Re-sterilizing Off-pump CABG supplies

OnCall4Life · Aug 7, 2005

Hi we also had talked about doing that because the retractors are so expensive and there were some back-order issues. While the company that resterilizes it will guarantee its sterility we didn't feel it was worth the risk. We have a policy in place that states that one-time use items cannot be resterilized or reused. And I believe that the original guarantee of performance from the manufacturer becomes null if you send it to be resterilized. So if it breaks or causes pt harm you are on your own. Maybe you need to remind the powers that be about libility???

drmrnfla · Aug 9, 2005

Our facility performs roughly 75% of our CABG cases as off-pump (800/year) and we do not re-sterilize our Octopus retractors. We seldom use the Starfish and do not re-sterilize that either. We, the nursing staff strongly agree that every patient should be treated the same when it comes to disposable products, thus if patient A gets a brand new Octopus for his/her case then patient B should get the same!! I do agree that the company could reduce the cost by developing a Starfish/Octopus that only have the retractor part as disposable, but that will never happen !!! Just my thoughts ........... David RN CNOR RNFA

OnCall4Life · Aug 10, 2005

I agree!!! I don't think that it is fair to use "used" items on patients. While I understand that some facilities are facing a financial crunch I think we need to keep reminding them that patient safety comes first! And a lawsuit would wipe out all of the savings that they think they have gained. Plus I would not want it used on me or my family. I think that facilities that use resterilized items need to do more research before they put into practice something that might be detrimental to their patients. Am I wishing in one hand....????

MissJoRN, RN · Aug 10, 2005

I can't speak for cardiac cases, we don't do them, but our OR only uses reprocessed items that didn't make it to the table- items dropped or contaminated while opening or cases opened then cancelled. As for truly used stuff...blech. Our processing company has warrenties and insurance that picks up where the manufactures leaves off so we aren't "on our own" but that policy might be null if the item was actually used- I don't know?

huckfinn · Aug 18, 2005

The FDA certifies companies to provide reprocessed "single use" supplies. The certification requires validations that the item meet or exceed the original equipment manufacturer (OEM) specifications for that product as indicated in the original FDA approval to the OEM. Also required is that the item is proven to be sterile. Also that the reprocessor carry Liability Insurance to cover any adverse situations related to the use of the product. In effect the reprocessor becomes the OEM for that product and assumes all liability for it. In some instances I think the reprocessed item is better than a new one.

OEM usually only tests a certain quantity in a product batch and then claim the batch to be acceptable. Have you ever had a brand new product fail right out of the package and wonder WHY? Ever heard of product recalls?The reprocessor must test each product and certify it as meeting the OEM specs for form and function. With that being understood and done under the strict supervision of the FDA, reprosessing makes sense.

The previous arguments for not using reprocessed products lead me to ask the questions......Why are we using surgical instruments over and over and not asking the same questions regarding their cleanliness, expert tested quality certified and sterility? Are your processing techs factory trained quality control experts? Isn't the lumen of a mini ureteroscope only 1mm or less and 40cm long? There aren't brushes to fit down those things. Do your instuments ever come out of a "sterile" package from processing with valves closed, clamps locked and scissors closed? Do you refuse the entire set or just the ones that don't "seem" OK because you don't want to tell the doctor that the entire set will need to spend 2 hours in processing to meet your standard of care issues while you wait with the patient asleep on the table? Consider just flashing it you say?????...You didn't flash for every other case that day or even every other item used for that case! OK! My sleep deprived rant is finished. I am not invested in nor do I work for a reprossing company. I am a 20 year OR Nurse veteran. I am proud to say I am now a Healthcare Value Analysis Professional! My goal is to make healthcare affordable. Isn't it a shame that caregivers can't afford to buy their own product because of BIG MEDICAL SUPPLY MANUFACTURER. MEDICAL INSURER AND PROFESSIONAL LITIGATOR GREED? Give me a properly reprocessed item any time. At least I know it has been tested once and worked correctly!

HUCKwww.ahvap.org

OnCall4Life · Aug 23, 2005

Hi Huck, While I understand where you are coming from aren't we really talking about apples and oranges here? Metal instruments can be taken apart and manually cleaned and processed. These items that are being sent for reprocessing have plastic and rubber parts that cannot be taken apart and manually cleaned. Our facility is very strict about how instruments are processed and sterilized too. We do reject instruments and instrument sets that are not up to our standards (closed clamps, etc). We don't mind telling the surgeon that something had to be sent back because it wasn't processed correctly. We have to inspect all instruments before they can be placed within our sterile field. We have pretty much solved that problem by placing our instruments on stringers that prevent clamps from closing. And by placing them in containers that prevent them from becoming damaged. I think in the long run the surgeons appreciate our adherence to high quality standards. But you have to agree the likelyhood of equipment failure goes higher each and every time it is reprocessed and reused. That goes without saying. But we can with an almost certainty say that a metal non-disposable instrument is more cost effective in the long run because 1) It can be kept and maintained for a longer period of time than a one-time reprocessed item. 2) The cost to process it at our facility using steam or Sterrad is cheaper. (we actually did research this) 3) We manually inspect these items before and after they are processed and can cull them before they are exposed to the patient. 4) We can decide if that re-processed item is up to our standards and not just take it for granted that whoever inspected it knew what they were doing. As we see the item in action we know what it can and cannot do. But the company that re-processes the item does not. Like you stated earlier even brand new products right out of the package can fail. That makes the liability fall on that company, not us. But if we use a re-processed item (with plastic or rubber parts) knowing that it's failure rate has increased then that makes us liable as well. I guess it is up to each facility to weigh the negatives and advantages of re-processed items and make their own decisions. This was just ours.

huckfinn · Aug 23, 2005

Oncall,

On the reprocessing of items-It is up to the clinical site as to use or not to use. The fact that the FDA certifying the individual items for the number of times it can be used, is a scientifically investigated process. Not just some guy saying I can resterilize this stuff and doing it. Some hospitals actually reprocess for themselves in accordance with the FDA guidlines. Who ever does this becomes the liable party. I hope you don't think the OEM is going to step up and say: "It is our fault." when a patient got injured while using their product. If there is a law suit everybody will be named and the oem will not send a lawyer to accept the blame or represent you.

I also agree with you that a metal instrument is the best option economically. However, we use lots of disposable stuff where a reusable instrument is the better option financially. Are all of your docs using steel trocars? In my perfect world they do. Reality says they don't and won't.

The reprocessors do know how the things are supposed to work and must assure that every piece works as specified. They have physicians and nurses on their staffs for consultation. Reprocessors are required to have all of the technical data and design information that the OEM used to make it and the item must leave the reprocessor meeting the exact OEM spec. Do you think the Malasian, Mexican, Brazilian or other third world native that works in the manufacturing facility knows how to use the thing they make and can assure that every one of the thousands they made that day work exactly as specified? No! The OEM is only required to select a sample from that batch and test those. They then either accept or reject the others in the batch base on the few tested. Again....reprocessors must check each and every item and accept or reject each one.

Emotion of some of the parties posting here must be removed. Poopsiebear thinks reusing things is disgusting. Don't we reuse things every day? As far as liability goes-Thinking you are not liable for using a hopital processed re-usable instrument and you will be liable for using a reprocessed item is silly. Yes, a reusable device is the best option but not always possible. Sometime a disposable is required to be used. If it can be reused shouldn't it? It may be more economical to throw things away but due diligence is required before making those decisions, not just paranoia over liability issues and thinking reprocessing is disgusting.