oh what's happening okay i think it's recording all right folks let's give this a try so i'd like to deal today with the issue of regulatory agencies that govern our profession right first things first question for you can anyone tell me the difference between these two words here rules versus regulations any thoughts from government you have to follow the rules uh if not what happens you can yeah okay so let's see rules you must wear uniform to class one person the rest no uniform okay now so what are my options how shall i punish all of you not you ah okay who made this rule okay so i made the rule so i can't really punish you too much well unless you ask but the fact of the matter is i make the rules what's the most i can do kick you out of class right i mean that's basically what it boils down to now regulations the best way to define the word regulation would be laws so regulations equals laws who makes laws okay so laws equals government abbreviation govt so we got regulations which are laws laws are made by the government or government agencies okay which is basically government so to make a long story short government makes laws now if laws are broken you may be deprived so if broken you may be deprived of money liberty or life i mean it gets pretty severe out there if laws are broken you get punished and they take away your money your freedom or your life i mean does that make sense sure it does so we better stay away from breaking regulations and laws right which are one and the same now what are rules rules well rules are primarily guidelines right they are created by professional organizations who else employers violation of rules results in loss of membership so you may be deprived of your membership to an organization all right nobody wants that but it's really not punishable by law so there are various organizations and entities that govern our profession health care in general or in reality just about any industry so we have regulations which are laws put together by government and we have rules that we follow that we adhere to the standards of our profession if we violate those things we are booted out from our profession but we don't go to jail and we're not penalized financially i mean sometimes you could be but not like i said pay this or go to jail no pay this and get your membership back over here if you screw around with the laws hey you go to jail hey you got a parking ticket speeding ticket and if you don't pay that guess what they don't renew your license to drive or depending what you have done they will put you in jail does that make sense and also you should understand that when you violate the laws you violate the laws against society not against one individual it's against society you may you know walk down the street and feel the urge to punch somebody in the mouth okay and you do that and that person says oh no no i don't want to sue you i i deserved it really i shouldn't have looked at you funny but the fact of the matter is if you punch somebody in the mouth on the street you actually committed a crime against society not against that person because when you violate the laws and freedoms of one individual you actually violate the laws and freedoms against the entire society okay and that's why it's the state that sues you right so you may have heard cases you know commonwealth of massachusetts versus mr steve all right so you know so it's the commonwealth of massachusetts that actually files the lawsuit not the person whom you struck that person has a right to sue you as as well for damages but it's the state that will actually put you away make sense all right so we don't mess around with these guys we really don't want to mess around with these but if you don't care about your membership at some point in time you'll take the national certification boards you'll pass them you'll be a member in good standing but you break the rules they boot you out makes sense okay let's talk about some of the government agencies all right let me erase the board it's always a pleasant trip and again remember what i keep telling you not everything that's in the book is on the test but everything i put on the board is and so the biggest beast of them all as far as we're concerned well there's two beasts uh that we're dealing with and that would be first one would be osha i may have mentioned it before when we talked about uh bloodborne pathogens did i not did i talk about that when i talked about the chain of infection well i may have but it doesn't matter i'm gonna mention them one more time okay also i'd like to give you like a little bit of a warning okay i don't really have to put this on the board but every time you see words like agency um like central intelligence agency bureau department you know you're talking about government agency of what and lately they introduced words like authority authority is neither there nor there they have some government roles and some private enterprise roles and they don't know how and what they're governed by but anytime you see agency bureau department uh section all these words mean you're dealing with government state or federal makes no difference okay ready first government agency osha occupational safety and health administration administration right government occupational safety and health administration the thing about to remember about osha osha today as the name suggests it's occupational if we talk about occupation we talk about employee so if osha employee safety employee safety please memorialize it for yourself because if they do ask you a question about osha it'll be this don't let the you know these questions fool you at times osha is always about employee safety thing to remember about osha as far as we are concerned osha the biggest thing that they created for the healthcare industry is the bloodborne pathogen standard okay so let's look at the words bloodborne and pathogens because you do need to know their meanings first and foremost the word blood borne is made up of two word parts blood and born blood actually includes blood and body fluids by the way things like feces poop is also considered to be a fluid because it's moist okay so anything that contains moisture in the body is considered to be a fluid born it's not like having giving birth where somebody is born b-o-r-n-e means carried like airborne troops paratroopers the word pathogen patho means disease gen means causing and of course the word standard does anyone know the meaning of the word standard sure you do ever been to a parade ever see uh have you ever seen a person who's called the standard bear in the parade standard bear is a person that carries the flag the word standard actually means flag so what's a flag flag is something that represents something for which you stand for all right up till now american flag was life liberty pursuit of happiness right something like that so standard look at the root of the word stand some you stand on okay or something you stand for all right so the best example of a standard right outside no parking sign speed limit sign right speed limit sign is better right says 35 miles per hour that means if you go 40 miles per hour you're five miles over the speed limit because this limit is posted it's the standard something against which you measure yourself does that make sense now from bloodborne pathogen standard evolved some things which are important to us things called standard precautions i do not provide for you the book example or definition of standard precautions you can look that up yourself i will not give it i give it my own way and i want you to memorialize it okay i may have mentioned it before i'll mention it again and again and again and again standard precautions first and foremost represents a state of mind where you believe that all patients all patient care equipment are contaminated and contagious and will kill you i'll say it again and again all patience and that includes all their body fluids that includes your aunts and uncles grandpas and grandmas makes no difference who that person is all patients all patient care equipment is contagious a contaminated and contagious and will kill you why am i telling you in this uncertain you know in this certain terms that something like that will kill you well it's known fact that not everything will kill you well if you keep thinking that you're not going to know what's going to kill you what's not going to kill you i mean truth be told the biggest killer in the world is the flu are you concerned about the flu oh i've got the flu the answer is no i'm not concerned about that you know it's it's even get it's either going to get better in seven days or a week you know one or the other right it's going to get better not so not so is the case in the in the world biggest killer kills more people than any than anything else the flu it's nothing so to make a long story short you don't know who's got what and you don't know what it's going to do to you yes you do it's going to kill you why am i telling you because you need to take precautions precautions include something called ppe p p e for personal protective equipment osha mandates that your employer provides you with a ppe i didn't say give it to you for free i said provides you with the ppe and you know what else they say they should give you a hepatitis b vaccination it should be available to you okay so they should provide ppe and they should provide a hepatitis b vaccination that's what they want from the employer that's on the test every test i've seen so far every person i asked these questions were were there okay so line of logic osha occupational safety and health administration okay came up with bloodborne pathogen standard here's our definition and from bloodborne pathogens standard came standard precautions which dictate the use of personal protective equipment which dictate the fact by mandate by law that the employer must provide you with a ppe personal protective equipment and a hepatitis b vaccination is that clear any questions about this shall we move on all right let's talk about the next beast all right the next big one is something called the fda f d a for the food and drug administration there's that telltale word administration which means government so you may ask yourself a question what does the what was the food and drug administration having to do with us we have no food or drugs in in our department and in the vast majority of the department who has the food in the in the hospital the dietary but what do they have to do with sterile processing well the fact of the matter is that food and drug administration which has been around for a long time the name should be changed but it dictates and regulates anything and everything that comes in contact with the human body i mean right in a little room next door we have the dental chair over there well guess what it's not just a dental chair but the fda regulates the type of material used to construct that dental chair especially the material on which the patient sits so for patients to have any kind of physical contact with the uh with the body fda regulates it the x-ray machine that's hanging over there this guy right over here all these things i mean the sterilizer the x-ray machine anything and everything that comes in contact with the patient whether directly or indirectly is regulated by the fda okay does that make sense not only that how do they regulate it they regulate and they classify medical equipment and you know what they regulated by classes they assign classes to medical equipment class 1 class 2 class 3. okay each class has a value of dangerousness to the patient so that's how the classes is really assigned if something is almost impossible to cause any harm to the patient no matter what happens like for example the covering on the dental chair what could possibly happen to the patient if he comes in contact with that particular device or with a blood pressure cuff you've all had blood pressure taken haven't you before could anything truly harmful come to you from that medical device like a blood pressure cuff the answer is no i mean what is it some kind of a canvas or some other material that comes in contact with human skin skin well the fact of the matter is that some allergens could be present on that or in that material or some dye and you may get a minor skin rash does that present a major problem no could that evolve into a major problem no therefore it's a class one device so class one device means virtually no chance of injury now you may have already guessed that we're progressing from class 1 to class 3 to a degree of dangerousness okay i'm going to skip class 2 for a second and i'm going to go to class 3. and class 3 is something that is certain to cause death or serious injury let me ask you a question a sharp scalpel what would you consider that to be three class three okay kind of makes sense right very sharp scalpel but no it's not so i could ask you the same question is a loaded gun that's lying down on the table dangerous no it's only dangerous if somebody holds it in their hand and points it at you the same thing with the scalpel the scalpel is only dangerous if it's in the surgeon's hands now surgeon is the class iii device if a surgeon was to be classified by the fda certainly that would be a separate class class iv really dangerous a killer okay in any case you see how the logic works if a device by itself that's just sitting there mining no you know its own business is it dangerous now counterweight that with um one second counter counterweight that or oppose that to a tiny little valve that they use for for heart surgery to replace valves in the heart you know what it is it's a little basket with a ball that goes up and down up and down it's not sharp it's not anything but if that little ball gets stuck in one position just like that person is dead so if that valve is already installed if that valve is already inside the patient and that's what its intended purpose is to be inside the patient's heart if that thing fails it is certain to cause injury serious injury or death stroke heart attack death do you see what i'm saying now i'm going to shock you even further by telling what the class 2 devices now class 2 device is somewhere between this in this it's between serious injury and death and between virtually no chance of injury so if we have a device for example that under its normal operation may cause or lead to some injury then we have an issue give you an example table top sterilizer or every sterilizer that we have in the hospital is a class 2 device packaging material for surgical instruments is a class 2 device why well because if that thing fails to work properly then the device that you sterilize is unsterile and that will lead to injury you understand does that make sense packaging material the same thing if the packaging material fails to provide an adequate barrier against infection it will expose the instrument within and it will lead to injury not really death that would be like a remote possibility very remote but its actions will lead to a problem because of this classification the fda instituted special procedures that every company that wants to manufacture medical devices that come in contact with the patient have to go through a certification process and this certification process is called 5 10 k certification and the 510 k certification is designed to make sure that every manufacturer of medical devices certifies and undergoes extensive testing that will fit into this classification of instruments okay and it works properly the x-ray machines the uh the sterilizers all have to get 510k number so today if i wanted to buy for example a dental x-ray machine it would cost me i don't know between three and five thousand dollars or i can go online and buy one from china for five hundred dollars okay well the one from china may do the same thing for a little while but we don't know how much radiation it emits outside of its case so the fact of the matter is the fda didn't didn't go through the testing didn't issue 510k certification and the person who's taking the x-rays or the person sitting in the chair that constantly gets exposed over and over to extra you know scatter radiation from the machine is getting exposed so there's your reason for having you know these uh certifications do they work all the time no are there issues with it sure but it's better than nothing okay so uh having said that the fda also has a system in place to get these devices off the shelves or out of the hands of the doctors if they find something wrong with it so they also classify that okay and also by numbers one two and three except vice versa so class one recall so recall classifications is also one two and three except this time it's by priority priority number one we go after class three devices the ones that are liable to kill number two goes with number two and number three goes with number one does that make sense right so i i don't know if you've been watching the news they said kraft foods is recalling some cottage cheese so all the cottage cheese that they sold has to get packaged or brought back to the store for a full refund and the store will send it back to craft foods they screwed up something went into the cheese or people already ate it nothing bad happened they just went to the bathroom one extra time or two all right and so they recalled it but you know what back in the day when there was a scare with tylenol many many years ago already in america somebody was putting you know poisonous pills inside tylenol they yanked tylenol off the shelves like nobody's business just like this overnight the tylenol was gone and you know you may look at all these boxes or little bottles with pills nowadays they come with super ceiling caps and extra glue on top it all happened after 1981 when the tylenol when there was a killer i think in chicago was spiking all the tylenol with poison and people were dying so now they introduced the tamper resistant bottles for this you know specifically also for drinks too all these drinks that come and it makes a popping sound when you open it up that's because of that poisoning scare make sense does this make sense okay good i'm not gonna you know burden you too much more with the with the fda this is cool some of the stuff you have to leave for yourself for your own pleasant reading of the chapter but there isn't really that much more that you need to know make sense any questions all right next one we have a couple they're not quite as important uh to us you know for the purpose of the examination they're just gonna be very generic questions they are the epa and believe it or not the dot epa is the environmental protection agency believe it or you know you can believe it for sure that they have their dirty little fingers in our business they do i mean for good reason we do deal with all sorts of toxic chemicals that we use all right we're going to be talking about you know disinfectants you'll know all about it in the meantime believe me when i tell you we have some toxic stuff that we deal with and guess what when we're done using it where do you think we put it down that drain remember that goes in the water you drink we don't get it from the streams and from the rivers and and reservoirs we get it recycled every time you flush you feel you you fill your glass with that stuff in any case um moving right along so the environmental protection agency regulates what you may or may not do to dispose of your used and spent disinfectants and steroids and other stuff that you use in the department does that make sense do i need to bother writing that down is that clear okay the dot the department of transportation there's a funny one how does the department of transportation have to do with with us i mean what well a couple of things i mean we have lots and lots of these things in the hospital this is a uh hazardous medical waste container also known as a sharps containers uh biohazard infectious waste sensor right there that would be a good little symbol for you to remember that's a biohazard right there i'll bring a little bit closer to you so you can see it all right orange sign with black markings says biohazard on it okay box is usually orange or red well this is filled with biohazardous material okay so what well guess what let's say you have a big box of it filled and your boss tells you hey steve uh do me a favor put this in your car and drive it to our campus we have an inspection different campus put in your car and just drive it off to the other place he said yes ma'am yes sir you take this box you stick it in your car and off you go it's just down the street but guess what on the way to that other campus while transporting this stuff in your car you get into a car accident this big box of stuff just flies out the window all these things pop open and all these syringes and blood soaked and guts and everything else comes out of these boxes it gets strewn all over the street you're not going to come out there with a little whisk broom and a little pooper scooper to try to get that cleaned up let me tell you what's going to happen the fire department is go and the police are going to seal off one square mile radius around what happened all the people stuck in traffic will wish to kill you uh they're going to have people show up with you know space suits and so on and so forth you know like sounding like darth vader moving very slowly with their brews and space age equipment they're going to scoop everything up then they're going to spread some kind of a chemical that's going to soak up everything from the pavement street is going to be closed for a full day everyone and their uncle with blinking lights are going to be there you will go to prison you will be charged you will owe a lot of money to the hazmat team hazardous materials and disposal team from the fire department to have come in with their brooms to sweep that up and spread the stuff around i'm talking about tens of thousands of dollars you'll go on a show trial they're going to show you on tv folks having said all this please do not take anything that doesn't belong to you every time these boxes are moved every time you sneeze with these boxes you have to have a routing sheet that shows you where the darn thing went who took it and where it's going and when it gets there the other people put a stamps on on you know on that form so everyone knows that for the next seven years maybe longer in some cases you need to be able to see where these things went they are transported on special trucks with all sorts of permits on them and only specific times of the day because some of the stuff does not go during the normal business hours it goes either at night or very early in the morning okay and sometimes you may see state police pull over a truck like this with all sorts of you know uh square signs on them or rhomboid signs that show what they're licensed to carry and they're going to inspect them and they're going to ask hey what time is it what are you doing on my road to this hour you got something hazardous in the background no sir i don't or if you do guess what big trouble you understand why the d.o.t is involved if you're transporting hazardous or toxic gases or things that we use for you know sterilization like ethylene oxide and you know other chemicals they too are regulated by the dot okay and again that makes our stuff that's why you wonder why is it that this stuff costs so much money well this is one of the reasons the epa the fda the dot and osha i mean all these things are necessary is there overkill built in yeah yeah but you know what it is what it is it's better than finding like we did in the olden days where people used to take hazardous medical waste and just buried at the beach in quincy if you remember some years back about 20 years ago somebody did find all these things just buried there in quincy somebody didn't want to pay because it costs about 60 bucks to dispose of one of these little buckets over there it's not cheap it's not cheap all right does this make sense okay kill this