Cross-Posted at Bill of Health
As I have blogged about before, including in this post from 2010, and this one from 2009, about 1 in every 160 deliveries in this country ends in a stillbirth, and all too frequently no one can say why. An article by Robert Goldenberg and colleagues in this month’s issue of the American Journal of Perinatology suggests that the knowledge gap is likely to persist.
As Goldenberg explains, the three tests that provide the most information about what caused a stillbirth are (1) an autopsy, (2) an examination of the placenta, fetal membranes, and umbilical cord, and (3) a karyotype (a test for chromosomeabnormality). Of the members of the American College of Obstetricians and Gynecologists who responded to a 2011 survey, however, 23.3 reported that they infrequently ordered an autopsy when a stillbirth occurred (0.4 percent reported that they never did) and 24.8 percent reported that they infrequently ordered a karyotype (0.3 percent reported that they never did). These results comport with the findings of a qualitative study published in 2012 in BMC Pregnancy & Childbirth. The authors, Maureen Kelley and Susan Trinidad, reported that obstetrician-gynecologists in two focus groups “would not routinely offer an autopsy to the parents, but would conduct one if requested. Some would offer/order lab work on the placenta if the cause of the stillbirth were not known.”
A surprisingly high 30.2 percent of the doctors who responded to Goldenberg’s survey indicated that they frequently, but do not always, review the results of post-stillbirth testing; an additional 11.9 percent admitted that they infrequently review such results. The survey also revealed that “the large majority of stillbirth certificates are filled out prior to the return of all test results”, some “by providers other than the physician”, “making it “highly likely that that the vital statistic cause of death reports are inaccurate.”
As Goldenberg notes, there is, as with many surveys, the possibility of a response bias, since obstetricians who were interested in stillbirth were more likely to respond. In practice, the percentage of physicians who do not order the appropriate tests may be even higher than the survey revealed. The failure to order the appropriate tests and then interpret and report their results has obvious public health implications. Goldenberg explains that, despite advances, “the U.S. stillbirth rate is among the highest in developed countries, substantial disparities remain in stillbirth rates between various populations of U.S. pregnant women, and about one-third of stillbirths may be preventable.” Further study is needed and better data is a necessary first step.
Failing to order the appropriate tests can also harm individual grieving families. Soo Downe and colleagues conducted a qualitative interview study, published earlier this year in BMJ Open, and found that while “[f]ifteen [of the twenty-five parents interviewed] expressed a strong drive to find out why their baby died”, just ten had had an autopsy. These parents “emphasized the importance of discussions and accurate information about maternal and child blood tests, placental investigations, postmortem examination and any other tests that could be conducted.”
To improve stillbirth-related knowledge and practice among obstetricians, Goldenberg recommends addressing the relevant issues during residency, in continuing medical education programs, and in grand rounds. Learning how best to manage a relatively rare occurrence like stillbirth is likely to continue to fall low on the list of priorities of busy physicians with competing obligations, though. More promising, I think, is Goldenberg’s recommendation that hospitals help by, among other things, developing protocols and standardized order sheets. Goldenberg’s survey showed that ”only about half the hospitals had written guidelines for evaluation and management of a stillbirth, and only 25% of the respondents had preprinted orders at their hospital for stillbirth tests.” Remedying this would help physicians and patients navigating an exquisitely difficult time; it could also go a long way to improving the current quality and quantity problems with stillbirth data.
*I thank Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, for keeping me focused on this important issue. (My prior posts are here, here, here, and here). Cathy’s grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.
When patients undergo surgical or other medical procedures, they hope to receive optimal care provided by experienced physicians. They are rarely concerned about proper sterilization of surgical instruments and other medical equipment as it is likely assumed that the health care facility has applied this standard precaution. Unfortunately, however, not every medical center is adequately sterilizing its equipment, yet this is a crucial element of successful medical care.
According to a report by The Center for Public Integrity, a patient who underwent a routine rotator cuff repair surgery at a Texas hospital in 2009 was readmitted weeks later due to an infection from the deadly bacteria known as P. aeruginosa. An investigation conducted by the Centers for Disease Control and Prevention (CDC) and the hospital revealed that the arthroscopic shaver utilized for the surgery contained the deadly bacteria even after the sterilization process.  A more recent incident occurred in March of this year where a routine inspection at an oral surgeon’s office in Tulsa, Oklahoma exposed sterilization issues, including cross-contamination problems. The Department of Health stated, “more than 60 former patients [of the oral surgeon] tested positive for hepatitis and HIV.”
Medical device manufacturers originally sold “single-use” devices because of the demand for disposable equipment. In the late 1970s, hospitals began reusing medical devices intended for or labeled as “single-use” as a cost control measure. The FDA explains that “single-use” devices are to be used once or on one patient during a single procedure whereas reusable medical devices are those that can be reused to treat several patients.
Contaminated reusable medical devises can lead to infections but a method known as “reprocessing” involves meticulous sterilization intended to prevent infections. Reprocessing generally includes the following steps: 1) preliminary decontamination and cleaning in the area of use such as the operating room to inhibit drying of blood and other contaminants on the devises; 2) transfer of the devise to the reprocessing area where careful cleaning occurs and 3) final disinfection or sterilization to allow the devise to be reused. The FDA further explains that problems arise for reprocessing when sterilization instructions by the manufacturer are “unclear, incomplete, difficult to obtain from the manufacturer, or impractical for the clinical environment.”  Manufacturer designs that render proper cleaning difficult in addition to scantily paid sterilization technicians are other sources of concern.
There are some diseases that preclude the reuse of medical devices, specifically Creutzfeldt-Jakob Disease (CJD). CJD is a neurodegenerative disorder that causes rapidly advancing dementia, deteriorating memory, drastic changes in behavior, and coordination and visual issues. It is 100% fatal; patients with CJD usually die within one year of disease symptom onset. CJD results when normal brain proteins are transformed into abnormal and infectious forms known as prions. Infected pituitary hormones, dura mater transplants, cornea grafts, and neurosurgical instruments are some examples of materials that can transmit the disease to patients. Most disinfectant and sterilization procedures do not eliminate the infected prions. Importantly, although fatality normally occurs within one year of symptom onset, the disease has an incubation period of up to 50 years, it is not readily detectable until symptoms occur, and is seemingly capable of transmission to others during the incubation period.
The World Health Organization (WHO) released infection control guidelines for health facilities handling patients with CJD. Essentially, any reusable surgical instruments that come into contact with “high infectivity areas” including the brain, spinal cord, and eye should be disposed of and incinerated. But the difficulty, of course, is knowing who is infected with this infectious fatal disease with the disturbingly long incubation period.
Ensuring that hospitals follow proper sterilization is integral, but technician certification is also an important aspect of the overall sterilization scheme. As the director of sterilization at a healthcare facility in New York so accurately stated, “The people who do your nails, they have to take an infection control course before they can apply for a license …Yet the people who deal with lifesaving equipment, they are required to have zero education.” Currently, New Jersey is the only state that makes certification mandatory for sterilization technicians.
As the provision of health care becomes more transparent, patients not only have the ability to choose where to obtain services based on price and reputation of a facility, but they are also, presumably, able to learn about various quality measures. By filtering a search based on location or hospital name, the Centers for Medicare & Medicaid Services’ (CMS) Hospital Compare Website enables patients to view quality measures such as readmission, complication, and mortality rates. There, patients are able to examine the facility’s rates in comparison to the national average. Therefore, improper sterilization leading to increased infection rates will likely be exposed to the public, however attenuated, which could cause patients to seek care elsewhere—at least in time, among consumers able to bring choice to the equation (non-emergency, non-insurance dictated) and who have the ability to comprehend the data. But seemingly, more direct measures can be taken to ensure patient safety.
 http://www.publicintegrity.org/2012/02/22/8207/filthy-surgical-instruments-hidden-threat-americas-operating-rooms, http://www.today.com/health/today-investigates-dirty-surgical-instruments-problem-or-1C9382187
Filed under: Medical Malpractice, Quality Improvement, Research, Treatment
There was a time in medical science when doctors did not wash their hands prior to operating on their patients (some might say, that to a greater extent than seems possible, this is still the case among medical professionals and point to a number of recent studies as uncomfortable proof). This failure of doctors to wash hands in the medical forum led to the otherwise avoidable death of many of their patients. Up until the mid 1800s, medical science had simply not made the connection between bacteria, transference, infection and death.
Ignaz Semmelweis, a Hungarian physician who was Director of the maternity clinic at the Vienna General Hospital in Austria, made the connection after what is said to have been an extensive statistical analysis in the 1840s, and demonstrated that hand-washing could drastically reduce the number of women dying during childbirth. He introduced a rigorous hand scrubbing protocol and enough women stopped dying to earn him the honorific, “savior of our mothers.”
But as an article from the UK’s Science Museum, Exploring the History of Medicine, points out
Until the late 1800s surgeons did not scrub up before surgery or even wash their hands between patients, causing infections to be transferred from one patient to another. Doctors and medical students routinely moved from dissecting corpses to examining new mothers without first washing their hands, causing death by puerperal or ‘childbed’ fever as a consequence. As dissection became more important to medical practice in the 1800s, this only increased.
Semmelweis showing again that the common sense of one era is the uncommon brilliance of one bygone.
Which brings us to this latest study/project showing new solutions which decrease the risk of colorectal surgical site infection. According to the Associated Press in an article about the project,
“Almost 2 million health care-related infections occur each year nationwide; more than 90,000 of these are fatal.”
“Infections linked with colorectal surgery are particularly common because intestinal tract bacteria are so abundant.”
According to the press release regarding the Project,
A project to reduce colorectal surgical site infections (SSIs) saved more than $3.7 million in costs for 135 avoided SSIs. The two-and-a-half year project included seven hospitals and was directed by the Joint Commission Center for Transforming Healthcare in collaboration with the American College of Surgeons.
The participating hospitals were able to reduce superficial incisional SSIs, which affect skin and underlying tissue, by 45 percent and all types of colorectal SSIs by 32 percent. The average length of stay for hospital patients with any type of colorectal SSI decreased from an average of 15 days to 13 days. In comparison, patients with no SSIs had an average length of stay of eight days.
The press release further notes that
Colorectal surgery was identified as the focus of the project because SSIs are disproportionately higher among patients following colorectal surgeries. Colorectal surgery is a common procedure across different types of hospitals, can have significant complications, presents significant opportunities for improvement, and has high variability in performance across hospitals. The project addressed preadmission, preoperative, intraoperative, postoperative and post discharge follow-up processes for all surgical patients undergoing emergency and elective colorectal surgery, with the exception of trauma and transplant patients and patients under the age of 18. Project participants studied the potential factors that contribute to all three types of colorectal SSIs – superficial incisional, deep incisional and organ space SSIs, which affect organs and the space surrounding them.
The AP article:
Solutions included having patients shower with special germ-fighting soap before surgery, and having surgery teams change gowns, gloves and instruments during operations to prevent spreading germs picked up during the procedures.
Some hospitals used special wound-protecting devices on surgery openings to keep intestine germs from reaching the skin.
The average rate of infections linked with colorectal operations at the seven hospitals dropped from about 16% of patients during a 10-month phase when hospitals started adopting changes to almost 11% once all the changes had been made.
The AP article further notes the timely nature of the Project’s benefits:
Besides wanting to keep patients healthy, hospitals have a monetary incentive to prevent these infections. Medicare cuts payments to hospitals that have lots of certain health care-related infections, and those cuts are expected to increase under the new health care law.
Filed under: Medical Malpractice, Quality Improvement
I’ve written before here about hand-washing (or should I say, not-hand-washing) among hospital staff within the context of the wider issues of infection, avoidable patient harm, death and malpractice.
I noted prior that the New York Times had observed that a study of eight New York hospitals and hand washing showed “low compliance rates, which ranged from about 30 percent to 70 percent at individual hospitals….” And that
Findings of shockingly poor hand-washing compliance are not new in hospitals. Other studies have produced comparable figures, and the stories of fatal consequences have become tragically routine.
The disease control agency estimates there are 1.7 million infection cases a year in hospitals and that 99,000 patients die after contracting them (although infection may not be the sole cause). It projects the cost of treating those patients at $20 billion a year.
In response, I suppose, we have this. A study by Armellino D., et al., entitled “Using high-technology to enforce low-technology safety measures: the use of third-party remote video auditing and real-time feedback in healthcare.”
I’ll save you the commentary and just go straight to the Abstract listed over at Medscape with a hat-tip to Natural News and Dr. William R. Jarvis (further details of study, plus video). Truth is, I really don’t know how to feel about this.
Department of Epidemiology, North Shore University Hospital, Manhasset, NY, USA.
Hand hygiene is a key measure in preventing infections. We evaluated healthcare worker (HCW) hand hygiene with the use of remote video auditing with and without feedback.
The study was conducted in an 17-bed intensive care unit from June 2008 through June 2010. We placed cameras with views of every sink and hand sanitizer dispenser to record hand hygiene of HCWs. Sensors in doorways identified when an individual(s) entered/exited. When video auditors observed a HCW performing hand hygiene upon entering/exiting, they assigned a pass; if not, a fail was assigned. Hand hygiene was measured during a 16-week period of remote video auditing without feedback and a 91-week period with feedback of data. Performance feedback was continuously displayed on electronic boards mounted within the hallways, and summary reports were delivered to supervisors by electronic mail.
During the 16-week prefeedback period, hand hygiene rates were less than 10% (3933/60 542) and in the 16-week postfeedback period it was 81.6% (59 627/73 080). The increase was maintained through 75 weeks at 87.9% (262 826/298 860).
The data suggest that remote video auditing combined with feedback produced a significant and sustained improvement in hand hygiene.
Here’s an abstract of my review of Gregg Bloche’s fascinating book, The Hippocratic Myth:
Not many policymakers or scholars can write with the authority of Gregg Bloche. Bloche is not only a law professor, but a physician, who knows his way around a hospital. Throughout The Hippocratic Myth, Bloche cements his authority in the mind of the reader by relating stories of his experience as a clinician. In each of these stories, his humane and insightful approach as psychiatrist shines through. These fluently-written passages strike one as the work of one of those rare practitioners who manages to care deeply about the patient at hand while simultaneously contextualizing the encounter in a larger framework. Thus The Hippocratic Myth should take its place among other well-received books by physicians with a sense of the big picture, including Atul Gawande’s The Checklist Manifesto and Better and Jerome Groopman’s How Doctors Think.
In The Hippocratic Myth, Bloche leverages this authority to advocate for a more cost sensitive health care system, where individuals frankly acknowledge that they should expect trade-offs between cost and access to certain forms of care. My concern in this review is that Bloche the caring and expert physician would have a tough time in a health care world too deeply influenced by Bloche the cost-conscious author.
Bloche’s book is one of those rare volumes that merits a careful read by scholars, classroom reading by students, and a broad popular audience.