ECRI Institute recently released its list of the Top 10 Health Technology Hazards for 2020, highlighting the medical device hazards that the independent, nonprofit organization believes warrant priority attention for the coming year.
“The report highlights problems that we know can occur and can cause harm, possibly serious harm,” notes David Jamison, executive director, medical device selection and evaluation at ECRI Institute. “The problems can, however, be prevented if appropriate measures are taken.” ECRI encourages health care facilities to assess the likelihood of these hazards at their facility and to implement preventive measures, as recommended in the report. “Health technology managers can play a key role in patient care by being proactive when it comes to health technology hazards,” adds Jamison.
Following are the 10 topics covered in ECRI Institute’s list for 2020. Is your organization on the lookout for these hazards?
1. Misuse of Surgical Staplers
Internal surgical staplers have been the subject of significant media attention in the past year. News reports, FDA’s release of incident information from its Alternative Summary Reports database, and the agency’s actions to reclassify internal surgical stapler models have thrust these devices into the spotlight. The high profile nature of this hazard, combined with the potential for severe harm, propelled the topic to the top of ECRI’s list.
Staplers are complex devices requiring meticulous technique to operate. Misapplication can lead to potentially fatal intraoperative or postoperative hemorrhaging or leaking. Often, adverse consequences can be traced to errors in use, such as selecting an incorrect staple size, clamping on tissue that is too thick or too thin, or firing over another instrument.
2. Adoption of Point-of-Care Ultrasound Is Outpacing Safeguards
Point-of-care ultrasound (POCUS) scanners are changing the practice of health care in many specialties. But the change is happening so quickly that safety policies and practices have struggled to keep up.
POCUS scanners are highly portable, comparatively inexpensive and easy to use – features that have fueled the technology’s rapid growth. However, a lack of oversight may place patients at risk and facilities in jeopardy. Concerns include POCUS not being used when warranted, misdiagnoses, inappropriate use of the modality and overreliance on POCUS when a more comprehensive exam by an imaging specialist is indicated.
3. Infection Risks from Sterile Processing Errors in Medical and Dental Offices
Failure to consistently and effectively reprocess (clean and disinfect or sterilize) contaminated items before use can expose patients to virulent pathogens. In previous editions of its list, ECRI Institute addressed reprocessing challenges in hospital or central sterile processing environments. This year the organization turned its attention to sterilization process failures in certain ambulatory care settings.
Infection concerns exist in all settings where patients may come in contact with contaminated items, particularly items intended to enter sterile tissue or the vascular system. Yet not all settings have similar resources for infection prevention practices. Medical and dental offices are among the settings that should be assessed for oversights and improper actions associated with sterilization processes.
4. Hemodialysis Risks with Central Venous Catheters – Will the Home Dialysis Push Increase the Dangers?
Central venous catheters (CVCs) that are used for hemodialysis require significant care and attention to prevent fatal complications. CVCs provide a pathway directly from the outside of the body to the patient’s heart. As a result, the consequences of infection, clotting, disconnection (with a potential for massive blood loss) and air embolism can be severe.
The potential for harm is even more pronounced if hemodialysis patients that use a CVC are treated at home. While currently uncommon in the U.S., this circumstance has the potential to become more frequent, given a new U.S. government push toward increasing the rates of home dialysis.
5. Unproven Surgical Robotic Procedures May Put Patients at Risk
Surgical robotic systems are used to assist surgeons in performing a continually expanding range of procedures. While the use of surgical robots in innovative ways can help advance clinical practice, such uses can also lead to injury or unexpected complications and the potential for poorer long-term outcomes. Health care facilities need robust processes for approving the application of surgical robots in new procedures and for assuring staff competency
6. Alarm, Alert and Notification Overload
The problem of alarm overload is well known. Just as important to consider, however, is the global notification burden – that is, the combination of alarms, alerts and notifications from all sources. As the number of devices that generate notifications increases, so too does the risk that the clinician will become overwhelmed. A global approach can help prevent the cognitive overload that can lead to clinically significant events being missed.
7. Cybersecurity Risks in the Connected Home Healthcare Environment
Remote patient monitoring technologies are increasingly being used for at-home monitoring. As network-connected medical technologies such as these move into the home, cybersecurity policies and practices that address the unique challenges involved must be instituted as well.
As with any networked medical device, connected devices used in the home must be protected against threats that could interrupt the flow of data, alter or degrade performance, or expose protected health information.
8. Missing Implant Data Can Delay or Add Danger to MRI Scans
Because some implants can heat, move or malfunction when exposed to a magnetic resonance imaging (MRI) system’s magnetic field, imaging staff must screen patients for implanted devices to avoid harm. Unfortunately, information about patient implants is often scattered throughout various information systems or records of patient encounters, if it is captured at all. Without a single place within the electronic health record (EHR) to store implant information, care providers have no reliable means for determining the type and location of any implants.
9. Medication Errors from Dose Timing Discrepancies in EHRs
Missed or delayed medication doses can result from discrepancies between the dose administration time intended by the prescriber and the time specified within the automatically generated worklist viewed by the nurse. Depending on the patient’s condition and the medication prescribed, these errors can have significant clinical consequences.
Administration times are typically determined by hospital-defined defaults programmed into the EHR. In some systems, the EHR may not allow the prescriber to specify a different time or to view the scheduled default time (to verify if it matches the intended administration time).
10. Loose Nuts and Bolts Can Lead to Catastrophic Device Failures and Severe Injury
The nuts, bolts and screws that hold together medical device components can loosen over time with routine use. Failure to repair or replace loose or missing mechanical fasteners can lead to severe consequences: Devices can tip, fall, collapse or shift during use – any of which could harm people in the vicinity. Over the past two years, ECRI Institute has published nearly two dozen reports involving a wide variety of medical devices with loose fasteners.
This article is adapted from ECRI Institute’s “Top 10 Health Technology Hazards for 2020” (Health Devices 2019 Sep 26). An Executive Brief version of that report is available for complimentary download at www.ecri.org/2020hazards. The full report, accessible to ECRI Institute members, provides detailed steps that organizations can take to prevent adverse incidents. For more information, contact ECRI Institute at 610-825-6000, ext. 5891, or by email at email@example.com.
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