Effect of emergency authorizations, hasty insertion of UV cleaning devices, and remote operation of devices prompt the ECRI Institute to suggest remedies.
The COVID-19 pandemic continues to impact every aspect of healthcare, and a popular annual list of health technology hazards reflects this as well.
Complexity of managing medical devices with COVID-19 emergency use authorization (EUA) are the leading medical technology hazard for 2021, according to the ECRI Institute.
Other top concerns of ECRI's latest such report include reliance on consumer-grade products for important healthcare decisions and hasty deployment of UV disinfection devices, which can reduce effectiveness and increase exposure risks.
Here is the ECRI Institute's Top 10 list of health technology hazards for 2021.
1. Complexity of managing medical devices with COVID-19 emergency use authorization.
Responding to the surge in medical equipment need when the pandemic struck, the U. S. Food and Drug Administration (FDA) temporarily authorized use of hundreds of medical devices not previously approved for use. The ECRI report warns that EUA devices "may not be as safe or effective as devices have been through FDA's normal clearance process."
Healthcare facilities must also monitor each device's status daily to verify that the EUA remains active and unchanged, and leaders must figure out what to do with the devices once the EUA ends, ECRI notes.
2. Fatal medication errors can result when drug entry fields auto-complete after just a few letters
Many medication ordering, storage, and delivery systems let clinicians enter only a few letters of a drug's name before these systems populate the drug selection field with a list of drugs from which to select. With many similar-looking drug names presented as options, risk increases that the user will mistakenly choose an incorrect drug.
"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," ECRI's report states.
3. Rapid adoption of telehealth technologies can leave patients and data at risk
Rapid expansion of telehealth programs as a result of the pandemic can create problems and challenges. Programs may struggle to provide adequate user training, coordinated patient care, or assure equitable treatment across all populations.
"The solution may involve…modifying or ceasing the use of some of these technologies," ECRI's report states. Modifications could include technology assessment, including cybersecurity risks.
4. Imported N95 masks may fail to protect workers from infectious respiratory diseases
In particular, ECRI warns about some N95 masks imported from China. ECRI testing through December 2020 determined that, of the imported masks 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 says most products such as consumer-grade finger-pulse oximeters, blood pressure cuffs, and glucose monitors have not been through the FDA's U medical device approval process. Users should not rely on these products to make healthcare decisions, as they cannot rely upon the accuracy or reliability of these non-FDA-approved devices, ECRI warns.
Within the healthcare environment, ECRI advises avoiding the use of consumer-grade devices whenever possible. "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. Rapid deployment of UV disinfection devices can reduce effectiveness and increase exposure risks
If not used properly, UV disinfection devices might not deliver a sufficient dosage of UV rays to subdue microorganisms, leaving people at risk of exposure to these microorganisms.
"Surfaces to be disinfected should be in a direct line of sight, and should first be cleaned of soil," the ECRI report states. "In addition, users must take appropriate safety precautions to protect themselves and others from UV light exposure."
7. Vulnerabilities in third-party software components present cybersecurity challenges
Third-party software components that become part of medical devices continue to pose unique cybersecurity challenges, ECRI's report states. Among these are difficulties identifying which devices include the affected software; delays in guidance from vendors auditing their product lines and providing software patches; and challenges applying mitigation to devices in continuous patient use.
8. Artificial intelligence (AI) applications for diagnostic imaging may misrepresent certain patient populations
The quality of the data used to train an AI algorithm may subject that algorithm to inherent bias. AI developers are challenged to obtain large, high-quality, and relevant data sets, ECRI's report states.
Risk-benefit assessments of AI technology can help. "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," the ECRI report states.
9. Remote operation of medical devices designed for the bedside introduces insidious risks
When medical devices, such as ventilators and infusion pumps, are operated remotely to protect clinicians lacking adequate personal protective equipment, they can introduce persistent risks, ECRI says. Among these are less frequent visual assessment of patients, adverse effects on equipment due to longer tubing sets, tripping hazards when devices are placed in hallways, and greater chance of unauthorized device access or tampering.
ECRI recommends such remote operation only during public health emergencies, only for as long as necessary, and after assessing and mitigating risks.
10. Insufficient quality assurance of 3D-printed patient-specific medical devices
3D-printed patient-specific devices need to have appropriate clinical verification of the design, quality control, and validation of the final product, ECRI's report warns. The individual physician using the device plays a key role in the design process. Healthcare facilities need a written acceptance policy, including control of approval of 3D device use, before such devices are accepted for clinical use, ECRI's report states.
Scott Mace is a contributing writer for HealthLeaders.
Emergency-use authorization medical devices top the hazard list. They may not be as safe or effective as devices cleared by the FDA under normal circumstances.
The auto-completion function in medication ordering, storage, and delivery systems may lead to the selection of incorrect drugs, inviting fatal medication errors.
Third-party components in medical devices are a grave cybersecurity concern.