-sized 'cargo ships' to target and destroy tumors 3Researchers develop nano-sized 'cargo ships' to target and destroy tumors 4
(Date:7/11/2014)... , July 11, 2014 Research and ... Transfection Technology Market - Global Industry Analysis, Size, Share, ... their offering. http://photos.prnewswire.com/prnh/20130307/600769 ... nucleic acids (either DNA or RNA) into cells. This ... of cancer cells and protein metabolism by affecting the ...
(Date:7/11/2014)... Cayenne Medical, Inc., a privately ... soft tissue reconstruction segment, announced the worldwide launch ... involving the shoulder and extremities. The SureLock System ... deployment method. The unique delivery eliminates manual tensioning ... or anchor displacement (also commonly know as anchor ...
(Date:7/10/2014)... (PRWEB) July 10, 2014 Terascala, the ... announced that Alan Swahn, a former vice president of ... team as vice president of marketing. Terascala’s software when ... and NetApp create the highest performance and most reliable ... appointed to guide Terascala’s channel expansion and broaden its ...
(Date:7/10/2014)... CA (PRWEB) July 10, 2014 Senior ... institutions and professional associations, addressed the challenges of “Reducing ... Medical Device Industries” through strategic sourcing. Describing the partnership ... with the Supply Chain Management Institute ( SCMI) ... event on June 24 at the Kroc Institute of ...
Breaking Biology Technology:International Transfection Technology Market - Industry Analysis, Size, Share, Growth, Trends and Forecast to 2019 2Cayenne Medical Launches SureLock™ All-Suture Anchor System for Shoulder and Extremity Surgery 2Cayenne Medical Launches SureLock™ All-Suture Anchor System for Shoulder and Extremity Surgery 3Terascala Expands Executive Team 2Terascala Expands Executive Team 3Biotech & Biopharm Supply Chain Management Executives Launch BSMA in San Diego 2Biotech & Biopharm Supply Chain Management Executives Launch BSMA in San Diego 3Biotech & Biopharm Supply Chain Management Executives Launch BSMA in San Diego 4
... Its one thing for a dictator to control a ... its quite another for a totalitarian regime to block ... wireless laptop. , ,Perhaps that explains why some global ... Internet away from its American roots and substitute United ...
... Madison, Wis. Wisconsin businesses and individuals are ... New Products Awards Competition, which recognizes benefits coming ... emerging technologies. , ,Governor's New Products Awards ... (1,000 or more employees); large companies (500-999 employees); ...
... Madison Area Technical College's Network Security Specialist degree ... threats to computer systems and data, has earned federal certification ... Systems . , ,It is only one of two in ... MATC had to match its curriculum precisely to what the ...
Cached Biology Technology:Democracy and the Net - How American ideals are quietly influencing the world 2Democracy and the Net - How American ideals are quietly influencing the world 3
... Biomek FXP is the latest entry in the ... positional accuracy and increased robustness, it can meet ... can be configured with either one or two ... Biomek FXP sets the standard for flexible laboratory ...
... The Biomek FX P is the ... hardware design for greater positional accuracy and increased ... about any application. It can be configured with ... large deck capacity, the Biomek FX P ...
... reduce the chance of error. Thats the ... using Beckman Coulters extensive experience in laboratory ... the CEQ 8000 is a fully automated ... the capillary array with a patented linear ...
... Detergent-OUT Kit is a simple high performance ... Removes detergents without significant dilution of ... solution on the Detergent-OUT Spin column and ... Med column is suitable for removing detergents ...
Biology Products: