SPD, manufacturers should partner on medical device design and cleaning

Inadequate cleaning of medical devices causes patient safety problems: Healthcare-associated infection (HAI), foreign body reactions and patient death. HAIs are a major problem throughout the world. They are the most frequent adverse event that occurs in healthcare delivery worldwide. Several factors influence if a medical device associated HAI will occur. These include: Improper cleaning, disinfection and/or sterilization of medical devices; improper use of devices; and lack of aseptic practice when using or inserting devices.

Device-related HAI risk factors

Any device that compromises the integrity of the skin or mucous membrane increases the potential for an HAI to occur, e.g., urinary catheter, intravenous catheter or surgical instrument. Reusable medical devices can cause HAI problems because of inadequate cleaning, disinfection or sterilization of the device.

Invasive devices that remain in place provide the highest risk. Devices that contact sterile body cavities and the blood stream have the next highest risk of infection. The lowest infection risk includes devices that contact intact mucous membranes and intact skin. Implants cause some of the most virulent and difficult to treat infections. The biggest issue with device-related infections involves improper cleaning of the devices. Devices that have been implicated in HAIs due to inadequate cleaning include:

• Duodenoscopces
• Bronchoscopes
• Arthroscopic shavers
• Flexible ureteroscopes
• Complex surgical instruments

The stakeholders

There are many stakeholders involved in developing and following reprocessing instructions for reusable devices, including the medical device manufacturer and the healthcare facility where the device will be reprocessed.

Development of reprocessing procedures starts with the medical device manufacturer. The device manufacturer designs the device and ensures that it is possible to effectively clean, disinfect and, if needed, sterilize the device using processes that are readily available to the healthcare facility. This involves validating the cleaning, disinfection and sterilization processes and then using the validated procedures to create the device instructions for use (IFU).

Resources needed for device reprocessing depend on many factors. The number of procedures expected to be performed will impact the number of devices that will be needed or if the device will need to be reprocessed quickly between uses. The SPD is responsible for reprocessing reusable medical devices. They need to follow the manufacturer’s IFU and they must verify that the manufacturer’s IFU works at their facility.

Causes for reusable device reprocessing problems

There are many reasons why problems exist with reprocessing reusable medical devices. Devices can be complex or poorly designed. It can be difficult to get cleaning cloths and brushes to the surfaces that need to be cleaned. The IFU can be difficult to understand, incomplete, or difficult to follow. IFUs might not consider human factors, e.g., it might be difficult to follow a procedure while wearing personal protective equipment (PPE). Sometimes there is poor understanding of sterilization science and the importance of cleaning. Unfortunately, many people think that sterilization will take care of inadequate device cleaning. It does not!

Training and education of reprocessing technicians is an ongoing problem. Only a few states require these technicians to be certified. Some healthcare facilities require certification; however, many do not. Reprocessing technicians must have in-depth training on how to perform complex procedures. Ideally this training occurs before a person begins working as a reprocessing technician.

Another cause of device cleaning problems involves the lack of verification of the procedures performed. At minimum, the healthcare facility must perform cleaning verification similar to what is done with sterilization processes. Monitoring of cleaning processes and cleaning verification tests need to be performed to ensure that the cleaning processes are effective.

Manufacturer IFUs are provided so that the reprocessor knows how to reprocess the medical device. Some people think it is only necessary for the reprocessor to follow the IFU and the result will be a clean and, if applicable, sterile device. However, the IFU is at best a guideline.

The manufacturer does not control many factors that are needed for the cleaning, disinfection and sterilization processes to be effective, e.g., water quality. This means that the facility that reprocesses a reusable medical device must verify that the IFU is effective when performed at their facility. Verification involves performing PQA testing of all reprocessing activities, including cleaning, disinfection and sterilization. According to ANSI/AAMI ST79 10.9 Quality assurance testing of routinely processed items representing a product family should be performed on an ongoing basis. A program should be established to periodically test routinely sterilized products. Effective cleaning is required for the sterilization process to work and achieve the desired sterility assurance level (SAL).

Solutions to reprocessing reusable devices

Reprocessing of medical devices starts with the medical device manufacturer during the design process. Devices should be designed that can be easily and effectively cleaned and sterilized.

Healthcare facilities need adequate and appropriate equipment to perform all reprocessing activities. Some devices require the use of mechanical means to reprocess the device. An adequate number of instrument sets and devices (including loaner sets) are needed to meet the needs of the healthcare facility. Ideally, there should be enough sets and devices available so that it is not necessary to quickly turn over these items for use later the same day.

Management software is needed so the SPD can monitor work load and react appropriately to changing needs. Workflow needs to be streamlined to minimize time needed and to ensure processes can be followed. Departments that use the medical devices need to be held accountable for following the IFU point-of-use processes. Training is needed to ensure that all involved parties understand what is required to reprocess a medical device.

Reprocessing technicians must be paid salaries that are commensurate with the skills and knowledge that are needed to effectively reprocess medical devices. At the same time, these technicians must be held to high standards of competency. Technicians need increased scientific knowledge to understand how to monitor and verify all reprocessing activities.

Baseline is the bottom line

Medical device manufacturers need to work with healthcare facilities to ensure that the validated reprocessing procedures and instructions are possible to perform, are effective and work at the healthcare facility. The employees of the healthcare facility need to learn how to perform complex procedures and testing to ensure that medical devices are acceptable for use on the next patient