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U.S. Department of Health and Human Services

Show #2, March 2002

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Show #2, March 2002

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 New Medical Products

March2002FDA Patient Safety News Homepage
Camera Pill Cleared for Marketing (Video, print, and e-mail functions)
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The FDA has recently cleared a tiny video camera that a patient can swallow, and that will take video pictures of the small intestine. It's called the Given Diagnostic Imaging System, and it's made by Given Imaging Ltd., of Norcross, Georgia.

Here's how it works. What the patient swallows is actually a capsule, a little more than an inch long, that contains the camera, a light, a transmitter, and batteries. As the device passes through the small bowel, it takes video pictures and transmits them via radio signals to a small recorder on the patient's belt. The images can then be interpreted by the physician. The capsule, which is not reusable, passes out of the body during normal defecation in about 8 to 72 hours.

The clinical use for this device is to visualize the small intestine when there's chronic or unexplained rectal bleeding and small bowel disease is a concern. It should only be used after the patient has received other imaging procedures to visualize the small bowel.

It's interesting to note that endoscopes can visualize only the upper part of the small intestine, whereas the camera can see its entire length.

There are circumstances where the camera can't be used. For example, when the patient has a cardiac pacemaker or other implanted electromagnetic device. And also when the patient has an intestinal blockage, or a significantly narrowed small bowel. In fact, before using the camera, an x-ray exam of the small bowel should be done if it's suspected that it may be too narrow.

And while the camera is in place, the patient should avoid bending, or stooping, or vigorous movement. Also, the video pictures taken by the camera can be lost if the patient comes too close to other devices that can cause electromagnetic interference, like mobile radios or MRI machines.

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March2002FDA Patient Safety News Homepage
Skin Substitute for Diabetic Ulcers Approved (Video, print, and e-mail functions)
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In another recent action, FDA approved a skin substitute that's used to help in the wound closure of diabetic foot ulcers. It's called Dermagraft, and it's made by Advanced Tissue Sciences of La Jolla, California. Basically, the product consists of human fibroblasts that are incorporated in a dissolvable mesh material.

When the product is placed on the ulcer, the mesh material is gradually absorbed and the human fibroblasts grow into place and replace the damaged skin. As they grow in, those fibroblasts produce many of the same proteins and growth factors found in healthy skin, and this helps in replacing and rebuilding damaged tissue in the ulcer.

The specific indications are for full-thickness diabetic foot ulcers that have been present for longer than 6 weeks. The ulcers can extend through the dermis, but they can't be so deep as to expose tendon, muscle, joint capsule or bone.

This product shouldn't be used if the ulcer is infected, or if it has sinus tracts, or tunneling into adjacent tissue. It also shouldn't be used on patients allergic to products derived from cows, because there's bovine serum in the packaging solution.

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March2002FDA Patient Safety News Homepage
Pacemaker for Treating Congestive Heart Failure (Video, print, and e-mail functions)
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In the cardiovascular area, FDA recently approved a pacemaker that can treat some of the symptoms of moderate to severe congestive heart failure. In some heart failure patients, the left and right ventricles don't contract simultaneously, as they should. This device corrects that condition by providing specially timed electrical impulses to the ventricles.

It's called the InSync® Biventricular Cardiac Pacing System, and it's made by Medtronic, Inc., of Minneapolis. The system includes a pulse generator implanted in the patient's chest, which is connected to three lead wires that deliver the electrical impulses. One lead goes to the right atrium; the other two are placed in each of the ventricles, where they stimulate those chambers to beat simultaneously.

People with congestive heart failure typically experience fatigue and shortness of breath during exertion, often making it difficult to perform even the most routine tasks. During the clinical study of the Insync system, patients were implanted with the device and then randomized into two groups - one group of patients had the implant turned on. The control group didn't. When compare to the controls, the patients with the active implant were more likely to have an improvement in their heart failure classification, the distance they were able to walk, or their quality of life scores.

Even though this device may relieve some of the symptoms of congestive heart failure, it's not been shown to be useful in all heart failure patients. It should be used only in patients with moderate to severe symptoms of congestive heart failure whose ventricles are not contracting simultaneously and aren't likely to improve with additional drug therapy. And it shouldn't be used in patients whose congestive heart failure is reversible.

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 Recalls and Safety Alerts

March2002FDA Patient Safety News Homepage
FDA Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients (Video, print, and e-mail functions)
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The FDA recently sent a public health advisory to radiologists, hospital risk managers and radiation health professionals, alerting them to the need to keep radiation doses during CT procedures as low as possible, particularly for children and small adults. Unless the settings on the CT unit are adjusted to accommodate to a small body, the child or small adult can receive more radiation than needed to get the diagnostic image.

And of course there's special concern about children getting unnecessary radiation exposure, because they're generally more sensitive to the harmful effects of radiation than adults.

To compound the problem, the overexposure of children and small adults during CT procedures can go unnoticed. With conventional x-rays, overexposing the patient generally means overexposing the film, and that results in an image that's too dark. So it's obvious to the operator that there's a problem. But with CT, the quality of the image may not be compromised, so the operator may have no idea that the patient is getting needless radiation.

The FDA advisory recommends several things.

* First, take several steps to optimize the settings on the CT scanner based on the patient's size.
* Second, when it's medically indicated, reduce the number of scans taken before the injection of contrast media.
* And third, when it's medically appropriate, consider using other imaging modalities that can sometimes provide the same diagnostic information with less or no radiation exposure-things like conventional x ray, or ultrasound, or MRI.

This FDA advisory recognizes the important benefits of CT scanning in diagnosing disease and trauma and guiding interventional procedures, and it doesn't suggest curtailing the use of this modality. What it does do is suggest ways to retain those benefits while minimizing the possible risk to a sensitive part of the patient population.

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 Preventing Medical Errors

March2002FDA Patient Safety News Homepage
More Gas Mix-Up Fatilities (Video, print, and e-mail functions)
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Now we want to do a follow-up to a story we covered in an earlier broadcast. That story was about reports we'd been receiving about medical gas mixups, in which deaths and injuries occurred when patients were accidentally given the wrong gas. That happened when a gas like nitrogen or carbon dioxide was mistakenly connected to the oxygen supply system. And it happened despite the fact that oxygen containers are designed so that they'll only fit the oxygen connector on the patient's gas supply system. The reason it happened was that someone altered or changed the connector on the gas container so that it would fit. In other words, they over-rode the system's built-in safeguard, and the result was that the patient got another gas instead of oxygen. We cautioned people not to use adapters, or change the connectors or fittings on gas containers to make them fit the oxygen connector on the patient's gas delivery. We said if a gas container doesn't fit the connector, it's probably the wrong gas, so don't try to connect it.

Shortly after that broadcast, two more patients died because they received nitrous oxide instead of oxygen. This happened in a cardiac catheterization lab in a New Haven, Connecticut hospital. According to a report from ECRI, an independent health services research agency, the gas mixup probably did not occur because someone tried to use an adapter or connector. Instead, one of the small tabs on the oxygen fitting of the gas supply system was reportedly broken off. That would have allowed it to be connected to the nitrous oxide gas outlet without changing anything.

According to the ECRI report, the way to prevent this kind of accident from happening is to routinely inspect medical gas and vacuum systems, and also any medical devices used to administer gases, from ventilators to fittings. Those inspections, according to ECRI, should be done yearly, or at a minimum, every two years. And they should be performed more frequently in areas of high gas use, such as the emergency department.

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 Recalls and Safety Alerts

March2002FDA Patient Safety News Homepage
Hip Implants Recalled Because of Potential Fracture Problem (Video, print, and e-mail functions)
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A problem with an artificial hip component has prompted a widespread recall by the manufacturer, here in the US and abroad. The component of the implant is the femoral head. That's the ball portion of the hip prosthesis that connects the femoral stem to the pelvis.

This particular femoral head is made of a zirconia ceramic, and it's manufactured by a French company, St. Gobain Demarquest. The French company supplied the component to a number of other manufacturers who make the finished implants.

This component was recalled because it was fracturing at a higher rate than expected within about 2 years after the hips were implanted. Eight United States companies that manufacture the finished implants are voluntarily recalling them as well, because they contain this component.

If you use hip implants in your facility and you want to identify the specific products and batches that were recalled, you can get this information on our web site. The web address will be listed at the close of the broadcast.

The recall doesn't mean that all of these components are expected to fail, or that all patients will experience a problem. Unfortunately, there's no way to predict which implants are going to fail.

FDA is not recommending surgery to replace any hip implants that have not fractured or aren't causing problems. But clinicians may choose to monitor the performance of these implants more closely, and watch for patients complaining of a sudden onset of pain in the implanted hip joint. Some patients have reported hearing a "pop" from their hip just before experiencing this pain.

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 Preventing Medical Errors

March2002FDA Patient Safety News Homepage
Headline: Article on Physicians Personal Experiences with Health Care System (Video, print, and e-mail functions)
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Now for the part of the broadcast that we call Journal Scan, where we share interesting articles on patient safety with you. This time we want to call your attention to a study called "Family Physicians' Personal Experiences of Their Fathers' Health Care," by Dr. Frederick Chen and others. It appeared in the September 2001 issue of the Journal of Family Practice.

This is a study in which several senior physicians were asked to report on the health care their fathers received during a serious illness. It's an unusual study, made up of a series of in-depth interviews, and it sheds a lot of light on how patients and their families interact with the health care system, and particularly how they react to adverse events and medical errors.

One recurring theme in this article, the one most closely tied to promoting patient safety, is the need for each patient to have an advocate to act as a guide and watchdog in negotiating the health care system.

In part, it says:

"The physicians in this study…felt strongly that patients need an informed, accountable advocate; each witnessed events and situations where such an advocate was absent when needed."

And the article points out that this function should be the role of the patient's primary care physician. It says:

"Health care systems could affirm the continued presence of one physician who is in charge of the patient's care and accountable to the patient and the patient's family."

But the article also acknowledges that family members sometimes have to take on this role. It says:

"As a patient's medical care becomes increasingly complex, the advocate becomes more important and, ironically, more elusive. In many cases, the responsibility for being the advocate fell to the physician family member."

In any case, there's food for thought in this article about whether the patient's family may have a role in helping to promote safety and prevent adverse events.

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March2002FDA Patient Safety News Homepage
Article: "Human Error in Perspective" (Video, print, and e-mail functions)
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We also want to call your attention to an interesting article by Drs. Charles Billings and David Woods, in the January 2001 issue of Postgraduate Medicine. It's called "Human Error in Perspective."

The article starts out with a little history of the so-called "patient safety movement," including the influence of the famous report of the Institute of Medicine in 1999, with its disturbingly large estimate of patient deaths due to medical error. The article then goes on to stress that it's not enough to attribute the cause of an adverse event to "human error." Here's what they say:


"Attributing adverse events to human error is too often the final step in the investigation, when in fact it should be simply the first step in understanding how and why such failures occur."

They close the article with five prescriptions for success in achieving patient safety:

First, recognize that failures can and will happen in any system. No one is immune. Look for and find the vulnerabilities in your system through purposeful, interdisciplinary effort.

Second, understand the problem before you fix it. Applying apparent solutions before you understand the many facets of a problem ensures failure.

Third, fix the whole system, not just the immediate problem. Chalking an incident up simply to "human error" will give you an incorrect, incomplete or shallow explanation.

Fourth, simplify, don't complicate. Make it easier for people to do it right, and harder for them to do it wrong. Simplifying the operation of a system can dramatically improve its reliability by making it easier for the humans in the system to operate effectively.

And fifth, instead of blaming people, help them to do it better. The authors close the article by saying that the most effective prescription for healthcare system improvement is to support people as they perform their day to day tasks.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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