Nurse accused of giving patients bleach arrested

Fri May 30, 9:13 PM ET

A former nurse accused of intentionally injecting two patients with bleach at an East Texas dialysis center was arrested Friday, police said.

The arrest warrant charges Kimberly Clark Saenz, 34, of Angelina County, with two counts of aggravated assault, a second degree felony. She was being booked into jail Friday afternoon. Bond was set at $200,000.

Two witnesses reported seeing Saenz draw bleach into syringes and inject the bleach into two dialysis lines on April 28, Lufkin police said in a news release.

Both DaVita Dialysis Center in Lufkin patients injected with bleach survived. One required treatment at a hospital, police said.

Police said that syringes and dialysis lines used on the patients were tested and bleach was found.

It was unclear Friday whether Saenz had an attorney.

The Lufkin center has been closed since April 28 for an investigation by authorities into a spike in deaths there of four patients in April. Lufkin police spokesman Lt. David Young told The Associated Press on Friday that the investigation remains open.

Saenz was fired from the center on April 29, said DaVita spokesman Michael Chee.

"We hope that this individual is prosecuted to the fullest extent of the law," said Chee, who added that they are continuing to work with the police and state health authorities.

El Segundo, California-based DaVita has more than 1,300 outpatient facilities across the U.S.

Miracle Baby Survives Ovarian Pregnancy


The proud father of a "miracle baby" born in Darwin has described his wife's pregnancy as "a time bomb".

Durga Thangarajah is the only child in Australia - and possibly the world - to survive a full-term ovarian pregnancy.

But the healthy 2.8kg bundle was on Friday oblivious to all the fuss caused by her remarkable entry into the world at 8.47am(CST) on Thursday.

"This form of pregnancy is rare enough, but to have it full term is unheard of," said obstetrician Andrew Miller from Darwin Private Hospital.

"I have never come across it in any hospital ... .

"It truly is a miracle she got a living baby out of it."

Ovarian pregnancies are the rarest form of ectopic pregnancies and occur when the egg fails to travel down the fallopian tube and into the uterus.

Instead, the foetus fertilises inside the ovary itself.

Midwife Dee Keogh said the operating room was astonished when 34-year-old Meera Thangarajah was cut open to deliver her second child during a routine caesarean section at 38 weeks.

"We could see the baby straight away," she said.

"Normally the baby is inside the uterus (but) we could see the baby clearly, its hair, all its features. I think everybody just thought wow - she is one lucky lady."

Ovarian pregnancies affect one in every 40,000 pregnancies and are considered a life threatening complication, with pregnancies usually terminated before 10 weeks.

Ms Keogh said most expectant mothers suffering from the condition experienced pain or bleeding.

Ravi Thangarajah, 40, was all smiles as he spoke about his new daughter Durga, which means Goddess in Hindu.

"The doctor and the paediatrician came in and told me it was like a miracle baby, you're one of the luckiest men in the world at the moment," he said.

"When you look at all the odds against us. I work for Sportingbet Australia and people reckon it's all about the odds. I tell you we beat all the odds!"

Mr Thangarajah said he had to "go to Google" to find out about the condition.

"It's slowly sinking in for me what happened. They keep telling me how risky it was for the mother. We didn't know it was this time bomb," he said.

"It could have been a disaster."

As for his wife, still sore after a two-hour operation, she said the family was looking forward to going home in a week.

"When they told me about it, I just thought 'Oh, my goodness'," she said.

11 Prairie View nursing students caught cheating on test

Eleven Prairie View A&M University nursing students were caught cheating on a comprehensive examination last month and were not allowed to graduate with their class, the university said.

The students, who were using cell phones to text-message other students who had finished the exam, will be allowed to re-enroll this fall and will be required to take a course in ethics. They also must take the examination again. If they pass, they will be allowed to graduate in December.

"We never want to have any type of break in our university policies," said Betty Adams, dean of the nursing school. "We always take it as a matter of criticality when there is one. We have a protocol in the university and believe in due process. We handled this as we would any other matter on any other day."

Other students noticed the cheating and reported it to faculty members who were present. An ensuing university investigation brought students before a student court.

"They did go through student hearings," said school spokesman Bryce Kennard. "These 11 'fessed up, if you will, but it was never clearly defined who precisely did what and how many were involved."

Ten of the students agreed to return in the fall. The 11th student has not responded, he said.

The examination takes four to five hours to complete. Students are allowed to take breaks and leave the room, Kennard said, however, the text-messaging was done while students were seated and taking the test.

Approximately 45 Prairie View nursing students graduated this spring.

MRI Innovation Allows Detection of Subtle Traumatic Brain Injuries

DALLAS, May 12 -- Tracking progress and predicting outcomes after severe traumatic brain injury may be possible with an innovative MRI-based technique, researchers here said.

Called diffusion tensor tractography, the method offers an improved way to measure multifocal nerve damage within the brain after severe head trauma, according to Ramon Diaz-Arrastia, M.D., Ph.D., of the University of Texas Southwestern Medical Center, and colleagues in the May issue of Archives of Neurology.

In a case-control study involving 12 patients with head injuries and 12 healthy volunteers, the technique showed clear differences in axonal integrity within key brain regions, the researchers reported.
Action Points

* Explain to interested patients that the small study found that a novel MRI technique could measure an otherwise hard-to-detect form of brain injury that correlates with functional outcome.

* Explain that the case-control study involved only two dozen patients. The findings need to be confirmed in a larger study.

* Point out that the method is investigational and is not commonly available.

The scans also highlighted changes within the brain that correlated with patients' clinical condition for up to 11 months after injury, which had not previously been possible with imaging technologies.

In an interview, Dr. Diaz-Arrastia said the goal is to find a good measure for diffuse axonal injury, an "overlooked and understudied" phenomenon that increasingly appears to be an important factor in head-injured patients.

He said it used to be considered a rare form of injury, but mainly because it was hard to see with technologies such as CT imaging.

Recent studies suggest it plays a role in at least half of fatal head injuries," he added. Diffuse axonal injury may also explain puzzling cases in which people with apparently mild head injuries suffer lingering disability.

Diffusion tensor tractography measures water movement within tissues on the basis of MRI data. When nerve cell axons are damaged, as they frequently are in severe head trauma, they swell, absorbing water from surrounding tissues. That reduces movement of extracellular water.

On the other hand, when axons later die, they release water, thereby increasing extracellular water flows.

The method allows individual neuronal fibers to be measured and counted.

Dr. Diaz-Arrastia and colleagues used serial MRI scans to detect changes in fiber lengths, volumes, counts, and other parameters in the corpus callosum, the fornix, and the peduncular projections of the study participants.

Patients were adults with closed-head injuries and no history of neurological disorders or previous brain injury. The controls were matched for age and gender.

Clinical condition was assessed with the Glasgow Outcomes Scale-Extended by raters who were blind to the imaging data.

Significant differences between patients and controls in many fiber parameters were found immediately after injury.

"At least one fiber variable of the whole corpus callosum, all subareas of the corpus callosum and peduncular projections, and the fornix body were significantly different between the patients and controls, with patients showing worse measures (P< 0.005)," the researchers wrote.

Changes in fiber measures were also strongly correlated with outcome, with a Spearman rank coefficient of 0.76 (P<0.005) for at least one fiber variable of the whole corpus callosum and subareas 2 and 4 with Glasgow scores.

Overall, said Dr. Diaz-Arrastia, "we could explain 60% to 70% of the variance" in Glasgow scores with diffusion tensor tractography.

The researchers also analyzed the MRI data with another method that has been used to study diffuse axonal injury, called fluid attenuation and inversion recovery imaging. These findings did not correlate significantly with clinical outcomes.

The researchers pointed out that diffusion tensor tractography still has wrinkles to be ironed out. For example, the fiber assignment algorithm has limitations when dealing with crossing fibers.

They also noted that brain regions other than those included in this study may have diffuse axonal injury. The small sample size is a limitation as well.

Dr. Diaz-Arrastia said that, in addition to helping with prognosis, a reliable system for measuring diffuse axonal injury will be valuable in developing new treatments.

"When we develop therapies for this mechanism of injury, it will allow us to measure efficacy," he said.

The study was funded by the National Institute on Disability and Rehabilitation Research and the National Institutes of Health.

No potential conflicts of interest were reported.

Primary source: Archives of Neurology
Source reference:
Wang J, et al "Diffusion tensor tractography of traumatic diffuse axonal injury" Archives of Neurology 2008; 65: 619-26.

Men Common Victims of Domestic Violence

SEATTLE, May 19 -- Domestic violence against men is common, though often under-reported, and may damage mental health, a retrospective cohort study showed.

In a survey of 420 men, 28.8% had been the victim of either physical or psychological abuse during their adult lifetime, Robert Reid, M.D, Ph.D., of the Group Health Cooperative Center for Health Studies here, and colleagues reported in the June issue of the American Journal of Preventive Medicine.

In a similar study, the group found the prevalence to be 44% among women.
Action Points

* Explain to interested patients that this study found that domestic violence -- either physical or psychological -- affects about 30% of men during their lifetime.

Men 55 and older who had been abused had lower mental health scores and were more likely to be depressed than older men who had not been abused, the researchers found.

And men younger than 55 who had been subjected to physical or psychological abuse reported more difficulty in functioning socially.

"The findings … suggest that the failure of healthcare personnel to ask about and acknowledge men's experiences of [intimate partner violence] may be shortsighted," the researchers said.

"Asking men about [intimate partner violence] may open a conversational space about abuse -- perhaps bi-directional in nature -- that may be occurring in their relationships," they said.

Future research, the researchers said, is needed to determine effectiveness of various interventions.

Dr. Reid said that this study should not overshadow the effects of abuse against women.

"This study doesn't downplay or mitigate the experience that women have with domestic violence. It's common for women, and health consequences -- including death -- can be devastating," he said. "But violence appears to go in many directions, directed against children, against women, and, in some cases, men."

The researchers conducted a telephone survey of 420 adult men (mean age 53.8, 86.1% white) who were insured by Group Health for at least three years.

They were asked about past episodes of intimate partner violence using the Behavioral Risk Factor Surveillance Survey.

Health was assessed using the Short Form-36 version 2, the Center for Epidemiological Studies Depression Scale, and the National Institute of Mental Health Presence of Symptoms Survey.

A total of 18.4% of the participants reported being a victim of childhood physical or sexual abuse and 14.5% had witnessed intimate partner violence.

Overall, 4.6% of the participants had been abused in the past year by an intimate partner and 10.4% had been a victim of violence in the past five years.

Those younger than 55 were more likely than older men to have been abused in the past five years (14.2% versus 5.3%) and to have been subjected to physical violence at any time (8.8% versus 1.1%) (P<0.01 for both).

Most of the men said they had been a victim of intimate partner violence more than once -- 68.1% for those reporting physical abuse and 92.4% for those who had been abused psychologically.

Physical violence generally lasted less than a year but psychological abuse persisted longer.

Among men younger than 55, 82% said they were a victim of non-physical abuse for a year or longer. The figure for older participants was 72.5%.

Those 55 and older who had been physically abused at any time had lower mean scores out of 100 for mental health (-5.86), vitality (-3.48), and a summary of the mental component of the assessment (-4.70) compared with older men who had not been a victim of physical abuse. These changes were statistically and clinically significant, Dr. Reid said.

Participants younger than 55 who had been abused had lower scores for social functioning whether the abuse had been physical (-2.53) or psychological (-2.51).

Older participants who had been abused physically were 2.8 times more likely to have depressive symptoms (prevalence ratio 2.80, 95% CI 1.23 to 6.34) and 3.14 times more likely to be severely depressed (PR 3.14, 95% CI 1.06 to 9.32) than those who were not abused.

Older participants who were victims of non-physical abuse were 2.61 times more likely to have depressive symptoms (PR 2.61, 95% CI 1.28 to 5.34).

Intimate partner violence did not have any significant effects on physical health, in contrast to the effects on women.

The authors said that the results may not be generalizable to uninsured or more diverse populations.

Also, they said, the study had a low response rate and the small sample size precluded the assessment of a direct connection between abuse and health outcomes.

They also pointed out that "because the men were asked to remember events that may have occurred long ago, the findings may underrepresent the occurrence of events in the distant past. As such, the estimates of lifetime

prevalence may be biased downward for older men compared to younger men, and may explain the lower reported lifetime prevalence found for older men."

Finally, the participants were not asked about reciprocal violence, as the study was focused on the consequences for male victims.

The study was supported by a grant from the Agency for Healthcare Research and Quality and by the Group Health Cooperative Center for Health Studies. Dr. Reid and one of his co-authors received salary support from the Group Health Permanente medical group.

Primary source: American Journal of Preventive Medicine
Source reference:
Reid R, et al "Intimate partner violence among men: prevalence, chronicity, and health effects" Am J Prev Med 2008; DOI: 10.1016/j.amepre.2008.01.029.

Early Insulin Hit Leads to Diabetes Remission

GUANGZHOU, China, May 22 -- Giving newly diagnosed type 2 diabetes patients intensive insulin therapy for a few days or weeks can drive the disease into extended remission and at least partly restore β-cell function, researchers here said.
Action Points
  • Explain to interested patients that insulin therapy is usually not initiated in patients with newly diagnosed type 2 diabetes until diet and lifestyle changes and oral hypoglycemics have been tried.

  • Note that this study suggests that early, intensive insulin treatment might restore normal blood glucose and allowed extended remission without the need for treatment other than diet or exercise.

In a randomized controlled trial, patients treated with intensive insulin achieved normal glucose levels faster than those treated with oral hypoglycemic agents, according to Jianping Weng, M.D., of Sun Yat-Sen University, and colleagues.

Once blood glucose levels were normal, all patients in the trial stopped medication and attempted to control their diabetes with diet and exercise alone, Dr. Weng and colleagues reported in the May 24 issue of The Lancet.

But a year later, the rate of remission among the patients given insulin was significantly higher (at P=0.0012) than among those who got oral agents, Dr. Weng and colleagues found.

The findings "support the initiation of early, transient, intensive insulin treatment" in newly diagnosed diabetes patients, the researchers concluded.

Their study randomized 381 patients newly diagnosed with type 2 diabetes to get either a continuous subcutaneous insulin infusion, multiple daily insulin injections, or oral hypoglycemic agents (gliclazide, metformin, or both.)

Overall, 92.1% of patients achieved normal glucose levels in 7.9 days on average. But more of those getting the insulin reached normal levels and they did so more quickly, Dr. Weng and colleagues said.

Among those getting continuous insulin, 97.1% reached normal levels, in 4.0 days on average, while 95.2% of those getting multiple injections reached the target, in 5.6 days on average.

In contrast, 83.5% of those on the oral agents reached the target, in 9.3 days on average. The differences were significant at P<0.0001>P=0.01 for the injections.

Dr. Weng and colleagues also found that immediately after the treatment period, acute insulin response was partly restored, β-cell function was significantly increased, and insulin resistance was significantly decreased in all patients (at P<0.0001).>

A year after stopping therapy, the remission rate was 42% among those who reached normal blood glucose levels during the treatment period, the researchers said.

But the rates were 51.1% among those who were treated with insulin infusion, 44.9% among those given insulin injections, and only 26.7% in the oral hypoglycemic agents group.

The risk of relapse was reduced by 44% with the insulin infusion and 31% with injections compared with the oral hypoglycemic agents, reductions that were significant at P=0.001 and P=0.032, respectively.

The data suggest that the use of intensive insulin therapy early in the course of the disease "warrants further clinical investigation," wrote Ravi Retnakaran, M.D., of the University of Toronto, and Daniel Drucker, M.D., of the Banting and Best Diabetes Centre in Toronto, in an accompanying comment.

They said the findings might support the idea that the insulin therapy allows damaged β-cells to rest and perhaps recover -- the so-called "β-cell rest" theory.

But other biological mechanisms might also play a role, they said, adding that an "increased mechanistic understanding" of the process might lead to an explanation of why and how the β-cells decline in the first place.

They also pointed out some limitations of the study, including limited description of β-cell function and glycemic control during the year, absence of clinical characterization of the remission and non-remission

groups at 1 year; and the single ethnic group under study.

The study was supported by the 973 Programme of the Chinese government, Natural Science Foundation of Guangdong Province Government, Novo Nordisk (China), and Roche Diagnostics (Shanghai). Sun Yat-Sen University has an unrestricted research grant from Novo Nordisk (China) and Roche Diagnostics (Shanghai).

The study authors said they have no conflicts of interest.

Dr. Retnakaran receives research support from Merck. Dr. Drucker has served as an adviser for or consultant to Amylin Pharmaceuticals, Arisaph Pharmaceuticals, Conjuchem, Eli Lilly, Emisphere Technologies, GlaxoSmithKline, Glenmark Pharmaceuticals, Isis Pharmaceuticals, Merck Research Laboratories, Novartis Pharmaceuticals, Novo Nordisk, Phenomix, Takeda, and Transition Pharmaceuticals. He also receives research support from Merck and Novo Nordisk.

By Michael Smith, North American Correspondent, MedPage Today
Published: May 22, 2008
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.

Hospitals reusing single-use devices without validated cleaning:


TORONTO - A significant number of Canadian hospitals are still reusing single-use medical devices and the vast majority of those that do sterilize or "reprocess" the devices in-house - a practice fraught with risk, infection control experts say.

But while there appears to be consensus that a national policy is needed and that the practice of in-house reprocessing ought to be banned, a regulatory void means that in many parts of the country hospitals can do as they wish when it comes to reuse of single-use medical devices.

Among the devices being reused are biopsy forceps used in stomach and bowel surgery, membrane scrapers used in eye surgery, breast pump kits and blades, burrs and drill bits used to bore through bone.

"I'm absolutely appalled," says Dr. Mark Miller, head of infection prevention and control with Montreal's Jewish General Hospital, and the author of a 2001 report on reuse of single-use devices that for a time put the issue on the political front burner.

Miller was commenting on the findings of the latest survey into single-use device reuse by Canadian hospitals, the results of which are published in the May issue of the journal Infection Control and Hospital Epidemiology.

Of 398 hospitals that responded, 28 per cent admitted to reusing single-use devices. While some of the reprocessing is farmed out to U.S. companies certified by the U.S. Food and Drug Administration, 85 per cent of the hospitals that admitted to reprocessing said they did the work in-house.

The senior author of the study, Dr. Michael Gardam, says the numbers are probably even higher. "I doubt that we're underestimating the problem."

Forty per cent of the hospitals that reprocess single-use devices reported that they had no written policy on the practice. "They just do it," Miller says, sounding incredulous.

In fact, the percentage of hospitals that currently reuse single-use medical devices is only slightly lower than the 31 per cent that reported reuse of single-use devices in a survey taken in 1986.

In the 20-plus years since that earlier survey, tragedies like the tainted blood scandal and cases of variant Creutzfeldt-Jacob disease - the human form of mad cow disease - linked to reuse of tools used in brain surgery have deepened the understanding of infection risks and raised the bar for infection control in hospitals.

And in recent years, a number of hospitals have had to ask former patients to be tested for HIV and hepatitis after discovering they had not been properly cleaning devices they reused. In 2004, nearly 1,500 Quebecer who had undergone hip surgery had to be tested after it was learned hospitals weren't completely cleaning a reamer, a type of surgical drill part.

Most in the field believe some single-use devices can be reused safely, if they are put through a thorough reprocessing procedure. They say medical device manufacturers almost routinely designate devices "single-use," for economic not safety reasons.

"If they can make it disposable, they can sell a hell of a lot more devices and it's actually a lot easier to bring it to market," explains Gardam, head of infection control for Toronto's University Health Network.

"Because if you want to make it reusable, you have to ... prove you can reprocess them. So obviously the manufacturer would far rather churn out single-use devices, because they only have to prove that it's sterile in the package when you get it."

The multitude of single-use devices drives up health-care costs and generates extraordinary amounts of waste.

In the United States, the FDA regulates an industry that has cropped up to reprocess single-use devices. Companies in the business must provide proof that the devices they reprocess can be thoroughly sterilized without compromising the integrity of the material from which the device is made.

A number of Canadian hospitals - Gardam's and Miller's among them - take advantage of that industry, trucking things like $3,000 single-use cardiac catheters to Minnesota to be reprocessed for about $1,000 a trip.

Accredited companies log each device, using bar codes and similar technology to ensure each one goes back to the sending hospital and that devices are only reprocessed the number of times that testing suggests is safe. That means if it's been determined the cardiac catheter can be safely reprocessed 10 times, it will be discarded if it makes an 11th trip to Minnesota.

Health Canada does not regulate this field. And while infection control experts have called for the department to take on this task, it says it does not have the legal authority to do so.

"The Food and Drugs Act, from which the Medical Devices Regulations derive their authority, is not intended to apply to the use of a device after its sale," the department explains in an e-mail from spokesman Paul Duchesne.

"Reprocessing of a device by a hospital for reuse in that hospital does not constitute sale. Therefore, Health Canada does not have the authority to regulate reuse or reprocessing."

Furthermore, it doesn't plan to seek those powers.

"The practice of reprocessing by hospitals of medical devices relates to health-care system management in provincial and territorial jurisdiction and therefore is not within the federal role. Therefore, creating new authorities is not being considered."

Instead, it says it is exploring with provincial and territorial partners the possibility of creating a "pan-Canadian framework."

Currently some jurisdictions have rules, while others are silent on the issue.

Manitoba bans reuse of devices that come in contact with blood or are used inside the body. Since the start of this year, British Columbia has ordered that these so-called critical contact devices can only be reused if they are reprocessed by regulated companies.

In Ontario, guidelines Gardam helped to write for the Ontario Hospital Association say reuse of single-use devices is only permissible if hospitals prove it is safe to reuse them.

The only way to do that, he says, is to use licensed third-party reprocessors. "They take them through far more hoops than a hospital would to reprocess a multi-use device. So they're very, very stringent in terms of what they do."

But Gardam believes a large percentage of hospitals that are reusing single-use devices haven't taken the steps to prove what they are doing is safe. And Miller says hospitals that reprocess in-house simply don't have the wherewithal to do the work the way it needs to be done.

"We don't have the resources, the people and the money to be able to do it properly. And I know that the hospitals that are reprocessing - unless they're different than every other hospital that's been reprocessing across North America - that they're not doing it according to all the norms," he says.

"And therefore if they're not doing it according to all the norms, then they're exposing patients and the workers who are working with these instruments to potential dangers. And that's just the way it is."