Metal in medical tools

Submit your comments by August 18, On May 20, , the FDA published a discussion paper, Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework, intended to stimulate discussion and to solicit feedback from a variety of stakeholders on how materials information could be communicated. The discussion paper highlights considerations for labeling of medical devices as it relates to material composition of the device. The last day to submit comments to the docket is August 18, Numerous types of materials, including metals, polymers and ceramics, are commonly used in medical devices, and these materials can be in contact with parts of the body for extended periods of time.

Part of the FDA's evaluation to determine whether a medical device is safe and effective involves reviewing information about the materials used in the device. Part of the FDA's evaluation of the safety and effectiveness of a device involves the premarket review of information about the materials used in the device. The FDA considers the specific properties of the material, the intended use of the device, and the function of the device when evaluating the safety of the device materials.

As part of premarket submissions , medical device manufacturers submit information such as an evaluation of biocompatibility, to the FDA to demonstrate that the materials they plan to use in their device can be safely used in or on the human body.

The FDA has published guidance , which describes how a risk-based approach is utilized to determine what types of biocompatibility information are typically needed to support device material safety.

Medical device manufacturers typically assess the biocompatibility of a material by determining how the human body may respond to the material they plan to use in their device. You can now place the pouches in the autoclave. Method 3. Choose a cycle on the autoclave machine. Autoclaves use high temperature steam emitted at a high pressure over a certain period of time to sterilize medical objects. This works by killing the microorganisms through time, heat, steam, and pressure.

There are different settings on an autoclave machine that work for different things. Since you have bags of instruments, you should use the fast exhaust and dry cycle. This works best for wrapped items like instruments. Autoclaving fast exhaust will also sterilize glassware. Stack the trays. You need to place your instrument bags onto the trays that go into the autoclave machine.

You should stack them in a single row. They should not be on top of one another. The steam needs to get to each instrument in each bag. You need to make sure that all instruments remain apart during the sterilization cycle.

Leave space between them to allow steam to circulate. Load the autoclave. Set the trays about 1-inch apart in the machine to permit steam circulation. Don't overload the sterilizer trays. Overloading will cause inadequate sterilization and drying. You should also make sure the instruments don't shift and overlap when you set them inside the machine. Place any empty canisters upside-down to prevent accumulation of water. Run the autoclave.

The autoclave machine should run for a certain period of time at a specific temperature and pressure. Wrapped instruments should be in the autoclave at degrees for 30 minutes at 15 PSI or degrees for 15 minutes at 30 PSI. Once the machines has run, you need to open the door a small bit to let the steam out. Then, run the drying cycle on the autoclave until the instruments are dry.

Drying should take about 30 additional minutes. Check the tape. After they are finished drying, take the trays of pouches out of the autoclave with sterile tongs.

You now need to check the indicator tape on the pouches. If the tape turned the color according to the manufacturer's instructions, it's been exposed to degree or higher heat and considered decontaminated. If the tape does not turn a different color or you see wet spots inside the pouch, then the process of autoclaving needs to be redone. Once they are cooled, store them in the pouches in a warm, dry closed cabinet until they are needed.

They will remain sterile as long as the pouches are dry and closed. Keep a log. Keep a record in a log sheet, using information such as the initials of operator, date the instruments were sterilized, the length of the cycle, the max temperature of the autoclave, and the results. For example, note if the indicator strip turned color or if you ran a biological control.

Make sure you follow your company's protocol and keep records for as long as you are required. Run a biological control test in the autoclave every quarter. A biologic control run is essential to determine if the sterility process is adequate. Place a test vial of the bacteria Bacillus stearothermophilus in the center of a pouch or on a tray in the autoclave.

Next, perform a normal operation. This will test to see if the machine can get rid of the Bacillus stearothermophilus in the autoclave. Check the results of the control test. Keep the vial at degrees for hours, depending on manufacturer protocols. Compare this vial to another control vial at room temperature that was not autoclaved.

The product inside the non-autoclaved vial should turn yellow to show growth. If not, there may be a problem with the sample vials. If that is the case, repeat the testing. If it still doesn't change color, it may be a bad batch of vials and you may need a whole new set. If there is no growth on the autoclaved vial after 72 hours, then sterilization is complete.

If you see yellow on the test vial, sterilization has failed. Contact the manufacturer if failure happens and do not continue to use the autoclave. This test should be run every 40 hours of use or once a month, which ever one is sooner. The spore test should be placed in an area that is the most difficult for the steam to reach.

Be aware testing standards may vary. Method 4. Understand the method. Ethylene Oxide EtO is used for items that are moisture and heat sensitive, such as devices with plastic or electrical components that cannot withstand high temperatures.

EtO helps perform antimicrobial sterilization to protect the instruments from making people sick. Studies prove that EtO is a critical sterilization technology for medical and health care purposes. It is a unique and irreplaceable sterilization method. Start the process. When using ethylene oxide as a cleaning option, the process has three stages, which are the preconditioning stage, sterilizer stage, and degasser stage.

In the preconditioning stage, the technician needs to get organisms to grow on the equipment so they can be killed and the tools can be sterilized. This is done by sending the medical equipment through a controlled temperature and humidity environment. Perform the sterilizer stage. After the preconditioning stage, the long and complicated sterilization process starts.

The whole process takes about 60 hours. The temperature control is the most important. If the temperature falls below sterilization level, the process has to start over. The vacuum and pressure of the machine is also important. The machine will not start without the perfect conditions.

Towards the end of this phase, the batch report is produced, which tells the operator if there are any issues with the process. If the machine was set on the auto mode, the machine will move on to the degasser stage if the report shows no errors. If there were errors, the machine will automatically stop the process and let the operator fix it before any further sterilization is done.

Carry out the degasser stage. The final phase is the degasser stage. During this stage, any leftover particles of the EtO are removed from the tools. This is important because EtO gas is extremely flammable and harmful to humans. You must make sure this happens completely so you and any other lab workers are not harmed. This is also completed under temperature control. Be warned that it is a very dangerous substance. Any operator, personnel, and patients that might come into contact with the gas must have training about the hazards.

It also takes longer than an autoclave. Method 5. Learn the process. Dry heat is a process used on oils, petroleum, and powders. For more than 50 years, we have manufactured custom medical electronic equipment and devices for our customers across the world. We adhere to the strictest industry standards and specifications in order to provide the medical equipment industry the most effective and reliable equipment on the market.

Sheet metal is the best long-term material for medical parts and metal enclosures. At Midwest Metal Products, we can customize and manufacture any piece of equipment you need.