Manufacturers instructions for use
During reprocessing, critical decision making is a skill that has to be accompanied by strict adherence to instructions from the manufacturer for products and procedures to achieve cleanliness, functionality, and sterility. Let’s examine some of these hallmark concepts surrounding manufacturers’ instructions for use. Please note that these concepts are not in any particular order and they are all important! All of our activities are driven by the need for patient safety.
- ‘Do no harm’ is the overlying umbrella for patient care.
- Only devices, (in these articles, both instruments and devices are together simply referred to as ‘devices’), manufactured with the intent of use and licensed for use in healthcare should be used in healthcare as these have had to be demonstrated to be safe for use during patient care.
- Devices developed for use in healthcare are ‘labelled’, meaning that the manufacturer has to provide instructions for their reprocessing.
- Obtain and follow manufacturers’ instructions for use, known as MIFIs in Canada and IFUs in the United States. Assumptions about how to reprocess or assumptions that all devices can be sterilized using the same parameters for time, temperature, and pressure can result in devices that are not sterile and therefore, are not safe for patient care. Only the manufacturer knows the composition of the device and how it should optimally be reprocessed to prevent premature degradation of the device while providing instructions to achieve sterility. Manufacturers are required to provide instructions for reprocessing for all classes of instruments and the type of information provided should conform to an International Standards Organization (ISO) directive which has been adopted by the FDA (Unites States) and Health Canada (Canada)1 from preparation at point of care to storage. In the excitement of purchasing new devices, it is easy to forget that the first question to ask is ‘how will this be reprocessed?’ and it will take a team effort to remind each other to develop this change in purchasing practices. Requesting manufacturers’ instructions for use prior to purchasing any devices is done to ensure that:
- The written reprocessing instructions provided by the manufacturer adhere to ISO directives. Preferably these instructions are ‘validated’. Validated instructions are instructions that have been shown by an independent testing company to verify that when the reprocessing instructions provided by the manufacturer are followed, this will result in a sterile device.
- Equipment required for reprocessing is available in your office. For example, your hygienists recommend purchasing a new type of highspeed suctioning device that would be more effective during ultrasonic scaling. Upon checking the instructions for reprocessing, it was found that the manufacturer had only provided instructions for use of a gravity sterilizer. Even after contacting the company, no instructions were provided for use with a dynamic sterilizer. Since your office uses a steam flush pressure pulse (SFPP) sterilizer (dynamic sterilization), your office would not be able to sterilize the device because the device has only been tested (validated) for gravity, not for use in a dynamic sterilizer.