Tuesday, September 11, 2018

Who is responsible for sponge and instrument count?


Retained surgical sponges and instruments are a common occurrence in surgical practice despite all the count policies, electronic counting and adjunct methods used in the operation theater. When discovered years later, they raise many medicolegal questions.

Lawsuits are brought forth by patients against the operating surgeons and medical facilities and the question about who is responsible for sponge and instrument count is often debated in the court of law. The captain of the ship or the surgeon is no longer responsible for a correct sponge or instrument count at the end of surgery and members of the entire operating team can be held liable in litigation for retained foreign bodies.

In August 2005, Maurine Villapando went to the emergency room at Raritan Bay Medical Center (Raritan Bay), New Jersey complaining of severe abdominal pain on her right side. Physical examinations and imaging studies revealed an ovarian cyst. The attending obstetrician/gynecologist (OB/GYN) surgeon Dr. Nath, performed a laparotomy, an open incision directly into the abdomen, to remove the cyst.

As per the hospital policies, a laparotomy involved three distinct "counts" of instruments and lap pad sponges performed by the nurses, who, in this case, were defendants Virginia Ko Chua, the circulating nurse, and Liza Abundo, the scrub nurse.

The initial count was done before the start of surgery, the second count occurred during the initial closure of the peritoneal lining, wherein the nurses would count aloud for everyone in the operating room to hear. The third and final count occurred when the surgeon was ready to close the skin.

After the third count, the nurses would verbally inform the surgeon that the count is correct, puts a hash mark against each item on the “count-sheet” to ensure that nothing is missing. At the end of the procedure, the circulating nurse would sign the sheet indicating that the surgeon was verbally notified of the final count status, and the surgeon would acknowledge the count report by signing the count sheet.

In this case, the circulating nurse committed an error while adding the hash marks on the “count-sheet” and reported that all the 13 sponges were accounted for. The hash marks denoting the tally revealed a count of only twelve sponges retrieved, thus one was missing. However, the circulating nurse mistakenly wrote the number “13” next to the hash marks after adding them incorrectly. Neither nurse noticed the counting error and after verbally being advised that the count was correct, the gynecologist acknowledged the count by signing the count sheet.

After surgery, the plaintiff developed a fever and continued to have pain, but a repeat CAT scan did not reveal the forgotten sponge. She was then discharged after her symptoms resolved. 

Approximately after 5 years, the plaintiff had an X-ray done for back pain when the missing sponge was found. The sponge has formed a large mass with a lot of scar tissue that involved the right fallopian tube and ovary. She had to undergo a right-sided salpingo-oophorectomy and was told that if she wishes to have children in the future, she would require some assisted reproductive technique.

On February 20, 2013, the plaintiff sued the hospital, the surgeon who performed the laparotomy, the circulating nurse, and the scrub nurse. She eventually settled with all the other defendants except the OB/GYN surgeon, Dr. Nath who proceeded to trial.

At trial, the gynecologist testified that he relied on the nurses' count and didn’t himself do the math.  The plaintiff expert witness, an OB/GYN himself admitted that at the other two hospitals where he has worked, it was the nurses, not the surgeons, who were responsible for the sponge count, but argued that the doctor’s mistake was in not reading the form in detail before he signed it.

Two expert witnesses from the defending gynecologist side testified that the doctor simply signed the form to acknowledge that the nurse told him the count was correct and the surgeon is not required to double-check the nurses tally.

At the end of the trial, the jury did not find Dr. Nath guilty of medical negligence, and according to the established standard of care, the doctor is not required to confirm the nurses’ count. The doctor’s signature only meant that the doctor had received an oral confirmation from the nursing staff that the count was complete was correct.  

While this legal case revolved around the individual responsibility of the operating team, it requires teamwork to prevent such type of complications. Whether cases of retained surgical sponges occur because of negligence, mistake or merely human error is irrelevant in the overall picture. What is relevant is that healthcare providers can now potentially eliminate the risk entirely using new computer-assisted advanced technologies.

SITUATE™ DETECTION SYSTEM X
Medtronic’s Situate™ Detection System utilizes low-frequency radio waves to detect sensors embedded in the sponges. Another method, Stryker’s SurgiCount Safety-Sponge System®, utilizes a technology that tracks each medical sponge used with a unique identifier. In the case of SurgiCount, the manufacturer offers a $5 million indemnification guarantee to hospitals that implement it.

In the end, surgeons being the captain of the ship, face increased liability, ultimately assuming responsibility for any negligence committed by those working under their directions. Hence, it is incumbent upon the surgeon to do everything in his capacity to protect the health of patients and protect himself or herself—as well as his or her support team—from potential medical malpractice claims.




Monday, September 10, 2018

FDA clears Natural Cycles as the first digital method of contraception in the US


Natural Cycles became the first and only app to receive FDA clearance as a method of birth control. The app contains an algorithm that calculates the ‘fertile window’ based on basal body temperature (BBT) and menstrual cycle information. It makes the women aware of her ‘fertile days’ to avoid sex or use a barrier method if practicing birth control.

Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health said in a press release, "Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly." 

"But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device," she added further.

“Natural Cycles can adapt to each woman’s body and, with a high degree of precision and accuracy, determine when she is ovulating,” says Dr. Elina Berglund, a physicist who created the app along with her husband Dr. Raoul Scherwitzl, a postdoctoral researcher.

Natural cycles is just like old times period tracker with some added features. The app requires the women to input her daily basal body temperature recordings and the date of menstruation. LH test result is an optional entry point.

The app’s calendar then labels fertile days as red (when you should abstain or use a condom) and the rest green, when you are “safe.” Using the sensitive thermometer and some mathematics the app claims itself “as good as the pill" at preventing pregnancy.

The app is primarily based on the fact that a woman’s body temperature rises slightly (about 0.4℃) after ovulation and remains slightly elevated throughout the rest of the cycle. The app uses an algorithm that considers body temperature, cycle irregularities, sperm survival, length of menstrual cycle and cycle irregularities. The algorithm learns from previously recorded cycles from the same woman and can provide predictions of her fertility status and upcoming ovulation, LH and menstruation days.

Initially, the app shows a nearly equal number of a green and red day but, as women continue using the app and fed more data, the number of red days is reduced to 8 each month. The app is 99.95% sure before it assigns a day red or green. If in doubt it will go red.

Clinical studies involving 15,570 women found that when used correctly, the failure rate for the app was 1.8%, while with typical use, or women sometimes not using the app correctly, the failure rate was 6.5%. "Based on the strength of our clinical data, we are delighted that the FDA granted De Novo classification for Natural Cycles and look forward to working together with healthcare professionals to offer a digital form of birth control to women in the US," said Elina Berglund.

"Our mission at Natural Cycles is to pioneer women's health with research and passion, and this milestone marks a very important step in that journey."


Anyone can use it, even women with PCOD or irregular cycles, only these women will have more red days on the calendar than green. Natural Cycles is contraindicated in women in whom pregnancy poses a serious risk to mother or fetus or in those who use other forms of contraception that prevent ovulation.  The method also does not prevent STIs.

The Natural Cycles app can be purchased through the Apple store or Google Play on a yearly subscription basis for $79.99 a year (includes oral basal thermometer) or monthly for $9.99 per month. They also offer a free trial period of 1 month.

Here is a video about Natural Cycles app for healthcare professionals. 






Friday, September 7, 2018

The fertility doctor who secretly fathered many children is barred from medical practice


Dr. Donald Cline, MD, from Marion County, Indiana who secretly used his sperm during the IVF treatment for many of his patients has surrendered his license and is barred from ever practicing again.

Dr. Cline practiced as infertility specialist in Indianapolis area during the 1970s and 1980s and may have fathered dozens of children under the guise of using "fresh sperm" from a medical student or resident. In the United States, the Centers for Disease Control and Prevention report that from 2011 to 2015, as many as 12 percent of women reported having used infertility services such as artificial insemination.

It is currently not known that how many couples did Cline deceived, exactly how many children were fathered and what was his motive behind this action. The matter came to light when Jacoba Ballard's discovered that she shares her DNA with 8 unknown siblings when she took a DNA test from 23andMe.com—a direct-to-consumer DNA testing service.

Out of 8, only one was identifiable by name, and she and Ballard got together to construct a family tree only to realize that their mothers have gone to Cline clinic for fertility treatments.  Ballard and her half-siblings arranged a meeting with Cline himself who finally confessed that he had used his sperm in as much as 50 cases to help unknowing patients who desperately wanted children. For now, it is not precisely known that how many women have Cline exactly fertilized using his sperms.

Many families and children have since come forward for DNA testing, and reports from ancestry.com and 23andMe have found another three dozen of Kelly half-sibling. They have formed a group on social media, and many of them are in contact with each other. With the rising popularity of DNA testing and social media presence of more and more people, the Ballard is sure of adding more siblings to her group.

Ballard filed a complaint against Cline with the Indiana attorney general's office. Cline was charged with obstruction of criminal justice after lying to investigators about two confirmed cases of paternity. US laws differ state wise when it comes to fertility doctors using their sperms, and Indiana law does not explicitly prohibit fertility doctors from using their sperms.

In December 2017, Cline pleaded guilty to two counts of obstruction of justice, admitting that he intentionally lied about using his sperm to impregnate his patients. Cline was given a 365-day suspended sentence for the felony conviction.

“Not only did Dr. Cline abuse his position of complete trust with his patients, his decisions will have a lasting impact through generations of the impacted families,” Prosecutor Terry Curry stated after the sentence was announced. “There were significant limitations to how a criminal case could proceed against Dr. Cline, but ultimately he admitted to his actions and to intentionally misleading investigators.”

The FDA clearance of direct-to-consumer DNA testing and a lot of TV advertisement has made DNA testing look like fun. Many of the ads promote it as a holiday or Christmas gift. However, consumers should be aware of the potential downside of casual genetic testing—they may find something that has the potential to change the life for good or bad and physician should always explain patients about the pros and cons of genetic testing.