home has led to the increased use of medical devices in that setting . This includes devices that were originally intended for use in a clinical environment , such as infusion pumps and ventilators . The use of medical devices in the home can support more comfortable and convenient patient care , but it is not without risk : Devices often are not designed with home users in mind , and patients and lay caregivers may lack the expertise needed to operate them properly . Plus , the home setting can introduce environmental limitations ( e . g ., space restrictions , unreliable power supply ) that impact device operation . Severe harm can result if patients or their caregivers do not fully understand how to use a device and troubleshoot problems that arise . Over the past decade , ECRI has encountered numerous examples of patient harm in this setting — from medication errors that resulted from a switch to an unfamiliar infusion pump to tragic fatalities that occurred when a ventilator alarm failed to activate , or when a venous needle became dislodged during hemodialysis .”
ECRI emphasizes that minimizing the risk of harm requires selecting devices that are well matched to the patient and the environment of use , and providing the support that home users need to operate the device successfully . ECRI also challenges manufacturers of devices that may be used in the home to consider the needs of users in this setting , adding that “ Device operation should be intuitive , instructions should be written for a lay audience , and user support should be available .”
Gaps in recalls for at-home medical devices that cause patient confusion and harm topped ECRI ’ s health tech hazards list for 2023 .
Insufficient cleaning instructions for medical devices
Some failure in processing or breach in infection control or other sterile processing hazard has frequently been included in ECRI ’ s annual lists ; last year , the growing number of defective single-use medical devices that put patients at risk was No . 2 on the list .
As the ECRI report ( 2024 ) explains , “ Failure to properly clean and disinfect or sterilize reusable medical devices between uses can lead to the spread of infection , device damage , and other forms of harm . Successful reprocessing is made more challenging , however , by the wide variation in the content , quality , and feasibility of reprocessing instructions provided by product vendors . ECRI is aware of numerous reusable medical devices and healthcare items that have incomplete , impractical , or onerous reprocessing instructions . As a result , healthcare workers who perform reprocessing may find it difficult or impossible to complete this task effectively — or they may suffer harm in the process ( e . g ., pain or fatigue from repeatedly performing onerous reprocessing procedures ).”
In my opinion , IFUs are not always focused just on infection prevention ; there are many factors that go into it . What we try to do right now is work with manufacturers to say , ‘ Hey , there are human factors involved here , not just the life cycle of disposable parts .’” — James Davis , MSN , RN , CIC , HEM , CCRN-K , FAPIC
ECRI experts acknowledge the staying power that sterile processing-related issues have on the annual hazard lists .
“ The issue of inadequate or onerous manufacturers ’ instructions for use ( IFUs ) in reprocessing , which is primarily for cleaning , disinfection or sterilization , has been persistent ,” says Amanda Sivek , PhD , a-IPC , principal project engineer II at ECRI . “ We frequently hear from our members about medical devices or healthcare equipment damage that occurred after reprocessing . When we examine the IFUs for processing those items , we often find that they are incomplete or in some cases they don ’ t even exist . Or we find that they are impractical to complete like a device that requires sterilization in between patient cases . Or they ’ re onerous to complete , like instructions that have more than 50 steps that sterile proceeding techs must perform , such as for some flexible endoscopes . Ultimately , the solution to this problem lies with the vendors of medical devices and healthcare items , and we are requesting that they provide validated , practical reprocessing instructions for their reusable products . And just to be clear , validated reprocessing instructions have been shown to be effective and ensure that the healthcare products can be safely reused over their intended use life .”
In the last decade , there have been numerous calls from clinicians , medical associations and other stakeholders – including the Food and Drug Administration ( FDA ) through its warning-letter system — for manufacturers to address complex IFUs , but progress has been very slow .
“ There are some devices that when manufacturers change the labeling , they ’ re performing a complicated process to update the IFUs , so we have to be sensitive to the vendors ,” says James Davis , MSN , RN , CIC , HEM , CCRN-K , FAPIC , manager of infection prevention and control services at ECRI . “ That said , however , there are many situations with IFUs that create potential confusion . For example , an IFU may say to change a filter
monthly , but given what we learned about COVID and aerosolization of the virus , and debate around droplet and aerosol precautions now , there is the question of whether filter changes are user serviceable , meaning are clinicians on the floor like nurses or a sterile processing tech or a biomed engineer able to conduct routine maintenance on the equipment . Is it about viewing this issue through the human-factors perspective , so maybe it ’ s now changing the filter between every patient because if you do it monthly , it ’ s going to get missed . Things like that come to mind when you talk about the complexity of IFUs and how they can contradict evolving scientific thought .”
Davis continues , “ So , when the manufacturer conducted its scientific testing and it says , ‘ Well , this lasts a month or two weeks ,’ but then we say , ‘ Well , why did you choose a month ?’ and they say , ‘ That ’ s the life cycle .’ If we change it too often , we ’ re spending more money , but now the answer is , ‘ We should probably go back and say , ‘ Change this between patients from an infection perspective .’ In my opinion , IFUs are not always focused just on infection prevention ; there are many factors that go into it . What we try to do right now is work with manufacturers to say , ‘ Hey , there are human factors involved here , not just the life cycle of disposable parts .”
ECRI emphasizes that manufacturers of reusable medical devices and healthcare items must provide practical , validated reprocessing instructions for their products . These instructions should adhere to relevant FDA guidance and should involve the use of common healthcare-grade cleaning and disinfection agents .
Sivek adds that the regulation of medical devices often comes into play . “ The FDA requires a 510 ( k ) -pre-market review process for FDA Class 2 products . The vast majority of 510 ( k ) products are not required by the FDA to have the validation of the reprocessing instructions with the submission of their 510 ( k ) paperwork . Another thing to consider is that a lot of products used in a healthcare facility are not undergoing FDA 510 ( k ) review ; many of them are exempt as being Class 1 products . There are so many other kinds of products and it ’ s almost the Wild West regarding pre-market review . We want to bring that awareness to healthcare facilities , and we want to push manufacturers of these products to improve their IFUs . We want sterile processing technicians to be able to complete the reprocessing effectively as well as safely for them , the workers , so they don ’ t develop musculoskeletal disorders over time , for example . And we want their process to be effective so that the patient isn ’ t being contaminated with various pathogens on the device that wasn ’ t cleaned properly .”
The complexity of today ’ s medical devices and instrumentation is a significant
14 • www . healthcarehygienemagazine . com • february 2024