To read more about these brilliant individuals, click here to go to MIT News.
Showing posts with label Institute of Medicine. Show all posts
Showing posts with label Institute of Medicine. Show all posts
Tuesday, October 13, 2009
Two MIT professors elected to the Institute of Medicine
Thursday, September 24, 2009
501(k) to be evaluated by the IOM
Do you follow the FDA press releases? Here's one that's interesting (if you like to follow information regarding medical devices). How does one approve a medical device? I was just discussing this topic with several people over the past few days. You can get a medical device on the market before you test it on any humans. Well, the FDA would like the IOM to study the whole 510(k) process. Here's the scoop:
FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.
The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.
“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, M.D., acting director of CDRH. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”
The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:
* Make safe and effective devices available to consumers
* Promote innovation in the medical device industry.
During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for CDRH to review the adequacy of the premarket notification program in meeting these two goals.
Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.
As part of the study, the IOM will convene a committee to answer two principal questions:
* Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
* If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?
The $1.3 million IOM review is slated for completion in 2011, and is one of six priorities Dr. Shuren has outlined for CDRH. Others include:
* Creating an internal task force on the use of science in regulatory decision-making
* Developing an effective compliance strategy
* Optimally integrating premarket and postmarket information
* Increasing transparency in decision-making
* Establishing clear procedures to resolve differences of opinion.
The IOM will hold two public workshops during the next nine months as part of its review, and will publish a final report in March 2011 containing its conclusions and recommendations.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.
Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval.
Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
To read the complete FDA press release, click here.
FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.
The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.
“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, M.D., acting director of CDRH. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”
The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:
* Make safe and effective devices available to consumers
* Promote innovation in the medical device industry.
During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for CDRH to review the adequacy of the premarket notification program in meeting these two goals.
Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.
As part of the study, the IOM will convene a committee to answer two principal questions:
* Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
* If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?
The $1.3 million IOM review is slated for completion in 2011, and is one of six priorities Dr. Shuren has outlined for CDRH. Others include:
* Creating an internal task force on the use of science in regulatory decision-making
* Developing an effective compliance strategy
* Optimally integrating premarket and postmarket information
* Increasing transparency in decision-making
* Establishing clear procedures to resolve differences of opinion.
The IOM will hold two public workshops during the next nine months as part of its review, and will publish a final report in March 2011 containing its conclusions and recommendations.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.
Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval.
Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
To read the complete FDA press release, click here.
Wednesday, May 20, 2009
Reducing Resident Work Hours Could Cost $1.6 Billion!
The IOM (Institute of Medicine) has a new report that recommends, among other changes, improved adherence to the 2003 Accreditation Council for Graduate Medical Education (ACGME) limits, naps during extended shifts, a 16-hour limit for shifts without naps, and reduced workloads.
The New England Journal of Medicine (NEJM) has a story about the "Cost Implications of Reduced Work Hours and Workloads for Resident Physicians." What are these cost implications? $1.6 billion! Not million, but billion! The authors of this study conclude that "Implementing the four IOM recommendations would be costly, and their effectiveness is unknown. If highly effective, they could prevent patient harm at reduced or no cost from the societal perspective. However, net costs to teaching hospitals would remain high." The reference year in this study was 2006, so imagine the implications for 2009 and beyond!
I remember when resident work hours were capped at 80 hours per week. That occurred in 2003. If you stop to think about it, 80 hours is still a lot of work! It's practically two full-time jobs! Many hospitals and universities had tremendous difficulty implementing proper changes to accommodate this new requirement. They tried different things like a "night float" system to "call-free weeks" to "take one day off this week" to "this just isn't working so don't tell anyone and continue working your 120 hours this week."
So what's going to happen? Will resident work hours get reduced from 80 hours to something even less?
Thursday, April 30, 2009
IOM Report
I'm still in the process of reading the lengthy IOM (Institute of Medicine) report that recently came out. The interpretation of the IOM report may have a significant impact on the CME (continuing medical education) industry. Stay tuned...
Tuesday, April 28, 2009
IOM
The IOM has recently come out with some recommendations regarding the relationships between healthcare professionals and industry. I'm still reading and digesting, so I'm not going to provide any comments right now, but stay tuned...
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