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U.S. Department of Health and Human Services

Show #103, October 2010

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Show #103, October 2010

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 Recalls and Safety Alerts

October2010FDA Patient Safety News Homepage
Importance of Influenza Vaccination for Health Care Personnel (from November 2008) (Video, print, and e-mail functions)
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As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and also decrease the chance that they will infect others. This is especially important because these personnel often provide care to patients at high risk of serious and even fatal complications if they contract influenza. Of course another benefit of vaccinating staff is that it also protects their families from getting the disease.

Persons who should be immunized include physicians, nursing staff, pharmacists, technicians, emergency personnel, dental personnel, and students. The list also includes those who are not directly involved in patient care, such as clerical, dietary, housekeeping, and security staff.

CDC estimates that only 40% of health care workers get the flu vaccine each year. Yet studies have shown that low vaccination rates among health care personnel contribute to influenza outbreaks in healthcare facilities, and this needlessly puts patients at risk. It has also been shown that there is a lower incidence of nosocomial influenza cases in those facilities where staff vaccination rates are higher.

For example, in one study, influenza cases and immunization records at a single hospital were followed for 12 years. Over that time, staff vaccination coverage increased from 4 percent to 67 percent, while influenza cases among the staff decreased from 42 percent to 9 percent. At the same time, nosocomial influenza cases among hospitalized patients decreased from 32 percent to zero.

So educate staff about the importance of getting a flu shot, and try to ensure that vaccination programs are available for them. Fall is the best time to be immunized, but getting the vaccine in the winter months is also recommended.

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Preventing Cross-Contamination in Endoscope Processing (from February 2010) (Video, print, and e-mail functions)
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The FDA, the CDC and the Department of Veterans Affairs have issued a joint safety communication cautioning healthcare facilities about the risks to patients if endoscopes and their accessories aren't processed properly between patients. The communication points out that if flexible endoscopes aren't cleaned and then disinfected or sterilized adequately, patients can be exposed to body fluids and tissue contaminants from prior patients.

The three agencies are concerned about this problem because of continuing reports to FDA of processing errors. These include the use of improper accessories for endoscopy irrigation setups, improper reprocessing intervals for reusable endoscopy accessories, failure to discard single-use accessories, and failure to follow the manufacturer's instructions for endoscope processing.

The safety communication stresses that the only way facilities can assure that their patients are adequately protected against cross contamination is to set up a quality system program covering all aspects of endoscopy processing, and then to rigorously comply with it. The communication provides several general recommendations for a quality system program, plus a more detailed set of recommended policies and procedures.

Here's a summary of the general recommendations:

• Establish an institutional program with written procedures for endoscope processing, and ensure that those responsible for processing understand the importance of this job.

• Train and re-train employees to process endoscopy equipment properly, periodically assess their competence, and be sure they follow the endoscope manufacturer's processing instructions.

• Be sure staff members understand that endoscopes cannot be properly disinfected or sterilized without first cleaning them thoroughly in order to remove gross contamination and debris.

• Be sure your automatic endoscope reprocessor or sterilizer is compatible with the endoscope, and that the connecting parts of these devices fit properly.

• Finally, be sure that endoscopes or accessories that will come in contact with sterile tissue are sterilized before each use, and that endoscopes that will come in contact with intact mucous membranes -- in the respiratory and GI tracts, for example -- undergo at least high level disinfection before each use.

The safety communication also lists the responsibilities of manufacturers in helping to assure that endoscopes and their accessories are properly processed.

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 Preventing Medical Errors

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Never Use Parenteral Syringes for Oral Medications (from January 2010) (Video, print, and e-mail functions)
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A recent report by the Institute for Safe Medication Practices says that despite past warnings, serious medical errors continue to occur when parenteral syringes are used to administer oral medications. The underlying problem is that once a parenteral syringe is filled with a liquid intended for oral use, it can be accidentally connected to an intravenous line. That is why oral syringes should always be used for oral medications because they cannot readily be connected to an IV line and cannot accommodate a needle.

ISMP describes several cases in which oral medications were prepared in a parenteral syringe and accidentally given intravenously. In one case, a week-old infant died after an intermittent feeding was prepared in a parenteral syringe and administered intravenously instead of through a nasogastric tube.

In still another case, Versed and Tylenol liquids were withdrawn into a parenteral syringe, to be given orally to a child being prepared for surgery. When the nurse in charge was called away, a student nurse gave the drugs intravenously. The child was unconscious for nearly an hour and required several days of antibiotics. In these cases and others, it took only a momentary mental lapse to connect a parenteral syringe containing an oral liquid to the wrong line - sometimes with fatal results.

ISMP points out that it's not enough to have the pharmacy dispense oral liquids in a unit-dose cup. In some cases, nurses have withdrawn the liquid from the cup into a parenteral syringe and then administered the dose intravenously.

ISMP stresses that all patient care and procedure units should be supplied with oral syringes, even if they're used infrequently, and nurses need to understand the importance of using them. They should carry an auxiliary label that prominently says, "for oral use only."

ISMP's alert features a ten-point strategy for promoting the use of oral syringes in healthcare facilities.

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Burns from Medicated Patches during MRI Exams (from May 2009) (Video, print, and e-mail functions)
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FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings aren't ferromagnetic, so they are not attracted to the MRI machine's magnetic field. But the metal does conduct heat, and that's what can cause burns in the immediate area of the patch.

It can be difficult to determine whether a patch has metal in the backing, because the metallic component may not be visible. Also, at this point the labeling for some of these patches does not contain a warning about the possibility of burns if worn during an MRI. FDA is working with patch manufacturers to be sure that their labeling includes the warning.

In the meantime, FDA recommends that health care professionals note the presence of a patch when they refer patients for MRI exams, and advise patients about removing the patch before the exam and replacing it afterwards. MRI personnel should follow published safe practice recommendations for patients wearing patches.

There are precautions patients can take, too. They should tell the doctor who is referring them for an MRI exam that they are wearing a patch, and ask for instructions about how to remove and dispose of the patch before the exam, and how to replace it afterwards. It is also important that patients tell the MRI staff about the patch, both when they make the MRI appointment and when they arrive at the facility.

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Drug Name Confusion: Ephedrine and Epinephrine (from December 2008) (Video, print, and e-mail functions)
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The Institute for Safe Medication Practices is warning again about the possibility of mix-ups between ephedrine and epinephrine. Not only do the names of these drugs look and sound similar, but since they're both used as vasopressors and vasoconstrictors, they are often stored next to each other. Also, both drugs may be packaged in 1 mL ampuls or vials.

ISMP cites a recent case in which a 57-year-old patient was admitted for excision of a neuroma on her foot. She became hypotensive and nauseated soon after an IV was started preoperatively. An anesthesiologist gave a verbal order for ephedrine, but the nurse taking the order heard epinephrine, and that's what the patient was mistakenly given.

ISMP makes several recommendations for reducing the chance of these mix-ups. Here are some of them:

• Avoid storing epinephrine and ephedrine side-by-side.

• Use tall man letters on computer inventory listings, shelf labels and other places where the drug names appear.

• Use screen alerts on automated dispensing cabinets.

• Where possible, use prefilled epinephrine syringes.

• Keep large vials of epinephrine out of clinical areas to reduce chances of preparing large amounts of the drug.

• To ensure an independent double-check, have the pharmacy prepare infusions and bolus doses for these drugs, except in emergencies.

• And finally, when conveying orders verbally, use the "read back" technique. "Read back" means the person receiving the order transcribes it directly onto the patient's record or prescription as it is being given. Then the order is read back to the prescriber, rather than repeating it back from memory. Also, spelling drug names helps assure that the message has been heard and transcribed correctly. ISMP notes that the "read back" technique may not be fully understood, even though it's required by The Joint Commission.

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 FDA Consumer Corner

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Cautions about Sexual Enhancement Products (from March 2010) (Video, print, and e-mail functions)
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You can easily find them on the internet --- products sold as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs. That might make you think they're harmless. But they may not be.

FDA has found that many of these supposedly "all natural" products actually contain ingredients that aren't on the label, and these ingredients could lead to serious and even fatal effects.

An FDA investigation of a number of these sexual enhancement supplements found that a third of them actually contained the same or similar ingredients to the class of prescription drugs that includes Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil HCl.

Taking products that contain these kinds of ingredients can be particularly dangerous for people who are also taking prescription drugs that contain nitrates, such as nitroglycerin. That's because they can interact to cause dangerously low blood pressure.

People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. And since erectile dysfunction is common in men with these conditions, they may seek out these sorts of products.

To make matters worse, these so-called supplements are not likely to be made under the same quality controls as prescription drugs, so the identity or the amount of the Viagra-like ingredients could vary greatly.

Sometimes they have been found in enormous quantities --- much higher than approved dosages.

FDA has issued many alerts about these types of supplements over the past several years, but their number seems to be growing.

So the bottom line is this: Don't be misled by claims of "all natural" ingredients. Sexual enhancement products that claim to work as well as prescription products are likely to contain ingredients that could pose a serious health risk.

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