Infection risk at dialysis clinics spurs new legislation in California

Human kidney cross section

Saying they are concerned about safety in California’s dialysis clinics, a coalition of nurses, technicians, patients and union representatives is backing legislation that would require more staffing and oversight.

The bill, introduced by Sen. Ricardo Lara (D-Bell Gardens), would establish minimum staffing ratios, mandate a longer transition time between appointments and require annual inspections of the state’s 562 licensed dialysis clinics.

More than 63,000 Californians receive hemodialysis, which filters impurities from the blood of those with end-stage kidney disease. Demand for the procedure is growingstatewide and nationwide as the population ages and more people suffer from chronic conditions that can lead to kidney failure, such as diabetes, hypertension and heart disease.

If the legislation passes, California would join several other states that have imposed minimum ratios for dialysis centers, including Utah, South Carolina and New Jersey.

The California bill, SB 349, says that inadequate staffing is leading to hospitalizations, medical errors and “unnecessary and avoidable deaths.”

In one case, three patients contracted an infection at a dialysis clinic in Los Angeles County after workers failed to clean and disinfect the machines properly, according to a report in the American Journal of Infection Control.

Patients undergoing dialysis are at risk for low blood pressure, fluid buildup or infections.

Problems can be overlooked if nurses don’t have enough time to devote to their patients and to transition between patients, said Megallan Handford, a registered nurse at a dialysis clinic in Fontana who helped draft the bill. Handford said nurses and technicians often have too many patients at once, making it difficult to ensure they are getting safe care. In some cases, patients left dialysis before they were ready, only to die in their cars, he said.

“We deal with short staffing day in and day out. … Enough is enough,” Handford said during a briefing at the offices of Service Employees International Union-United Healthcare Workers West (SEIU-UHW), which is sponsoring the bill and hopes to unionize dialysis workers. “We’re gonna do what it takes to change this industry.”

Lara agreed, saying oversight of the state’s growing dialysis business is overdue. “We need to keep a closer eye on the dialysis industry,” Lara said in an email.

Dialysis clinics in the state argue that the industry is already well-regulated and the bill would add unnecessary requirements.

Clinics already have a difficult time hiring enough workers and would need even more to satisfy the proposed staff-to-patient ratios, said Kristi Foy, assistant director of the California Dialysis Council, the statewide association of clinics. Besides, she said, there is no evidence that mandated ratios improve quality or patient satisfaction.

Foy added…

Diabetes management 3: the pathogenesis and management of diabetic foot ulcers

The final part in this three part series on diabetes looks at causes, management and complications of diabetic foot ulcers. A handout for a journal club discussion is available online

Download a print-friendly PDF file of this article here

Download the NT Journal Club handout here to distribute with the article before your journal club meeting

In this article…

  • Causes and complications of diabetic foot ulcers
  • Diabetic foot assessment, treatment and prevention
  • Effective management options for diabetic foot ulcers


Yamni Nigam is associate professor in biomedical science; John Knight is senior lecturer in biomedical science; both at the College of Human Health and Science, Swansea University.


Two frequent features of diabetes are peripheral vascular disease leading to ischaemic lower limb extremities, and sensory neuropathy, which renders the patient prone to foot injury and vulnerable to the development of diabetic foot ulcers. This final article in our three-part series on diabetes describes the clinical features of the diabetic foot and discusses the importance of early assessment and effective management.


Nigam Y, Knight J (2017) Diabetes management 3: the pathogenesis and management of diabetic foot ulcers. Nursing Times [online]; 113: 5, 51-54.

Key points

  1. Most diabetic foot ulcers (DFUs) result from either neuropathy or ischaemia – or both
  2. Infection is secondary to the development of a DFU
  3. Gangrene is a complication of DFUs and often precipitates the need to amputate
  4. Early and continuous assessment of patients with DFUs is imperative
  5. Wound debridement is important to promote the healing of DFUs

Diabetes is a costly disease that takes a heavy toll both on patients and families, as well as on healthcare resources. It is estimated to affect around 3.2 million people in the UK and to take up a tenth of the NHS budget (Hex et al, 2012). Disease of the foot is one of the most frequent complications of diabetes: around 15-25% of patients will, at some point, develop foot ulceration and infection. Patients with diabetes may also develop Charcot foot (Box 1).

Box 1. Charcot foot in diabetes
Box 1. Charcot foot in diabetes

One of the negative outcomes of diabetic foot ulcers (DFUs) is amputation – the loss of part or all of the foot, or the foot plus a portion of the lower limb (Clerici and Faglia, 2016). Among patients with DFUs, 5-24% will have an amputation (Moawad, 2016) and the number of people who require an amputation as a result of diabetes is growing worldwide.

Five-year survival rates for amputees is generally low (51%) but it is even lower for amputees with diabetes (30.9%) and, among the latter, almost 69% die within five years of the amputation (Aulivola et al, 2004).


The diabetic foot results from an interplay between a number of factors: vascular disease, neuropathy, trauma and infection – the two main ones being peripheral neuropathy and peripheral vascular disease (PVD).

In type 1 diabetes, neuropathy progresses more rapidly, and structural and functional changes are more severe, than in type 2 diabetes (Sima, 2008). The underlying pathophysiology is complex and takes the form of a dying back of the nerves, the distal portions of neurons being first and more severely affected (Azhary et al, 2010). Neuropathy can affect the spinal cord, although nerve degeneration begins in the periphery and sensory nerve injury generally precedes motor nerve injury.

Neuropathy leads to an insensitive and sometimes deformed foot, often with an irregular walking pattern. Limited joint mobility can result in abnormal, bio-mechanical loading of the foot. Nonetheless, the patient obliviously continues walking on a desensitised foot, potentially aggravating and precipitating injuries, which may result in the development of chronic ulcers.

Dry, cracked fissures and repetitive high pressure (particularly in overweight patients with type 2 diabetes), can cause the skin of the abnormally loaded foot to thicken and calluses to form. If these are left untreated they can become thicker and break down, leading to the development of an ulcer or subcutaneous haemorrhage. If PVD is present, the result may be a painful, ischaemic foot ulcer. If neuropathy is also present, then pain perception is altered or pain is not perceived at all despite the severe peripheral ischaemia.

Diabetic neuropathy can affect sensory, motor and autonomic functions. It creeps in slowly, usually going unnoticed by the patient (Khanolkar et al, 2008).

Sensory neuropathy renders the foot ‘deaf and blind’ to stimuli (Khanolkar et al, 2008), such as discomfort, temperature changes or pain. The progressive lack of these sensations allows the foot to be subjected to repetitive trauma and tissue damage.

Motor neuropathy leads to:

  • Muscle atrophy;
  • Foot deformity caused by an imbalance between flexor and extensor muscles;
  • Altered foot biomechanics and redistribution of foot pressures, which can eventually lead to soft tissue damage and predispose the foot to ulceration (Greenman et al, 2005).

The formation of a callus or hammer toe may lead to abnormally bony points over which diabetic foot ulcers may commonly form.

Autonomic neuropathy causes a decrease in sweat production, resulting in dry skin; this can lead to the formation of cracks and fissures that may become infected.

All of these neuropathies increase the risk of trauma caused by factors such as ill-fitting footwear, walking barefoot, injury with foreign objects or scalding (Patnaik et al, 2015).

Diabetes is associated with an increased risk of accelerated atherosclerosis (Kanter et al, 2008). As described in part 2 of this series, diabetic arteriopathy (fatty streak and plaque formation in the artery wall leading to narrowing and occlusion of the lumen) is associated with dysfunction of the endothelial lining of capillaries and of the smooth muscle cells in blood vessels. Inflammation and hypercoagulation of blood are also prominent features of the negative impact of PVD. Due to the reduced blood flow to the cells of the legs, hallmark symptoms include claudication – the pain and muscle aching that occurs in the legs when a patient walks (Knight et al, 2017).

Diabetes is most strongly associated with PVD below the knee, whereas other risk factors (such as smoking and hypertension) are associated with problems higher up, above the knee (Chen et al, 2013). Patients with PVD also have impaired wound healing.

Infection is not a cause but rather a consequence of DFUs: after an ulcer has developed and broken through the protective epidermis, the secondary phenomenon of infection can occur, manifesting as a red, inflamed and purulent wound. The presence of an infected ulcer has been shown to increase the risk of lower-extremity amputation by 50% compared with patients who had an ulcer that was not infected (Van Battum et al, 2011).

Most diabetic foot infections are poly-microbial but the most common pathogens are aerobic bacteria – mainly Staphylococcus species. Osteomyelitis…

Guidance for persons living with diabetes

Do annual diabetic reviews

I see many persons with this disease. Having diabetes increases the risk of developing a wide range of foot problems, often because of two complications of the disease: nerve damage (neuropathy), and poor circulation.

For those living with diabetes, foot problems, such as the following, can lead to serious complications:
• Corns
• Calluses
• Cracked heels
• Hammertoes
• Bunions
• Ingrown toenails
• Ulcers (sores) that do not heal
• Skin infection (cellulitis) from an open wound
• Abscess formation (collection of pus under the skin)
• Osteomyelitis (bone infection)

Untreated diabetes can result in other conditions, such as:
Diabetic peripheral neuropathy – this condition does not emerge overnight. Instead, it usually develops slowly, and worsens over time. Some patients have this condition long before they are diagnosed with diabetes. Having diabetes for several years may increase the likelihood of having diabetic neuropathy. It is a condition that affects the nerves and symptoms are usually numbness, tingling, burning, pins and needles.
Charcot foot – is a condition in which the bones of the foot are weakened enough to fracture. It is a sudden softening of the foot’s bones, caused by severe neuropathy, or nerve damage, a common diabetic foot complication. It can trigger an avalanche of problems, including joint loss, fractures, collapse of the arch, massive deformity, ulcers, amputation, and even death. As the disorder progresses, the bottom of the foot can become convex, bulging like the hull of a ship. Since most people with Charcot cannot feel pain in their lower extremities, they continue walking on the foot, causing more injury. With sustained walking, the foot eventually changes shape. The joints then collapse, and the foot takes on an abnormal shape, with a rocker-bottom appearance.
Charcot cannot be reversed, but its destructive effects can be stopped if the complication is detected early. The symptoms of Charcot foot appear suddenly. They include warm and red skin, swelling, and pain. A person living with diabetes who has a red, hot, swollen foot or ankle, requires emergency medical care anyway, because these can also be symptoms of deep vein thrombosis, or an infection.
To prevent complications…

5 takeaways from Becton Dickinson’s $24B acquisition of C.R. Bard

Give and take concept on black background

Another week, another ginormous medical device deal. This time it is Becton Dickinson which has acquired C.R. Bard in a $24 billion deal to extend its product footprint in the latest of many medical device acquisitions that are reshaping the manufacturing landscape.

The deal is expected to close sometime in the fall. Here are a few items to keep in mind with this deal.

Expansion of disease states Bard will expand BD’s focus on the treatment of disease states beyond diabetes to include peripheral vascular disease, urology, hernia and cancer, the company press release said.

A boost to BD’s hospital acquired infection capabilities The acquisition will also expand BD’s leadership in infection prevention. It gives BD the ability to address the majority of the most costly and frequent hospital-acquired infections. BD will also have a more comprehensive, clinically relevant offering to address Surgical Site Infections and Catheter-Related Blood Stream Infections, the release noted.

Hospital partner factor Medical device companies have been under the gun to consolidate as the face increased…

Viral trigger may underlie development of celiac disease

Reovirus, which commonly infects humans without causing any symptoms, may trigger an immune response to gluten that causes celiac disease, report US researchers.

In a study published in Science, orally infecting mice with the seemingly benign virus triggered an immune response to gluten and led to celiac disease symptoms in the rodents.

The study raises the possibility that, in the future, vaccines could be used to prevent celiac disease and other autoimmune disorders such as type 1 diabetes.

Virologist Herbert Virgin (University of Washington), who collaborated with some of the study authors but was not involved in the research says: “It’s been hypothesized for decades that virus infection can trigger autoimmune processes. This study provides an example of that phenomenon and some mechanistic insight into how this might work for celiac disease.”

For the study, lead author Bana Jabri (University of Chicago Celiac Disease Center) and colleagues orally infected mice with two different human reovirus isolates and showed that genetic differences between the virus…

A Breathalyzer to Detect Inflammatory Signs of Influenza Infection

Detecting diseases non-invasively by sampling exhaled breath is a growing field. Previously, we featured Owlstone Medical, who have developed breath sampling devices to store breath samples for later analysis along with an integrated unit for the detection of lung cancer biomarkers. Recent research on breath testing has suggested that viral infections, such as influenza, might be also be diagnosable using breath samples. Researchers at the University of Texas at Arlington have developed a prototype breathalyzer that could detect signs of influenza infection on a patient’s breath.

Influenza epidemics are a worry, with the continued mutation of the virus and the emergence of new strains. Confirming influenza infections rapidly and accurately would be very useful to prevent the spread of flu epidemics, but current testing…

Sleep may be regulated by several brain-based immune proteins, study reveals

Sleep — one of the most basic, yet most mystifying processes of the human body — has confounded physicians, scientists and evolutionary biologists for centuries.

Now a study conducted in mice and led by investigators at Harvard Medical School and VA Boston Healthcare System reveals that sleep may be regulated in part by several brain-based immune proteins collectively called inflammasome NLRP3.

The researchers say the inflammasome — which works by unleashing a cascade of immune molecules in response to inflammation and infection — emerges as a central promoter of sleep following such events.

A report on the team’s findings was published Jan. 19 in Brain, Behavior and Immunity.

Scientists have known for a while that certain immune molecules enhance sleep and are activated by infection, but this is the first study suggesting a common underlying mechanism that regulates sleep and plays a critical role in recuperative sleep responses.

Results of the study show that the inflammasome recruits a sleep-inducing molecule to trigger somnolence following sleep deprivation and exposure to a bacterial toxin. Animals lacking genes for this protective immune complex showed profound sleep aberrations.”Our research points, for the first time, to the inflammasome acting as a universal sensing mechanism that regulates sleep through the release of immune molecules,” said study senior investigator Mark R. Zielinski, instructor in psychiatry at HMS.

Although warranting further study, the observations suggest that the inflammasome, the constellation of sleep-regulating proteins, may play…

‘All diabetics should be screened for diabetic foot’

'All diabetics should be screened for diabetic foot''All diabetics should be screened for diabetic foot' - Image

Aurangabad: Appealing to delegates present at the three-day conference on diabetic foot that kicked off on Friday, experts said patients with severe infection of diabetic foot ulcers should usually be hospitalised as they often require surgical interventions, fluid resuscitation and control of metabolic derangements.

While giving insights to doctors on assessment of complications of diabetes on foot, physician and diabetologist from Tanzania Zufiquarali Abbas insisted that each diabetic patient should be screened for diabetic foot. “It is also the responsibility of the patient to tell symptoms to the doctor and also…

Tuberculosis and Diabetes Mellitus

Co-Infection in Pakistan

Tuberculosis or TB, a common and fatal infectious disease, has been a serious problem for mankind for centuries. According to the WHO, TB comes in second against the human immunodeficiency virus (HIV) related to infectious micro-organisms that cause death. Pakistan is also included in the five countries which experience largest number of reported TB cases in the world. The country ranks at number 5 amongst a list of 22 countries with highest TB burden. It also ranks at number 4 amongst a total of 27 countries with highest Drug resistant TB burden. The DM and TB co-morbidity is re-emerging due to the progressive epidemiology of both diseases all over the world, especially in developing countries like Pakistan. The adverse effects of both diseases may result in poor glycemic control in DM and poor response to anti-TB drug treatment. The relative risk (RR) of developing pulmonary TB is 3.47 to 5.15 times higher in diabetics as compared to non-diabetics. In Pakistan, the prevalence of tuberculosis in diabetic patients is almost 10 times than in non-diabetics.

In this connection a study by researchers from University of Veterinary and animal sciences Lahore has found strong link between TB and diabetes co infection in Pakistan. Above mentioned study was conducted at Department of Epidemiology & Public Health, University of Veterinary & Animal Sciences, Lahore by myself under supervision of Professor Dr Mansur ud Din Ahmed. The prevalence of Diabetes among TB patients was found 14.8% while in general public it was found 7.9%. Worldwide, 70% of diabetic patients live in TB…

Do You Have a Stomach Bug, or Was It That Food You Ate?

It’s that time of year when illness spreads like jam on toast. Have you been hit by a stomach virus? Or maybe it was food poisoning? It’s good to know which it is, so you know whether or not you are contagious or if other people shouldn’t eat the mystery meat in your fridge.

Stomach VirusFood Poisoning
CausePassed by a virus that attacks the intestines; you catch it by coming in contact with someone who is infected, or by touching something he or she has touched. This virus can also be passed on through contaminated food or water.You get it by eating contaminated food that contains infectious organisms, bacteria (like E. coli), viruses, or parasites.
  • Watery diarrhea
  • Nausea and/or vomiting
  • Abdominal cramps
  • Fever
  • Muscle aches
  • Headache

Symptoms appear one to two days after exposure to the virus and usually last for one to two days but can last for up to 10 days.

  • Abdominal pain, which can be quite severe
  • Loss of appetite
  • Watery diarrhea
  • Nausea and/or vomiting
  • Fever

Crowdsourcing Citizen Scientists to Combat Zika at Texas A&M: Interview with Dr. Jenifer Horney

Infectious disease monitoring and management is not only a challenge abroad but also locally in the continental United States. At Texas A&M, Dr. Jennifer Horney PhD, MPH, CPH from the School of Public Health and Dr. Daniel Goldberg, PhD from the College of Geosciences have lead an effort to attack Zika, an Aedes mosquito-borne virus, at its source, standing water, through iOS and Android apps. The platform crowdsources data from citizen scientists about the locations of standing water that health departments can use to identify hotspots where samples can be collected to test for the presence of Zika. We had a chance to sit down with Dr. Horney to learn more about the group’s mobile platform.

Mike Batista, Medgadget: Tell us a little about your background and interest in Zika.


Dr. Horney: I am an epidemiologist whose research focuses on outbreak investigations and natural disasters. I worked a lot on the novel influenzas that were happening in 2006 (avian flu) and 2009 (H1N1). Since coming to Texas A&M, I’ve been able to work with researchers across the university on issues related to infrastructure and health, climate and health. Zika is a great example of how we might be facilitating the spread of new diseases through issues like infrastructure and climate.

Medgadget: Within the past couple of years efforts have been underway to fight Zika. What led you to the idea of creating a mobile app to address the problem?

Dr. Horney: We heard from local health department partners that they needed volunteers to help with surveillance for mosquitoes. The mosquitoes are collected from standing water and then tested for Zika virus. By crowd-sourcing the data collection, we can collect a lot of data about where standing water might be concentrated to improve the…

Infection-related deaths expose deficiencies in FDA oversight of medical devices


At first, Vincent Karst, 55, was recovering well from his open-heart surgery in March 2015.

He resumed the activities he enjoyed, such as visiting car shows and eating out. But some months later, his condition mysteriously deteriorated. By fall he was so short of breath, nauseated and overwhelmed by fatigue that he needed to be rehospitalized in York, Pennsylvania.

There, doctors diagnosed a new problem: a serious mycobacterial infection that was acquired during his surgery, according to his subsequent lawsuit. Aggressive treatment with antibiotics left him with partial hearing and vision loss.

Federal regulators acknowledge they were aware of infections tied to a heart-surgery device used in Karst’s operation by the summer of 2014. But they waited 14 months before issuing a public alert about the risks, and it wasn’t until last month — more than two years later — that they issued detailed recommendations to hospitals and patients on what to do.

Critics say a swifter response could have saved thousands of patients like Karst from being exposed to potentially deadly bacteria. Some patients fell ill or died without knowing the real cause, doctors say.

Now hospitals, which consider the heater-cooler machines crucial in open-heart surgery, are scrambling for ways to protect patients. And authorities have urged hospitals from New Jersey to California to notify hundreds of people who underwent surgery in recent years that they might be harboring a dangerous infection. Patients have sued, claiming they were infected in Pennsylvania, Iowa, South Carolina and Quebec.

Experts and patient advocates say these cases are only the latest to expose holes in the nation’s approach to spotting and responding to dangerous deficiencies in medical devices.

“It’s another example of the poor oversight of medical devices and how the industry has accepted infection as the cost of doing business,” said Helen Haskell, founder of the patient advocacy group Mothers Against Medical Error in Columbia, South Carolina.

About 60 percent of U.S. hospitals that do heart surgeries rely on the Sorin 3T heater-cooler device used in Karst’s surgery, which was approved for sale in 2006. But five other manufacturers sell heater-coolers in the U.S., and FDA officials say they share similar design features that make them prone to contamination.

The devices circulate water to warm or cool patients during bypass surgery, valve replacements and some transplants. More than 250,000 heart bypass operations using heater-cooler devices are performed annually in the U.S. The infections caused by the devices can be slow-growing and often don’t trigger symptoms for months or even years, making them difficult to track.

Schematic representation of heater–cooler circuits tested for transmission of Mycobacterium chimaera during cardiac surgery despite an ultraclean air ventilation system. Blue arrows indicate cold water flow, and red arrows indicate hot water flow and patient blood flow.
Schematic representation of heater–cooler circuits tested for transmission of Mycobacterium chimaera during cardiac surgery despite an ultraclean air ventilation system. Blue arrows indicate cold water flow, and red arrows indicate hot water flow and patient blood flow.

As a result, the risk is hard to quantify. At least 79 cases of infection tied to Sorin heater-cooler units in the U.S. and worldwide have been reported to the FDA since 2010, including 12 deaths. Those numbers are expected to rise.

“This particular machine is everywhere and it will be quite a while until we know the real extent of how many people were infected by this,” said Dr. Michael Edmond, an epidemiologist at the University of Iowa Hospitals & Clinics.

It’s In The Air

The potential for contamination of heater-coolers was raised as early as 2002. In a published study, doctors at a German hospital found that “germs and particles pollute” the units and that disinfecting them is very difficult.

The study, presented at a medical conference in New Orleans, said the makers of the devices often “do not provide any technology to reduce bacterial or other contamination,” posing potentially serious consequences for patients.

The study focused primarily on water spilling out of the unit and contaminating the operating room. But it also raised the prospect of waterborne pathogens causing infection through “aerosolization” — which is believed to be the way the recent infections occurred. The units examined were not Sorin devices.

The FDA visited Sorin’s Munich, Germany, plant in April 2011 to address safety concerns about the heater-cooler machine, according to a lawsuit filed this month. That suit says Sorin’s instructions for disinfecting the heater-cooler every two weeks allowed for “bacterial overgrowth well in excess of safe standards” in just a day and a half.

Despite the 2002 German study, a spokeswoman for Sorin, Karen King, said the company wasn’t aware of the threat of airborne mycobacteria until receiving a report from Swiss authorities in January…