Capnography, Patient Safety

Can There Be Too Much FDA Oversight?

by Michael Wong

Update (Jan 23, 2012):

The FDA “significantly narrowed” its ban on these capnography products. For the full story, please see click here

Thanks, Dr. Julian Goldman for pointing this out to us!

As a result of this issue, a number of publications and magazines have expressed interest in the issue of monitoring and patient safety. If you’d like to be included in this panel discussion (emailed Q&A) on this matter, please contact Mike at mike.ppahs@gmail.com

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.”

One thought on “Can There Be Too Much FDA Oversight?

  1. I nave been a consultant to aerospace and medical device companies for over 25 years. The hazards in the PCA systems can be eliminated or controlled with high return on investment. Unfortunately most device companies don’t use the right risk analysis tools, such as Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA), and Failure Mode & Effects Analysis (FMEA), during the early design of the products. These are recommended in the international standard ISO14971 for medical devices. Some use FMEA but most of them use it very poorly. FDA expects manufacturers to use this standard but it is not mendatory. If FDA just makes sure that the manufacturers use these tools properly, the safety hazards will drop by at least 80% quickly. I am talking from my experience of consulting to aerospace companies also.
    Dev Raheja-author “Safer Hospital Care.”

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