Re: Sterilized surgical equipment

[Guest guest]

,

Shelf life of autoclaved sterilised surgical instrumentation can be

anything from 1 - 3 years, depending on the environment in which its

kept (which should be in a cool room away from direct sunlight /

heat / humidity). Also depends on the condition of the packaging ect

in the hospital where i work in theatres we dont keep anything

longer than 1 year

regards

Glenn, CMT1, Final year ODP Student

>

> Hey All,

>

> I was wondering if anyone out there can help me with the following

question.

>

> How long can one keep pre-packed and sterilized surgical equipment

before it

> needs to be sent back for re sterilization?

> Thanx in advance

> --

> Rundle

> Offshore Medic/ Health and Hygiene

> P.O. Box 257

> Gordon's Bay

> South Africa

> 7151

> Cell: +27 (0) 82 656 9747

>

>

>

[Guest guest]

,

I have been told by surgeons that in our environment (remote sites) that the

stuff is good until it has been opened or gets wet or is dusty or dirty. If your

kits are well wrapped (that is triple wrapped in plastic so they cannot be

contaminated unless opened you are good until they are opened. Some may have

arbitrary or subjective rules about the expiry of these things but there is

little objective documentation to support them that I have found.

Cheers,

Steve

Rundle <jeremy.rundle@...> wrote:

Hey All,

I was wondering if anyone out there can help me with the following question.

How long can one keep pre-packed and sterilized surgical equipment before it

needs to be sent back for re sterilization?

Thanx in advance

--

Rundle

Offshore Medic/ Health and Hygiene

P.O. Box 257

Gordon's Bay

South Africa

7151

Cell: +27 (0) 82 656 9747

[Guest guest]

Agree with Stevan

if the packaging is intact the item in qustion is not yellowed or appearing

tarnished it is still sterile. Putting expiration dates on for exampl e ET

tubes is silly as long as they are not damaged, yellow and package is intact

they are good. Me thinks its a plot by the man to shore up sagging

economies!

Cheers

Tom

>From: Stevan Pierce <ermedicsp@...>

>Reply-

>

>Subject: Re: Sterilized surgical equipment

>Date: Fri, 20 Oct 2006 06:35:32 -0700 (PDT)

>

>,

>I have been told by surgeons that in our environment (remote sites) that

>the stuff is good until it has been opened or gets wet or is dusty or

>dirty. If your kits are well wrapped (that is triple wrapped in plastic so

>they cannot be contaminated unless opened you are good until they are

>opened. Some may have arbitrary or subjective rules about the expiry of

>these things but there is little objective documentation to support them

>that I have found.

>Cheers,

>Steve

>

> Rundle <jeremy.rundle@...> wrote:

> Hey All,

>

> I was wondering if anyone out there can help me with the following

>question.

>

> How long can one keep pre-packed and sterilized surgical equipment before

>it

> needs to be sent back for re sterilization?

> Thanx in advance

> --

> Rundle

> Offshore Medic/ Health and Hygiene

> P.O. Box 257

> Gordon's Bay

> South Africa

> 7151

> Cell: +27 (0) 82 656 9747

>

>

[Guest guest]

Is this is your professional opinion?

Maybe because of such wild ideas on patient safety we have medical

standards/policies that clarify exactly what¹s right, and what¹s not ie. in

regards to expiry dates... Try to find an anesthetist who wouldn¹t throw an

expired tube back at you, and the same goes for surgeons asked to use

expired instruments... I would, and I am still to meet one who wouldn¹t.

What¹s next? As long as a drug doesn¹t smell funny or changes colour it can

still be ie injected?? Come on, this is topic simply isn¹t up to opinion,

and working remote is not just legally a very weak excuse... I am left to

believe that there are ³medics² out there who think the very same way, and

hopefully remember what they have learned during their education.

No offence, but maybe the Hippocratic oath should be introduced to

paramedical staff too...

From: thomas greaber <tom5255@...>

Reply-< >

Date: Fri, 20 Oct 2006 14:20:10 +0000

< >

Subject: Re: Sterilized surgical equipment

Agree with Stevan

if the packaging is intact the item in qustion is not yellowed or appearing

tarnished it is still sterile. Putting expiration dates on for exampl e ET

tubes is silly as long as they are not damaged, yellow and package is intact

they are good. Me thinks its a plot by the man to shore up sagging

economies!

Cheers

Tom

>From: Stevan Pierce <ermedicsp@... <mailto:ermedicsp%40> >

>Reply-

<mailto:%40>

>

<mailto:%40>

>Subject: Re: Sterilized surgical equipment

>Date: Fri, 20 Oct 2006 06:35:32 -0700 (PDT)

>

>,

>I have been told by surgeons that in our environment (remote sites) that

>the stuff is good until it has been opened or gets wet or is dusty or

>dirty. If your kits are well wrapped (that is triple wrapped in plastic so

>they cannot be contaminated unless opened you are good until they are

>opened. Some may have arbitrary or subjective rules about the expiry of

>these things but there is little objective documentation to support them

>that I have found.

>Cheers,

>Steve

>

> Rundle <jeremy.rundle@... <mailto:jeremy.rundle%40gmail.com> >

wrote:

> Hey All,

>

> I was wondering if anyone out there can help me with the following

>question.

>

> How long can one keep pre-packed and sterilized surgical equipment before

>it

> needs to be sent back for re sterilization?

> Thanx in advance

> --

> Rundle

> Offshore Medic/ Health and Hygiene

> P.O. Box 257

> Gordon's Bay

> South Africa

> 7151

> Cell: +27 (0) 82 656 9747

>

>

[Guest guest]

I know anesthetists who would happily use a non sterile but clean ET tube. I

for one, am an Intensive Care Paramedic, who would. I also use non sterile

eating utensils.

I agree that we need to stick to sterilization standards when we can. But

there is no doubt that a valid point was made in the post below that throws

suspicion on the motives behind the regulations.

When it comes to drug expiration, I have had personal communication from

manufacturers who grant extensions of the expiry dates. In fact some state

categorically that they are happy with their drug being used two years past

their announced expiry dates, as long as it is checked with them first.

No problems with a Hippocratic Oath, however, I am wondering which one

though. Since you mention " The ....Oath " I figure you refer to the classic

one, and there I have a problem with Panacea.

Cheers,

Gösta

Re: Sterilized surgical equipment

>Date: Fri, 20 Oct 2006 06:35:32 -0700 (PDT)

>

>,

>I have been told by surgeons that in our environment (remote sites) that

>the stuff is good until it has been opened or gets wet or is dusty or

>dirty. If your kits are well wrapped (that is triple wrapped in plastic so

>they cannot be contaminated unless opened you are good until they are

>opened. Some may have arbitrary or subjective rules about the expiry of

>these things but there is little objective documentation to support them

>that I have found.

>Cheers,

>Steve

>

> Rundle <jeremy.rundle@... <mailto:jeremy.rundle%40gmail.com> >

wrote:

> Hey All,

>

> I was wondering if anyone out there can help me with the following

>question.

>

> How long can one keep pre-packed and sterilized surgical equipment before

>it

> needs to be sent back for re sterilization?

> Thanx in advance

> --

> Rundle

> Offshore Medic/ Health and Hygiene

> P.O. Box 257

> Gordon's Bay

> South Africa

> 7151

> Cell: +27 (0) 82 656 9747

>

>

[Guest guest]

Jens,

Please provide documentation to support your assault on my integrity. I do not

appreciate having words put in my mouth either. Please provide evidence. There

are vast and lengthy examples of practices that are based on tradition or

hearsay (even in medicine) that are not supported by fact. Witness most of the

ACLS protocols of the last 15 years. Thanks

Steve

jens_worldwide@... wrote: Is this is your

professional opinion?

Maybe because of such wild ideas on patient safety we have medical

standards/policies that clarify exactly what¹s right, and what¹s not ie. in

regards to expiry dates... Try to find an anesthetist who wouldn¹t throw an

expired tube back at you, and the same goes for surgeons asked to use

expired instruments... I would, and I am still to meet one who wouldn¹t.

What¹s next? As long as a drug doesn¹t smell funny or changes colour it can

still be ie injected?? Come on, this is topic simply isn¹t up to opinion,

and working remote is not just legally a very weak excuse... I am left to

believe that there are ³medics² out there who think the very same way, and

hopefully remember what they have learned during their education.

No offence, but maybe the Hippocratic oath should be introduced to

paramedical staff too...

From: thomas greaber <tom5255@...>

Reply-< >

Date: Fri, 20 Oct 2006 14:20:10 +0000

< >

Subject: Re: Sterilized surgical equipment

Agree with Stevan

if the packaging is intact the item in qustion is not yellowed or appearing

tarnished it is still sterile. Putting expiration dates on for exampl e ET

tubes is silly as long as they are not damaged, yellow and package is intact

they are good. Me thinks its a plot by the man to shore up sagging

economies!

Cheers

Tom

>From: Stevan Pierce <ermedicsp@... <mailto:ermedicsp%40> >

>Reply-

<mailto:%40>

>

<mailto:%40>

>Subject: Re: Sterilized surgical equipment

>Date: Fri, 20 Oct 2006 06:35:32 -0700 (PDT)

>

>,

>I have been told by surgeons that in our environment (remote sites) that

>the stuff is good until it has been opened or gets wet or is dusty or

>dirty. If your kits are well wrapped (that is triple wrapped in plastic so

>they cannot be contaminated unless opened you are good until they are

>opened. Some may have arbitrary or subjective rules about the expiry of

>these things but there is little objective documentation to support them

>that I have found.

>Cheers,

>Steve

>

> Rundle <jeremy.rundle@... <mailto:jeremy.rundle%40gmail.com> >

wrote:

> Hey All,

>

> I was wondering if anyone out there can help me with the following

>question.

>

> How long can one keep pre-packed and sterilized surgical equipment before

>it

> needs to be sent back for re sterilization?

> Thanx in advance

> --

> Rundle

> Offshore Medic/ Health and Hygiene

> P.O. Box 257

> Gordon's Bay

> South Africa

> 7151

> Cell: +27 (0) 82 656 9747

>

>

[Guest guest]

Gents,

Whew a bit of a storm this.

I opened, as you can see, by stating I have this info from surgeons, not medics;

who, when I describe my operating environment, have said with no equivocation

that sterile packages are sterile until they are opened intentionally or

inadvertantly (perforation, abrasion, etc.). That IS the point of sterilizing

them is it not, no bugs to grow on them?

Further, the " rules " about expiration (for both surgical instruments and drugs)

are not based on ANY scientific analysis save one from the US military that big

Pharma doesn't really like to talk about since it supports the long expiry of

antibiotics, (>7years). The US military examined their emergency stores of

antibiotics, held for 10 years and found that all of them maintained a greater

than 90% potency when kept sealed in their original sealed state.

There significantly different expiry dates on drugs obtained from different

countries as well. Norway for instance cites an expiry of 5 years for drugs

purchased there, same in Cost Rica, Mexico and many other places (even though

the drugs themselves may have all been manufactured in the same factory in

Puerto Rico). The U.S. on the other hand cites 3 years, why? It is because the

FDA in the US wanted expiry dates on the drugs they certify for use in the US.

They originally wanted 5 years but left it up to the pharm companies to set

their own dates and because of the manufacturing cycles in these companies, 3

years was the shortest period they could get away with.

There is an economic connection here. The pharm companies are in it for the

money, not the good will. Yes we get some great pharmaceutical salvation from

them, but it is not free. They are businesses and very big ones at that.

The rules about sterilization on land vary place to place. Why? Is an item less

sterile in Toledo than it is in Los Angeles or Bergen or Sao o? I doubt it.

It depends on who makes the rules and how much rationality and critical thinking

goes into the rules. In the U.S. you can be sure the rules are, in some part,

driven by litigation history. Other parts of the world are less fear driven (the

fear of lawsuits that is) and have applied standards according to what they

know, not what they suspect or imagine. The inverse is also, unfortunately,

true.

My thirst for knowledge about this is unquenched and if anyone has more

pertinent resources I'd love to get them.

Best,

Steve

Stevan Pierce <ermedicsp@...> wrote:

,

I have been told by surgeons that in our environment (remote sites) that the

stuff is good until it has been opened or gets wet or is dusty or dirty. If your

kits are well wrapped (that is triple wrapped in plastic so they cannot be

contaminated unless opened you are good until they are opened. Some may have

arbitrary or subjective rules about the expiry of these things but there is

little objective documentation to support them that I have found.

Cheers,

Steve

Rundle <jeremy.rundle@...> wrote:

Hey All,

I was wondering if anyone out there can help me with the following

question...snip

Stevan Pierce, WEMT-IDP

Independent Duty Paramedic

Remote & Wilderness Service

A.C.E. Personal Trainer

Health, Safety and Fitness Support

ermedicsp@...

" some say a hero could save us, I'm not going to stand here and wait "

[Guest guest]

Can you provide a link to that US military study?

Thanks

Jim

Stevan Pierce wrote:

>

> Gents,

> Whew a bit of a storm this.

>

> I opened, as you can see, by stating I have this info from surgeons,

> not medics; who, when I describe my operating environment, have said

> with no equivocation that sterile packages are sterile until they are

> opened intentionally or inadvertantly (perforation, abrasion, etc.).

> That IS the point of sterilizing them is it not, no bugs to grow on them?

>

> Further, the " rules " about expiration (for both surgical instruments

> and drugs) are not based on ANY scientific analysis save one from the

> US military that big Pharma doesn't really like to talk about since it

> supports the long expiry of antibiotics, (>7years). The US military

> examined their emergency stores of antibiotics, held for 10 years and

> found that all of them maintained a greater than 90% potency when kept

> sealed in their original sealed state.

>

> There significantly different expiry dates on drugs obtained from

> different countries as well. Norway for instance cites an expiry of 5

> years for drugs purchased there, same in Cost Rica, Mexico and many

> other places (even though the drugs themselves may have all been

> manufactured in the same factory in Puerto Rico). The U.S. on the

> other hand cites 3 years, why? It is because the FDA in the US wanted

> expiry dates on the drugs they certify for use in the US. They

> originally wanted 5 years but left it up to the pharm companies to set

> their own dates and because of the manufacturing cycles in these

> companies, 3 years was the shortest period they could get away with.

>

> There is an economic connection here. The pharm companies are in it

> for the money, not the good will. Yes we get some great pharmaceutical

> salvation from them, but it is not free. They are businesses and very

> big ones at that.

>

> The rules about sterilization on land vary place to place. Why? Is an

> item less sterile in Toledo than it is in Los Angeles or Bergen or Sao

> o? I doubt it. It depends on who makes the rules and how much

> rationality and critical thinking goes into the rules. In the U.S. you

> can be sure the rules are, in some part, driven by litigation history.

> Other parts of the world are less fear driven (the fear of lawsuits

> that is) and have applied standards according to what they know, not

> what they suspect or imagine. The inverse is also, unfortunately, true.

>

> My thirst for knowledge about this is unquenched and if anyone has

> more pertinent resources I'd love to get them.

>

> Best,

> Steve

>

> Stevan Pierce <ermedicsp@... <mailto:ermedicsp%40>>

> wrote: ,

> I have been told by surgeons that in our environment (remote sites)

> that the stuff is good until it has been opened or gets wet or is

> dusty or dirty. If your kits are well wrapped (that is triple wrapped

> in plastic so they cannot be contaminated unless opened you are good

> until they are opened. Some may have arbitrary or subjective rules

> about the expiry of these things but there is little objective

> documentation to support them that I have found.

> Cheers,

> Steve

>

> Rundle <jeremy.rundle@...

> <mailto:jeremy.rundle%40gmail.com>> wrote: Hey All,

>

> I was wondering if anyone out there can help me with the following

> question...snip

>

>

> Stevan Pierce, WEMT-IDP

> Independent Duty Paramedic

>

> Remote & Wilderness Service

> A.C.E. Personal Trainer

> Health, Safety and Fitness Support

> ermedicsp@... <mailto:ermedicsp%40>

>

> " some say a hero could save us, I'm not going to stand here and wait "

>

>

[Guest guest]

Jim:

http://www.medscape.com/viewarticle/460159

There is reference in this article in regards to the US Military study as

well, it backs the statements by Tom and Steve an interesting read.

I will keep on looking for those that may have limited internet time or

" peasant " internet connections.

Cheers

Wilf

[Guest guest]

Hi Goesta,

Thank you. I appreciate your comments.

> I know anesthetists who would happily use a non sterile but clean ET tube. I

> for one, am an Intensive Care Paramedic, who would. I also use non sterile

> eating utensils.

Well, now you know one who isn¹t happy with a ³clean² one. The word ³clean²

hasn¹t much of a meaning in medicine. It gives me the shiver, and it makes

me remembering Ignaz Semmelweiss...

So why did it take so long to find one, you might ask yourself (well, I am

facing the same question at the moment...). The entire discussion about the

need for an ETT tube to be sterile is a very old one and has been discussed

amongst Anesthetists for ages. I thought such discussion to be generally

over by now (whilst accepting the fact that there will always be someone who

just wants to do things his own way, and different to others), but after

reading all the comments, I think I will bring this topic up again in some

anesthesia meetings.

However, in the end it all came down to few points which I will try to put

down as plain & simple as I can. I¹ll spare you (and myself) time with not

digging through statistics, research etc and as I think some simple

arguments do the trick (well, they did it so far).

1. It¹s an invasive procedure that bears a significant risk of injury, (even

minor injury opens the gate for infection), and is you obligation to

minimize all potential risks.

2. Medical law is very clear about expiry dates (for a reason), and you¹re

not doing your patient and yourself any good if you break it.

3. Best practice / professionalism. Yes, we can do a lot of things, the

human body can cope with a lot of what we are doing to it, -but- there will

always be one who won¹t (kinda like ¹s Law). However, harming just one

(infection etc), by softening your regime on patient safety - is one too

much. In other words: ³in dubito pro aegroto². If you¹re in doubt - decide

in favour of your patient.

> I agree that we need to stick to sterilization standards when we can. But

> there is no doubt that a valid point was made in the post below that throws

> suspicion on the motives behind the regulations.

Yep, but that¹s an entirely different discussion topic, isn¹t it? I.e.

³should medical practitioners/lawyers question expiry dates²

Right now I see us discussing ³should one apply what is present medical law

and best practice²

> When it comes to drug expiration, I have had personal communication from

> manufacturers who grant extensions of the expiry dates. In fact some state

> categorically that they are happy with their drug being used two years past

> their announced expiry dates, as long as it is checked with them first.

I think, ³as long as you check with them first² is the key sentence in what

you¹ve written.

Goesta, one significant aspect I seem to have totally missed in all

discussions, is the fact that ³expired² is very much depending on how a drug

was stored, handled etc. Talking remote places you will surely have seen

drugs expiring even before the actual date on i.e. the ampoule? Maybe this

was because the item was exposed to heat, significant temperature changes,

intense sunlight, repacked, humidity etc and all those factors one needs to

keep in mind before giving drugs, doing procedures etc ³at the end of the

world² - often in an environment that can barely be called ³clinical². So if

this is the environment you and your drugs are exposed to ­ I am sure you¹ll

agree that it makes ³sense² to be ³conservative² (well, I could say ³patient

focused²), and working as ³safe² as possible?...

> No problems with a Hippocratic Oath, however, I am wondering which one

> though. Since you mention " The ....Oath " I figure you refer to the classic

> one, and there I have a problem with Panacea.

Not really. I am old, but not that old Lets use a more modern version...

Most of who are working in the field, will have a copy of the Oxford

Handbook of Clinical Medicine (if not ­ it¹s a good one to have), and my

trusted version comes with a 1998 revision of ³the² oath. The one I am bound

to in regards to what I am doing professionally. Hm, some relevant

professional bodies have gone even more modern; have come up with ³codes of

conduct², and there are some very good ones in regards to i.e. best

practice, and patient advocacy. However, in the end it all comes down to

³do no harm².

> Cheers,

> Gösta

All the best,

J

Re: Sterilized surgical equipment

>Date: Fri, 20 Oct 2006 06:35:32 -0700 (PDT)

>

>,

>I have been told by surgeons that in our environment (remote sites) that

>the stuff is good until it has been opened or gets wet or is dusty or

>dirty. If your kits are well wrapped (that is triple wrapped in plastic so

>they cannot be contaminated unless opened you are good until they are

>opened. Some may have arbitrary or subjective rules about the expiry of

>these things but there is little objective documentation to support them

>that I have found.

>Cheers,

>Steve

>

> Rundle <jeremy.rundle@... <mailto:jeremy.rundle%40gmail.com>

<mailto:jeremy.rundle%40gmail.com> >

wrote:

> Hey All,

>

> I was wondering if anyone out there can help me with the following

>question.

>

> How long can one keep pre-packed and sterilized surgical equipment before

>it

> needs to be sent back for re sterilization?

> Thanx in advance

> --

> Rundle

> Offshore Medic/ Health and Hygiene

> P.O. Box 257

> Gordon's Bay

> South Africa

> 7151

> Cell: +27 (0) 82 656 9747

>

>

[Guest guest]

Steve,

I have assaulted your integrity? Well, in fact, and maybe when you read over

it again you will see that my comment was directed towards Tom¹s (the recent

one to who I¹ve replied and, NO I am not intending to assault Tom by

this...). Tom, if you¹re listening, and you¹re feel offended ­ please drop

me an email and tell me.

Well, whatever... that was certainly not my intention when I¹ve voiced my

opinion the same as i.e. you did in this open forum. You¹re finding me

surprised, and you¹re now leaving me with the question on why you see this

as an assault???. If you like we can certainly discuss this rather personal

topic in more detail, but please directly via email. However, if you truly

feel assaulted in your integrity, and even if you don¹t want to talk about

the reasons in details ­ I¹ll certainly apologize to you.

On the question of providing evidence:

What I am saying is IMHO backed by current medical / legal / best practice

in anesthesia and intensive care medicine. If we cannot agree on that, may I

ask you in return for me digging out tons of regulations, standards,

policies, guidelines etc., to provide me with one valid document or piece of

evidence that is supporting the idea that ³expiry dates² are just

³hocus-pocus² and a (para)medical professional (in whatever capacity) can

forget about it?. Thanks in advance.

Yes, you might be working in a remote environment, but talking (not only)

legally again ­ where are you registered and licensed? If you are registered

anywhere i.e. in Europe or the US, your (para)medical practice is not just

legally bound to and based on a system of evidence based best practice

medicine, which applies to you individually, outlines your do¹s & don'ts,

and regardless on where you are working. I agree it¹s a can of worms

(liability whilst working abroad, and in different health care settings you

might not be registered with ­ as so often) but isn¹t it fact that comes all

down to you having to apply what you know is current best practice, whilst

sticking to what you are legally allow to do in regards to your practice?

So, if we agree on this ­ lets skip the talk about having, or not having to

go by expiry dates and start a new discussion about if current legislation

(various countries) in regards to expiry dates makes any sense to us as

practitioners. I think it will be a dry and short one, but feel free to

prove me wrong.

Regards,

J

From: Stevan Pierce <ermedicsp@...>

Reply-< >

Date: Sat, 21 Oct 2006 05:11:57 -0700 (PDT)

< >

Subject: Re: Sterilized surgical equipment

Jens,

Please provide documentation to support your assault on my integrity. I do

not appreciate having words put in my mouth either. Please provide evidence.

There are vast and lengthy examples of practices that are based on tradition

or hearsay (even in medicine) that are not supported by fact. Witness most

of the ACLS protocols of the last 15 years. Thanks

Steve

jens_worldwide@... <mailto:jens_worldwide%40.de> wrote:

Is this is your professional opinion?

Maybe because of such wild ideas on patient safety we have medical

standards/policies that clarify exactly what¹s right, and what¹s not ie. in

regards to expiry dates... Try to find an anesthetist who wouldn¹t throw an

expired tube back at you, and the same goes for surgeons asked to use

expired instruments... I would, and I am still to meet one who wouldn¹t.

What¹s next? As long as a drug doesn¹t smell funny or changes colour it can

still be ie injected?? Come on, this is topic simply isn¹t up to opinion,

and working remote is not just legally a very weak excuse... I am left to

believe that there are ³medics² out there who think the very same way, and

hopefully remember what they have learned during their education.

No offence, but maybe the Hippocratic oath should be introduced to

paramedical staff too...

From: thomas greaber <tom5255@... <mailto:tom5255%40hotmail.com> >

Reply-<

<mailto:%40> >

Date: Fri, 20 Oct 2006 14:20:10 +0000

<

<mailto:%40> >

Subject: Re: Sterilized surgical equipment

Agree with Stevan

if the packaging is intact the item in qustion is not yellowed or appearing

tarnished it is still sterile. Putting expiration dates on for exampl e ET

tubes is silly as long as they are not damaged, yellow and package is

intact

they are good. Me thinks its a plot by the man to shore up sagging

economies!

Cheers

Tom

>From: Stevan Pierce <ermedicsp@... <mailto:ermedicsp%40>

<mailto:ermedicsp%40> >

>Reply-

<mailto:%40>

<mailto:%40>

>

<mailto:%40>

<mailto:%40>

>Subject: Re: Sterilized surgical equipment

>Date: Fri, 20 Oct 2006 06:35:32 -0700 (PDT)

>

>,

>I have been told by surgeons that in our environment (remote sites) that

>the stuff is good until it has been opened or gets wet or is dusty or

>dirty. If your kits are well wrapped (that is triple wrapped in plastic so

>they cannot be contaminated unless opened you are good until they are

>opened. Some may have arbitrary or subjective rules about the expiry of

>these things but there is little objective documentation to support them

>that I have found.

>Cheers,

>Steve

>

> Rundle <jeremy.rundle@... <mailto:jeremy.rundle%40gmail.com>

<mailto:jeremy.rundle%40gmail.com> >

wrote:

> Hey All,

>

> I was wondering if anyone out there can help me with the following

>question.

>

> How long can one keep pre-packed and sterilized surgical equipment

before

>it

> needs to be sent back for re sterilization?

> Thanx in advance

> --

> Rundle

> Offshore Medic/ Health and Hygiene

> P.O. Box 257

> Gordon's Bay

> South Africa

> 7151

> Cell: +27 (0) 82 656 9747

>

>

[Guest guest]

Steve,

I appreciate your comment. I am not saying this because of the ³bit of a

storm² this topic comes with, ...I mean it.

I very much agree that this topic is i.e. economically driven, and I support

the fact that different countries, states etc have different views about it

for whatever reasons.

The only thing I¹d like to add is that one should be careful in regards to

working by some sort of ³expert info², (a bit like: ³I only trust those

statistics who I've falsified myself²...) and one needs to keep in mind that

such views might change drastically, or might even be reversed if the

³expert² suddenly has to work in your environment... Colleagues can say a

lot of things, and like always in your professional life - it is down to you

to filter out what might be contradicting your efforts in providing the best

possible care to your patients. Looking into the ³rules² that apply to you,

is usually helping a lot in this process of finding your way. If an existing

rule is broken for lets say ³a higher purpose² i.e. trying to saving a life

in a emergency situation by any means possible ­ I believe that's a

different story, and must / will be reviewed individually. This would IMHO

include the use of ³expired² equipment. As you know there are environments

that are less or more ³accepting² (as long as they understand the aim of

your actions), however can we please agree that it should not become any

sort of ³routine² getting yourself & your patient into such a situation?

That would ³calm² me down significantly...

Regards,

J

From: Stevan Pierce <ermedicsp@...>

Reply-< >

Date: Sat, 21 Oct 2006 05:47:02 -0700 (PDT)

< >

Subject: Re: Sterilized surgical equipment

Gents,

Whew a bit of a storm this.

I opened, as you can see, by stating I have this info from surgeons, not

medics; who, when I describe my operating environment, have said with no

equivocation that sterile packages are sterile until they are opened

intentionally or inadvertantly (perforation, abrasion, etc.). That IS the

point of sterilizing them is it not, no bugs to grow on them?

Further, the " rules " about expiration (for both surgical instruments and

drugs) are not based on ANY scientific analysis save one from the US

military that big Pharma doesn't really like to talk about since it supports

the long expiry of antibiotics, (>7years). The US military examined their

emergency stores of antibiotics, held for 10 years and found that all of

them maintained a greater than 90% potency when kept sealed in their

original sealed state.

There significantly different expiry dates on drugs obtained from different

countries as well. Norway for instance cites an expiry of 5 years for drugs

purchased there, same in Cost Rica, Mexico and many other places (even

though the drugs themselves may have all been manufactured in the same

factory in Puerto Rico). The U.S. on the other hand cites 3 years, why? It

is because the FDA in the US wanted expiry dates on the drugs they certify

for use in the US. They originally wanted 5 years but left it up to the

pharm companies to set their own dates and because of the manufacturing

cycles in these companies, 3 years was the shortest period they could get

away with.

There is an economic connection here. The pharm companies are in it for the

money, not the good will. Yes we get some great pharmaceutical salvation

from them, but it is not free. They are businesses and very big ones at

that.

The rules about sterilization on land vary place to place. Why? Is an item

less sterile in Toledo than it is in Los Angeles or Bergen or Sao o? I

doubt it. It depends on who makes the rules and how much rationality and

critical thinking goes into the rules. In the U.S. you can be sure the rules

are, in some part, driven by litigation history. Other parts of the world

are less fear driven (the fear of lawsuits that is) and have applied

standards according to what they know, not what they suspect or imagine. The

inverse is also, unfortunately, true.

My thirst for knowledge about this is unquenched and if anyone has more

pertinent resources I'd love to get them.

Best,

Steve

Stevan Pierce <ermedicsp@... <mailto:ermedicsp%40> > wrote:

,

I have been told by surgeons that in our environment (remote sites) that

the stuff is good until it has been opened or gets wet or is dusty or dirty.

If your kits are well wrapped (that is triple wrapped in plastic so they

cannot be contaminated unless opened you are good until they are opened.

Some may have arbitrary or subjective rules about the expiry of these things

but there is little objective documentation to support them that I have

found.

Cheers,

Steve

Rundle <jeremy.rundle@... <mailto:jeremy.rundle%40gmail.com> >

wrote: Hey All,

I was wondering if anyone out there can help me with the following

question...snip

Stevan Pierce, WEMT-IDP

Independent Duty Paramedic

Remote & Wilderness Service

A.C.E. Personal Trainer

Health, Safety and Fitness Support

ermedicsp@... <mailto:ermedicsp%40>

" some say a hero could save us, I'm not going to stand here and wait "

[Guest guest]

Hi

jen not offended but do wonder that the only reason you want expiration

dates on ET tubes or plasters for that matter is someone made a law saying

they need expiration dates? Must be the same guys who mandated hard hats for

high wire acts recently in the U.K......................

Show me evidence based studies and I will change my mind but until then will

contiune to view expiration dates on non medication items as silly and a

waste of money.

Cheers

Tom G

>From: <jens_worldwide@...>

>Reply-

>Remote Support Medics < >

>Subject: Re: Sterilized surgical equipment

>Date: Sat, 21 Oct 2006 17:12:11 +0100

>

>Hi Goesta,

>

>Thank you. I appreciate your comments.

>

> > I know anesthetists who would happily use a non sterile but clean ET

>tube. I

> > for one, am an Intensive Care Paramedic, who would. I also use non

>sterile

> > eating utensils.

>

>Well, now you know one who isn¹t happy with a ³clean² one. The word ³clean²

>hasn¹t much of a meaning in medicine. It gives me the shiver, and it makes

>me remembering Ignaz Semmelweiss...

>

>So why did it take so long to find one, you might ask yourself (well, I am

>facing the same question at the moment...). The entire discussion about the

>need for an ETT tube to be sterile is a very old one and has been discussed

>amongst Anesthetists for ages. I thought such discussion to be generally

>over by now (whilst accepting the fact that there will always be someone

>who

>just wants to do things his own way, and different to others), but after

>reading all the comments, I think I will bring this topic up again in some

>anesthesia meetings.

>

>However, in the end it all came down to few points which I will try to put

>down as plain & simple as I can. I¹ll spare you (and myself) time with not

>digging through statistics, research etc and as I think some simple

>arguments do the trick (well, they did it so far).

>

>1. It¹s an invasive procedure that bears a significant risk of injury,

>(even

>minor injury opens the gate for infection), and is you obligation to

>minimize all potential risks.

>2. Medical law is very clear about expiry dates (for a reason), and you¹re

>not doing your patient and yourself any good if you break it.

>3. Best practice / professionalism. Yes, we can do a lot of things, the

>human body can cope with a lot of what we are doing to it, -but- there will

>always be one who won¹t (kinda like ¹s Law). However, harming just

>one

>(infection etc), by softening your regime on patient safety - is one too

>much. In other words: ³in dubito pro aegroto². If you¹re in doubt - decide

>in favour of your patient.

>

> > I agree that we need to stick to sterilization standards when we can.

>But

> > there is no doubt that a valid point was made in the post below that

>throws

> > suspicion on the motives behind the regulations.

>

>Yep, but that¹s an entirely different discussion topic, isn¹t it? I.e.

>³should medical practitioners/lawyers question expiry dates²

>Right now I see us discussing ³should one apply what is present medical law

>and best practice²

>

> > When it comes to drug expiration, I have had personal communication from

> > manufacturers who grant extensions of the expiry dates. In fact some

>state

> > categorically that they are happy with their drug being used two years

>past

> > their announced expiry dates, as long as it is checked with them first.

>

>I think, ³as long as you check with them first² is the key sentence in what

>you¹ve written.

>

>Goesta, one significant aspect I seem to have totally missed in all

>discussions, is the fact that ³expired² is very much depending on how a

>drug

>was stored, handled etc. Talking remote places you will surely have seen

>drugs expiring even before the actual date on i.e. the ampoule? Maybe this

>was because the item was exposed to heat, significant temperature changes,

>intense sunlight, repacked, humidity etc and all those factors one needs to

>keep in mind before giving drugs, doing procedures etc ³at the end of the

>world² - often in an environment that can barely be called ³clinical². So

>if

>this is the environment you and your drugs are exposed to ­ I am sure

>you¹ll

>agree that it makes ³sense² to be ³conservative² (well, I could say

>³patient

>focused²), and working as ³safe² as possible?...

>

> > No problems with a Hippocratic Oath, however, I am wondering which one

> > though. Since you mention " The ....Oath " I figure you refer to the

>classic

> > one, and there I have a problem with Panacea.

>

>Not really. I am old, but not that old Lets use a more modern version...

>Most of who are working in the field, will have a copy of the Oxford

>Handbook of Clinical Medicine (if not ­ it¹s a good one to have), and my

>trusted version comes with a 1998 revision of ³the² oath. The one I am

>bound

>to in regards to what I am doing professionally. Hm, some relevant

>professional bodies have gone even more modern; have come up with ³codes of

>conduct², and there are some very good ones in regards to i.e. best

>practice, and patient advocacy. However, in the end it all comes down to

>³do no harm².

>

> > Cheers,

> > Gösta

>

>All the best,

>J

>

> Re: Sterilized surgical equipment

> >Date: Fri, 20 Oct 2006 06:35:32 -0700 (PDT)

> >

> >,

> >I have been told by surgeons that in our environment (remote sites) that

> >the stuff is good until it has been opened or gets wet or is dusty or

> >dirty. If your kits are well wrapped (that is triple wrapped in plastic

>so

> >they cannot be contaminated unless opened you are good until they are

> >opened. Some may have arbitrary or subjective rules about the expiry of

> >these things but there is little objective documentation to support them

> >that I have found.

> >Cheers,

> >Steve

> >

> > Rundle <jeremy.rundle@... <mailto:jeremy.rundle%40gmail.com>

><mailto:jeremy.rundle%40gmail.com> >

>wrote:

> > Hey All,

> >

> > I was wondering if anyone out there can help me with the following

> >question.

> >

> > How long can one keep pre-packed and sterilized surgical equipment

>before

> >it

> > needs to be sent back for re sterilization?

> > Thanx in advance

> > --

> > Rundle

> > Offshore Medic/ Health and Hygiene

> > P.O. Box 257

> > Gordon's Bay

> > South Africa

> > 7151

> > Cell: +27 (0) 82 656 9747

> >

> >

[Guest guest]

Right-O Jens,

After imagining I missed something I spent no small amount of time tracking down

every reference I couild find in the past 15 years that cites research into this

issue. Two areas were sought. The drug issue, and the sterility issue.

There are mountains of rules about the ICU and how we are to deal with the

seriously to severely compromised souls that inhabit the ICU, and rightly so.

This is a scenario where most immune systems are low functioning and our

patients cannot tolerate any extra load of bacteria or virus or god-forbid

fungus, that wants to dine at their expense. I don't work there now, I have, and

in such an environ I don't even like to leave the department and return without

changing shoe covers and re-scrubbing. Sterile is the absolute rule of there to

be sure. The means of sterilization is another issue and another discussion.

Out in the reachs of space where I currently dwell, the level of grime and crud

that can get into wounds is significant. I have poor tangible resources for

supporting my patients for more than two or three days, but it is expected that

I will do so in the unhappy event it is required. It is nowhere near the level

of care I want for my patients. Nonetheless, it is where I am. Do I routinely

use " expired " drugs?, no. Do I throw out drugs that are " expired " that I have

yet to receive a replacement for? Never, and it could be months before they

arrive. Do I hold on to sterile packages, bandages and such that are

uncontaminated, in unbroken wrappers but past expiry? absolutely. These are

harder to come by than the drugs and there is no evidence that supports

discarding them, none.

Rules are good because it gives those without experience a path to follow thus

conveying knowledge and enhancing their follow-on work. Rules, to be valid,

require a factual basis. Without such a base, experience causes humans to deride

or just ignore them. The rules for a land based ED, or ICU with a dependable

supply chain and money to support it, do not apply in the remote environment

except as an ideal. It does one little good to dwell on such ideals when the

harshness of survival and management demand a studious and deliberate effort to

apportion meager resources on the micro as well as the macro level. You have had

this experience it seems Jens.

This is all about patient care anyway is it not? One has to assume that those of

us who are denizens of this site have that as a primary focus or we would not

last too long at this. I know there are plenty of folks up my management line

who scrutinize every step of patient care I make. I can support the assertion I

have less room for error than an M.D. .

I search and solicit evidence based practices continuously. Evidence based

practice as a standard is, unfortunately, fairly new. Many an ego had to step

back for it to get here and generally it has happened and it is very good. It is

an unfortunate fact that with the ACLS protocols (sorry, easy target) of the

past 20 years we probably killed nore people than we saved because we did not

use an evidence based approach.

I am still looking for evidence to support the assertions about sterility

expiring in the field as well as drugs expiry. There is very little valid

research material about the sterility arguments and only slightly more about the

stability of drugs in the tropics, usually on a drug by drug basis with plenty

of caveats.

Best,

Steve

jens_worldwide@... wrote: Steve,

I appreciate your comment. I am not saying this because of the ³bit of a

storm² this topic comes with, ...I mean it.

I very much agree that this topic is i.e. economically driven, and I support

the fact that different countries, states etc have different views about it

for whatever reasons.

The only thing I¹d like to add is that one should be careful in regards to

working by some sort of ³expert info², (a bit like: ³I only trust those

statistics who I've falsified myself²...) and one needs to keep in mind that

such views might change drastically, or might even be reversed if the

³expert² suddenly has to work in your environment... Colleagues can say a

lot of things, and like always in your professional life - it is down to you

to filter out what might be contradicting your efforts in providing the best

possible care to your patients. Looking into the ³rules² that apply to you,

is usually helping a lot in this process of finding your way. If an existing

rule is broken for lets say ³a higher purpose² i.e. trying to saving a life

in a emergency situation by any means possible ­ I believe that's a

different story, and must / will be reviewed individually. This would IMHO

include the use of ³expired² equipment. As you know there are environments

that are less or more ³accepting² (as long as they understand the aim of

your actions), however can we please agree that it should not become any

sort of ³routine² getting yourself & your patient into such a situation?

That would ³calm² me down significantly...

Regards,

J

From: Stevan Pierce <ermedicsp@...>

Reply-< >

Date: Sat, 21 Oct 2006 05:47:02 -0700 (PDT)

< >

Subject: Re: Sterilized surgical equipment

Gents,

Whew a bit of a storm this.

I opened, as you can see, by stating I have this info from surgeons, not

medics; who, when I describe my operating environment, have said with no

equivocation that sterile packages are sterile until they are opened

intentionally or inadvertantly (perforation, abrasion, etc.). That IS the

point of sterilizing them is it not, no bugs to grow on them? . . .snip

The rules about sterilization on land vary place to place. Why? Is an item

less sterile in Toledo than it is in Los Angeles or Bergen or Sao o? I

doubt it. It depends on who makes the rules and how much rationality and

critical thinking goes into the rules. In the U.S. you can be sure the rules

are, in some part, driven by litigation history. Other parts of the world

are less fear driven (the fear of lawsuits that is) and have applied

standards according to what they know, not what they suspect or imagine. The

inverse is also, unfortunately, true.

Stevan Pierce <ermedicsp@... <mailto:ermedicsp%40> > wrote:

,

I have been told by surgeons that in our environment (remote sites) that

the stuff is good until it has been opened or gets wet or is dusty or dirty.

If your kits are well wrapped (that is triple wrapped in plastic so they

cannot be contaminated unless opened you are good until they are opened.

Some may have arbitrary or subjective rules about the expiry of these things

but there is little objective documentation to support them that I have

found.

Cheers,

Steve

Rundle <jeremy.rundle@... <mailto:jeremy.rundle%40gmail.com> >

wrote: Hey All,

I was wondering if anyone out there can help me with the following

question...snip

Stevan Pierce, WEMT-IDP

Independent Duty Paramedic

Remote & Wilderness Service

A.C.E. Personal Trainer

Health, Safety and Fitness Support

ermedicsp@... <mailto:ermedicsp%40>

" some say a hero could save us, I'm not going to stand here and wait "

[Guest guest]

Hi Jens,

I think there are a number of angles to this

discussion that have been covered and indeed

qualified. It would be difficult to find evidence

to support the use of instruments beyond their

expiry as with most of anything in the remote

medical field. If the instruments are sterilised

correctly, packaged correctly and stored

correctly, there is no opportunity for them to

take on any infection. Tom's view about the

colouring of the packaging and the state of repair

is very valid as these are the areas where there

is a risk of leakage.

Examples quoted from mainstream operating theatres

are not valid in the remote environment.

Availability of surgical instruments and the

volume of sterile service is not the same outside

of the theatre. Most remote clinics can function

with less than 10 named surgical instruments. Some

clinics do own their own sterilising equipment and

can maintain a few sets of instruments however,

some still need to rely on prepackaged instruments

and procedure packs. Disposable instruments are

just that and are sadly thrown away after a

procedure and not before it with procedure packs

coming a close second.

Clinically clean instruments are certainly better

than none. Recent papers in military medicine

point towards a change in resus focus to CABC

rather than ABC, the first C being control of

traumatic bleeding. In such situations does the

medic try another way round or use the out of date

artery forceps on the bleed? First do no harm or

negligence (any lawyers on the list). If the

skills and equipment are available, this will be

in the closing arguments of the plaintiffs lawyer

against the said medic.

'Primum non nocere' does not come from Hippocrates

at all, but has seemed to have crept into common

usage as quoted from there. Just a minor point,

but one to be made

Ross

Send instant messages to your online friends http://uk.messenger.

[Guest guest]

--- thomas greaber <tom5255@...> wrote:

> Hi

> jen not offended but do wonder that the only reason you want expiration

> dates on ET tubes or plasters for that matter is someone made a law saying

> they need expiration dates?

Actully

That is exactly what happened

Following a few strange infections thought to be related to insufficiently or

improperly sterilised equipment

The FDA mandated that all medical supplies had to show an expiry date

This left a lot of manufacurer scratching their heads

(remember the old notice : Sterile if package intact)

I think they turfed the determination of expiry dates to their Marketing

department

Who did a fine job of it)))))

At th AA I worked we had in house Ethylene Oxide steriliser

We would re-sterilised (sometime better repackage)each year our expired

surgical kits (All inert material)

Mind you the sterile packaging do take a beating in our environment

When doing purchasing, the type of package becomes a major issue

I will not buy paper backed packaging

I am looking for all plastic packaging

Will tolerate fibrous paper backed packages

(We repackaged and resterilised at the AA)

One of our specialised cardiac hospital started recycling angioplasty catheters

! ! ?? ... intelligently

- Sterilisation protocol

- swabing and testing cultures post sterilisation

- Follow up on Pts

- Non critical Pt use only

All the science was pointing that they were doing a good job of it

BUT

.... government stepped in and made them stop (and paid for the difference)

As for sterile tubes

The tubes picks up a lot of microbes from the ORL sphere on it's way down

And then becomes an autoroute for all that sh* & ?%$T to come down the sides of

the tube

Point is, it's the Pt's sh* & ?%$T he does need any new ones

Especially some ATB resistant strain that comes from an other Pt

(The wickedest microbes are usually found at the hospital)

Also do take note that intubated Pt are usually

Hoe should we say

Very sick Pts

i.e. Immuno suppressed

And deserve all our " sincere " efforts at sterility

As drugs are concerned

I am like any of you guys

AR about expiry dates

Setting up Excel Med Inventory sheets with 3 month, 6 month expiry alerts

And screeming(no not me!!) blood y incompetence when the supply chain can't

come up with the stuff

I am doing all this knowing full well

That months, read years of expiry does not make much diff.

And that I am not going to poison my Pt with expired meds

Might merely up the dose based on clinical response

.... par for the course

Note on the other hand that some meds lose potency prior their expiry dates

Big culprits are :

All the catecholamines, lorazepam, Succinylcholine (heat)

The Nitros (Light)

Mannitol (cold)

And Insuline and Nitro (Absorbed by IV system)

I also know that storing conditions (Soft pack, heat, cold)

Increase the risk of introducing contamination

I do not store D5W in the Ambo and date the Salines with a 2 month expiry when

under high heat conditions. Based on no science, Xcept common sense

Also because I CAN do it (cheap)

That's my attitude with expiry dates and package integrity

I will respect them

Because I CAN

.... and if I can't

The choice is not that hard, really

In a similar vein

I am religious about my spinal immobilisations

But I know it does not much a difference makes

(Most Damage is done definitely and instantly)

Rapid extrication is totaly mandated

In certain circumstances

And I am fine with all these " special " circumstances

I just thought everybody else was also ! ?

[Guest guest]

hi there jeremy hope things are well and not to cold out there. you will see

that the packs that are steriled have usaully got tape covering the opening and

has stripes on the tape. When the stripes start blending it is best to send back

for resterilisation.I spoke to toby bentley and he says that you also get an red

dot on those packs an when the dot starts fading it must also be resterilized.

Rundle <jeremy.rundle@...> wrote: Hey All,

I was wondering if anyone out there can help me with the following question.

How long can one keep pre-packed and sterilized surgical equipment before it

needs to be sent back for re sterilization?

Thanx in advance

--

Rundle

Offshore Medic/ Health and Hygiene

P.O. Box 257

Gordon's Bay

South Africa

7151

Cell: +27 (0) 82 656 9747