Thomas Marmor A lot of questions.
Medical Device Manufacturer are required during developing of medical devices wether the device can be re-used or not. According to this decission the medical device Needs to be labeled (single use, do not sterilize,...(see also ISO 15223-1)).
In case a Medical Device Manufacturer defined the device for only single use it is in the responsibility of the user to refurbish it (cleaning, packaging, steilization,...). In this case the organization that will do the refurbishment is also responsible to validate the process. In Europe they are also in responisble for an assessment to declare the conformity according to the legal requirements (CE).
In case that a medical device is expired you should reject it. Otherwise you have to bring the evidence that after re-packaging and sterilazation the device will be according to legal requirements. Also you have to bring the evidence that neither the functional safety nor the Patient safety is affected.

Thank you very much for your quick answer.

Clarisa Tate That question worries me. I've been part of teams bringing products from concept to commercial and this question has always been foremost in my mind throughout that process: would I feel comfortable using this expired, re-sterilized device on my children, spouse, or beloved family member? That's a lot of testing and proof you're going to have to give me for me to feel comfortable consenting the use of that device on my family.

Stephane Morvan Clarisa, the expiry date on a sterile implants indicates that the packaging holding the implant holds until a given date and does protect against contaminations from foreign (aka non-sterile) environments. In fact, the expiry date characterises the packaging.

Under normal storage conditions, and with proper packaging, many implant do not degrade. When the expiry date is reached, the implant are returned to the manufacturer.

Before reprocessing (which not only includes resterilization, but also repackaging, decontamination etc...), the manufacturer is responsible for asserting that reprocessed implants still meet original specifications. There are strict tests which must be carried out.

hello,
In some cases packaging could be reuse, if it is possible to reach two sterilization process. Only manufacturer can approve or do this, to take this decision the knowledge of all parts and sterilization process is needed. Reprocessing need to be validated.

It is a dilemma, one with varying degree of conformity dependent on practice area. I think Clarisa summed it up perfectly...Ask yourself those questions and ensure required standards are not compromised at any stage.

Jack Gleason Reprocessing happens every day. How many times have retractors, scissors & other instruments been reprocessed? "SingleUse Only" is determined by the mfgr company; they'd rather sell a new device.
If it's expired, that means the package has expired & needs to be redone. In most cases the expired device can be repackaged in sterile tyvek wrap.
Tissue devices like heart valves, etc are a different ballgame so be sure to do your homework. You've got to get this right.

Todd Abraham For a device to be appropriate for re-sterilization, that re-sterilization must be established during the product development process and included in the process/design validations. Product validations determine the "shelf life" for a device factoring all the variables involved (materials, bonds, storage conditions, sterility, packaging, etc.), as such expiration dates must be respected. If indicated as acceptable the manufacturer is required to clearly indicate in their labeling / IFU the approved re-sterilization process (source, parameters, etc.) and the number of times it can be done. Typically implantable devices and the delivery systems associated with them are not designed for this purpose. Surgical instruments on the other hand are typically designed for multiple resterilizations. All this said, there are resterilization companies and hospitals (particularly in developing regions) that re-sterilize devices that are absolutely not intended for re-use..... very bad practice!

Michael Marburger Of course you can re-process medical devices. There is a great company called Sterile Med out of Minnesota. Not everything, but 80 percent can be reprocessed. Lumens can be tricky, but they have a process for that type of product. I manufacture and can tell you that they are awesome.

As a rule, it should be disposed. Or someone must do a guarantee for it's sterilization, disinfection, packaging with validation. If you want to use only for yourself, you may use it with your guarantee but it can not be sold to others.

this is what I know If a medical device expires it needs to go back to the manufacturer for reprocessing or it can go to a certified third party to be reprocessed. if you or any other organization resterilizes it you become the manufacturer of the item

Your question sounds like you are looking to satisfy a DME requirement? If yes then depends on the class of the device you are designing/manufacturing. Let me know if you need more help I think you are talking about replacing certain components and repackaging.

Ethics aside, I would want to (1) ensure the device's structural integrity is not compromised by resterilization, and (2) make sure your new sterilization process is verified. Multiple sterilization processes may damage materials in ways we aren't aware of until testing is performed. By adding a 2nd process it makes any previous V&V testing (performed by the manufacturer to gain regulatory approval) invalid. Thus the device could be prone to failure which jeopardizes patient safety. Tread carefully!

Also, you need to take in consideration legal statement , which is another aspect besides technical or moral one .

It depends upon what you are looking to reprocess. A blade from stryker, brassler, or microaire is going to be one solid piece of steel. So those, you can. A lot of medical products like sutures, conmed burrs, trocars say on the package "Do not re-sterilize." Anything which is plastic like those trocars would melt in a steris machine because steris machines can go up to 4 - 500 degrees.

May I jump in here with a semi- related question? Has any work been done related to the baskets used to hold devices during sterilization? By that I mean are there any chemical incompatibilities between certain basket and the devices, and also has any work been done to minimize the small cavities within the weave of a wire mesh basket to eliminate the potential for particle residue or bacteria accumulation?

I think there's confusion between sterility and shelf life in the question. Typically, the expiry date represents the maximum period of time within which a device is safe and effective; that's also referred to as shelf life. Manufacturers may validate a process that allows it to resterilize a device within this period of time X number of times. To do so, the manufacturer would have to prove that resterilization does not negatively impact the safety and effectiveness of the device. Most manufacturers use this method successfully.

Michael Marburger Of course you can re-process medical devices. There is a great company called Sterile Med out of Minnesota. Not everything, but 80 percent can be reprocessed. Lumens can be tricky, but they have a process for that type of product. I manufacture and can tell you that they are awesome.

I read most of the answers. I do believe that the heart of the matter has been missed. When reprocessing ANY item you must have the manufacturer's IFU. If they say it cannot be reprocessed safely then that is the law. The FDA requires all manufacturers to provide IFU's which would include any applicable reprocessing parameters. It is quite possible it can be reprocessed but sterilization is far from one size fits all. If in any doubt check the IFU first.

Functionality. The item might not be designed to be exposed to the dynamic process, hence risk to patient injury. You can only reprocess medical devices designed or manufactured to withstand the rigours of chemical and physical exposures. I do agree however if we could avail of a written instruction from manufacturers that it won't compromise the same functionality as it was designed to perform/deliver and will work as effective as its original un reprocessed condition. Patient safety on functionality of device rather than sterility of item. If manufacturers can provide the written instruction or IFU , will give the burden of liability to the manufacturer when adverse events results.

Brian Matthews Your question appears to relate to an unused device that has passed its expiry date.

The expiry date was presumably set based on studies conducted by the original manufacturer, and there may be stability or suitability for use issued that were taken into account in setting the expiry date. If you are not the original manufacturer, will you have sufficient information to extend the expiry date?

The second issue in your question appears to be can you reprocess the product (that has not been used) - specifically to resterilise it. Has the packaging been compromised? Will the product withstand a second sterilisation process? If you are not the original manufacturer will you have sufficient information to ensure that the product is suitable for use or to set a new expiry date?

I agree that you need to have the instructions for use from the original manufacturer available before you even contemplate reprocessing a device. If no advice, then it cannot be reprocessed.

Bill Watson There's no regulatory requirement that forbids this, but you'll have some hurdles to clear. If dollar values are high for scrapping material, and you know that the product probably would be just fine undergoing another sterilization run, then it's probably worth the time and effort to proactively document and approval re-sterilization as part of your business process.

Ruth Grant i am very experienced in this field after training with the TGA and Medsafe- Please let me know if you require further assistance

Raja Ram Gurung

Packaging material of all medical devices are written with "Do Not Re-sterilized" because we can not asses the effect on properties of medical device, patient safety and suitability for use.