Nurse Blogs

Since April, 1,256 people have been infected with Salmonella Saintpaul.  In June, the FDA blamed certain kinds of tomatoes for the outbreak, and issued a warning to consumers to avoid them.  But long after growers in affected areas stopped shipping tomatoes, and the produce was removed from stores and shelves, people kept getting sick.  What’s more, not a single tomato sample  tested by the FDA came up positive for Salmonella Saintpaul.

It wasn’t until earlier this week that the FDA finally announced that it had found the Salmonella strain  on a single jalapeno pepper at a Texas warehouse.  Now the agency is telling consumers to stay away from fresh jalapenos.

Critics of the FDA say that it and the Centers for Disease Control (CDC) were hampered by their own tunnel vision concerning tomatoes.   Health officials at the CDC and in New Mexico - which had the second highest number of illnesses - identified tomatoes as the culprit behind the outbreak in June, and no one ever looked back.  History also played a part, as tomatoes had caused at least a dozen Salmonella outbreaks in the past several years.

Jalapenos, on the other hand, had never been involved in an outbreak.   The hot peppers were not even listed on the questionnaire health officials used to interview patients early in the outbreak.

The FDA also was deterred in its hunt for tainted tomatoes because of poor record-keeping and the common practice of mixing and processing tomatoes from many different farms together.  Even if the FDA had found a contaminated tomato, figuring out what packing plant, processing facility, and farm field it came from would have been difficult, if not impossible.

Both the FDA and some prominent lawmakers want to enact regulations that would enhance the FDA’s ability to trace the source of contaminated food.  Traditionally, the agricultural industry has resisted such efforts, fearing liability.  But that may be changing, especially now that tomato growers have suffered millions in losses, in part because of the FDA’s inability to trace this Salmonella outbreak.   In fact, the Produce Marketing Association, an industry trade group, is now working on its own plan to set up a global, electronic tracking system for produce.

In the meantime, the FDA has lifted its tomato warning, but says that they could have still played a role in the outbreak.   And while jalapenos seem to be a culprit, the FDA has not ruled out other foods, including cilantro or Serrano peppers, as possible suspects.

The list of fines assessed against the American Red Cross over the past several years is long.  Just this past June, the Food & Drug Administration (FDA) fined the organization $1.7 million after the agency found that the Red Cross had washed six units of red blood cells with hypertonic saline solution.  Sterile normal saline solution should always be used for this purpose. The defective red blood cells were transfused to three patients in 2006 and 2007 at three Red Cross chapters in the Northeast and Southeast.   

The June fine followed another in February, when the FDA ordered the Red Cross to pay $4.6 million after the agency discovered 113 incidents in which the organization collected blood from an ineligible donor, failed to undertake proper testing, or shipped the collected blood at wrong temperatures.

In September 2006, the Red Cross was penalized $4.2 million for non-compliance with federal and FDA regulations concerning the collection of blood products.  In that incident, the fine was levied for the American Red Cross’s “failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products.”  The FDA said that the fines were “assessed under an amended 2003 consent decree that called for significant financial penalties when” the American Red Cross “fails to comply with FDA regulations and consent decree provisions designed to ensure the safety of the nation’s blood supply.”

The 2003 consent decree required the American Red Cross to “establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; enhance training programs; and improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions.”  Between the conception of the consent decree and the September 2006 fine, the FDA levied another $5.7 million in fines against the American Red Cross.

Despite the consent decree and subsequent fines, apparently not much has improved at the American Red Cross.  According to The New York Times, the FDA has become so frustrated over the situation that in January, agency commissioner Andrew von Eschenbach attended a meeting of the Red Cross board of directors.  The commissioner warned meeting attendees that they could face criminal charges for their continued failure to bring about compliance.

The Red Cross controls 43 percent of the country’s blood supply.  According to FDA records, some of the safety lapses at the Red Cross that resulted in fines put patients in danger, and exposed them to diseases like hepatitis, malaria and syphilis.  Despite repeated incidents, the FDA says the Red Cross has failed to investigate the results of its mistakes, so no one knows for sure if any of the incidents resulted in patient injuries.

Hijazi implanted an amplatzer muscular VSD to close a hole between the lower chambers of the heart in a child from Massachusetts.  The device was manufactured by Minneapolis-based AGA Medical and was available for nine years in Jordan before finally being approved in the US in 2007.  Hijazi said over 90 percent of the medical devices he uses on children are “off-label”–approved by the U.S. Food and Drug Administration (FDA) for other uses, such as adult use.  “We take responsibility as physicians for using unapproved devices on kids,” he said.

In the years 1989-2000, only one stent—a device that props open heart vessel walls—was appropriate for pediatric use, said Thomas Forbes, director of cardiac catheterization at Children’s Hospital of Michigan in Detroit.  “In the ’90s, we lost lives in the cath lab.  Patients have died on the table because we were using stents that were made for adults and weren’t flexible enough,” Forbes said.  Having to use adult-sized devices on children can be the difference between “potentially dangerous care and very good care,” he said.  Three stents can be modified for pediatric use; none are approved for such use in the US, Forbes said.  Other pediatric specialists voice similar complaints, saying they either use devices approved for adults or hand-make their own.

Companies often focus on adult-sized devices because the market is bigger.  Also, heart diseases in children, are likelier to be congenital and rare; in adults they are more likely to be progressive, and common.

Meanwhile, a law signed late last year provides financial incentives to companies for making devices for children; however, those companies must also track patients at their own expense.  “It’s a paperwork nightmare. They have to commit resources and follow these patients forever,” Forbes said.  There are other issues and some solutions, for instance a significant tax credit for research and development in this area, but that is not being discussed, Federici said.  Richard Ringel, a pediatric cardiologist at Johns Hopkins Hospital, said he is awaiting the next innovation in cardiovascular medicine:  Stents that dissolve inside the body   “… do you think Johnson & Johnson is going to be interested in doing this for babies?  No, they want to do it for (adult) coronary patients because the numbers are so much larger,” Ringel said.

“Development (of pediatric devices) is time-consuming, there are regulatory hurdles, and how do you recoup your investment?  The math generally does not work,” said Edwards Chairman and Chief Executive Michael Mussallem, who is president of AdvaMed, who added that it comes down to economics and physicians are just used to getting by with what they have.