What You Should Know:
– ECRI Institute identified the complexity of managing medical devices with COVID-19 emergency use authorization as the number one technology hazard in its Top 10 Health Technology Hazards for 2021 report.
ECRI Institute’s Top 10 Health Technology Hazards, now in its 14th year, identifies top health technology concerns that warrant attention from healthcare leaders. The hazards selected are based on a rigorous review of ECRI’s incident investigations, medical device testing, and public and private incident reporting databases.
Background
During this global public health emergency, healthcare workers have stepped up to devise new processes, often in the face of significant adversity, to provide the level of care that their patients deserved. Clinicians, clinical engineers, supply chain professionals, patient and medication safety advocates, executives, IT specialists, environmental services staff, administrative assistants—everyone played a role. The significance of their contribution cannot be overstated. And the world’s gratitude for it cannot be sufficiently expressed.
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.
Impact of COVID-19 Emergency Use Authorization
The full list of 2021 health technology hazards include:
1. Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization
Healthcare facilities that use EUA devices face a complex challenge: They must manage inventories of EUA devices and their documentation, monitor each device’s status daily to determine whether the EUA remains active and unchanged, and determine what to do with these devices once the EUA ends. ECRI offers comprehensive guidance to help healthcare facilities complete each of these steps.
2. Fatal Medication Errors Can Result When Drug Entry Fields Populate after Only a Few Letters
The likelihood of such errors could be significantly reduced if systems are designed or configured to require entry of, at minimum, the first five letters of a drug name before populating search fields. An ECRI analysis of drug names found that 92% of FDA-approved drugs have the same first three letters as at least one other drug, compared with only 58% when looking at the first five letters. Thus, increasing the number of characters entered from three to five greatly reduces the possible number of matches.
3. Rapid Adoption of Telehealth Technologies Can Leave Patients and Data at Risk
Failure to address these challenges could adversely affect patient care: It could lead to suboptimal treatment, increase the risk of medical errors, or hinder certain populations from accessing care. An additional concern is that a rushed implementation could lack adequate cybersecurity controls, putting the patient’s and the facility’s data at risk.
4. Imported N95-Style Masks May Fail to Protect Healthcare Workers from Infectious Respiratory Diseases
Although KN95s have not been certified by NIOSH, they are marketed as meeting the requirements of a Chinese standard that aligns with NIOSH’s N95 mask requirements. However, ECRI testing through December 2020 found that, of the imported nonNIOSH-certified respirator alternatives tested, more than 60% failed to filter airborne particles as well as claimed.
5. Relying on Consumer-Grade Products Can Lead to Inappropriate Healthcare Decisions
ECRI recommends avoiding the use of consumer-grade devices whenever possible, particularly when monitoring critically ill patients. If such a device must be used, do so only for the time that’s necessary and only on the condition that the clinical team knows how to use it and understands how its performance could differ from that of medical-grade equipment.
6. Hasty Deployment of UV Disinfection Devices Can Reduce Effectiveness and Increase Exposure Risks
UV disinfection devices are not typically regulated by FDA (most are not considered medical devices), and they’re not required to demonstrate safety and effectiveness according to any standardized protocol. Thus, understanding the capabilities and limitations of each device is vital.
7. Vulnerabilities in Third-Party Software Components Present Cybersecurity Challenges
Protecting against such vulnerabilities requires assessing a medical device supplier’s ability to manage the software on its devices, obtaining security information for the devices in inventory (such as that available from an MDS2 form or a software bill of materials), and using appropriate tools to store and retrieve this information.
8. Artificial Intelligence Applications for Diagnostic Imaging May Misrepresent Certain Patient Populations
Conducting a risk-benefit assessment of AI functionality can help healthcare institutions assess the safety and effectiveness of medical technologies that incorporate AI. A key part of this process will involve verifying that the data used to train the algorithm is sufficiently representative of the organization’s patient population.
9. Remote Operation of Medical Devices Designed for Bedside Use Introduces Insidious Risks
Remote device operation should be considered only during highly unusual circumstances (such as a public health emergency), only for as long as necessary, only after assessing the risks and benefits based on the individual patient’s condition, and only after verifying that the concerns outlined above can be mitigated.
10. Insufficient Quality Assurance of 3D-Printed Patient-Specific Medical Devices May Harm Patients
Unlike with traditional medical devices, the particular physician who will be using the patient-specific 3D-printed device plays a key role in the design process. Thus, providers bear increased responsibility for verifying that sufficient quality assurance measures have been followed. Healthcare facilities should establish a written acceptance policy specifying the need to approve the object design, as well as the quality of the finished device, before a 3D-printed patient-specific medical device is accepted for clinical use.
