Validation of instrument reprocessing methods for the Ipas manual vacuum aspiration devices

To validate recommended reprocessing methods for Ipas manual vacuum aspiration (MVA) devices.

Manufacturers of reusable medical devices are responsible for providing labeling that includes instructions for reprocessing devices and accessories safely and preparing them for reuse, 3 while following clinical practice guidelines and recommendations for infection control. 4,5 Additionally, the Food and Drug Administration (FDA) requires manufacturers to validate how a device should be cleaned and disinfected or sterilized adequately for safe reuse over its intended period of use.
Reflecting scientific advances in the complexity of reusable medical devices and reprocessing technology, recent regulatory changes by the FDA strengthened validation requirements, requiring new studies to update product documentation and recommendations for all reusable medical devices. 3 In response, Ipas and WomanCare Global, a non-profit organization that manufactured and distributed Ipas MVA devices globally, commissioned studies in 2014 to update the validation of effectiveness of the recommended reprocessing methods to achieve highlevel disinfection (HLD) and/or sterilization and to test their physical effect on the MVA instruments. This paper describes the validation processes, results, and the ensuing evidence-based recommendations for reprocessing the Ipas MVA devices, thus addressing questions regularly received from field staff, distributers, trainers, and users of the Ipas MVA devices.

| Why reprocessing is important
Microorganisms such as hepatitis B and C and HIV can contaminate instruments used during abortion procedures. If reusable instruments are not adequately cleaned and either high-level disinfected or sterilized, healthcare-associated infections can result. 4,5 Healthcare workers must use appropriate methods of reprocessing and carefully follow all instrument reprocessing steps to remove microorganisms from contaminated instruments to prevent them from infecting other women during subsequent procedures.
Ipas MVA instruments have been designed for reuse wherever regulations permit. Although cannulae are labeled for single use in the United States and other high-resource countries, when properly reprocessed, cannulae are permitted for multiple use in many settings globally. The re-design of the Ipas MVA Plus Aspirator (Fig. 1) and Ipas EasyGrip Cannulae (Fig. 2) (Ipas) are single-use devices everywhere and must be disposed of after use (Fig. 4).
For decades, the MVA aspirators were considered "non-critical" devices per the Spaulding classification (Box 1) because they generally did not touch the patient during use, or if they did, it was only against intact skin. During that era, the MVA was commonly reused after soaking and cleaning but did not require either HLD or sterilization.
In 2006, the MVA was reclassified as a "semi-critical" device per the Spaulding classification for the following reason: when it is used, the cylinder fills with blood, creating the potential risk that some contaminants from a previous patient could be introduced to another woman if the MVA aspirator is not fully reprocessed (cleaned and HLD or sterilized) between each use and the contents of the aspirator F I G U R E 1 Ipas manual vacuum aspiration plus aspirator.
F I G U R E 2 Ipas EasyGrip cannulae.
are discharged into the uterus due to user error. While not known to have ever occurred, it is a theoretical risk. With this change, the guidance for reuse of the MVA aspirator additionally required either HLD or sterilization after soaking and cleaning to meet the instrument reprocessing requirements of semi-critical devices. 6 The EasyGrip cannulae are reusable after reprocessing where regulations allow. These cannulae, classified as semi-critical devices, require full reprocessing between patients, including cleaning and HLD or sterilization, and must be high-level disinfected or sterile before intrauterine use.

| MATERIALS AND METHODS
Validation studies to assess the methods of reprocessing listed in Table 1  All studies were performed using worst-case scenario testing.
For the Ipas EasyGrip cannula, the 4-and 12-mm sizes represented the cannula product family since they covered all applicable steps for reprocessing, materials/components, and intended uses for the product. The 4-and 12-mm cannulae are the smallest and the largest, respectively, of the cannula family and represent the extremes of sizes and difficulty cleaning. The 4-mm cannula has the smallest orifice, making the cleaning brush more difficult to use. The 12-mm cannula has the largest surface area and two apertures at the tip.
Both the MVA Plus and the SV aspirators were tested since they covered all applicable steps for reprocessing, materials/components, and intended uses for the product. These aspirators were selected for their multiple pieces, sizes, and complexity of cleaning.
The SV is the smallest and simplest aspirator and the MVA Plus is the largest and has more pieces from which organic and inorganic material must be removed.
Guidelines recommend that simulated-use testing includes a representative inorganic and organic challenge that mimics actual in-use conditions. 3 The study protocols replicated standard steps for reprocessing: a decontamination soak; cleaning; HLD or sterilization; and then use or storage. 2 A 0.5% chlorine solution was used for the initial soak before cleaning for simulated-use testing due to potential damage of chlorine to instruments and because this is common practice in the field. All studies regarding HLD and sterilization were conducted under written and monitored protocols guiding calibration of instruments, soaking, cleaning, and application of the methods of disinfection or sterilization (Table 1). In each study, the specified method of reprocessing was performed 25 times on multiple devices. For runs 1, 2, 3, 15, and 25, the analysts performed inoculation of the device, including positive and negative controls with the ATS soil and microorganisms (Table 2), before the soaking step. Inoculum verification was performed to confirm an inoculum level of 10 6 cfu/mL per microorganism.
Following a 24-hour drying period, the devices were soaked, cleaned, and HLD or sterilized per protocol.

| RESULTS
The cleaning studies demonstrated that the tests for residual protein, carbohydrate, and hemoglobin from the ATS were negative for all devices

| DISCUSSION
Results show that the Ipas MVA Plus and SV aspirators, and the EasyGrip cannulae, can be safely reused (where regulations permit) F I G U R E 5 Major steps in reprocessing of Ipas manual vacuum aspiration (MVA) instruments.
following recommended methods and steps of instrument reprocessing. Current recommendations for reprocessing, based on the results of these validation studies, are summarized in Figure 5. Supporting this reassurance are the consecutive reductions achieved with adequate cleaning followed by HLD or sterilization.
Cleaning significantly reduces microbial load and HLD results in the reduction of another 4-6 log 10 while sterilization can achieve a reduction of 12 log 10 . 12 The combination for cleaning and sterilization provides a large margin of safety and a substantial but narrower margin with cleaning and HLD. Strictly following the reprocessing protocols are key to achieving these margins of safety.
The limitation of our study involves the use of chlorine in the presoak step. At the time of these studies, Ipas's guidance regarding instrument reprocessing included a "decontamination soak." However, Ipas guidance, like that of WHO, noted that while a "0.5% chlorine solution can be used," the primary purpose of this soak is to keep instruments wet until cleaning. 2,11 The "Ipas Decontamination Statement" produced in 2003 and updated in 2014 stated that soaking in chlorine solution does not make instruments safe or safer to handle with bare hands and for this step, any solution, including tap water, could be used. 12 Since the implementation of these studies, WHO and others have issued new guidance on infection prevention and reprocessing of instruments. 4,14 One notable change is that "soaking of instruments in 0.5% chlorine solution or any other disinfectant before cleaning is not recommended." 14 This recommendation is based on potential damage to the instruments, inactivation of the chlorine by blood and body fluids, risks in subsequent transportation, and contribution to the development of antimicrobial resistance to disinfectants. As our studies included a chlorine presoak before disassembly and cleaning, we note the results would have been strengthened by conducting comparison studies using a presoak with water and/or enzymatic spray to assess comparative effectiveness. Nevertheless, in our collective agency experience, most low-income countries are still using chlorine presoaks; thus, our study reflects common practice. Users, however, should heed the clear guidance from WHO to avoid the use of chlorine for presoaking 14 and that instruments should be presoaked, rinsed or sprayed with water or an enzymatic spray, and kept moist until cleaning. 4,14-16 Given this recent guidance, the assertion that "Cleaning is the first and most essential step before any process of disinfection or sterilization can be carried out," 14 and the margin of safety achieved by cleaning combined with HLD or sterilization as discussed above, it is likely our results would hold when water is used for presoaks rather than chlorine.
In conclusion, the results from this study support reuse of the Ipas MVA devices following the validated methods of instrument reprocessing with HLD or sterilization, which do not negatively affect the devices for up to 25 reuse cycles. The STERRAD and Cidex OPA methods did not meet the standards assessed in these studies and are therefore not recommended, which represents a change from earlier recommendations. Strict adherence to the reprocessing guidance is critical to achieve effective reprocessing of instruments.

AUTHOR CONTRIBUTIONS
BP and NK conceived the idea; BP drafted the manuscript and NK provided substantive revisions to the manuscript.