product , if applicable , to determine if they can provide additional information regarding compatibility . When contacting a manufacture to determine if alternative products may be used , organizations should include a discussion of biological , chemical , and functional compatibilities . Organizations may also wish to consider the impact of their decision on liability , warranty and long-term maintenance of the item . If clear compatibility information is not able to be obtained , the organization should clearly identify the risks , the strategies to mitigate those risks , and implement their risk mitigation plan .”
For example , a healthcare organization contacted the manufacturer to determine if an alternative high-level disinfectant can be used ; it received correspondence that the alternative product is acceptable , and the organization provides it to the surveyor . The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers . The manufacturer states that if soaking exceeds the alternative product instructions for use , temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry . The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated .
As another example , the manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment ; however , the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer ’ s instructions were followed . The organization contacts the manufacturer to determine what type of damage could be anticipated , reads FDA MAUDE reports , ECRI alerts , etc . They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens . To mitigate the risk , they identify clear rejection criteria for use of the equipment and staff is trained on those criteria . In addition , the item is added to a checklist for biomedical engineering to review on a quarterly basis .
For deemed organizations , the Centers for Medicare and Medicaid Services ( CMS ) requires that “ Hospital policies address steps to take when there are discrepancies between a device manufacturer ’ s instructions and automated high-level disinfection
There ’ s a balancing act between how onerous that process is and how frequent that updates need to be issued ; we ’ ll have to figure that out in partnership with the manufacturing sector .”