Menstrual cup cleaning practices

A mixed methods study of published instructions and key informant interviews Executive summary

In many cultures, the onset of marks a girl’s coming of age, yet it can be a source of shame, stigma, and heightened health risk. Millions of women lack the products, knowledge, and social support systems to safely and effectively manage their menstruation. Therefore, menstrual cups, which provide a cost savings and potential health advantages, are increasingly being viewed as a viable alternative to other menstrual health products. However, there is a dearth of effective standards and processes to reduce the risk of irritation and infection from improper cleaning of menstrual cups during and between use. In an effort to close this gap, PATH conducted a rapid landscape and qualitative analysis of menstrual cup products and cleaning instructions with a focus on determining their feasibility for women and adolescent girls in low-resource settings. The principal objective of the review was to identify existing evidence-based cleaning processes and products and key research gaps to inform evidence-based, practical menstrual cup cleaning recommendations and future research. We conducted a search of the literature related to menstrual cup products, cleaning products, and practices; organizations promoting or distributing menstrual cups; and the websites of manufacturers, consumer sales outlets, and menstrual health advocates. We also received referrals and suggestions from manufacturers and public health organization staff and conducted key informant interviews with representatives of four menstrual cup manufacturers, one social enterprise, and six organizations implementing menstrual health and menstrual cup distribution programs. Of 34 menstrual cups identified, 24 were included in our analysis. Eighteen came with the specific recommendation to boil prior to the first use; however, the recommended boiling time varied widely. The instructions for all 24 cups included recommended cleaning during a ; rinsing the cup with mild soap and water was the most frequently recommended practice. Additional cleaning practices during the cycle included wiping the cup with clean tissues or proprietary wipes, boiling, sterilizing in a steam- based menstrual cup sterilizer, or soaking the cup in a sterilization solution. Actively boiling or soaking the menstrual cup in boiled water between menstrual cycles was recommended by 23 manufacturers as a primary or optional practice. Secondary cleaning approaches included using chemical tablets/solutions, sterilization via microwave, wiping off with proprietary wipes or isopropyl alcohol, and using a steam- based menstrual cup sterilizer or an ultraviolet light sterilizer. Key informants reported that users typically boil their menstrual cup before initial use and between cycles. Most users rinse their cups with water during their menstrual cycle. The importance of washing hands before touching, removing, or inserting the cup was frequently highlighted as a necessary practice. The majority of manufacturers recommended storing menstrual cups in the bag provided with the cup or in a breathable cotton bag to prevent the growth of . The majority also provided the instruction to avoid storing cups in plastic bags, in airtight containers, in areas with direct sunlight, or near anything scented, which could lead to bacterial growth, concentration of odors, and damage to the cup material. However, key informants noted that some users store their menstrual cup in a sealed container because they are wary of rats and cockroaches damaging the cup. Key informant feedback also indicated that privacy and fear of theft by family members are key concerns for some users, so they keep their cup under a mattress or in an underwear closet or chest, as examples. Several products were recommended by manufacturers for cleaning menstrual cups, including chemical tablets, mild soaps, and sterilization devices. Menstrual cup instructions specifically mentioned materials and practices users should avoid; among them, scented soaps, corrosive or harsh cleaners, and petroleum-based lubricants. However, discrepancies became evident when comparing the materials and practices users should avoid with the recommended cleaning practices suggested in all menstrual cup instructions. For example, several chemical cleaners were recommended by some manufacturers for cleaning menstrual cups at various stages of the use process yet discouraged by others. Some manufacturers recommended sterilizing in a microwave, and others recommended against this. And no evidence was provided to validate the rationale for the various cleaning practices. Finally, using broad terms such as “harsh” may not provide users with enough guidance on which cleaners to avoid. Key informants agreed that strong cleaning products should not be used; this was reported as generally recognized by most users.

Possible barriers to continued use of menstrual cups: Limited access to clean running or potable water is a possible impediment to the use of menstrual cups, although informants described women as “resourceful” and therefore able to obtain water to rinse and clean their cups. Informants also noted that access to mild soaps could prove challenging. Obtaining containers for boiling menstrual cups was noted as an issue for many users—either a dedicated container, which may not be affordable, or a cooking pot, due to lack of privacy in the kitchen and stigma related to menstruation. Some women and girls improvise, using discarded paint cans, for example, however, these may contain harmful residue that could be transferred to the cup. Seldomly have distributors provided a container for cleaning their menstrual cup; therefore, informants felt this was not a sustainable solution. Finally, some users are concerned about contamination from their cup touching a common surface when they need to clean it in a public restroom when they are “on the road.”

Conclusions and next steps: • Manufacturers should standardize cleaning terminology to internationally agreed-upon definitions. The terms “sterilization,” “disinfection,” and “sanitization” are used interchangeably, inconsistently, and sometimes incorrectly in menstrual cup cleaning recommendations. Terms should correlate with the level of microbial inactivation needed and evidence included to inform users of the rationale for those recommendations. • Publicly accessible evidence is needed to create consumer confidence in the recommended cleaning practices. Recommendations for cleaning menstrual cups before, during, and after each menstrual cycle do not include the evidence and reasons for these practices. Manufacturers have an opportunity to educate and raise consumer confidence by commissioning and publishing independent studies of their products that verify the effectiveness of their recommended cleaning practices. A harmonized set of hygiene criteria could establish a normative standard for the product category. • Menstrual cup manufacturers should reconsider their menstrual cup cleaning instructions to reflect the contextual realities of women and adolescent girls in low- and middle-income countries (LMICs). Boiling menstrual cups is widely recommended by manufacturers; however, feedback from users in LMICs indicates that a dedicated menstrual cup cleaning pot or fuel to boil the cup are not accessible to all LMIC users. USB-powered sterilizers, proprietary menstrual cup cleaning solutions—even sufficient water for daily cup washing—are out of reach for millions of users, particularly those in informal or non-urban LMIC settings. Manufacturers should work with menstrual health implementing organizations and cup distributors to develop instructions that are applicable to users in LMICs and do not place undue cost burden or require inaccessible cleaning inputs. • Comprehensive introduction strategies are needed to encourage uptake and consistent use of menstrual cups. For many first-time users, menstrual cups represent a significant departure from “traditional” menstrual hygiene products (e.g., sanitary pads). Introduction strategies should consider a holistic approach to engaging new and repeat users, including but not limited to menstrual, sexual, and reproductive health education; market requirements for sustained distribution; and establishment of peer support networks to allow for trusted sources and flow of information. • A human-centered design process should be employed to collect user perceptions and gain understanding of the contextual realities around menstrual cup cleaning and storage and the feedback incorporated into cleaning and storage instructions. This would improve the appropriateness of instructions and inform and improve messaging around cup maintenance, reducing the burden on users of trying to guess the best cleaning practices.

Background

Period poverty and the importance of menstrual hygiene management The onset of menstruation is a landmark event in a girl’s life. In many cultures, it marks her maturity and coming of age, yet it is dually a source of shame, stigma, and sometimes a heightened health risk for women and girls across the globe. An estimated 500 million women worldwide (roughly a quarter of the globe’s reproductive-age women) lack the products, knowledge, and social support systems to safely and effectively manage their menstruation.1 This burden is felt especially in low-resource settings. With few effective and affordable options for menstrual management, women and girls often resort to unhygienic methods, such as strips of soiled cloth, sheets of an exercise book, pieces of sponge torn from a mattress, tissue paper, and even leaves.2,3 Some evidence suggests that women and girls have engaged in transactional sex to afford menstrual products.4 In addition, often they are restricted to the household during their period. These limitations, whether practical, self-imposed, or the result of cultural taboos, compromise the participation of women and girls in the workplace, the classroom, and in social activities.5,6

The potential of menstrual cups With a robust market of more than 199 brands across 99 countries, menstrual cups are increasingly being viewed as an alternative to disposable menstrual hygiene products. Research suggests the technology may be transformative and highly accepted by women and girls, particularly in low-resource settings.6,7,8 Menstrual cup users have reported greater mobility and freedom to decide for themselves when, where, and how they manage menstruation.8 Based on data from 15 studies, a pooled estimate of 73% of menstrual cup users indicated their desire to continue using their menstrual cup following an initial use period.9 Women and girls in Nairobi, , were given menstrual cups to try over five months and reported the devices gave them renewed confidence.8 They no longer had to worry about dressing in particular clothes to hide bloodstains or conceal bulky sanitary pads, and concerns about odor were virtually eliminated. A study involving rural schoolgirls in Uganda found menstrual cups decreased levels of anxiety and stress related to staining, cleaning, and leakage compared to use of cloth rags, pads, and period panties. This same study found menstrual cups led to higher levels of independence and social mobility.5 Because menstrual cups are less likely to leak than other menstrual hygiene products and can be worn for up to 12 hours, girls could plan around the school day and rinse their cups at home. With reusable cloth, on the other hand, girls often avoided school altogether when menstruating, or had to leave class early to find a private place to wash.10 Menstrual cups offer distinct cost savings and potential health and environmental reduction advantages compared to other menstrual health products, which include menstrual cloths, reusable and disposable pads, and . Using average sanitary pad and purchase cost estimates from six countries (Canada, China, India, Spain, the United Kingdom, and the United States), researchers showed that consistent use of a menstrual cup over a ten-year period can generate significant cost savings for users: 95% and 93% of sanitary pad and tampon purchase costs, respectively.9 In addition, studies involving women and girls in Europe, Kenya, South Africa, and the United States found no increased risk of reproductive tract or systemic infection resulting from menstrual cup use compared to use of other menstrual health products. In fact, decreased rates of candidiasis and were found in menstrual cup users in Kenya compared to users of sanitary pads, cloth, tissues, or other makeshift materials.9 These findings indicate the menstrual cup may be a safer product option for women and girls. Finally, menstrual cups have been estimated to consume a fraction – anywhere from 0.4 – 6% of the plastic waste compared to pads and tampons.9 Despite these benefits, however, there is a glaring gap in appropriate and effective cleaning standards and processes to reduce the risk of negative health outcomes from menstrual cup use (e.g., bacterial vaginosis, candidiasis, vaginitis, and ). Recommendations for cleaning menstrual cups prior to initial use, during a period, and between menstrual cycles range from boiling for up to 5 minutes to sterilizing using innovative technologies such as high-temperature steam sterilizers, ultraviolet light irradiation, or ozone generation. These wide-ranging recommendations raise questions about necessary cleanliness thresholds, feasibility of recommended cleaning practices, and usefulness of sterilization recommendations, especially for consumers in low- and middle-income countries (LMICs) with limited access to water, fuel, and sterilization technologies. Additionally, nearly all menstrual cup manufacturers fail to provide any publicly available independent evidence that supports their recommended cleaning practices. This widespread lack of evidence leads to consumer uncertainty, hindering menstrual cup purchase, use, and adoption. In an effort to close this gap, PATH conducted a rapid landscape and qualitative analysis of menstrual cup products and cleaning protocols appropriate for menstrual cup users in LMICs. The principal objective of the review was to identify existing evidence-based menstrual cup cleaning processes and products and key research gaps that can inform evidence-based, practical cleaning recommendations and future research. Our secondary objective was to identify existing menstrual cup cleaning regulations and standards. While guidelines and international standards exist for menstrual cup manufacturing processes and have gained traction with manufacturers and at the global level,a no guidelines for menstrual cup cleaning practices were found and thus no evidence is presented in this report on this topic.

Methods

We searched PubMed and the World Health Organization’s Global Health Library for materials in English, using the terms “menstrual cup,” “menstrual cup cleaning,” “menstrual cup hygiene,” “menstrual cup washing,” and “menstrual cup sterilization” to find peer-reviewed articles related to menstrual cup products, cleaning products and practices, and organizations promoting or distributing menstrual cups. We searched through grey literature, including PATH and external reports, stakeholder meeting summaries, and abstracts from conferences (UNC Water and Health, Women Deliver, the American a. Relevant International Organization for Standardization (ISO) standards for menstrual cup manufacturing: Packaging and labeling (ISO 15223-1), regulation/conformity (ISO 13485 or ISO 9001), safety and product standards (ISO10993-1, ISO 10993- 3, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 188), and environmental requirements (ISO 14001). Society of Tropical Medicine and Hygiene Annual Meeting), and received referrals and suggestions from manufacturers and public health organization staff. We searched through menstrual cup manufacturer websites, consumer sales websites (Amazon, Kasha, Alibaba), and menstrual health advocate websites for additional information. Searches were completed in November 2020. The literature review was complemented by key informant interviews conducted with a purposive sample representing menstrual cup manufacturers, global thought leaders in menstrual health and hygiene, and organizations working to facilitate use of menstrual cups. All interviews were conducted remotely using Zoom or Microsoft Teams, in English, and key informants were given a chance to ask questions at any point during the process. A structured questionnaire was used to guide the interviews, designed to collect feedback and perceptions from respondents on user knowledge, attitudes, and practices related to menstrual cup cleaning. Interviews were transcribed for analysis. No personal identifiers were included in the data collection or analysis and data were de-identified before analysis. Transcripts were analyzed using content and thematic analysis. Recurrent themes were first identified through an independent, initial reading of the transcripts. Following this, transcripts were analyzed for sub-themes, nuances, apparent contradictions, and any additional patterns.

Findings

Manufacturer descriptions A total of 34 menstrual cup products manufactured across the globe were identified. Of these, ten were excluded due to lack of market availability at the time of this review or because no cleaning instructions were available. Ultimately, 24 menstrual cup products were included in our analysis. Table 1 provides a summary of those products, and additional details are included in Appendix A.

Table 1. Summary of menstrual cup products evaluated.

Number of menstrual cups 24 included in the analysis Argentina, Australia, Canada, Chile, China, Czech Republic, Manufacturer locations Denmark, Finland, France, Germany, India, Nigeria, South Africa, Spain, Sweden, United Kingdom, United States, Zimbabwe

Menstrual cup per-unit price $2.50 to $39.00 (one menstrual cup product price was not found) range in US dollars

Cup materials Medical-grade silicone (n = 23) and thermoplastic elastomer (n = 1) The bfree cup A distinctive menstrual cup included in this review is the bfree cup by Women’s Global Health Innovations. Described as a physically antibacterial menstrual cup, the bfree is manufactured using a microtopographic design that incorporates micron-scale thick lubricant. The combination of the design and lubricant creates a superhydrophobic non-wetting cup surface that prevents bacterial attachment and staining on the cup’s surfaces. Data on the bfree cup website point to reduced levels of Pseudomonas aerugninosa biofilm formation following four hours under static culture compared to standard medical-grade silicone menstrual cups. In addition, cleaning requirements are relatively simpler than other menstrual cups due to this characteristic. Data show that bloodstains dried for 1 hour, 24 hours, and 7 days on bfree cups can be removed by wiping the cup, whereas those same bloodstains remained on standard medical-grade silicone cups. For the purposes of this review, the bfree cup is included in the analysis below; however, beyond rinsing the cup with water, no other cleaning process is applicable or required. With regard to storage, bfree is exploring the concept of including with the distribution of its cups, a storage bag with the same antibacterial properties, which would last up to five years.

Key informant interviews A total of 11 experts were interviewed: four menstrual cup manufacturers, one social enterprise, and six organizations implementing menstrual health programs and menstrual cup distribution programs. Key informants indicated that menstrual cup users hail from a diverse range of socioeconomic backgrounds. However, there is a distinct segmentation in the market; users from middle- and high-income backgrounds tend to buy menstrual cups at market price, and users from lower-income backgrounds typically receive cups from nongovernmental organizations. Some companies even price the same product differently for different target groups. For example, RubyCup markets its menstrual cups for €29 each to more well-off women. However, for each menstrual cup sold commercially, at least one cup is provided free of charge to a woman in a low-resource setting. Programs that support and promote menstrual cup use emphasize that even though they may appear to be difficult and/or expensive to maintain prima facie (e.g., the need to have access to water to clean them during a menstrual cycle and vessels in which to boil them prior to use at the start of a menstrual cycle), menstrual cups are more hygienic than using rags and random pieces of cloth, as well as less expensive in the long run when compared to disposable commodities such as sanitary pads and tampons. Furthermore, in many low- income settings, houses do not have discrete areas for disposing of menstrual waste, which makes reusable menstrual cups that can be decanted in a toilet or latrine more advantageous for users when managing menstruation. Key informants indicated that most menstrual cup users are older girls and younger women. The youngest users are typically girls aged 13 to 14 years. Older women (40 years and above) are often hesitant to take up a new menstrual hygiene product, as they feel they only “have a few years of menstruation left.” According to a few respondents, in certain settings, parental consent is required when targeting menstrual cups to users under the age of 18 years (thought this was not independently verified). Respondents also shared the perspective that parents, especially in South Asia, may be hesitant to let their daughters use a menstrual cup out of a perception that an object inserted in the may damage the and therefore interfere with their “.” Furthermore, in many countries, there are often larger systemic taboos and misconceptions around menstruation itself, which make it hard to promote the use of menstrual cups—or for that matter, any interventions or products related to menstrual hygiene—in an open manner. Key informants emphasized that it would be important to promote menstrual cups not as a standalone intervention, but instead to situate their use within the broader context of menstrual hygiene and sexual and reproductive health. In addition, given the still “innovative” nature of menstrual cups, it is important to provide adequate instruction on their use and maintenance through tutorials and graphics. In general, informants believed menstrual cups should not be shared without education and without ensuring that users understand instructions for their use and maintenance. But perhaps most importantly, it is necessary to have peer support and encouragement to boost uptake. For example, one manufacturing company features interviews with menstrual cup users, while an organization that encourages uptake of menstrual cups makes use of menstrual hygiene “ambassadors” to enhance their appeal. Another organization makes deliberate efforts to target boys and men—both to sensitize them on sexual and reproductive health and to encourage them to become champions of menstrual hygiene. And in India, one organization surveyed is running an innovative program in which health care workers are recruited as early users of menstrual cups; in turn, they recruit women from their communities. The health care workers are not only sensitizing women on the use of menstrual cups but are also disabusing them of myths and misconceptions around menstrual cups in particular—and menstruation in general.

Cleaning practices Prior to initial use Of the 24 menstrual cups analyzed, 18 instructions included the specific recommendation to boil prior to the initial use; however, the boiling duration varied widely, from 2 minutes to more than 20 minutes. One set of instructions recommended boiling the menstrual cup in a solution of vinegar and water (1:9 dilution, respectively). Additionally, seven manufacturers recommended secondary cleaning methods prior to use, which included soaking the menstrual cup in a sterilization solution prepared with a chemical tablet (n = 4), placing the menstrual cup in a proprietary container with water and microwaving the cup for 5 minutes (n = 1), soaking the menstrual cup in a solution of isopropyl alcohol for 10 minutes (n = 1), and using proprietary soap-based wipes (n = 1) (see Figure 1).

Figure 1. Manufacturer-recommended cleaning practices prior to the first use of a menstrual cup (MC).

Boiling (18/24) 0-5 minutes (7/18)

5-10 minutes (7/18) Chemical tablets (4/24) Has a recommendation for Yes 10-20 minutes (1/18) cleaning MC prior to use Microwave for 5 minutes (1/24) > 20 minutes (2/18) No

No time specified Proprietary wipes (1/24) No recommendation (6/24) (1/18)

Isoprophly alcohol for 10 minutes (1/24) Primary recommendation Secondary recommendation

No recommendation

Key informants shared that users typically boil their menstrual cup before initial use. They also indicated the importance of reinforcing proper handwashing and personal hygiene as a core component of the initial sensitization of menstrual cup users when distributing cups. Relevant messages include washing hands (ideally with soap) before touching, removing, and inserting the cup. While the usual recommendation is to boil the cups for no more than 5 minutes, some users believe that “longer is better,” which can damage the structural integrity of the cup in the long run. Furthermore, when boiling over extended periods of time, the water in the container may evaporate. This can cause the menstrual cup to melt/stick to the bottom of the pot and ruin it. In order to prevent “over-boiling” and the risk of menstrual cups being damaged, some cup distributors recommend pouring boiling water over the cup and waiting for 10 minutes before first use. Some users boil their cup in a container of water placed in a microwave; however, this practice is relevant/feasible only in high-income settings. Access to containers for boiling menstrual cups was noted as an issue for many cup users. Some users boil their cups in pots available in the kitchen, which are used for other purposes, such as boiling tea. However, there are often issues with being able to access kitchen utensils, given their constant use in the household for cooking purposes and the fact that cup users are often hesitant to use kitchen utensils for boiling cups due to lack of privacy—possibly given the connotation of menstruation being a “dirty” practice. While cup distributors often encourage users to buy a separate pot for the exclusive purpose of boiling their menstrual cup, some key informants felt this may create an additional perceived barrier to uptake of the cups. Some distributors provide users a pot with the cup, but key informants felt this was not a sustainable practice. In the absence of having a proper pot in which to boil their menstrual cup, some users improvise by using discarded aluminum tins—including paint cans. This comes with a fresh set of concerns, as there might be corrosive/harmful residue left in the discarded tins that is transferred to the menstrual cup.

During the menstrual cycle All 24 menstrual cups analyzed came with recommended cleaning practices for cups during the menstrual cycle. The recommendation made most frequently, by 17 of the 24 manufacturers, was to rinse the cup with mild soap and water. Fourteen of the 17 specifically mentioned to use unscented, oil-free, water-based, nonantibacterial soap. Nine of the 17 instructions also noted users could apply the manufacturer’s proprietary cleaning solution as an alternative. Interestingly, one set of menstrual cup instructions specifically advised against using soap for cleaning and one stated soap was not necessary. A total of ten instructions recommended simply rinsing the menstrual cup with water, either as the primary (n = 6) cleaning process or as an alternative to washing with soap and water (n = 4). Eight manufacturers recommended wiping the cup with clean tissues or proprietary wipes, again as a primary (n = 1) or an alternative cleaning practice (n = 7), and three recommended either boiling the cup, placing the cup in a steam-based menstrual cup sterilizer (n = 1), or soaking the cup in a sterilization solution (n = 1) to clean it during a menstrual cycle. Finally, instructions for one menstrual cup stated that disinfection (i.e., cleaning beyond daily water or soap and water washing) during the menstrual cycle was not necessary, whereas two sets of instructions stated cups should be sanitized at the start and end of each menstrual cycle and that boiling the cup for more thorough cleaning could occur as often as the user desired. Figure 2 illustrates the recommended cleaning practices.

Figure 2. Manufacturer-recommended menstrual cup (MC) cleaning practices during the menstrual cycle.

Clean with water & soap Mild soap (14/17) (17/24)

Proprietary wash Rinse with water (10/24) Has a recommendation for (9/17) YES cleaning MC during cycle

Wipe clean (8/24) No Boil (3/3)

No recommendation (0/24) Sterilize (3/24) Steam (1/3)

Primary recommendation Sterilization solution (1/3) Secondary recommendation

No recommendation

Key informants shared that most users tend to clean their cups using water during their menstrual cycle. This is typically done with tap/potable water. As with cleaning menstrual cups prior to initial use, key informants mentioned the importance of washing hands before touching, removing, or inserting the cup during a cycle. In settings where running water is not available, users may take a bottle of water with them into the toilet or shower stall to rinse their cup. This is generally an acceptable practice, although some users—especially early- stage users—have been reported to drop their cup into a pit latrine, from which it is impossible to retrieve. Users are also occasionally wary of the need to empty their menstrual cup while they are “on the road.” For such purposes, they carry a bottle of clean water with them—which may create a perceived barrier to the continued use of menstrual cups. Such users are also wary of the possibility of contamination arising from their cup touching common surfaces when they clean them in public restrooms. Most key informants felt that prima facie, limited access to running water was a possible impediment to the use of menstrual cups. This is especially relevant for women living in areas such as northern Uganda and Kenya, as well as those living in refugee and internally displaced persons camps. In these settings, access to clean/potable water is a major issue and literally every drop counts, as women often need to walk and/or wait for hours to fetch clean water. However, key informants also felt that this was not an insurmountable barrier, as cups require less water to clean than washing cotton rags and other reusable sanitary products. Furthermore, key informants felt that women are “resourceful” in being able to find water to rinse their cups. Between menstrual cycles Nearly all instructions (23/24) included specific steps for cleaning menstrual cups between menstrual cycles (see Figure 3). Actively boiling or soaking the cup in boiled water was the most frequently mentioned practice, either explicitly recommended (n = 21) or noted as optional (n = 2). Similar to the cleaning instructions prior to the first use, boiling times ranging from 2 to 20 minutes, or recommended times were not included. Additionally, 15 menstrual cup manufacturers recommended additional cleaning approaches, including using chemical tablets/solutions (n = 9), sterilization via microwave (n = 4), proprietary wipes (n = 3), rubbing with isopropyl alcohol (n = 2), a steam-based menstrual cup sterilizer (n = 1), and an ultraviolet light sterilizer (n = 1).

Figure 3. Manufacturer-recommended menstrual cup (MC) cleaning practices between cycles.

Boiling (23/24) 0-5 minutes (11/23)

Chemical tablet/solution (e.g., 5-10 minutes (5/23) Milton) (9/24) minutes (2/23) Has a recommendation for Microwave (4/24) Yes cleaning MC between cycles No time specified (5/23) Proprietary wipes (3/24) No

No recommendation (1/24) Isopropyl alcohol (2/24)

Steam-based sterilizer (1/24) Primary recommendation Secondary recommendation Soaking in water + vinegar or No recommendation water + bleach solution (1/24)

User practices and concerns around cleaning of menstrual cups between cycles broadly mirror cleaning practices and concerns prior to initial use, with the majority of users preferring to boil their cups. Storage A majority of menstrual cup manufacturers (17/24) included storage recommendations in their instructions. All 17 noted menstrual cups should be stored in the storage bag provided with the cup or in a breathable cotton bag. Eleven of the 17 also specifically instructed users to avoid storing their menstrual cup in a plastic bag, an airtight container, in areas with direct sunlight, or near anything scented, as these factors could lead to moisture build-up, concentration of odors, and damage to the cup material.

Figure 4. Storage practices recommended by menstrual cup (MC) manufacturers.

Has a recommendation for MC Manufacturer-provided cloth Yes storage bags (17/24)

No

No recommendation (7/24)

Primary recommendation Secondary recommendation

No recommendation

Feedback from key informants indicated that privacy is often a key consideration for menstrual cup users when it comes to storing them. Given possible stigma around menstrual cups—and menstruation in general—users may store them in areas considered “private” (e.g., under a mattress, in a small nook, in a closet or chest of drawers where they also typically keep their underwear, inside a tin or wooden box, or in the bathroom)—the same areas where users would have stored sanitary towels prior to switching to a menstrual cup. At least one key informant mentioned that storing cups in such discreet places was not only because of stigma, but also because of fear of the cup being stolen by a sibling, aunt, or someone else in the family. Key informants mentioned that menstrual cup users in lower-income settings (e.g., rural areas, urban informal settlements) are often wary of rats and cockroaches chewing on the cups and damaging them. As a result, some users tend to store their cups in sealed plastic bags or containers, which is not recommended due to the potential for bacterial growth in humid, enclosed containers. Organizations distributing menstrual cups in such settings counsel users to store their cups in breathable cloth bags or pouches—or in secure, airy areas such as closets. When such bags/pouches are not available, these organizations recommend that menstrual cups be air-dried thoroughly before storing in sealed bags or containers. Cleaning products As noted in the analysis above, several cleaning products—ranging from mild soap to isopropyl alcohol — were recommended by manufacturers for cleaning menstrual cups. In a landscape of commercially available cleaning products recommended by manufacturers or specifically designed for menstrual cup cleaning, we identified 24 products, which included chemical tablets (n = 1), mild soaps/detergents (n = 10), cleaning wipes (n = 4), containers for use in cleaning menstrual cups (n = 5), and steam-based sterilization devices (n = 4) (see Table 2 for details). The chemical tablets recommended in manufacturer instructions were Milton® sodium dichloroisocyanurate tablets (used for sterilizing breastfeeding equipment). Eight of the ten mild soaps/detergents identified are produced by menstrual cup manufacturers and are made of different product formulations and active ingredients; the other two mild soaps are general castile soap and a face cleaner. The cleaning containers identified in the landscape ranged from 94 mL to 225 mL medical-grade silicone or polypropylene cups, designed for users to insert their menstrual cups and either pour boiling water over the cups, letting them soak in the boiling water for 5 minutes, or fill with water and place in the microwave for 3 to 5 minutes. Finally, the five steam-based sterilizers are small, electrically powered devices that generate steam in a small chamber containing the menstrual cup and sterilize the cup in 8 to 10 minutes.

Table 2. Manufacturer-recommended cleaning products and devices for use with menstrual cups.

Cleaning product category Description Chemical tablets/solutions The Milton tablet, recommended for sterilizing breastfeeding equipment and infant utensils, is a wide-spectrum disinfectant and cleaning agent that contains sodium dichloroisocyanurate (19.5 weight/volume), which produces an aqueous solution when combined with 5 L of water. The resulting solution has been shown to be effective against bacteria, viruses, and spores. Mild soaps/detergents Many menstrual cup manufacturers offer proprietary menstrual cup cleaning solutions to users. These solutions are water based, though their specific formulations differ, and they are designed to be used with water to rub, lather, and clean the menstrual cup. Non-menstrual cup options, such as castile soap, face wash solutions, and other unscented soaps, fall within this category. They come in a variety of package volumes, from 3.4 ounces to 8 ounces (100 mL to 236 mL) and range in price from US$3.41 (3.4 oz./100 mL) to $18.99 (3.4 oz./100 mL). Cleaning wipes Menstrual cup cleaning wipes are cotton-based, disposable wipes that provide users with an alternative cleaning option. When unfolded, individual wipes measure an average of 6 inches x 8 inches (15 cm x 20 cm). They come packaged either in a 10- or 20-wipe bundle or individually and are largely manufactured and marketed by menstrual cup manufacturers. The wipes are soaked in a variety of active ingredients, from purified water to 85% denatured alcohol, and range in price from $4.99 for 10 wipes to $13.95 for a package of 30 wipes. Menstrual cup cleaning Menstrual cup cleaning containers, offered by both menstrual cup containers and third-party manufacturers, range from a volumetric size of 95 mL to 225 mL and are made of medical-grade silicone and polypropylene. Menstrual cups can be placed in these containers and cleaned using soap and water, by pouring boiled water over the menstrual cup, or by microwaving in water for 3 to 5 minutes. Menstrual cup cleaning containers range from $6.99 to $14.50. Steam-based sterilization Steam-based menstrual cup sterilizers measure roughly 5 inches x 5 devices inches x 7 inches and are designed to sterilize, dry, and store menstrual cups. The devices use electricity (110V to 240V, 50 Hz to 60 Hz) to generate steam from 5 mL of water added by the user to the internal cleaning chamber where the menstrual cup is placed. The sterilization process takes 8 to 10 minutes. The four steam-based menstrual cup sterilizers identified range in price from $26.95 to $34.19.

In addition to providing users with guidance on cleaning steps to follow, 15 of the 24 menstrual cup instructions specifically mentioned materials and practices users should avoid. The most frequently mentioned materials to avoid were scented soaps (n = 7), corrosive or harsh cleaners (n = 6; type of cleaner not specified), essential oils (n = 6), and petroleum-based lubricants (n = 5). The rationale for avoiding these substances highlighted the potential irritation and effect on vaginal pH level after reinsertion, resulting from residue left by these substances on the cup. Related to cleaning processes, four menstrual cup instructions recommended against using dishwashers and microwaves for cleaning. Finally, several other chemical-based cleaners and types of soaps were discouraged by menstrual cup manufacturers in their instructions (listed in Table 3).

Table 3. Cleaning products manufacturers recommend against using to clean menstrual cups.

Soaps Chemical cleaners Other Scented soap (n = 7) General corrosive/harsh Essential oils (n = 6) Antibacterial soap (n = 3) cleaner (n = 6) Petroleum-based lubricants Oil-based soap (n = 3) Bleach (n = 3) (n = 5) Dish soap (n = 2) Isopropyl alcohol (n = 3) Dr. Bronner’s Castile soap (n = 2) Vinegar (n = 3) Heavy-duty facial cleanser (n = 1) Baking soda (n = 2) Practices Sterilizing tablets (n = 1) Alcohol wipes (n = 1) Dishwasher (n = 4) (n = 1) Microwave (n = 4) Boiling > 5 minutes (n = 2) Boiling > 10 minutes (n = 1)

Clear discrepancies arise when comparing the materials and practices users avoid with the recommended cleaning practices suggested in all menstrual cup instructions. First, several chemical cleaners (e.g., sterilization tablets, isopropyl alcohol, bleach, hydrogen peroxide, vinegar) are recommended by some manufacturers for cleaning menstrual cups at various stages of the use process, yet discouraged by others. There is no clear evidence in any of the instructions as to why these products are either appropriate or conversely not advised for use. Second, two of the three cleaning practices not recommended (e.g., using a microwave and boiling for more than 5 or more than 10 minutes) are counter to many manufacturers’ suggested cleaning practices noted above. The rationale provided for not boiling for longer than the instructed period of time is to protect against any damage to the design of the cup, specifically its rigidity and form; however, no evidence is provided that validates this claim. Finally, while not a discrepancy, using the broad term “corrosive” or “harsh” to describe some cleaners may not provide users with enough guidance on which cleaners to avoid. Similarly, the broad recommendation that users should use a “mild soap” could benefit from additional details and a definition of “mild.”

Key informants agreed that strong cleaning products, such as bleach, vinegar, scented or fragrant soaps, and antiseptic solutions, should not be used, and this was reported as generally recognized by most users. Despite menstrual cup manufacturer instructions recommending soap and water for cleaning cups during the menstrual cycle, informants noted that access to mild soaps created a perceived barrier to the routine maintenance of menstrual cups. Some menstrual cup distributors and implementing organizations have addressed this gap by donating soap to users; however, this has happened only seldomly. Furthermore, given issues around availability of clean water in some settings, key informants worried that cups would not be rinsed properly after being washed with a cleaning product such as soap, which may cause irritation in the vagina. Given the perception of menstruation being “dirty,” informants noted users may still use soap. There are some users and communities that feel that during a pandemic like COVID- 19 or Ebola, using a cleaning product that is “strong,” such as bleach, may be acceptable, even though the use of bleach is strongly discouraged by menstrual cup manufacturers and distributors. Moreover, at least one key informant noted that they had heard of users using vinegar, salt, or hydrogen peroxide for cleaning—presumably to remove stains. The lack of consistency of cleaning materials and processes recommended raises questions about the effectiveness of recommended cleaning practices and materials, raises a question about how clean is clean enough, and ultimately, may lead to confusion and inhibit demand by users.

Conclusions and future research areas

Manufacturers should standardize cleaning terminology to internationally agreed-upon definitions. Across the menstrual cup instructions for use, “sterilization,” “disinfection,” and “sanitization” are used interchangeably and inconsistently. These terms have specific definitions,11 and in some cases, are incorrectly used. Recommendations should both include the appropriate terms that correlate with the appropriate level of microbial inactivation needed, as well as provide evidence that informs users of the rationale for those recommendations. Publicly accessible evidence is needed to create consumer confidence in the recommended cleaning practices. Three-quarters of the menstrual cup instructions analyzed recommended boiling prior to initial use, yet none provided an explanation regarding the reason for and benefit of this practice. Similarly, cleaning practices recommended during the menstrual cycle and in between cycles ranged from rinsing cups with water, to boiling 2 to 20 minutes, to using ultraviolet light for sterilization. These recommendations were put forth without clearly defined evidence that shows the effectiveness of the recommended practices on the intended outcome of those actions (e.g., reducing the risk of infection in users, preventing discoloration, maintaining menstrual cup integrity and durability).11 While there may be no concrete cleanliness threshold that can be established, narrowing the range of recommended practices based on evidence is possible and needed. Menstrual cup manufacturers have an opportunity to both educate and raise confidence in menstrual cup consumers by commissioning and publishing independent studies of their products that verify the effectiveness of their recommended cleaning practices. A harmonized set of hygiene criteria could establish a normative standard for the product category. Menstrual cup manufacturers should reconsider their menstrual cup cleaning instructions to reflect the contextual realities of women and adolescent girls in low- and middle-income countries. Menstrual cup cleaning instructions reflect the contextual realities of middle- and high-income consumers, while largely obviating the contextual realities and resource availability of a growing market segment: women and adolescent girls in LMICs. Boiling menstrual cups prior to use or between cycles is widely recommended by manufacturers; however, feedback from users in LMICs shows that the requirements for this practice—having the resources to purchase a dedicated menstrual cup cleaning pan, having time and privacy to boil the cup, having water and fuel to boil the cup, using a microwave—are assumptions that do not reflect the realities of all LMIC users. USB-powered steam-based sterilizers, proprietary menstrual cup cleaning solutions and wipes, and in the most extreme cases, sufficient water for daily cup washing are simply out of reach for millions of users—particularly those in informal or non-urban LMIC settings. Menstrual cup manufacturers should work with menstrual health implementing organizations and menstrual cup distributors to reconsider their instructions so that they are applicable to LMIC users and guide those women and adolescent girls in how to effectively maintain hygienic menstrual cups while not placing undue cost burden on those users or requiring inaccessible cleaning inputs. Comprehensive introduction strategies are needed to encourage uptake and consistent use of menstrual cups. For many first-time users, menstrual cups represent a significant departure from more “traditional” menstrual hygiene products, such as disposable or reusable sanitary pads, cloths, and other products. Introduction strategies should consider a holistic approach to engaging new and repeat users, including but not limited to menstrual health and sexual and reproductive health care education, menstrual product awareness, benefits/challenges, use practices; market requirements for sustained distribution; and establishment of peer support networks to allow for trusted sources and flow of information. Menstrual cup users are resilient. Studies and feedback collected from key informants show very high levels of user acceptability and a desire to continue using menstrual cups once introduced. These high user acceptability rates are in spite of challenges women and girls face related to menstruation stigma, inconsistent and out-of-reach cleaning practices, and storage concerns related to menstrual cups. Key informants noted how incredibly resourceful menstrual cup users are in finding the means to clean and store their cups. A human-centered design process should be employed to collect user perceptions and gain understanding of the contextual realities around menstrual cup cleaning and storage and the feedback incorporated into menstrual cup cleaning and storage instructions. This would not only improve the appropriateness of those instructions but would also inform and improve messaging around cup maintenance and reduce the burden on users of trying to guess and determine best cleaning practices.

References

1. The World Bank website. Menstrual hygiene management enables women and girls to reach their full potential page. https://www.worldbank.org/en/news/feature/2018/05/25/menstrual-hygiene- management. Accessed May 25, 2021. 2. African Population and Health Research Center (APHRC). Experiences and problems with menstruation among poor women and schoolgirls in Nairobi. In: Policy Brief No. 20. Nairobi: APHRC; 2010. https://www.susana.org/en/knowledge-hub/resources-and- publications/library/details/983. 3. Obiria M. Kenyan students could solve sanitary problem with banana-fibre pad. The Guardian. September 26, 2014. http://www.theguardian.com/global-development/2014/sep/26/kenyan-girls- sanitary-problem-banana-fibre-pad. 4. Phillips-Howard PA, Otieno G, Burmen B, et al. Menstrual needs and associations with sexual and reproductive risks in rural Kenyan females: a cross-sectional behavioral survey linked with HIV prevalence. Journal of Women’s Health. 2015;24(10):801–811. doi:10.1089/jwh.2014.5031.

5. Sommer M. Where the education system and women’s bodies collide: the social and health impact of girls’ experiences of menstruation and schooling in Tanzania. Journal of Adolescence. 2010;33(4):521–529. doi:10.1016/j.adolescence.2009.03.008. 6. African Population and Health Research Center (APHRC). Use of menstrual cup by adolescent girls and women: Potential benefits and key challenges. In: Policy Brief No. 22. Nairobi: APHRC; 2010. http://www.susana.org/_resources/documents/default/2-985- policybriefno222010useofmenstrualcupbyadolescentgirlsandwomenpotentialbenefitsandkeychallenge s.pdf. 7. African Population and Health Research Center (APHRC). Attitudes towards, and acceptability of, menstrual cups as a method for managing menstruation: Experiences of women and schoolgirls in Nairobi, Kenya. In: Policy Brief No. 21. Nairobi: APHRC; 2010. https://www.susana.org/en/knowledge-hub/resources-and-publications/library/details/984. 8. Tellier M, Hyttel M, Gad M. Assessing Acceptability and Hygienic Safety of Menstrual Cups as a Menstrual Management Method for Vulnerable Young Women in Uganda Red Cross Society’s Life Planning Skills Project. Kampala: Womena Ltd.; 2012. 9. Van Eijk A, Zulaika G, Lenchner M, et al. Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis. Lancet Public Health. 2019;4(8):E376–E393. doi:10.1016/S2468-2667(19)30111-2. 10. Pillitteri SP. School Menstrual Hygiene Management in Malawi: More Than Toilets [Master of Science thesis]. United Kingdom: Cranfield University; 2011. 11. US Centers for Disease Control and Prevention website. Introduction, methods, definition of terms: Guideline for disinfection and sterilization in healthcare facilities page. 2008. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/introduction.html. Accessed May 25, 2021.

Appendix A. List of menstrual cup products evaluated. Included in Cleaning Price in Available for Menstrual cup Brand/Manufacturer Manufacturer location analysis instructions Cup material USD purchase Website http://alexanderlifecare.com/products-

ALX Care Alexander Life Care Pvt. Ltd. India No No Medical-grade silicone $8.04 Yes detail.php?product_id=1

Be’Cup Laboratoires Juva Sante France Yes Yes Medical-grade silicone $20.97 Yes https://www.becup.fr/ bfree cup Women’s Global Health Innovations Canada Yes Yes Medical-grade silicone $26.38 Yes https://bfreecup.com/products/bfree-cup

Butterfly (now called Viva Lily) Butterfly Cup Co. Zimbabwe Yes Yes Medical-grade silicone $15.00 Yes http://www.thebutterflycup.co.zw/

Crimson Care Unknown Kenya No No Medical-grade silicone $22.11 Unknown https://www.facebook.com/Crimsoncareke Diamond Cup Unknown USA No No Medical-grade silicone Unknown No http://menstrualcupcomparison.com/diamond-cup/ Diva Cup Diva International, Inc. Canada Yes Yes Medical-grade silicone $34.99 Yes https://divacup.com/contact-us/

Duet ReProtect, Inc. United States No No Unknown Unknown No http://www.reprotect.com/products.shtml Femmy Cycle FemCap Inc. United States Yes Yes Medical-grade silicone $39.00 Yes https://femmycycle.com/ Flow Cycle Not clear India No No Unknown Unknown No No website

Grace Cup Unknown Kenya No No Medical-grade silicone $13.82 Yes https://thegracecup.co.ke/ Gynaeseal Chattan Australia Pvt. Australia No No Unknown Unknown No Out of production JuJu Cup Freedom Products Australia Yes Yes Medical-grade silicone $35.12 Yes https://www.juju.com.au/collections/menstrual-cups Czeck Republic, Germany,

LadyCup Jaguars, s.r.o. United States Yes Yes Medical-grade silicone $32.11 Yes https://www.ladycup.eu/ Lena Menstrual Cup Lena Cup United States Yes Yes Medical-grade silicone $24.90 Yes https://lenacup.com Sweden and United Lily Cup Intima/Suzhou Armocon Technology Co. Ltd. States/China Yes Yes Medical-grade silicone $24.95 Yes https://www.intimina.com/lily-cup-one Lunette Lue Group Oy Ltd. Finland Yes Yes Medical-grade silicone $37.25 Yes http://www.lunette.com/ Luv Ur Body Luv Ur Body Ltd. Nigeria Yes Yes Medical-grade silicone $17.99 Yes https://luvur-body.com/ Maggacup Ciclica Argentina Yes Yes Medical-grade silicone $16.25 Yes https://maggacup.mitiendanube.com/ Me Luna Me Luna GmbH Germany Yes Yes Thermoplastic elastomer $18.57 Yes https://www.me-luna.eu/en_GB Menses Cup Shanghai Newboasia Medical Rubber Factory China No No Unknown Unknown No Not clear if still in production

Miacup MiaCup South Africa South Africa Yes Yes Medical-grade silicone Unknown Yes http://www.miacup.co.za/eng/media.php

MiaLuna Mia SPA (manufactured in Hong Kong) Chile Yes Yes Medical-grade silicone $2.50 Yes https://www.mialuna.cl/ Mooncup Mooncup Ltd. United Kingdom Yes Yes Medical-grade silicone $26.02 Yes https://www.mooncup.co.uk/ Mpower Mpower South Africa Yes Yes Medical-grade silicone $19.11 Yes http://mpowercup.co.za/

OrganiCup OrganiCup ApS Denmark Yes Yes Medical-grade silicone $28.00 Yes https://www.organicup.com/product/organicup/

PixieCup Pixie Cup United States Yes Yes Medical-grade silicone $15.95 Yes https://www.pixiecup.com/product/pixie-cup/ Ruby Cup Ruby Cup, Ruby Life Spain, United Kingdom Yes Yes Medical-grade silicone $35.00 Yes https://rubycup.com/ Saalt SaaltCo United States Yes Yes Medical-grade silicone $29.00 Yes https://saalt.com/collections/cups/products/saalt-soft

She Cup MediAceso Pvt. Ltd. India Yes Yes Medical-grade silicone $30.37 Yes https://shecup.com/shesays/ Sirona Cup Sirona Hygiene Pvt. Ltd. India Yes Yes Medical-grade silicone $5.46 Yes https://www.sironaindia.com/product/menstrual-cup/

SochGreen Sterne France Yes Yes Medical-grade silicone $20.00 Yes https://www.sochgreen.com/sochcup Tasette Tasette, Inc. United States No No Unknown Unknown No Out of production Tassaway Tasette, Inc. United States No No Unknown Unknown No Out of production