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U.S. Department of Health and Human Services

Show #4, May 2002

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Show #4, May 2002

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 New Medical Products

May2002FDA Patient Safety News Homepage
FDA Approves Home Monitoring System for Pacemaker (Video, print, and e-mail functions)
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The FDA recently approved a home monitoring system that's used in conjunction with a cardiac pacemaker. It's made by Biotronik, Inc., of Lake Oswego, Oregon, and it automatically transmits data from an implanted Biotronik pacemaker to the patient's physician. The way it works is that the pacemaker contains a short-range radiofrequency transmitter. This transmitter sends the data from the pacemaker to a device that's similar to a cell phone. The patient carries it on a belt, a pocket or a handbag, and places it in a charging stand next to the bed at night. This cell-phone-like device automatically sends the data to the company's service center, where's it's stored in a computer database. The information is then faxed to the physician's office at preset intervals, ranging from once a day to once a month. The company also accumulates the data, and can provide the physician with trend information on the patient's heart over a period of time. The physician can program the device so that it sends the data whenever the patient places a magnet over the pacemaker. That way, the patient can notify the physician when unusual symptoms are occurring.

The data that can be transmitted with this system includes the patient's mean and maximum heart rates. That can be important in patients with ischemic heart disease and in patients who have both heart failure and atrial fibrillation, where it can be important to reduce heart rate. The system can also transmit data on the frequency of single or multiple premature ventricular contractions. This can be useful in helping the physician to determine the effectiveness of antiarrhythmic drugs the patient may be taking.

This home monitoring system is not a substitute for regularly scheduled office visits. It's designed to provide the physician with supplementary data between those visits. And it can't be used in areas that aren't covered by cell phone service.

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 Recalls and Safety Alerts

May2002FDA Patient Safety News Homepage
Update on A & A Medical Recall (Video, print, and e-mail functions)
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Now here's more on a breaking story we told you about during our last broadcast, when we notified you about an urgent recall of certain medical devices manufactured by A & A Medical, Inc. of Alpharetta, GA. This company also does business under the names Rocket USA and Lifequest, and it manufactures many types of Ob/Gyn and surgical devices. The reason for the recall is that devices labeled as sterile or ethylene oxide processed actually may not have been sterilized. As a result, using these devices could cause serious and possibly life-threatening infections.

This recall includes all products manufactured under those three names - A&A, Rocket USA and Lifequest - that are labeled as sterile or ETO processed. The recall includes a wide variety of OB/GYN products such as flexible and rigid curettes, uterine dilators, fetal blood samplers, and laparoscopy accessories. You can find more information on the affected products on our web site.

It's important to note that these devices were also sold by distributors other than the manufacturer, and that in some cases, the distributor's name may appear on the product, not the manufacturer's. FDA is contacting these distributors and asking them to contact their customers who received these affected products.

Here's how to handle this recall in your facility:

* First, do not use A & A Medical, Rocket USA, or Lifequest products that are labeled as sterile or EtO processed.
* Second, periodically consult our web site for updates on this recall.

Since the last broadcast, people have asked about re-sterilizing these devices on site. You should not attempt to do this. Instead, FDA is encouraging facilities to voluntarily destroy existing stocks by burning or pulverizing.

Additional Information:

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May2002FDA Patient Safety News Homepage
Alert on Implanted Neurostimulators and Diathermy (Video, print, and e-mail functions)
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Now we want to alert you to a serious problem that can occur when patients with neurostimulator implants receive diathermy therapy. If a patient has an implanted neurostimulator, treatment with diathermy can cause heating at the interface where the neurostimulator electrode comes in contact with the body. That can cause tissue damage that can lead to permanent injury or even death.

In 2001, 2 patients who had been implanted with deep brain stimulators and later received diathermy treatment, died as a result. One of them had the diathermy following oral surgery, the other to treat chronic scoliosis. In both cases, the energy from the diathermy treatment caused severe brain damage where the lead electrodes were implanted in the brain.

Medtronic, the manufacturer of the device, subsequently issued a safety alert to physicians, patients and facilities. The alert strongly warned against using diathermy on patients with any of the company's implanted neurostimulation systems, including those for the brain, spinal cord, peripheral nerves or sacral nerve. That includes diathermy of any kind - shortwave, microwave or therapeutic ultrasound. Other manufacturers of implanted neurostimulators have also warned about the dangers of using diathermy on patients implanted with their neurostimulation devices. These firms include Cyberonics and ANS,or Advanced Neuromodulation Systems. Cyberonics makes the NeuroCybernetic Prosthesis System, that stimulates the vagal nerve to help reduce the frequency of epileptic seizures. ANS makes the ANS Renew Neurostimulation System, which stimulates the spinal cord to treat chronic pain.

With all of these neurostimulators the message is clear. Patients with these devices should not have diathermy. And remember, the hazard exists even when the implanted device is turned off. And because diathermy can concentrate or reflect its energy off implants of any size, this warning extends to individual components of a neurostimulation system that might remain implanted even after the device is no longer being used.

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May2002FDA Patient Safety News Homepage
Warning on Using Nitrous Oxide After Intraocular Gas Injection (Video, print, and e-mail functions)
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Here's another example of patients being endangered because of an interaction between two devices or treatments, even though each one is working properly. This involves inert gases that are injected into the eye to treat retinal tears and detachments. If patients who have received this treatment later receive nitrous oxide in dental or surgical procedures, severe eye injury, and even blindness, can occur. The two gases are perfluoropropane (PFP) and sulfur hexafluoride. They're distributed by Alcon and Escalon.

These gases are injected directly into the vitreous cavity, where they produce a gas bubble that can help heal retinal tears. The gas bubble gradually diffuses from the eye over a period of about one to eight weeks.

While the gas bubble is still in the eye, patients must be careful to avoid activities that can increase intraocular pressure, such as flying in an airplane or making other significant changes in altitude. It's the increase in pressure that causes the eye injury. The same effect can occur if a patient with one of these intraocular gas bubbles receives nitrous oxide as an anesthetic during a dental or surgical procedure.

So if you use PFP or sulfur hexafluoride, it's important to warn these patients that until the bubble has diffused out of the eye, which could take up to eight weeks, they can not have nitrous oxide. To help do that, you can get special cards to give patients, explaining the situation. There's also a bracelet the patient can wear, warning any health care provider that might treat this patient about not using nitrous oxide.

And remember, if you're at the other end of this process—that is, if you use nitrous oxide in your practice—don't administer it to any patient who has one of these gas bubbles in the eye. And of course that means asking patients about previous retinal procedures.

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May2002FDA Patient Safety News Homepage
Avoiding Patient Injuries from Circumcision Clamps (Video, print, and e-mail functions)
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In 2000, we issued a warning about the potential for serious injury to patients from circumcision clamps. We were receiving about 20 injury reports per year, including laceration, hemorrhage, urethral damage and penile amputation. We're glad to tell you that the number of reports has gone down since we issued the warning, but they continue to come in, and the injuries, rare as they are, continue to be serious. And so we want to remind you about the steps you can take to avoid these injuries.
The 2000 warning explained what can go wrong with two widely used types of circumcision clamps, the Gomco-type and the Mogen-type. With the Gomco type clamps, the problem generally stems from mismatched parts----that is, from re-assembling the clamp with parts from different manufacturers, or using parts from the same manufacturer that aren't meant to go together, or using parts that have become bent. What makes things difficult here is that the parts may appear to be interchangeable, but often they're not. And so here's what the FDA warning said about how to avoid injuries with Gomco-type clamps:

* First, make sure that you reassemble a clamp only from its own parts. Don't mix up parts from different manufacturers, or even from the same manufacturer, unless the manufacturer has assured you that the parts are interchangeable.
* Second, if you can't be sure that a clamp component is part of the original clamp, or if any component is damaged, either contact the manufacturer to obtain replacement parts, or discard the entire clamp.
* Third, when you request a replacement part, get the manufacturer's assurance that the part you ordered is compatible with the other components of your clamp.
* Finally, if you choose to mark the clamp parts to assure that you correctly reassemble them, ask the manufacturer about the best way to do this. Some marking methods may weaken the device or interfere with your ability to sterilize it.

With Mogen-type clamps, problems arise when the jaws of the clamp are too large for the patient. This can allow too much tissue to be drawn through the opening in the clamp, so that an excessive amount of foreskin, or even a portion of the glans penis, is removed. That can happen either because the clamp is not within the manufacturer's specifications, or because the wrong size clamp is selected for the patient. Note that some manufacturers have two sizes of mogen-type clamps, one for infants and the other for adults.

There are two ways to prevent problems with this kind of clamp. First, be sure that the clamp is the correct size for the patient. And second, periodically measure the gap between the clamping jaws to be sure it's within the manufacturer's specifications.

Additional Information:

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 Preventing Medical Errors

May2002FDA Patient Safety News Homepage
Headline: Article on Preventing Ventilator Deaths and Injuries (Video, print, and e-mail functions)
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And now for the part of the broadcast we call Journal Scan, where we report on articles that are particularly relevant to patient safety.

This time we're talking about a Sentinel Event Alert issued on February 23 by the Joint Commission on Accreditation of Healthcare Organizations. In it, JCAHO summarized their review of a series of deaths and injuries in patients on long term ventilation. Three major causes for these incidents stood out. First, an alarm on the ventilator that malfunctioned or was inadequate or misused. Second, a tubing disconnect. And third, a dislodged airway tube Only a small percentage of the cases were related to mechanical errors, like an incorrect tubing connection or the wrong ventilator setting. And none of the cases were directly related to malfunctions of the ventilator itself. The vast majority of these cases also involved inadequate training, insufficient staffing levels, or communication breakdown.In fact, the numbers indicate that these adverse events were often related to multiple failures that led to negative outcomes.

Essentially, here's what JCAHO recommended to help prevent these kinds of events.

* Be sure that safety material on ventilators is included in training programs and in competency tests, and that staff receives the training.
* Be sure that ventilator patients have adequate staff available at all times.
* Regularly check equipment and alarm systems.
Be sure that alarms on ventilators are loud enough to be heard by staff.
* Observe patients directly. Don't depend only on alarms to warn of problems.

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May2002FDA Patient Safety News Homepage
Headline: Article on Campaign to Encourage Patients to "Speak Up" (Video, print, and e-mail functions)
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JCAHO has also kicked off a new campaign to encourage patients to play an active role in their own health care. That's an important way to promote patient safety and prevent medical errors. The campaign is called "Speak Up," and it's been developed in cooperation with the Centers for Medicare and Medicaid Services.

"Speak Up" is actually an acronym in which each letter stands for something patients should do.

"S" is for speaking up with questions or concerns about their health care.

"P" is for paying attention to the health care they're receiving, for example, whether they're getting the right treatments and medications.

"E" is for educating themselves about their diagnosis, as well as tests and treatments they will be undergoing.

"A" is for asking a family member or friend to act as their advocate in negotiating the health care system.

"K" is for knowing what medications they are taking and why they are taking them.

"U" is for using an accredited health care organization or hospital.

And "P" is for participating in all decisions that affect their treatment.

JCAHO has a brochure that's filled with information on each of these seven areas, with very useful advice for patients and their families. You can get this brochure, along with other promotional and educational materials, by going to this story on our web site.

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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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