A Japanese Perspective on Patient Safety

Katsuyuki Miyasaka, MD, PhD, FAAP

Anesthesia patient safety is a primary common concern of anesthesia providers all over the world. Yet my experience in academic institutions both in Japan and in North America has shown me there are distinct differences in the culture of clinical anesthesia, despite each region’s sharing the same sets of scientific evidence and similar procedures in everyday anesthesia care.

The history of Japanese anesthesia dates back to 1804, some 40 years before Morton’s Ether Dome event (1846).1 Seishyu Hanaoka (1760-1835) provided general anesthesia for breast cancer using datura extracts. However, modern Japanese anesthesia started in 1950 when Dr. Meyer Saklad (1901-1979), director of the department of anesthesiology at Rhode Island Hospital (Brown University), introduced the concept of anesthesiology into Japan. Dr. Saklad was a member of the Unitarian Service Committee Medical Mission, which was a part of the US occupation mission.2 At the time, anesthesia was provided mostly by junior surgeons in Japan. The mission contributed to academics by donating several textbooks that laid the basics for the study of anesthesiology in Japan and inspiring young physicians to study in the US. The nation’s first anesthesia department was established in 1952 at the University of Tokyo. Professor Hideo Yamamura (born 1920), who studied at SUNY, Albany, was appointed as the first head of the department. Therefore, Japanese anesthesiology, unlike other medical specialties which were influenced mainly by the German medical system, was strongly influenced by American medicine.1

Japan faced a critical health care crisis when WWII ended in 1945, as most major cities and daily life had been totally demolished, resulting in severe poverty and food shortages.1 Efforts by US occupational forces helped restore and establish a democratic society and public health. Japan attained a rapid improvement in health statistics (increased life expectancy 14 years between 1947 and 1955). Japan was able to introduce universal health coverage in 1961, long before rapid economic growth followed. The system is claimed to be responsible for the rapid attainment of its current excellent health care status, such as the longest longevity and lowest infant mortality in the world.1

The Japanese health care system is socialistic in that it is designed to provide equal access to health care with a universal fee schedule for all. This government-controlled system worked extremely well when the focus was mostly on curing diseases or decreasing mortality. As the economy grew and people started taking the medical system for granted, expectations also grew for perfect medical practice (zero fault) with the best possible quality. Physicians could now be blamed by patients if the outcome was not optimal, even though the physicians’ practice is controlled and restricted by the fee schedule.3

Two consecutive high-profile medical mishaps occurred in two major teaching hospitals in 1999, resulting in social distrust of the medical community. In one case, accidental injection of an antiseptic liquid instead of antibiotics caused a patient’s death.3 The 2 nurses and 1 physician involved were charged with professional misconduct. The president of the hospital was charged with not reporting the incident to the police soon enough (within 24 hours). False accusations by the media of a cover-up by the hospital staff and related gossip caused social turbulence. In the other case, accidental swapping of an open heart and a lung resection case occurred in the OR and resulted in 2 wrong-site surgeries. The cardiac surgeon, a thoracic surgeon, and 2 anesthesiologists, including one who noticed signs of the error, but could not stop the wrong surgeries, and 2 nurses were criminally charged.3

Significant changes were introduced into medical practice after these incidents. Ironically, the perceived value of anesthesia services increased, and the suboptimal practice of surgeons providing anesthesia by themselves while performing surgery rapidly decreased. While this change was welcomed by anesthesiologists, the increased need for anesthesia providers was not fully addressed.

Another more serious change was that society demanded that physicians report any unexpected in-hospital deaths to the police. This meant even medically explainable death became subject to criminal investigation. Anesthesiologists are at high risk as they are constantly dealing with life threatening situations. The conviction rate in Japan is extremely high (99.8%), and therefore, it is not only stressful, but frightening to innocent physicians involved, since they risk losing their medical license at any level of criminal charge. It is also very counter-productive from the point of view of preventing recurrence, as the main interest of Japanese law enforcement is to seek out and prosecute any wrongdoing. Punishing doctors will not improve patient safety if any well intended debriefings are interpreted the same way as man-slaughter confessions. In fact, a significant number of anesthesiologists have suffered from impairment of medical practice, have been forced to change their careers, quit working, or even commit suicide.

Medical malpractice lawsuits continued to increase until another striking incident happened in 2006. An obstetric/gynecologic surgeon was arrested on a charge of professional negligence resulting in a case of fatality (from massive bleeding during a caesarian section due to placenta previa and accreta). However, the surgeon was found not guilty in 2008 after nearly 2.5 years of intense legal battles. Fear of litigation produced a nationwide shortage of obstetricians. It was fortunate that medical malpractice lawsuits started to decrease overall after the settlement of this trial.3

In October 2015, after years of debate, Japan introduced a new medical accident investigation system which is aimed at preventing recurrences rather than pursuing individual responsibility or prosecuting health care workers.4 World Health Organization guidelines centered on non-punishment, confidentiality, and independence are referenced.5 The good news is that administrators are now not forced or rushed to report unexpected hospital deaths during medical care to the police unless the hospital deems it is a criminal case. It is too early to conclude whether the new system will work as expected, but it is definitely a big step forward to reducing our fear of facing unjustified criminal charges for less than optimal outcomes, and in the absence of negligence.

According to the 2015 report of the Japanese Ministry of Health,6 an estimated 2,700,000 cases of general anesthesia were given in Japan, which is a substantially small number compared to the estimated 25,000,000 cases or more in the US. Considering the fact that the population of Japan (127,000,000) is about 40% of the US (314,000,000), a mere 1/4 of general anesthesia cases are given per capita in Japan.6 Social and cultural differences definitely play a role, but equally or even more significant is the relatively small number of anesthesiologists in Japan and limited support by allied health care providers, such as nurses and pharmacists for activities outside the operating room (OR). As a result, anesthesiologists are rarely involved in procedural sedation services or acute pain services. Very few epidurals for labor analgesia are performed in Japan.

The majority of anesthesia care is provided by trained physician anesthesiologists in Japan. There are no nurse anesthetists (CRNAs) as only physicians are legally allowed to administer anesthesia. Although specialty training in anesthesiology and a board system exist, legally any physician can administer and bill for anesthesia with only a small difference in fees.

While an estimated 20% of anesthesia cases are still handled by surgeons, many more cases of so-called “anesthesia” or sedation are performed by non-anesthesiologists without any anesthesia supervision. Examples of where non-anesthesia providers deliver sedation include endoscopic procedures, interventional cardiac procedures, and pediatric MRI studies. Same day surgery cases are increasing, but they are based on hospital practice and there are very few stand-alone surgical centers. Thus, most anesthesia is provided in hospital based ORs with backup beds and other medical services, contributing to anesthesia safety.

A new system for perianesthesia nursing, in which specially educated (master’s degree) nurses exclusively support and assist anesthesiologists throughout the entire perioperative period, both in and out of the OR, is being developed.7 They will be strong allies to anesthesia services, especially anesthesia services outside of the OR, but their number is still small. Most professional anesthesiologists and their trainees belong to the Japanese Society of Anesthesiologists (JSA) with a membership of 12,240 as of March 2016.1

The JSA started a voluntary annual perioperative mortality and morbidity survey in 1992 among JSA approved anesthesia training hospitals (approximately 800 hospitals).8,9 The latest interim unofficial data available (2009-2011) encompasses 4,401,910 reported general anesthesia cases, including 5,353 cases of critical perioperative morbidity, indicating a rate of 3.93/10,000 deaths in the perioperative (within 30 days of anesthesia) period. This is significantly lower (better) than that of 5.51/10,000 in the previous 5-year period (2004-2008).8,9

Anesthesia was responsible for perioperative death in 32 cases, indicating an anesthesia mortality rate of 0.07/10,000, a continuing falling trend from previous years. Causes of death in the latest survey were drug related (6), aspiration (5), ventilation related (5), overdose of the main anesthetic agent (4), and inappropriate fluid/transfusion management (3). There was one reported case of death from anesthesia due to airway management at induction of anesthesia (0.002/10,000). The results of this survey are limited by the following: its reliance on voluntary reporting, its coverage of only cases carried out by professional anesthesiologists, the unknown quality of individual reported data, and a rather long follow-up period of 30 days following anesthesia. Still, it is a very unique and meaningful activity of the JSA to help us recognize the importance of anesthesia safety.8,9

JSA guidelines (last revised in 2014) and ASA guidelines (last affirmed in 2015) share almost identical standards for basic monitoring, except the ASA extends their scope to procedural sedation, such as the recommendation for capnometry in non-intubated patients, which is still not clearly established in JSA guidelines.7-9

Japanese anesthesiologists frequently refer to textbooks by Miller (translated into Japanese) or Smith, use mostly US or European made anesthesia machines, and frequently perform ultrasound guided regional nerve blocks. However, they have a preference for using sevoflurane, propofol by total continuous infusion, and hydroxyethyl starch (HES) (6% HES 130/0.4 in 0.9% NaCl). The use of electronic anesthesia recording systems is widespread in Japan, with adoption estimated to be around 70% in anesthesia training hospitals with over 300 beds. The practice of confirming monitored data by handwriting has largely vanished, but tracking of non-electronic data such as information obtained by precordial stethoscope or physical contact to the patient has also faded. I feel this is a concern for anesthesia safety. The availability of pharmaceuticals and medical equipment plays an important role in anesthesia practice, but some differences reflect differences in health care insurance systems where physicians may not be sensitive enough to the cost of care. Japanese anesthesiologists probably use more sugammadex than in any other country.10

As Japanese surgeons and hospital administrators wish to increase revenue by increasing the number of surgeries, the demand for anesthesia services is steadily rising. Our priority is always patient safety. In addition to securing patient safety and comfort in the OR, we should work hard to extend our services outside of the OR to promote a culture of safety.

Dr. Katsuyuki Miyasaka, MD, PhD, FAAP, is a designated professor of Perianesthesia Nursing at St. Luke’s International University, Tokyo, Japan. He claims no relevant financial relationships to disclose regarding this review.


References:

  1. Japanese Society of Anesthesiologists. www.anesth.or.jp/english/history_ayumi.htm.
  2. Ikeda S. The Unitarian Service Committee Medical Mission Contribution by the United States to Post–World War II Japanese. Anesthesiology 2007; 106:178–85.
  3. Leflar Robert B. The Regulation of medical malpractice in Japan. Clin Orthop Relat Res 2009; 467: 443–449.
  4. Takasugi N, Yokokura Y. Japan Medical Association’s basic proposal toward the establishment of a medical accident investigation system. JMAJ 2012; 55: 139–141.
  5. WHO draft guidelines for adverse event reporting and learning systems. World Alliance for Patient Safety Forward Programme 2005. Geneva, World Health Organization; 2004.
  6. Dynamic and static status survey of medical institutions in Japan, 2014. http://www.stat.go.jp/english/data/nenkan/1431-24e.htm & http://www.mhlw.go.jp/toukei/saikin/hw/iryosd/14/dl/01_tyousa.pdf (Japanese).
  7. Miyasaka K, Katayama M. Perianesthesia Nursing—a new program at St. Luke’s Nursing College—SLNR. Journal of St. Luke’s Society of Nursing Research 2012; 16: 16-18.
  8. The Japan Society of Anesthesiologists Committee on Operating Room Safety. Anesthesia mortality and morbidity during 1993. Masui 1996; 45:374-378. 8.
  9. Irita K, Kawashima Y, Tsuzaki K, et al. Perioperative mortality and morbidity in the year 2000 in 502 Japanese certified anesthesia-training hospitals : with a special reference to ASA-Physical Status—Report of the Japan Society of Anesthesiologists Committee on Operating Room Safety. Masui 2002; 51:71–85.
  10. Booklet of Anesthesia (Masuino Shiori). Japanese Society of Anesthesiologists, 2012.