A recent study sponsored by Partners for Child Passenger Safety, a research project of Children’s Hospital of Philadelphia and State Farm Insurance Company, found that children are not any safer when riding in sport utility vehicles than in passenger cars.  

This surprising finding is attributed mainly to the 200% higher risk of rollovers in SUVs that is seen as negating some of their perceived safety advantages such as greater size and weight.

It has been this perception that has led to the steady and significant increase in SUV sales between 1995 and 2002. In that period, the number of SUV registrations has increased by about 250 %.

According to Dr. Dennis Durbin, a pediatric emergency physician and study participant:
 “We’re not saying they’re worse of that they’re terrible vehicles.  We’re challenging the conventional wisdom that everyone assumed they were better.”

The study involved records of accidents that occurred between 2000 and 2003 involving some 4,000 children under the age of 16.  Child injury rates were found to be about 1.7% in both cars and SUVs.  

Researchers found that the SUVs weighed an average of 1,300 pounds more than the passenger cars in the study and that factor did provide a measure of enhanced safety.  That reduced risk of injury was negated, however, by the finding that SUVs were more than twice as likely as passenger cars to roll over in an accident.  

In addition, children involved in rollovers were three times more likely to experience a serious injury than those involved in non-rollover accidents.  

In defense of the SUV, the Alliance of Automobile Manufacturers, points to recent government research that found newer SUV models (post 2000) are less top-heavy and the fact that many manufacturers have made significant modifications to reduce the risk of rollovers.

As a result of these improvements, the Alliance claims SUVs are comparable to or even safer than conventional automobiles in “the vast majority of crashes.”  

According to researcher Durbin, new Congressional legislation will likely improve SUV safety by requiring the National Highways Transportation Safety Administration (NHTSA) to implement manufacturing standards for manufacturers that specifically deal with the issue of rollovers.

The NHTSA sees the study as an incentive for those in the market for an SUV to pay closer attention to safety ratings rather than simply assume that buying an SUV is a guaranty of added safety for their families.

So-called “Brazilian diet pills,” despite their possibly dangerous ingredients and unknown manufacturers have become incredibly popular based on reports that they are responsible for people losing  as much as 20 pounds in three weeks.

The Miami Herald has been following this story and it appears from yesterday’s report by John Dorschner that this situation is becoming serious.

Unfortunately, customers purchasing these pills are playing Russian roulette with their health since the pills, sold under the names Emagrece Sim and Herbathin, have become infiltrated with look-alikes, counterfeits, and bogus versions containing potentially harmful ingredients.

As a result of their enormous popularity, the Emagrece Sim pills have triggered a series of copycats that claim to use ‘’all-natural ingredients”  Some of these “other” pills have tested positive for amphetamines and tranquilizers, which are illegal substances in non-prescription drugs.

There is also no quality control with respect to the various look-alikes. Thus, no one is really sure what is in any of them despite their appearing to be the same as the “real” pills. 

 The pills are always sold in identical-looking white bottles with an orange or yellow top and with labels that, almost always, do not identify a distributor or manufacturer. They are available on the internet and on street corners from people with beepers.

The matter is currently under investigation by the Food and Drug Administration (FDA). Last spring the agency accused the Brazilian manufacturer, Fytoterapicos, which claims to be the original creator of Emagrece Sim, of improper labeling. Emagrece Sim labels were written entirely in Portuguese.

As for the question of what exactly the drugs contain, Fytoterapicos’s lawyer, Mitchell Fuerst said his clients maintain that their product contains no amphetamines or generic Prozac.

Although the company’s product has tested positive for these prohibited substances, Fuerst claims the false positive may have been the result of the fact that the legal dietary supplement, L-tryptophan , which is contained in the drug, can sometimes cause this anomaly.

According to Terry Hall of Toxicology Testing Service, which performs tests on the diet drugs, however, no such error was made. Hall said his lab does not confuse L-tryptophan and amphetamines. He believes his lab tests including results that found illegal substance in Emagrece Sim pills are correct. “We didn’t confuse anything.”

However, Fuerst said he has identified over a dozen “counterfeiters and copycats'’ of Emagrece Sim. So it is difficult to pinpoint the presence of illegal substances to the Fytoterapicos product in particular.

Another manufacturer of Emagrece Sim, Sergio M. Nuñez, president of Johnson’s Pharmaceuticals, obtained a trademark for the name last summer, when he found out the drug was not officially trademarked in the U.S.

His pills, which say Johnson’s Pharmaceuticals on the bottle label, supposedly contain the original ‘’all-natural'’ ingredients frequently listed on the drug’s bottles. He claims no illegal substances are used in the pills but would not reveal where they are manufactured.

In addition to finding illegal substances in Emagrece Sim, Toxicology Testing Service also found amphetamines and the tranquilizer benzos in the spin-off diet pill Herbathin.

Herbathin is sold on the internet at herbathin.com and emagrece.com. The sites describes Emagrece Sim as ‘’a thing of the past'’ and Herbathin as “the magical pill.'’ It claims they have imitators, and it’s possible that some of the some of the counterfeits contain amphetamines.

According to the site, Herbathin is shipped from West Kendall and manufactured in the Brazilian lab that makes Emagrece Sim.
Fuerst, the lawyer for Fytoterapicos, disputed this claim, stating that Herbathin has nothing to do with the company. Herbathin, owned in part by Robert M. Schnur, did not respond to requests for comment from the Miami Herald.

The FDA is trying to prohibit the sale of diet pills that contain amphetamines and tranquilizers. Although the agency is attempting to prevent the Fytoterapicos product from entering the United States, Fuerst reports that large quantities of Emagrece Sim were making their way through customs.

He said that the largest amount was coming from Venezuela but that many pills also came from Colombia and Mexico. They may be getting through by being mislabeled as vitamins.

For consumers, accidentally taking a counterfeit pill that contains illegal drugs has serious consequences. In some cases it has led to positive drug tests at work.  In other instances, it caused physical problems such as yellow skin and swelling of the face.

In extreme cases, however, amphetamines can be very dangerous for people with heart problems since they cause blood pressure to increase.

Despite the highly questionable safety of the product, and although buyers often don’t know exactly what they are getting, the “drugs” sell for as much as $140 to $230 for a month’s supply. This promise of a “magic pill” is scheme which will only hurt the consumer in the end and may even have deadly consequences for some.

Overweight Americans now have several surgical options to help them lose weight, including gastric bypass surgery, adjustable stomach bands, and an operation which removes part of the stomach and reroutes the intestines. Doctors, however, are divided on what is the safest and most effective procedure.

Gastric bypass, in which the stomach is stapled to reduce its size, is currently the most frequently performed weight loss surgery in America. It is effective in facilitating the rapid loss of a large amount of weight and is used to treat people with heart problems and diabetes caused by obesity.

In Europe and Australia, adjustable stomach bands are preferred over gastric bypass. In this type of surgery, a ring is placed over the top of the stomach and inflated with saline to tighten it and restrict how much food can enter and pass through the stomach.

This reversible procedure is safer, with a 0.1% death rate compared to about 2% for gastric bypass. Long-term it is nearly as effective at helping patients lose weight. It is also the recommended procedure for children or women who may want to get pregnant after surgery.

According to the research of Dr. Paul O’Brien, director of the Centre for Obesity Research and Education at Monash University in Melbourne, Australia, the bands are just as successful as gastric bypass for achieving weight loss over an extended period.

O’Brien considered results on 23,638 patients in 43 published studies to determine that although bypasses induced a greater weight loss in the first three years, bands were comparable after seven years, with 55% (bypass) and 51% (bands) of excess weight lost.

The third, and by far the most risky, option is a surgical procedure that removes three-quarters of the stomach to create a banana-shaped organ that is connected to the small intestine. This surgery bypasses more of the small intestine than a regular gastric bypass does. Although the mortality rate can be as high as 5%, the procedure is becoming more common and now represents 5% of U.S. obesity surgeries.

While a large U.S. government study has begun to evaluate the benefits and risks of the three procedures, studies indicate that no surgery will have a significant impact without the patient’s commitment to a healthy diet and exercise routine.

Overweight patients should not undergo any surgical procedure unless other methods of weight loss have proved unsuccessful. To qualify for the surgery they must also be at least 100 pounds overweight, or have a Body Mass Index over 35 as well as diabetes or high blood pressure.
Increasingly, many people fall into these categories and the numbers of surgeries have risen dramatically. Whereas less than ten years ago, fewer than 10,000 surgeries were done in the United States, in 2005 it is estimated there will be more than 170,000 according to the American Society for Bariatric Surgery.

In the future there will be more options for obese Americans trying to lose weight. These include vagus nerve stimulation, to curb the desire for food, and new drugs such as rimonabant that shuts off a pleasure signal in the brain that triggers people to eat.

In a related story, a investigative report by the Boston Globe has prompted Massachusetts Senator Richard T. Moore to call for an investigation of mortality and complication rates for obesity surgery at hospitals that fail to meet existing safety guidelines in that state.

A comprehensive report by the Boston Globe found that, even though they fail to meet voluntary patient-safety guidelines, at least five Massachusetts hospitals continue to perform obesity surgery.

But starting in 2007, Blue Cross and Blue Shield of Massachusetts, the state’s largest health insurer, will no longer pay for the procedure at hospitals that do not meet these and other standards.

In the wake of a highly publicized patient death, the state-appointed committee of health officials urged (in August 2004) that the medical community in Massachusetts adopt strict standards for gastric bypasses and other popular obesity surgeries.

The committee offered several suggestions to hospitals, one being that they handle more than 100 cases per year, and that individual surgeons perform a minimum of 50 operations per year.

The Globe surveyed hospitals that did not meet this volume standard in 2004 and found that at least five hospitals still perform obesity surgery, even though they treat fewer patients than recommended by the committee: Caritas St. Elizabeth’s Medical Center in Boston, Morton Hospital in Taunton, Beverly Hospital, Tobey Hospital in Wareham, and Winchester Hospital.

Although the hospitals did between seven and 70 of the surgeries during the fiscal year that ended Sept. 30, 2005, they defended their programs.  Several said they expect to exceed 100 cases by the time the Blue Cross payment policy takes effect in 2007.

The panel had other recommendations for hospitals and doctors, including how to train surgeons, the level of hospital staff expertise, and how to select patients. The Globe did not ask hospitals whether they comply with these recommendations, however.

According to state officials, 22 Massachusetts hospitals performed 3,040 obesity surgeries in the fiscal year that ended Sept. 30, 2004.  Just 402 obesity operations were performed in 1998.

On average, obesity surgery carries a 1% risk of death and a 1% to 15% risk of complications, according to the panel. A recent study found that the risk of death is elevated for the elderly: 2% within 30 days of surgery and 4.6% within a year.

Blue Cross spent $20.5 million to cover obesity surgery for 1,214 members in the year ended June 2004. Executives at Blue Cross believe that the surgery should be done only at hospitals that demonstrate high-quality care and a good performance record.

"We know there is a significant variability in care across Massachusetts," said Dr. John Fallon, Blue Cross’s chief physician executive and a member of the committee that developed the surgery guidelines.

Hospitals will now receive applications from Blue Cross asking for detailed information on obesity surgery programs. The hospitals will have one year to comply with the panel’s recommendations. Blue Cross and Blue Shield of Massachusetts will stop paying for obesity surgery at hospitals that fall short of these standards starting in January 2007.

Moore wants that date moved up to October 2006, when hospitals begin their fiscal year, and he will request Blue Cross to accelerate its starting date. He also intends to request that the state’s other major insurers adopt a similar policy.

According to the  Globe, Moore, co-chairman of the Legislature’s Joint Committee on Health Care Financing, requested the investigation in a letter to Paul Cote, Commissioner of the Massachusetts Department of Public Health, asking him ‘’to take strong corrective action if any of [the hospitals’] patients were harmed in any way as a result of the failure."

Moore said that if any of the low-volume hospitals also fail to meet other safety guidelines, they should be prohibited from performing the surgery. ‘’This surgery has had a lot of deaths in the past few years; that’s why we set up this panel to recommend specific practices."

Overweight Americans now have several surgical options to help them lose weight, including gastric bypass surgery, adjustable stomach bands, and an operation which removes part of the stomach and reroutes the intestines. Doctors, however, are divided on what is the safest and most effective procedure.

Gastric bypass, in which the stomach is stapled to reduce its size, is currently the most frequently performed weight loss surgery in America. It is effective in facilitating the rapid loss of a large amount of weight and is used to treat people with heart problems and diabetes caused by obesity.

In Europe and Australia, adjustable stomach bands are preferred over gastric bypass. In this type of surgery, a ring is placed over the top of the stomach and inflated with saline to tighten it and restrict how much food can enter and pass through the stomach.

This reversible procedure is safer, with a 0.1% death rate compared to about 2% for gastric bypass. Long-term it is nearly as effective at helping patients lose weight. It is also the recommended procedure for children or women who may want to get pregnant after surgery.

According to the research of Dr. Paul O’Brien, director of the Centre for Obesity Research and Education at Monash University in Melbourne, Australia, the bands are just as successful as gastric bypass for achieving weight loss over an extended period.

O’Brien considered results on 23,638 patients in 43 published studies to determine that although bypasses induced a greater weight loss in the first three years, bands were comparable after seven years, with 55% (bypass) and 51% (bands) of excess weight lost.

The third, and by far the most risky, option is a surgical procedure that removes three-quarters of the stomach to create a banana-shaped organ that is connected to the small intestine. This surgery bypasses more of the small intestine than a regular gastric bypass does. Although the mortality rate can be as high as 5%, the procedure is becoming more common and now represents 5% of U.S. obesity surgeries.

While a large U.S. government study has begun to evaluate the benefits and risks of the three procedures, studies indicate that no surgery will have a significant impact without the patient’s commitment to a healthy diet and exercise routine.

Overweight patients should not undergo any surgical procedure unless other methods of weight loss have proved unsuccessful. To qualify for the surgery they must also be at least 100 pounds overweight, or have a Body Mass Index over 35 as well as diabetes or high blood pressure.
Increasingly, many people fall into these categories and the numbers of surgeries have risen dramatically. Whereas less than ten years ago, fewer than 10,000 surgeries were done in the United States, in 2005 it is estimated there will be more than 170,000 according to the American Society for Bariatric Surgery.

In the future there will be more options for obese Americans trying to lose weight. These include vagus nerve stimulation, to curb the desire for food, and new drugs such as rimonabant that shuts off a pleasure signal in the brain that triggers people to eat.

In a related story, a investigative report by the Boston Globe has prompted Massachusetts Senator Richard T. Moore to call for an investigation of mortality and complication rates for obesity surgery at hospitals that fail to meet existing safety guidelines in that state.

A comprehensive report by the Boston Globe found that, even though they fail to meet voluntary patient-safety guidelines, at least five Massachusetts hospitals continue to perform obesity surgery.

But starting in 2007, Blue Cross and Blue Shield of Massachusetts, the state’s largest health insurer, will no longer pay for the procedure at hospitals that do not meet these and other standards.

In the wake of a highly publicized patient death, the state-appointed committee of health officials urged (in August 2004) that the medical community in Massachusetts adopt strict standards for gastric bypasses and other popular obesity surgeries.

The committee offered several suggestions to hospitals, one being that they handle more than 100 cases per year, and that individual surgeons perform a minimum of 50 operations per year.

The Globe surveyed hospitals that did not meet this volume standard in 2004 and found that at least five hospitals still perform obesity surgery, even though they treat fewer patients than recommended by the committee: Caritas St. Elizabeth’s Medical Center in Boston, Morton Hospital in Taunton, Beverly Hospital, Tobey Hospital in Wareham, and Winchester Hospital.

Although the hospitals did between seven and 70 of the surgeries during the fiscal year that ended Sept. 30, 2005, they defended their programs.  Several said they expect to exceed 100 cases by the time the Blue Cross payment policy takes effect in 2007.

The panel had other recommendations for hospitals and doctors, including how to train surgeons, the level of hospital staff expertise, and how to select patients. The Globe did not ask hospitals whether they comply with these recommendations, however.

According to state officials, 22 Massachusetts hospitals performed 3,040 obesity surgeries in the fiscal year that ended Sept. 30, 2004.  Just 402 obesity operations were performed in 1998.

On average, obesity surgery carries a 1% risk of death and a 1% to 15% risk of complications, according to the panel. A recent study found that the risk of death is elevated for the elderly: 2% within 30 days of surgery and 4.6% within a year.

Blue Cross spent $20.5 million to cover obesity surgery for 1,214 members in the year ended June 2004. Executives at Blue Cross believe that the surgery should be done only at hospitals that demonstrate high-quality care and a good performance record.

"We know there is a significant variability in care across Massachusetts," said Dr. John Fallon, Blue Cross’s chief physician executive and a member of the committee that developed the surgery guidelines.

Hospitals will now receive applications from Blue Cross asking for detailed information on obesity surgery programs. The hospitals will have one year to comply with the panel’s recommendations. Blue Cross and Blue Shield of Massachusetts will stop paying for obesity surgery at hospitals that fall short of these standards starting in January 2007.

Moore wants that date moved up to October 2006, when hospitals begin their fiscal year, and he will request Blue Cross to accelerate its starting date. He also intends to request that the state’s other major insurers adopt a similar policy.

According to the  Globe, Moore, co-chairman of the Legislature’s Joint Committee on Health Care Financing, requested the investigation in a letter to Paul Cote, Commissioner of the Massachusetts Department of Public Health, asking him ‘’to take strong corrective action if any of [the hospitals’] patients were harmed in any way as a result of the failure."

Moore said that if any of the low-volume hospitals also fail to meet other safety guidelines, they should be prohibited from performing the surgery. ‘’This surgery has had a lot of deaths in the past few years; that’s why we set up this panel to recommend specific practices."

The Food and Drug Administration (FDA) has announced it intends to investigate claims that canned tuna fish being marketed in the United States contains species believed to have an unhealthy amount of mercury.

David Acheson, the FDA’s chief medical officer, told the Chicago Tribune that the FDA would investigate reports that yellowfin tuna is being included in some cans of "light tuna" thereby creating the possibility that those cans contain unsafe levels of mercury.

Currently, the FDA recommendation is that consumers stick to varieties of canned tuna that are categorized as “light” or primarily skipjack tuna as opposed to “white” or albacore tuna. Skipjack is a small species of tuna that is less apt to contain high levels of the toxic heavy metal than larger species.

According to three articles the Tribune published in December, yellowfin tuna, recognized by the government as a high-mercury fish, is being included in as many as 180 million cans of what is labeled as “light tuna” per year.

Although the tuna industry has denied the claims made in the Tribune articles by stating the yellowfin matter was a “non-issue” and that the levels of mercury in its products do not pose a health risk to consumers, David Burney, the executive director of the U.S. Tuna Foundation, vowed cooperation with the FDA investigation.

According to a recent study from Northwestern Memorial Hospital, which will appear published in the January 3, print issue of the Journal of the American College of Cardiology, drug-eluting stents may trigger dangerous allergic reactions. Stents are commonly used to prevent blockage of the heart arteries.

The study considered 5,783 reports of allergic-like reactions associated with drug-eluting stents. Of these, there were 17 instances of allergic reactions, four of which resulted in death that were most likely, or definitely, caused by the stent.

As a result of the “cause and effect” the authors see with respect to the involvement of these stents in potentially serious adverse events, they suggest that doctor and patients watch for the symptoms associated with allergic reactions; including rash, difficulty breathing, hives, itching, and fever.

In isolating what may be responsible for the problem, the researchers have zeroed in on the polymer coating used  on the st

Recently, several news services reported that patients undergoing medical or surgical procedures are generally unaware of the increasing use of reconditioned medical devices.

A particularly enlightening article appeared in the Washington Post (12/11/05) that revealed how the practice of reusing so-called one-time-use medical devices is becoming more widely accepted at hospitals across the country.

Unlike consumer products, however, medical devices are often used internally and require a much higher degree of reliability. There are a number of issues that make the practice potentially problematic even though hospitals vouch for their safety and dependability.

As previously reported, some possible areas where difficulties may arise are as follow:

•    Hospitals are not required to inform patients that a recondition medical device will be used in a procedure or surgery.
•    The reconditioned devices are not guaranteed by the original manufacturer.
•    Manufacturers warn against reusing of one-time medical devices and will not vouch for their safety after being reconditioned.
•    While hospitals maintain sterilization of reconditioned devices is thorough and even meticulous, the fact that they have been used before makes it impossible to guarantee the same degree of safety as an unused, sterilized, and sealed devices.
•    There are numerous reported cases of reconditioned medical devices breaking or malfunctioning during reuse with anywhere from minor to catastrophic consequences.
•    One-time –use products are approved under a different standard than multiple-use devices. The one-time-use devices are often opted for by manufacturers because they do not have to be as sturdy and the manufacturer’s exposure to liability will be greatly diminished. One-time-use devices also ensure “a steady stream of replacement orders.

Hospitals see reconditioned medical devices as a significant cost-cutting measure since they regard the one-time-only “designation as a manufacturer’s ploy to force them to buy more devices then they need.” Thus, it is becoming more common for hospitals to ignore warnings against reuse.

Now, however, The Washington Post has published a follow-up article that raises the question of whether the reuse of potentially contaminated surgical devices may be responsible for infecting patients with a rare type of brain disease called Creutzfeldt-Jakob Disease (CJD).

CJD is not a typical bacterium or virus. It is believed to be an abnormal protein, or prion. Moreover, CJD and the other prion-based diseases are difficult to detect and often take several years to manifest themselves. When they do, the symptoms can include dementia or neurological impairment.

As pointed out by The Washington Post: “As a result, when hospitals reuse such devices, medical experts say, there is a small risk that they may be exposing patients to a fatal disease with no known cure. Over the past five years, dozens of patients in at least four U.S. hospitals have been potentially exposed to the disease because their surgeons reused medical instruments first used on patients who had the rare brain disorder, according to documents and interviews.”

As a result of a number of cases involving deaths or potential exposure to CJD or other prion diseases, several hospitals have revised their instrument procedures. In at least one case, a hospital “suspended its neurological surgeries and destroyed all equipment reused in such cases.”
According to the Association of Medical Device Reprocessors, none of its members reconditions invasive devices used in brain surgery. The Centers for Disease Control and Prevention (CDC) recommends using disposable surgical devices for the brain only once. The CDC, however, only makes recommendations, it does not  make rules.

The Joint Commission on Accreditation of Healthcare Organizations advises “against reusing instruments in brain biopsy procedures when a patient’s diagnosis is uncertain. But it does not have any requirements about how to handle devices potentially exposed to prion diseases.” (WP)

The Food and Drug Administration (FDA) has yet to impose rules addressing the issue of how “to effectively decontaminate devices potentially contaminated by prions.” (WP) The agency did state in an email, however, that "There are no specific rules/regulations that address this issue presently nor any acceptable decontamination protocols."

The FDA and Diamond Pet Food Company have announced that the pet food produced by the Diamond Pet Food Company at its Gaston, South Carolina, manufacturing plant has been responsible for killing 23 dogs and sickening at least 18 others.

Dog and cat owners are advised to stop using all affected products immediately.

The company, based in Meta, Missouri, recalled 19 varieties of dog and cat food on December 21 because some of the pet food made at the Gaston plant was found to contain aflatoxin.

Aflatoxin is a naturally occurring chemical that comes from a fungus sometimes found on corn and other crops that can cause severe liver damage.

The symptoms of aflatoxin poisoning include sluggishness, lack of appetite, and in serious cases, severe vomiting, fever, and jaundice.
The affected pet food products were sold in 23 states under the brand names Diamond, Country Value, and Professional.  It has the date codes of March 1, 2007, through June 11, 2007.

The contamination was discovered by a Rochester veterinarian after the death of three local dogs. Seven dogs from the Rochester, New York, area were reportedly treated at Cornell University Hospital for Animals.

The dogs suffered liver disease and failure after eating contaminated food, said university spokeswoman Sabina Lee.

In a December 20 press release, Diamond announced it had notified distributors to stop selling Diamond pet food that had used corn and the next day instituted the recall.

Jim Fallon, a company spokesman, stated "To ensure we got all the affected product or potential to be affected, we cast a very wide net with the recall.” He said the company is conducting tests and has set up a consumer information center, open seven days a week, to handle consumer questions.

Diamond is in the process of analyzing retained samples of all of the affected pet food products in Gaston in order to determine the specific lot numbers that were impacted so it could relay the information to distributors, retailers, and customers.

According to the company, the recalled pet foods were distributed to stores in Alabama, Connecticut, Delaware, Florida, Georgia, Kentucky, Maine, Maryland, Massachusetts, Mississippi, Michigan, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, West Virginia, Vermont, and Virginia.

In addition, the FDA said some of the recalled products were exported to at least 29 countries, including several in the European Union and that these countries have also been notified of the potentially deadly contamination.

Recently, several news services reported that patients undergoing medical or surgical procedures are generally unaware of the increasing use of reconditioned medical devices.

A particularly enlightening article appeared in the Washington Post (12/11/05) that revealed how the practice of reusing so-called one-time-use medical devices is becoming more widely accepted at hospitals across the country.

Unlike consumer products, however, medical devices are often used internally and require a much higher degree of reliability. There are a number of issues that make the practice potentially problematic even though hospitals vouch for their safety and dependability.

As previously reported, some possible areas where difficulties may arise are as follow:

•    Hospitals are not required to inform patients that a recondition medical device will be used in a procedure or surgery.
•    The reconditioned devices are not guaranteed by the original manufacturer.
•    Manufacturers warn against reusing of one-time medical devices and will not vouch for their safety after being reconditioned.
•    While hospitals maintain sterilization of reconditioned devices is thorough and even meticulous, the fact that they have been used before makes it impossible to guarantee the same degree of safety as an unused, sterilized, and sealed devices.
•    There are numerous reported cases of reconditioned medical devices breaking or malfunctioning during reuse with anywhere from minor to catastrophic consequences.
•    One-time –use products are approved under a different standard than multiple-use devices. The one-time-use devices are often opted for by manufacturers because they do not have to be as sturdy and the manufacturer’s exposure to liability will be greatly diminished. One-time-use devices also ensure “a steady stream of replacement orders.

Hospitals see reconditioned medical devices as a significant cost-cutting measure since they regard the one-time-only “designation as a manufacturer’s ploy to force them to buy more devices then they need.” Thus, it is becoming more common for hospitals to ignore warnings against reuse.

Now, however, The Washington Post has published a follow-up article that raises the question of whether the reuse of potentially contaminated surgical devices may be responsible for infecting patients with a rare type of brain disease called Creutzfeldt-Jakob Disease (CJD).

CJD is not a typical bacterium or virus. It is believed to be an abnormal protein, or prion. Moreover, CJD and the other prion-based diseases are difficult to detect and often take several years to manifest themselves. When they do, the symptoms can include dementia or neurological impairment.

As pointed out by The Washington Post: “As a result, when hospitals reuse such devices, medical experts say, there is a small risk that they may be exposing patients to a fatal disease with no known cure. Over the past five years, dozens of patients in at least four U.S. hospitals have been potentially exposed to the disease because their surgeons reused medical instruments first used on patients who had the rare brain disorder, according to documents and interviews.”

As a result of a number of cases involving deaths or potential exposure to CJD or other prion diseases, several hospitals have revised their instrument procedures. In at least one case, a hospital “suspended its neurological surgeries and destroyed all equipment reused in such cases.”
According to the Association of Medical Device Reprocessors, none of its members reconditions invasive devices used in brain surgery. The Centers for Disease Control and Prevention (CDC) recommends using disposable surgical devices for the brain only once. The CDC, however, only makes recommendations, it does not  make rules.

The Joint Commission on Accreditation of Healthcare Organizations advises “against reusing instruments in brain biopsy procedures when a patient’s diagnosis is uncertain. But it does not have any requirements about how to handle devices potentially exposed to prion diseases.” (WP)

The Food and Drug Administration (FDA) has yet to impose rules addressing the issue of how “to effectively decontaminate devices potentially contaminated by prions.” (WP) The agency did state in an email, however, that "There are no specific rules/regulations that address this issue presently nor any acceptable decontamination protocols."