Recalls in at-home medical devices and cybersecurity risks top 2023 health tech hazards list

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Picture by Tima Miroshnichenko by way of pexels

The nonprofit patient-safety group ECRI in January launched its annual report of the top 10 health technology hazards for 2023. The record — compiled by the group from member surveys, literature critiques, assessments of their lab and investigations of affected person security incidents — may give journalists masking hospitals, well being IT and/or affected person security a great primer on tendencies to look at and is a wealthy supply for story concepts. 

Topping this 12 months’s record was a priority that gaps in recollects for at-home medical gadgets could cause affected person confusion and hurt. Correct and comprehensible details about medical system recollects usually doesn’t attain sufferers utilizing these gadgets, the authors famous, and this info hole continues to develop.

 Gadget producers seldom have direct communication with dwelling care sufferers, and well being care suppliers might not proactively contact their sufferers about recollects. Consequently, sufferers might not find out about recollects till lengthy after they have been issued, and typically from doubtlessly unreliable sources like social media. 

Even when sufferers do obtain a notification, the language could also be laden with jargon, and so they might get confused about whether or not their system is affected or what to do about it. ECRI challenged producers to offer customers with easy-to-follow system registration directions, write simply-worded recollects, preserve an up-to-date database of gadgets, and designate workers to make sure that any recollects attain home-based customers.

Another expertise hazards on the 2023 record embody:

Rising variety of faulty single-use medical gadgets (#2). Single-use medical gadgets proliferate in well being care. ECRI has acquired reviews of cracked tubing and connectors, incorrect product labeling, or compromised sterility of needles and catheters. The group challenged producers to revisit and enhance high quality management processes to stop faulty merchandise from reaching the market.

Inappropriate use of automated dishing out cupboard overrides (#3). Automated dishing out cupboards — computerized medication cupboards for hospitals usually positioned on affected person flooring — are designed to be accessed utilizing particular protocols. Practitioners enter their credentials to unlock the cupboard and may choose patient-specific drugs already reviewed and verified by pharmacists. In emergencies, these steps may be overridden for fast entry to drugs. However some establishments are overriding the method routinely, doubtlessly placing sufferers in danger, the authors stated.

Failure to handle cybersecurity dangers related to cloud-based scientific methods (#5). Well being care organizations that retailer information like affected person digital medical data within the cloud usually depend on exterior firms to make sure the safety and reliability of that info — and to deal with any safety occasions to revive service. However well being services want to know the chance of any disruption in affected person care and plan for the chance, the authors famous. A safety breach to the cloud-based service might result in a lack of availability or integrity of that service, or attainable breaches of sufferers’ protected well being info (PHI). Well being care entities ought to implement acceptable inner safety controls to scale back dangers, they stated.

Confusion surrounding ventilator cleansing and disinfection necessities can result in cross-contamination (#7). Nobody doubts the significance of needing to successfully clear and disinfect ventilators, the elements of which may be contaminated by exhaled gasses and airway secretions. However reprocessing directions supplied by producers of the gadgets may be incomplete or complicated, which might depart workers accountable for reprocessing confused about which items want cleansing and disinfection, easy methods to do it correctly and the way continuously it ought to happen. ECRI challenged producers to make sure that directions for cleansing and disinfecting ventilator elements are full, clear, well-documented and achievable.

Underreporting device-related points might threat recurrence (#10). Reporting medical device-related issues is crucial to holding sufferers and workers secure, however for a wide range of causes issues aren’t at all times reported utilizing the suitable channels. Consequently, damaged, malfunctioning or poorly manufactured or designed gadgets might stay in use, doubtlessly contributing to affected person harms. To reduce disruptions to affected person care, well being care organizations must determine and remove boundaries to reporting and make the reporting course of as simple as attainable, the authors stated.

The opposite gadgets on the record have been:

  • Undetected venous needle dislodgement or access-bloodline separation throughout hemodialysis can result in dying (#4);
  • Inflatable strain infusers can ship deadly air emboli from IV resolution luggage (#6);
  • Frequent misconceptions about electrosurgery can result in critical burns (#8);
  • Overuse of cardiac telemetry can result in clinician cognitive overload and missed crucial occasions (#9).

The complete report is obtainable to ECRI members, however journalists can obtain an executive brief summarizing the main highlights.

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