patient safety & quality
By 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
What are Medical Devices and How are They Regulated ?
Infection preventionists are routinely consulted for guidance on medical device products and infection control risk assessments . Medical devices are used across all of healthcare and range from non-complex to extremely complex and high-risk devices . Basic devices such as blood pressure cuffs are routinely used during patient care and their safety is taken for granted by patients and healthcare providers . Food and Drug Administration ( FDA ) -cleared medical devices , however , have been repeatedly implicated in both infection
Healthcare facilities must perform a rigorous risk assessment before implementing any medical device and monitor device utilization even after usage begins . The FDA is the federal regulatory agency responsible for medical device regulation in the United
States . “ outbreaks and also patient harm . Healthcare facilities must perform a rigorous risk assessment before implementing any medical device and monitor device utilization even after usage begins . The FDA is the federal regulatory agency responsible for medical device regulation in the United States .
FDA is the oldest comprehensive consumer protection agency in the U . S . federal government . Its mission is to promote and protect public health . This scope is broad and covers foods , drugs , biologics , cosmetics , animal and veterinary medicines , tobacco , and , of course , medical devices and radiation-emitting products , the last two of which are regulated by the Center for Devices and Radiological Health , ( CDRH ). FDA ’ s authority to regulate medical devices originates from the Medical Device Amendments to the Federal Food , Drug , and Cosmetic Act ( FD & C Act ) of 1976 . The agency has continued to evolve its laws to ensure that it regulates these products in the most efficient way as our scientific knowledge advances over time . Starting in 2002 , CDRH began implementing a medical device user fee program in which the regulated device industry provides user fees to CDRH with the goal of advancing regulatory decision-making .
The 1976 Amendments provide us with the definition of a medical device . The full definition is found in Section 201 ( h ) of the FD & C Act . In summary , a device is an instrument , apparatus , machine , implant , or in vitro reagent that diagnoses , cures , treats or prevents a disease or condition . It does this by affecting the structure or function of the body but doesn ’ t achieve its purpose through chemical metabolism or as a drug . This definition excludes certain software functions , mostly involved with the administrative data storage and support , and transmission of electronic patient records .
Innovative products may feature aspects of devices , as well as components such as drugs or biologics . The FDA refers to these as Combination Products , which , by definition , involve at least two regulatory component types of drugs , devices and biologics . An example of a drug-device combination product is a drug-eluting cardiovascular stent , whose two components work together to keep an artery open and prevent restenosis . Combination products involve the applicable regulatory responsibilities from all the components involved . One FDA Center will usually take the lead and the agency ’ s Office of Combination Products helps facilitate product jurisdiction .
Our federal laws are intentionally written to be broad . We elaborate on the details and specifics of those laws in regulations . The regulations that are specific to medical devices are found in 21 Code of Federal Regulations , Parts 800 - 1050 . Parts 800 - 861 mostly address broad regulations that apply to most types of devices , and Parts 862 - 1050 largely address device-specific requirements . For example , 21 CFR 812 addresses Investigational Device Exemptions , a requirement that is applicable to all medical devices ; whereas 21 CFR 876 provides classification information and requirements specific to gastroenterology or urology . In addition , 21 CFR Parts 1- 99 contain general regulations that apply to all medical products regulated by the FDA , including medical devices . As a result , depending on your specific device , you may have regulatory responsibilities outlined in all these sections .
Sometimes , the FDA laws and regulations are not sufficiently detailed to describe how FDA intends to regulate a device policy . In such cases , FDA will publish a guidance document that describes what FDA is thinking . A guidance document is not binding , but it does reflect FDA ’ s current thinking , so it can often be an excellence source of detailed information and clarification on a particular policy . FDA may initially issue a draft guidance document that describes the agency ’ s proposed thinking on a topic . During this period , the public is invited to provide comments on the proposal . At the completion of the comment period , FDA will evaluate the public feedback and issue a final guidance document , which reflects the Agency ’ s current thinking .
FDA classifies devices , or more accurately , device types , to identify the degree of regulation for that product area . Classification is largely based on two factors : the device description , that is , its physical characteristics , and the intended use . As a result , to fully understand your device ’ s classification , you need to identify both the device description and intended use . FDA classifies devices into Class I , II , or III . The class of a device generally increases with its degree of risk . In addition , each device type is assigned a product code , which refers to a three-letter coding . This allows FDA to group similar devices and intended uses . Note that the same device with a different intended use may have a different classification , product code , and class .