Navigation Links
Physician-Patient Alliance for Health & Safety: Can There Be Too Much FDA Oversight?

CHICAGO, Jan. 19, 2012 /PRNewswire/ -- According to Marcia Crosse (Director, Health Care at GAO), FDA's ability to fulfill its mission to protect American health has been compromised. In her comments on why oversight of medical devices was placed on GAO's High-Risk List, she says:

"The Food and Drug Administration plays a key role in protecting the health of all Americans. FDA's role is far-reaching: from over-the-counter pain relievers to vaccines to prescription drugs to every medical device in your doctor's office or your local hospital. FDA is responsible for assuring the safety and effectiveness of every medical product before it is approved. After approval, FDA has a duty to ensure the continuing safety of hundreds of thousands of different medical products, regardless of whether they are manufactured here or abroad, and more than eight million shipments of medical products arrive at US ports in a single year. But, FDA is having difficulties in meeting its responsibilities."

With so many tasks, resource management is one of many priorities. As the GAO points out, "FDA has encountered difficulties in fulfilling its growing medical product responsibilities and does not have reliable estimates of its resource requirements or data showing its workload and accomplishments in some areas."

Moreover, strategic planning is a necessity. Says the GAO in its report, "Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed":

"To help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should ensure, as it completes its strategic planning process for the overseas offices, that it develops a set of performance goals and measures that can be used to demonstrate overseas office contributions to long-term outcomes related to the regulation of imported products ..."

So, with these resource and strategic planning issues that need solving, did the FDA fulfill its oversight role when it banned the importation of capnograph products into the US?

The ability of capnographs to measure the concentration of carbon dioxide that a person breathes out in exhaled air is an essential device for maintaining patient safety. Not only are capnographs the standard of care in hospital operating rooms, but capnographs are increasingly being used outside the operating room.

Explains David Watson (Vice President at ECRI):

"One instance where the use of capnographs outside the operating room benefits patient safety is patient-controlled analgesia (PCA). In 2011, ECRI listed the need to monitor for oversedation during use of PCA infusion pumps as one of the top ten health technology hazards. In that report, PCA therapy and the need for effective monitoring using capnography and/or pulse oximetry in order to detect respiratory depression monitored by continuous oximetry and capnography was described. Again, in 2012, ECRI has named infusion pumps as one of the top health technology hazards."

(ECRI Institute is an independent, nonprofit organization that researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care.)

As a result, FDA's actions could adversely affect patient safety. Says Dr. Melissa Langhan (Assistant Professor of Pediatrics, Emergency Medicine, at Yale School of Medicine):

"While I'm sure the FDA is doing what it thinks is in the best interest of the patient, a ban on this product could severely affect patients in a negative direction.  There is mounting evidence for this device in the detection of respiratory events prior to current standards, acting as an early warning system for healthcare providers.  There have been numerous accounts of patient deaths that could have been averted with this monitoring device – why put more patients at risk?"

Trevor Lewis, a medical device regulations expert, with substantial FDA experience, suggests a more balanced approach, "Any medical device denied market access cannot fulfill its intended purpose and will be likely to leave some patients at increased risk. The best way forward here means to me a regulatory system that is effective and cost effective, always has the patients' best interests at heart and everyone aims for the highest ethical, moral and technical standards possible within reasonable budgets."

About Physician-Patient Alliance for Health & Safety

Physician-Patient Alliance for Health & Safety (PPAHS) is an advocacy group devoted to improving patient health and safety. PPAHS is composed of physicians, patients, individuals, and organizations. Our website is

PPAHS is currently developing a caregiver safety checklist targeted towards patient-controlled analgesia and sedation. For expert commentary on this checklist initiative and how it may help to prevent "dead in bed" syndrome with patients after surgery, please see

For more information or to contact PPAHS, please email Mike Wong at

SOURCE Physician-Patient Alliance for Health & Safety
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Alliance Pharmaceutical Corp. Updates Oxygent(TM) Clinical Development Plan
2. Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe
3. Lung Cancer Alliance Commends NCCN on Screening Guidelines
4. Lung Cancer Alliance Hails Announcement of New Erbitux(R) Data
5. Alliance Pharmaceutical Corp. Announces Approval of Proposed Actions at Annual Shareholders Meeting
6. Vermillion Renews Strategic Alliance Agreement With Quest Diagnostics, Inc.
7. Ambrx and Merck Serono Expand Collaboration Through ARX424 Multiple Sclerosis Drug Development Alliance
8. ICON and MedAvante Sign Alliance Agreement
9. Pharmacyclics announces Global Strategic Alliance with Les Laboratoires Servier
10. Oxford BioTherapeutics and GlaxoSmithKline Form Strategic Alliance to Develop Novel Cancer Therapeutic Antibodies
11. SIRO Clinpharm and CambReg Ltd Strategic Alliance to Offer Regulatory Services in Europe
Post Your Comments:
(Date:11/25/2015)... 2015  Amgen (NASDAQ: AMGN ) today announced ... the United States (U.S.) Food ... candidate to Humira ® (adalimumab). Amgen believes this ... the FDA and represents Amgen,s first BLA submission using ... , M.D., executive vice president of Research and Development ...
(Date:11/25/2015)... -- On Tuesday, November 24, 2015, the jury ... Medical Technology, Inc. for product liability and misrepresentation ... device, awarded $11 million in favor of Plaintiff ... three days of deliberations, the jury found that ... and unreasonably dangerous, and that Wright Medical made ...
(Date:11/25/2015)... Nov. 25, 2015 Allergan plc (NYSE: AGN ... the New York State Attorney General,s ... Sherman Act, and other statutes with the Attorney General over ... to cease marketing and selling the now generic version of ... admits no liability, has released its counterclaims against ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., ... the 61st annual Employee Benefits Conference. The Employee Benefits Conference was hosted by ... through Wednesday, November 11th, 2015. The conference was held at the Hawaii Convention ...
(Date:11/26/2015)... ... November 26, 2015 , ... Indosoft Inc., developer and distributor of ... server to improve system efficiency and reliability. , The new Q-Suite 6 platform is ... the system avoids locking itself into a specific piece of software for many key ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... preparing the perfect dish and pleasing the palates of attendees is of the ... a dish to a seasonal get-together, give these recipes a try this holiday ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... offering factory direct sauna parts and accessories. , Sauna accessories help improve the ... bather’s style and personality. From basic styles for the purist looking for simplicity ...
(Date:11/25/2015)... ... ... On November 10, 2015, Bohrer Brady, LLC filed a class and collective ... home health care worker who provided companionship services for the elderly, ill or disabled ... Humana, Inc., Humana at Home, Inc., and SeniorBridge Family Companies (CT), Inc. since January ...
Breaking Medicine News(10 mins):