Rob Schluth , principal project officer in ECRI ’ s Device Evaluation group , addresses the need for clinicians and biomedical engineering staff to communicate and work together to ensure positive patient outcomes .
“ One of the lessons that can be drawn from the Top 10 reports that we ’ ve produced is that , in the healthcare environment , everyone plays a role in patient safety ,” he says . “ That includes the frontline healthcare workers who use medical devices and the clinical engineers who install , service , and maintain them ; but it also includes IT professionals , purchasers , administrators , and others .”
Schluth adds , “ Strong coordination and cooperation among all these professionals can help ensure that appropriate devices and systems are selected , that those devices and systems function properly and securely , that staff know how to use them , that the devices and systems are maintained , and that any problems are identified and remedied . A misstep in any of those areas can adversely affect patient outcomes .”
At the top of ECRI ’ s list as the nation ’ s most pressing health technology safety issue for 2023 are communications gaps with recalls of home-use medical devices
Recall notices for home-use products often do not reach users , placing patients at serious risk of harm , according to ECRI .
As ECRI ( 2023 ) notes , “ The safe use of health technology — from simple devices to complex information systems — requires identifying possible sources of danger or difficulty with those technologies and taking steps to minimize the risk that adverse events will occur .”
As the home healthcare trend accelerates , ECRI is concerned about home care patients not receiving safety notices that warn of problems with the medical devices they are using . Device manufacturers seldom have direct communication with home-care patients , and healthcare providers may not proactively contact patients about recalls . Patients with affected products may learn about a recall long after it was issued , and potentially from an unreliable source .
“ Even if patients do receive notifications , the language may be jargon-heavy and perplexing , and patients may have difficulty determining whether their device is affected or what to do about it ,” cautions Marcus Schabacker , MD , PhD , president and CEO of ECRI . “ Without clear , understandable information about a product recall , patients cannot accurately assess the health risks and may harm themselves by continuing to use an unsafe device , or by inappropriately stopping use of a device .”
One example is the recall of continuous positive airway pressure ( CPAP ) and bilevel positive airway pressure ( BiPAP ) machines . The recall was initiated in June 2021 and affected 5.5 million devices ; however , several months elapsed before some patients became aware of the recall . Moreover , because of the language used in the recall notice , patients were confused about whether to continue to use the device and what actions they needed to take .
For 2023 , ECRI ’ s report includes a series of challenges to industry , urging manufacturers to pursue device or process improvements that could mitigate — or even eliminate — some of the hazards included on the list .
“ Reducing preventable harm requires more than just vigilance on the part of technology managers and device users . The medical device industry also has a role to play ,” says Schabacker .
Defective Single-use Medical Devices The No . 2 item on ECRI ’ s 2023 hazards list is the increasing number of defective single-use medical devices that jeopardizes patient safety . As ECRI ( 2023 ) notes , “ An unacceptably high number of defective single-use medical devices continue to be present in the supply chain . Single-use medical devices — which include products that are used once and then discarded , as well as those that get consumed during use — play a role in virtually every patient encounter . As a result , defective products can have a broad , negative impact on patient care , causing delays and increasing costs — and most concerningly , contributing to patient harm or death in some circumstances .”
ECRI reports that it has heard about cracked tubing and connectors , compromised sterility of needles , catheters , and procedure kits , as well as incorrect product labeling – all significant defects that can lead to waste , delays , incorrect treatment , healthcare-acquired infections ( HAIs ), or other patient harm .
“ It ’ s not uncommon for ECRI to receive reports of defective disposable products or other single-use medical devices that were presented for use ,” Schluth confirms . “ Examples include debris within the supposedly sterile packaging of a procedure kit , catheter , or syringe ; cracks or broken tubing connectors in breathing circuits or IV administration sets ; or incorrect product labeling that could lead to the selection of the wrong product ( such as the wrong size ) for the patient or for the intended application . All such incidents could lead to harm , either directly or indirectly , if the defective product is used on a patient ; and all point to deficiencies in manufacturer quality control ( QC ) practices . Concerningly , data collected by ECRI shows this to be a significant , persistent , and increasing problem .”
Schluth continues , “ While this problem is not one that can be solved by healthcare providers , product purchasers nevertheless can take some proactive
Even if patients do receive notifications , the language may be jargonheavy and perplexing , and patients may have difficulty determining whether their device is affected or what to do about it .” — Marcus Schabacker , MD , PhD