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 .” — Amanda Sivek , PhD , a-IPC
accreditation-related inspections and surveys ,” Davis says . “ It does fall eventually on the SPD manager / director and the staff because they ’ re standing there with the surveyor in the SPD and the surveyor asks to be shown around , and they feel unprepared . So , management is a huge concern , because SPD personnel and even the infection preventionist are being held accountable for the almost-unmanageable task of keeping everything current within the workflow of the techs , whether they use actual manuals and binders , or third-party electronic systems so they can pull things up on the computer screen and know they ’ re working off the most current information . A lot of times the IFU will change , and a letter goes out , but it goes to purchasing or nursing or the C-suite , but it doesn ’ t reach the SPD . So there needs to be an internal process for those letters and someone who is responsible for handling that . It ’ s like the wrong people are being held accountable because that ’ s the only way they receive the information , and it breaks down and the SPD gets blamed .”
Building and maintaining relationships is also an important part of addressing sterile processing-related challenges and hazards .
“ It ’ s critical that representatives from infection prevention and control , sterile processing , environmental services , risk management and biomedical engineering are on the facility committee that oversees purchasing of reusable healthcare items and medical devices ,” Sivek confirms . “ That could be the medical device committee , healthcare value analysis , product evaluation , whatever committee is responsible for purchasing those products . So , the first thing for them to do is , if needed , request representation on that committee . Once they have representation , that committee is going to conduct a risk assessment for products being considered for purchase , as well as some products in their current inventory that have known reprocessing issues . As part of that risk assessment , the committee is going to consider if the vendor provided validated reprocessing instructions for the product , and the committee will assess if the processing instructions are practical for the healthcare workers to perform , considering their workflow and work environment . We want medical device and healthcare item reprocessing instructions that are effective in removing contamination from the product which supports patient safety and is practical to complete to support healthcare worker safety .”
ECRI advises that the best time for healthcare organizations to address this issue is before purchasing any reusable medical devices or healthcare items : “ Reprocessing considerations should be evaluated during the pre-purchase risk assessment of a product . Questions to consider include : Will the vendor provide validated reprocessing instructions for the product ? Validated reprocessing instructions have been shown to be effective and ensure the safe reuse of a product over its life . And are the reprocessing steps practical to complete in your environment ? If the answer to either question is ‘ no ,’ ECRI recommends considering alternative vendors and products .”
One of the most important stakeholders in this process is the healthcare facility ’ s leadership .
“ We want the C-suite to be aware that somewhere in the healthcare facility , whether it ’ s a hospital , ambulatory surgery center , long-term care facility or specialty medical office , there is very likely an issue with the reprocessing instructions of medical devices and healthcare items ,” Sivek continues . “ We want the C-Suite to be aware of this issue so that they can support the work of the purchasing committee and only procuring products that have validated , practical reprocessing instructions if possible . The C-Suite should also be aware of the consequences of ineffective reusable healthcare item reprocessing , which include potential citations from accreditation organizations , potential reimbursement issues from the Centers for Medicare & Medicaid Services ( CMS ), because CMS expects that reprocessing instructions for medical devices and healthcare items will be followed . There ’ s also the potential for lawsuits due to ineffective processing , something that the C-suite should be aware of . The bottom line is they must support their staff in only procuring products that have validated , practical reprocessing instructions .”
Davis concurs , adding that , “ Frequently , members of the C-suite are responsible for reviewing contracts with vendors and suppliers — or at least somebody near the suite is looking at contracts — and they should
be looking to build some of these safeguards into their contracts to hold the manufacturers accountable as well .”
Davis says he sees some bright spots on the horizon , in that dialogue is happening between stakeholders . For example , last year , the Association for Professionals in Infection Control and Epidemiology ( APIC ) developed a survey to help the organization quantify infection prevention-related challenges with medical device instructions for use ( IFUs ). APIC says the survey responses will help inform U . S . regulatory agencies of these challenges .
“ We work with vendors all the time , we have conversations with them about things we find , and we compare vendors as we ’ re talking to them ,” Davis says . “ I was just on a call with two separate ECRI members this week about the same issue with equipment and there ’ s varying responses from the vendors ; some are warming up to this idea , they ’ re getting a lot of attention and there have been certain associations with some surveys around this with infection preventionists and they ’ re starting to listen . We ’ re starting to understand the human factors pieces , especially around things like filter changes so I do think the needle is moving . Is it moving as quick as clinicians would like ? Probably not , but at least they ’ re hearing us and , you know , a lot of that comes from if I can purchase something that has a validated IFU versus not , I ’ m aware of this now , and I ’ m not going to go with that product . So , there are multiple reasons for manufacturers to respond , including the fact that our top healthcare tech hazards list lets clinicians know what to look for and ask about when they interact with vendors . Manufacturers that are not responding to clinical end users will not be getting their market share anymore . There ’ s pressure on them , they ’ re listening , and I think right now they ’ re responding so that they don ’ t get hit in the pocketbook .”
“ I do think this is a solvable problem ,” Sivek adds . “ If healthcare facilities have a device-related issue , we have a free problem-reporting network . There are engineers that investigate each problem that ’ s submitted to us , completely free . Do you have issues ? Report them to us . We ’ re here to help you .”
Drug compounding without technology safeguards
Another significant hazard on this year ’ s ECRI list is drug compounding , which is required when a commercially available formulation does not come in a ready-to-administer form or does not otherwise meet patients ’ needs , such as dosing requirements . It involves combining , reconstituting , repackaging , or otherwise modifying a drug product to create a new preparation .
The Institute for Safe Medication Practices ( ISMP ) reports that in the past two decades , there have been well over 200 adverse events
16 • www . healthcarehygienemagazine . com • february 2024