Understanding the Process
●IFUs – Similar to medical devices used in the OR , all dental instrumentation is delivered from the manufacturer with an IFU . Reviewing every step listed and securing all components required to complete the cleaning and sterilization process is critical to rendering a device that is clean and safe to use .
●Cleaning – To ensure handpieces are cleaned , there are several steps that must be followed . Each handpiece brand has different cleaning procedures . Some require the tip to be rinsed under running water , scrub , and rinse without submerging the handpiece and finally running the device in the maintenance system to complete the internal cleaning , lubrications , and drying . Other instruments must also be handwashed to remove cement residue that sometimes remains on the instruments from the procedure . Do not put handpieces in the ultrasonic cleaner unless the IFU of the device requires it . Keep instrument sets together to expedite the assembly process . Remember that all new burrs need to be cleaned before they are sterilized . Disinfect bins and transport boxes before they are transferred to the preparation area . If required , perform the validation process for the handpiece maintenance system at the intervals recommended by the manufacturer .
●Packaging – Ensure that sterilization packaging is adequate for the size and weight of the device being sterilized . The sterilization pouch must be large enough to allow for the steam sterilization vacuum . Frequently , handpieces and contra angles are packaged in peel pouches . If using self-seal pouches , apply pressure over the fold to ensure an even seal . Review the peel pouch IFU for shelf-life guidelines . Most cassettes are small and light in weight , thus allowing for both peel pouch or wrap packaging . Ensure to review AAMI ST 79 guidelines and the wrap manufacturer ’ s IFU for weight limits on the packaging material .
●Sterilization – Handpiece sterilization recommendations vary according to different manufacturers . It is recommended to review the handpiece sterilization guidelines before purchasing as some require a 10-minute sterilization cycle , which extends the reprocessing time . Use peel pouch racks to ensure there is adequate space between peel pouches . This allows steam to penetrate each package and prevents wet packs due to overloads . Do not stack peel pouches of handpieces or cassettes during the sterilization process . If the load is wet , the load must be reprocessed and all devices repackaged .
●Traceability of Instruments – All sterilized medical devices must be documented and a load control label must be adhered to the package . The load document must contain the name of the device , its delivery location and / or owner name , and sterilizer cycle information . At the end of the cycle , the sterilizer strip should be attached to the document . All items must have a traceable indicator or control label to facilitate the recall process in the event of sterilization process failure .
●Delivery of Goods – Handle sterilized medical devices immediately after they are cooled . Laser thermometers are one of the new tools used in SPDs to ensure the load has achieved room temperature and is ready for handling . Wash your hands prior to handling sterile instruments . Inspect packages to ensure the package was not damaged during the sterilization process . Place handpieces in a clean bin with a lid or in a transport cart . Document the number of items and location before delivery .
●Storage – Whether the dental instruments are stored in the SPD or at the clinic , storage locations must comply with AAMI St 79 : 11.1.1 Storage Facilities guidelines . Items should be stored in a location with adequate air circulation , at least 8-10 ” above the floor , 18 ” from the ceiling , and 2 ” from the wall . Heavy containers should not be on top of small items to avoid package damage , compression , or puncture . Always follow the packaging material manufacturer recommendations for storage .
●Customer Service Satisfaction – In spite of challenges , gaining new customers gives us the opportunity to be innovative when it comes to finding solutions to meet their needs . We can empower teams to understand the workflow better by having them spend time at the clinic to observe which devices are used for different procedures . Observing a dental procedure will equip them with knowledge , understanding , and consideration for the rapid turnover of these devices .
Dental surgical instruments have many similarities to surgical instrumentation used in other parts of the human physiology . Reprocessing these devices , whether in SPD or at the point of use in the clinic , must follow the same standards established by regulatory bodies and infection control to prevent cross-contamination and bioburden from reaching patients . Following these standard processes can eliminate errors , prevent infections , and protect patients from injury .
Mary Olivera , MHA , CRCST , CHL , FCS , has actively participated in the monitoring , surveying and training interdepartmental staff in the proper cleaning , decontamination and sterilization practices and has been highly committed to the standardization of interdepartmental processes . Currently , she is the president and CEO for OSPECS Consulting , LLC . a company dedicated to facilitating process re-engineering in healthcare organizations .