Editor’s note: A truncated version of this blog post will appear as the Final Word article in the July/August 2018 issue of BI&T.
Before starting clinical practice, most physicians take the Hippocratic Oath, whereby they promise to uphold specific ethical standards that are often summarized as “primum non nocere” (“first, do no harm”). This fundamental principle is the foundation for everyone engaged in healthcare. However, striving for safety in healthcare goes much further than “do no harm”—and it requires continued vigilance.
I am a clinical engineer and have seen firsthand that people suffering illness are especially fragile. If you treat them improperly, permanent injury or loss of life can be a terrible consequence. We need to continue to improve how we, as a community, deliver healthcare by creating a culture of safety, going beyond “do no harm” to embrace a new pledge: “Patient safety begins with me.”
This pledge is a simple one that encompasses the myriad of ideas, practice, cultural behaviors, and tools used in administering modern medicine. It also is an inclusive mindset because the potential for error or harm knows no boundaries of title, position, country, or ethnicity. It takes all of us, as a community, to recognize potential or actual harmful situations and intervene or speak up.
This is not a new idea. A great many people and organizations have already taken personal responsibility for increasing safety in healthcare, including:
- Joseph Lister, a British surgeon and a pioneer of antiseptic surgery, who promoted the idea of sterile surgery while working at the Glasgow Royal Infirmary. In the mid-1800s, despite skepticism from his contemporaries, Lister was able to successfully introduce carbolic acid (phenol) to sterilize surgical instruments and clean wounds. His contribution to reducing infections in healthcare is immeasurable. This practice has continued to evolve, with better equipment and methods improving, for example, sterilization of surgical instruments and patient rooms and high-level disinfection of intracavity ultrasonic probes.
- The first public demonstration of surgical anesthesia performed by William Morton and John Warren (1846) at the “Ether Dome at Mass General” was a notable milestone and accomplishment. Between 1821 and 1868, more than 8,000 operations were performed in the Ether Dome. The use of ether pioneered surgery without pain. Anesthesia, literally “without pain,” is a benefit to modern medical practice, but it still holds potential risk for patients. This risk is mitigated by equipment design and practice and the use of both technology (oxygen supply line monitoring) and clinical practice (nerve block stimulators) to attain a good outcome.
- Joel Nobel, who founded the ECRI Institute, an organization engaged in health services research, in 1965. Nobel developed the institute’s overall policies and programs, such as its healthcare technology assessment, product evaluation, and risk management initiatives. Every week, ECRI compiles and circulates a list of medical device recalls, hazards, and warnings.
- Donald Berwick, who founded the Institute for Healthcare Improvement (IHI) in 1991 and was among the authors of the seminal 1991 Institute of Medicine report, To Err Is Human, which documented serious patient safety problems in our healthcare system. In 2004, Berwick launched the 100,000 Lives Campaign, which aimed to reduce needless deaths in hospitals by 100,000 by June 2006. By providing guidance, materials, and support, IHI enrolled more than 3,000 hospitals in this campaign, which accounted for about three-quarters of all U.S. hospitals at the time and prevented more than 122,000 deaths.
- We are a democratic republic and collaboratively make rules and regulations. Through MedWatch, the Food and Drug Administration (FDA) plays an active role with both manufacturers and users of medical devices by reporting medical device performance and safety issues. Medical device reports are submitted to the FDA through both mandatory (e.g., manufacturers, importers, device user facilities) and voluntary (e.g., health professionals, patients, caregivers, consumers) channels.
- The issue of safety knows no borders or boundaries. For devices used in Europe, the European Union (EU) Medical Devices Regulation is in effect. The Medical Device Directive (of June 14, 1993) was created to harmonize the laws related to medical devices within the EU. These regulations establish guidelines for product development and safety. The International Organization for Standardization has developed more than 20,000 international standards on a broad range of topics that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose.
Although your actions don’t need to make the history books, we all can challenge ourselves to think of ways to contribute. Promoting safety can range from simple actions (e.g., proper hand hygiene) to cutting-edge innovations, such as developing a Star Trek tricorder–like device for imaging technology. It might mean researching a novel personalized genomic therapy or creating the next minimally invasive procedure.
By starting each day with the mindset that “patient safety begins with me,” we can build a culture in healthcare that better protects those afflicted by pain, disease, and suffering.
Eben Kermit, MS, CCE, is a biomed supervisor at Stanford Healthcare in Palo Alto, CA.