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Designing for safety is a process. When the right process is followed, results can be great, such as eliminating most of the warranty costs. The opposite is also true in the absence of the right process. There is a saying: “If we don’t know where we are going, that’s where we will go.”

“You can’t cross the sea merely by standing and staring at the water,” said Rabindranath Tagore, Nobel Prize recipient for literature. Not preventing harm is a practical application of this quote, which serves as an inspirational reminder that people achieve nothing unless they take purposeful action that has measurable results. Taking action on potential human errors so that harm never reaches patients is a productive goal because its impact is highly significant.

Laparoscopic robotic surgeries allow surgeons to make much smaller incisions than those used in traditional surgeries. When surgeons insert special instruments through small cuts in a patient’s body, they can use a video monitor and laparoscope (a tiny video camera) to view what’s happening inside the body and perform the operation. Using these instruments, the surgeon doesn’t have to manually reach into the patient, leading to a minimally invasive experience. Surgeons can make several small cuts instead of one large cut, each typically no more than a half-inch long. Yet laparoscopic surgeries are not without risk. Even highly used surgical robots, such as the da Vinci robot, have had their share of issues. Complications can occur due to the patient’s condition and the type of surgery being performed.

“Incident reporting” is frequently used as a general term for all voluntary patient safety event reporting systems which rely on those involved in patient care. Initial reports often come from frontline personnel directly involved in an event or the actions leading up to it (e.g., the nurse, pharmacist or physician caring for a patient when an error occurred). Voluntary event reporting is therefore a special form of surveillance for near misses or unsafe conditions that are unlikely to show up in formal surveys [Ref. 1]. The purpose of incident reports is to help identify potential and actual risks and, thus, mitigate hazards. Incident reports also alert risk managers to potential lawsuits. They are generated for at least five types of medical errors: near misses, adverse events, intentional unsafe acts, never events and sentinel events. These events may affect any person on the premises, including patients, employees, physicians, visitors, students or volunteers.

The objective of performing Failure Mode and Effects Analysis (FMEA) is to use sound risk management principles, coupled with innovative solutions that can assure high return on investment (ROI). Quality Guru Philip Crosby wrote in his book, Quality is Free, that quality is free if you do the right things at the right time. Essentially, the savings from avoiding fixes, process changes and lawsuits are much higher than the cost of doing things right. The principles of sound risk management, experienced by this paper’s co-author Dev Raheja as an international engineering management consultant over 30 years, include: Identifying risks Assessing risks Mitigating risks Orchestrating risk management Aiming at high ROI without compromising safety

Electronic Medical Records (EMR) are the digital version of paper charts. They are the electronic record of an individual’s health-related information that is created, gathered, managed, and consulted by licensed clinicians and staff [Refs. 1-3]. This article will focus on some of the challenges of health record integration between often disparate systems — internally, across a mix of systems, or externally, such as entities ranging from federal and state agencies, insurance companies, physician practices, medical facilities and pharmacies. The challenges of data collection, assimilation and integration remain at the forefront of our electronic medical record era [Refs. 1, 6-9]. Seamlessly moving information across disparate information systems becomes even more challenging when the data involves confidential medical information.

The popular theory that human error, such as making the wrong diagnosis, operating on the wrong body part or administering the wrong medication, in itself causes harm to patients may not always be completely true. According to system safety theory and the “Swiss Cheese” theory of healthcare, at least two things have to go wrong for harm to occur. Usually, the primary cause is a poorly designed care system that allows human errors to happen. Each weakness in the system is called a “hazard.” A human error is a trigger event that finally results in the harm. Therefore, human error is a symptom of a poorly designed system, not necessarily the primary cause of harm. Using the analogy of a gun, the loaded gun is a hazard, while pulling the trigger can result in harm. If the gun is not loaded, the trigger (human error) is not an issue.

Unique Device Identification (UDI) is a recent development to protect patients from hazards in medical devices. The UDI relates to adverse event reporting, identifying and analyzing devices in use. Currently, hospitals are unable to report many adverse events because the device identification has to be manually located — and often, they are not easily readable, or the person reporting makes an error in reading or documenting the identification information. If a cardiac monitor malfunctions, it’s critical for the information in the adverse event report to match the manufacturer’s product identification system; otherwise, the adverse event may go unreported to U.S. Food and Drug Administration (FDA), and the device may not be recalled as soon as it should. The same urgency holds for a product recall sent from a manufacturer to the doctor, hospital or patient. An inability to identify the device affected by the recall could have potentially disastrous results for patients. In addition, if the device is for personal use, the user may not have access to information about the hazards other users of the device have experienced. With this new system, a user can easily search for hazards.