There is an increasing realization that while consumergrade devices can offer value as a means to monitor a patient ’ s physiologic trends , they should not be relied on to prevent or diagnose medical conditions .”
— Priyanka Shah
cleared by FDA for marketing as medical devices . This limitation makes the devices insufficiently reliable for use in identifying situations that may require medical attention .”
Priyanka Shah , senior project engineer for device evaluation at ECRI , explains that there has been an increased interest in the use of these consumer grade items within the healthcare environment , noting , “ The concern around the use of consumer-grade items in the healthcare environment was prompted based on our research , evaluations of some of these devices , and hospital correspondence . Most of these devices are not medical devices , and thus are not intended for use in preventing or diagnosing medical conditions . There is little evidence on the reliability and accuracy of data obtained from unregulated consumer-grade products ; and these products may not function as intended which can lead to improper care decisions . ECRI ’ s engineering team recently evaluated subcutaneous continuous glucose monitors and consumer-marketed wearable and handheld blood pressure devices .”
Shah says there have been no adverse events reported , but adds , “ There is an increasing realization that while consumer-grade devices can offer value as a means to monitor a patient ’ s physiologic trends , they should not be relied on to prevent or diagnose medical conditions .”
Shah says there are a number of ways that healthcare biomedical engineers , materials management / purchasing , and healthcare value analysis experts can help address this potential hazard , including :
●Prioritize equipment purchasing and deployment decisions so that the necessary medical-grade equipment is available , especially in critical care units .
●Verify that you are buying from a reliable source . For example , if you buy a device online , check the customer reviews . Also , check the seller ’ s return policy and customer support statement before you place an order .
●Investigate whether the vendor offers responsive customer support for reporting problems with the device and for obtaining troubleshooting assistance .
●Identify and assess key purchasing considerations around usability , device configuration , and support factors ( such as accessories needed , operating requirements , Instructions for Use ( IFU )).
As the ECRI hazards report ( 2021 ) emphasizes , “ Within the healthcare environment , 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 .”
Healthcare value analysis professionals have seen ECRI ’ s No . 6 hazard – the hasty deployment of UV technology – a time or two and can attest that improper onboarding of a new technology can pose significant risk .
As the ECRI hazards report observes , “ At the right wavelengths and with an appropriate exposure time , ultraviolet ( UV ) light can be used to disinfect surfaces and spaces , making UV disinfection technologies an effective supplement to normal cleaning and disinfection processes . However , if not used properly , UV disinfection devices may not deliver a high enough dose to inactivate microorganisms , leaving individuals at risk of exposure to infectious pathogens . Improper use could also expose operators or bystanders to unsafe levels of UV radiation . The need to combat the SARS-CoV-2 virus has prompted healthcare facilities , public health officials , private companies , and consumers to consider UV disinfection technologies for a host of new applications . But decisions to use this technology should be proactive and deliberate , not hasty ; and prospective purchasers will first need to do their homework .”
Mairead Smith , senior project engineer at ECRI , says it has not received any reports from its members in 2020 regarding adverse events involving UV disinfection devices . However , Smith adds , “ HAIs are unlikely to be reported as adverse events related to a UV disinfection device , in part because issues may be difficult to identify – for example , without sampling , it can be nearly impossible to detect whether UV disinfection has been effective in reducing environmental bioburden . ECRI has seen that facilities that have UV disinfection programs in place may not be getting as much out of the equipment as they think they are in terms of dose delivery and expected log reduction of clinically relevant organisms , and that device operation can be very inconsistent from user to user . We ’ ve also seen that devices that are marketed to the non-healthcare population can be questionable – I saw one UV wand early in the pandemic that advertised that it could be used to disinfect your pets , which is both unlikely to provide much benefit and potentially dangerous to the pet .”
The ECRI hazards report ( 201 ) emphasizes that , “ 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 . Furthermore , users must understand the conditions required to achieve disinfection . Effective disinfection with UV light depends on the dose that reaches the microorganism . That , in turn , is a function of the intensity of the light emitted by the device , the duration of exposure , and any complicating factors , such as distance or shadowing . Surfaces to be disinfected should be in a direct line of sight and should first be cleaned of soil . In addition , users must take appropriate safety precautions to protect themselves and others from UV light exposure .”