1. Confusing recalls of at-home medical devices
This health hazard arises from Philips’ chaotic recall of defective respirators that cost the lives of hundreds of at home patients suffering from sleep apnea. Between April 2021 and October 2022, the FDA received 260 reports of patients who died while using the Philips respirator. The device was recalled but the manufacturer contacted mostly healthcare providers which were supposed to pass the information to their patients. The process was chaotic and many patients were never proprely informed. As a result, they continued to use the defective device and died. Some patients were contacted directly by the manufacturer, but the notification was unclear. The language was technological jargon that patients did not understand proprely.
2. Proliferation of defective single-use medical devices
For obvious reasons, multiple medical devices can only be used once and discarded. However, ECRI reports that too many of these devices are defective or not labeled proprely and can result in harm to patients. Compromised sterility of needles, catheters and procedure kits as well as cracked tubing and connectors are among the most common reports received by ECRI last year.
3. Overrides of Automated Dispensing Cabinets resulting in medication errors
Automated Dispensing Cabinets are a great way to provide controlled access to medication near the point of care. Medication needed for each patient is first reviewed and approved by a pharmacist then the practitioner can use the automated dispensing cabinet by logging in with his credentials and select patients’ medication. In case of emergency, pharmacist’s review and approval can be overriden in order to obtain the medication faster. While it can be useful, overriding the pharmacist review has lead to a number of high profile medication error cases including fatal accidents.
4. Deadly venous needle dislodgement or access-bloodline separation during hemodialysis
When hemodialysis is administered at home or in non hospital setting, there is an increased risk of accidents such as someone tripping on a bloodline, a line snagging on an object during patient movement or someone pulling the line unintentionally or intentionally. When such accidents happen, the venous needle can dislodge at the vascular access point or the central venous catheter, resulting in a massive loss of blood and causing severe injury or death. This type of accidents which could be prevented by equipping hemodialysis machine with a blood leakage detector are often underreported.
5. Cybersecurity risks associated with cloud-based clinical systems
Too many healthcare organizations do not evaluate proprely how cloud providers:
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- safeguard the confidentiality and the availability of their patients’ records
- maintain the functionality of their system.
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When working with a cloud system, health organizations must understand that they are relying on the cloud company for their security and online operations. Therefore, the cloud-based provider must be able to remediate any security events and restore service promptly to avoid causing harm to patients. In addition to proprely evaluating their cloud provider, health organizations must also have a reliable internal security service to mitigate risks.
6. Potential fatal air emboli caused by inflatable pressure infusers
The use of inflatable pressure infusers (IPE) increases the risk of infusing air from the IV bag to the patient, resulting in serious and sometimes fatal injury. Inflatable pressure infusers should not be used for patients requiring continuous infusion that terminate in the left heart as even a very small amount of air inadvertently getting to this location can be fatal.
7. Potential cross-contamination caused by inadequate ventilator cleaning
The process of proprely cleaning ventilators is too often inadequately documented by manufacturers. As a result, reprocessing employees are often confused about how to proprely disinfect and clean the ventilator and how frequently they have to do it. This confusion increases the risk of cross-contamination of infectious disease among patients.
8. Burns during electrosurgery
While electrosurgical units (ESUs) have been present in ORs for decades and are extremely helpful while cutting and coagulating patient’s tissues, too many clinicians have misconceptions about the risks associated with what they are doing. As a result, many patients are reporting burn injuries after:
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- multiple ESUs were used simultaneously on the patient
- surgeon activated the ESU’s active electrode before the tip is touching the patient, causing a high voltage in the ESU circuit that can injure the surgeon and the patient
- The return electrode was placed on an unsafe part of the anatomy instead of a safer place with a tattoo, piercing or orthopedic metal implant. According to ECRI only electronic implants such as pacemakers should be avoided but metal implants in patients do not increase the risk of burn injuries.
9. Alarm fatigue caused by cardiac telemetry monitors used for non cardiac patients
A recent trend in clinical settings has been to equip all patients with telemetry monitors including those who do not have any cardiac issues. A telemetry monitor is a patient worn device that monitors cardiac rhythm without restricting patients to their bed. It can causes alarm fatigue to clinicians who ultimately might not recognize critical events. Only patients presenting cardiac risks should be equipped with such devices.
10. Underreported device-related issues
Reporting broken, malfunctioning or poorly designed or manufactured medical devices as soon as a clinician notices it allows for the problem to be solved immediately and for patient’s care not to suffer any disruption. Unfortunately too often the problem is noticed but the healthcare provider.
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- might be too busy to report
- might not know how to report
- might not feel it is necessary to report particularly when it did not harm the patient
- might be fearing disciplinary action or other consequences.
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As a result broken devices continue to be used increasing risk of harm to patients.
Click to access ECRI_2023_Top_10_Hazards_Executive_Brief.pdf