Source : Food and Drug Administration
Even with these regulatory controls , the system is not perfect , and users of medical devices often fail to follow the manufacturer ’ s instructions for use which can lead to danger to patients and the user . While it is impossible to mitigate every risk associated with medical device utilization , it should remain our goal to prevent patient and healthcare team harm .”
This table describes the key characteristics of each class of medical devices . Moving from left to right , we describe each class according to the general risk of devices , controls necessary , and submissions required . As the risk of the device increases , so does the regulatory control to ensure its safety and effectiveness . Controls may be general , special , and PMA . Devices may be exempt from submission to FDA , or require 510 ( k ) or PMA , with some alternatives . For example , Class I devices generally present the lowest level of risk . They are subject to general controls only and most are exempt from premarket submission , but some may require a 510 ( k ).
So , what are regulatory controls ? These are requirements that apply to a product area , or product code . They provide consistent requirements to predictably foster safe and effective medical devices with the appropriate level of regulatory burden or oversight . Regulatory controls are usually broad , but some may be specific to a product area .
For example , one fundamental general control is labeling . 21 CFR Part 801 provides details involving labeling , which , broadly speaking , requires providing information about the device to ensure its safe and effective use . Another example is establishment registration . As described in 21 CFR 807 , businesses are required to register with FDA on an annual basis . Even with these regulatory controls , the system is not perfect , and users of medical devices often fail to follow the manufacturer ’ s instructions for use which can lead to danger to patients and the user .
While it is impossible to mitigate every risk associated with medical device utilization , it should remain our goal to prevent patient and healthcare team harm . Infection preventionists and other healthcare leaders such as clinical value analysis professionals must become well versed in medical device regulation and evaluation criteria to ensure
Infection preventionists and other healthcare leaders such as clinical value analysis professionals must become well versed in medical device regulation and evaluation criteria to ensure the safe use of these devices in our healthcare systems .”
the safe use of these devices in our healthcare systems . While medical devices provide truly lifesaving diagnostic and therapeutic functions , they carry inherent risks . Through risk mitigation , careful oversight , and proper usage , medical devices can provide an invaluable service to patients .
J . Hudson Garrett Jr ., PhD , MSN , MPH , MBA , FNP- BC , IP-BC , PLNC , CFER , AS-BC , VA-BC , BC-MSLcert™ , NCEE , NREMT , MSL-BC , DICO-C , TR-C , CPPS , CPHQ , CPXP , FACDONA , FAAPM , FNAP , FSHEA , FIDSA , is president and CEO of Community Health Associates , LLC and also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine , is a Fellow with the Institute for Healthcare Improvement , and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America . Garrett is a frequent lecturer globally on patient safety , infectious diseases , and medical device reprocessing and safety . He may be reached at :
Hudson . garrett @ chaassociates . com .
www . healthcarehygienemagazine . com • july 2022
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