ECRI’s annual list highlights 10 health technology management challenges that warrant priority attention. A point of emphasis for 2021 is the transition from the crisis phase of responding to a global pandemic to the more routine, though undoubtedly altered, delivery of patient care in the aftermath.
The 14th edition of ECRI’s Top 10 Health Technology Hazards list was developed under the shadow of the COVID-19 pandemic. Throughout the crisis, health care professionals have stepped up to devise new processes, often in the face of significant adversity, to provide the level of care that their patients deserved.
While the challenge remains, we are hopeful that a return to normalcy is not too far in the distance. Many of the topics on this year’s list address that theme: the need to move from just trying to cope during an emergency to building stronger and more resilient processes, utilizing the innovations developed and the lessons learned along the way.
“Several topics involve hazards that have developed in this environment of unprecedented stresses and rapid technological changes,” explains Rob Schluth, who manages the project for ECRI’s device evaluation group. “But that’s not the only focus. Standard health care practices continue, and the hazards that can develop under normal circumstances still demand vigilance.”
ECRI recommends that health care organizations consider the following topics in their patient safety discussions.
1. Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization
To meet the unprecedented need for medical equipment and supplies during the COVID-19 public health emergency, FDA issued Emergency Use Authorizations (EUAs) to temporarily permit the use of (or new uses for) hundreds of products. The resulting need to manage large numbers of devices that are authorized only for temporary use poses a unique challenge.
FDA can revoke or revise specific EUAs at any time. Plus, there’s no guarantee that the products being used under an EUA designation will be as safe and effective as products cleared through normal processes. Thus, health care organizations must monitor the safety and effectiveness of EUA devices, manage inventories of those devices and their documentation, continually track each device’s EUA status and determine what to do with these devices once the EUA ends.
2. Fatal Medication Errors Can Result When Drug Entry Fields Populate after Only a Few Letters
To make drug searching and selection easier, many medication ordering, storage and delivery systems allow the practitioner to enter only a few letters of a drug name before the system populates the selection field with a list of drugs to choose from. The display of similar-looking drug names, which is intended to be a convenience, increases the risk that users will mistakenly select an incorrect drug. The Institute for Safe Medication Practices (ISMP) has reported on several incidents in which such selection errors have led to severe harm or death.
3. Rapid Adoption of Telehealth Technologies Can Leave Patients and Data at Risk
Telehealth programs were implemented with great speed this past year, but not likely with the depth of analysis required to assure their long-term success. As facilities transition from the pandemic response to new telehealth care-delivery models, programs may need to re-examine how they train users, coordinate patient care or address technology resource inequalities among patients. Also, some of the technologies adopted may not be suitable for long-term use or may not integrate well with existing clinical workflows and systems.
4. Imported N95-Style Masks May Fail to Protect Health Care Workers from Infectious Respiratory Diseases
Shortages of NIOSH-certified N95 respirators prompted health care organizations to look for alternative products. Concerns exist, however, that some options – such as KN95 masks from China – may not adequately protect the wearer. ECRI testing through December 2020 found that, of the imported non-NIOSH-certified respirator alternatives tested, more than 60% failed to filter airborne particles as well as claimed. For individuals at high risk of being exposed to aerosols from COVID-19 patients, a mask that provides reliable, N95-level respiratory protection is essential.
5. Relying on Consumer-Grade Products Can Lead to Inappropriate Health Care Decisions
Products such as consumer-grade finger pulse oximeters, blood pressure cuffs and glucose monitors are being used not only in the home, but elsewhere within the health care continuum. Such devices can be useful to monitor a patient’s physiologic trends but should not be relied on for making health care decisions. The measurements from consumer-grade devices may not be sufficiently accurate or may be misleading.
6. Hasty Deployment of UV Disinfection Devices Can Reduce Effectiveness and Increase Exposure Risks
Ultraviolet (UV) disinfection technologies can be a useful supplement to normal cleaning and disinfection practices, but improper use could not only compromise device effectiveness, but also put users and bystanders at risk of harmful exposure to UV light. With these technologies being considered for use in many new environments, and by users with little experience with UV light or disinfection processes, the chances for error are high.
7. Vulnerabilities in Third-Party Software Components Present Cybersecurity Challenges
Vulnerabilities in third-party operating systems and other off-the-shelf software components incorporated into medical devices could allow a device to be compromised, possibly disrupting patient care (locally or system-wide) or leading to a data breach. Obstacles to remediating such vulnerabilities include delays while the medical device vendor validates software patches, difficulties identifying the devices that include the affected software and challenges associated with applying the mitigation in a clinical environment.
8. Artificial Intelligence Applications for Diagnostic Imaging May Misrepresent Certain Patient Populations
For medical devices and systems that incorporate AI, the quality of the output depends on the quality of the data used to train the AI application. Obtaining high-quality, broad-based datasets for refining AI implementations is a challenge for AI developers. For health care providers, the challenge is determining how much trust to place in the AI application. Unreliable AI functionality can lead to misdiagnoses or can prompt inappropriate care decisions.
9. Remote Operation of Medical Devices Designed for Bedside Use Introduces Insidious Risks
One option for hospitals coping with personal protective equipment (PPE) shortages and exposure risks during the pandemic has been to operate certain medical devices at a distance from the patient, rather than at the bedside, as intended. Concerns associated with the remote operation of bedside medical devices range from less frequent direct visual assessment of the patient, to adverse effects on device performance or workflow, to tripping hazards.
10. Insufficient Quality Assurance of 3D-Printed Patient-Specific Medical Devices May Harm Patients
3D-printing technology is being used to create a range of patient-specific devices, including implants, anatomical models for surgical planning, surgical guides for orthopedic procedures and prostheses. If such a device is created without appropriate clinical verification of the design, quality control of the manufacturing process and validation of the end product, the resulting object may not accurately represent key patient anatomy or may not perform as intended. Procedure delays, surgical complications, infection or patient injury could result.
This article is adapted from ECRI’s Top 10 Health Technology Hazards for 2021. An Executive Brief version of that report is available for complimentary download at www.ecri.org/2021hazards. The full report, accessible to ECRI members, provides detailed steps that organizations can take to prevent adverse incidents. To learn more, contact ECRI at 610-825-6000, ext. 5891, or by email at email@example.com.
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