Hazard Analysis. Good Manufacturing Practices, Food and Drug Administration (FDA), 21 CFR Part 820.

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1 Appendix D Hazard Analysis Introduction The purpose of this analysis is to identify hazards associated with CycleBeads and determine methods or techniques to eliminate or mitigate these hazards. This hazard analysis was conducted as a top down risk analysis of CycleBeads. This top down approach identifies hazards associated with using a device, determines possible causes of these hazards, and suggests possible methods to reduce the risk of this hazard occurring. Partners considering manufacturing or assembling CycleBeads should consider each of these causes and ensure that their system employs appropriate mitigations to reduce the likelihood of occurrence. Applicable Documents Center for Design and Radiological Health. Do It By Design: An Introduction to Human Factors in Medical Devices. Available at Accessed October 20, Good Manufacturing Practices, Food and Drug Administration (FDA), 21 CFR Part 820. Medical Device Use Safety: Incorporating Human Factors Into Risk Management, July 18, PATH Quality Procedure: Hazard Analysis. CycleBeads standard and low-literacy product instructions and calendar. Product Definition and Overview CycleBeads is a string of color-coded beads that represent the menstrual cycle and serve as a mnemonic for the Standard Days Method (SDM). Each bead represents one day of a woman s menstrual cycle. By moving a marker from bead to bead each day, the user can determine her daily likelihood for fertility. During days 8 to 19, white beads are used to indicate an increased chance of fertility. During the remainder of the month, brown beads indicate a lessened chance of fertility and a red bead indicates the onset of menstruation. The SDM and CycleBeads have been tested in a clinical efficacy trial to be 95 percent effective if used correctly. The SDM is included in the 18th Edition of Contraceptive Technology, and in the World Health Organization s reference documentation, including the Medical Eligibility for Contraceptive Use and the Selected Practice Recommendations for Contraceptive Use. The SDM is most effective for women with most menstrual cycles between 26 and 32 days long. 5 5 Arevalo M, Sinai I, Jennings V. A fixed formula to define the fertile window of the menstrual cycle as the basis of a simple method of natural family planning. Contraception. 1999;60: CycleBeads Procurement and Production Guide 71

2 Intended Users 1. Sexually active women who wish to reduce the risk of pregnancy. 2. Sexually active women who wish to increase the chance of pregnancy. Note: for the purpose of this hazard analysis, the intended users will be defined as women who wish to reduce the risk of pregnancy. Accessories The accessories associated with this device include: Instructional Insert This user instructional insert provides written and pictorial instructions necessary for the user to properly use the device. Calendar A calendar is provided for women to have an additional manner for tracking their menstrual cycles. Extra O-Ring An extra o-ring, used as the daily marker, is provided in case of breakage. Data for Hazard Analysis Because CycleBeads is not considered a device by the FDA, there are no reports in the Medical Device Reporting databases (MDR) or Manufacturer and User Facility Device Experience database (MAUDE). The MDR was established to be the mechanism for the FDA to receive reports of significant medical device adverse events from manufacturers, importers, and user facilities, so they can be detected and corrected quickly. The SDM and CycleBeads were clinically evaluated in three countries: Bolivia, the Philippines, and Peru, and results were reported in Based on self-reported intercourse records, the firstyear failure rate was 4.8 percent with correct use of the method. In cycles in which condoms or withdrawal were used, the failure rate was 5.7 percent. If all cycles are included (including those in which couples had intercourse during the fertile days) the failure rate was 12 percent CycleBeads Procurement and Production Guide

3 PATH staff conducted phone interviews with current CycleBeads manufacturers in Hong Kong, Peru, and India in January and February Through these interviews, information regarding current manufacturing practices, QC methods, and device failure mitigations were collected. Additional resources were used to inform possible mitigations including SDM of Family Planning Job Aids Packet for Counseling Clients, SDM research articles, and the CycleBeads and IRH websites. Definitions Definitions are from PATH s Quality Procedure: Hazard Analysis. Cause Feature or function of a system or subsystem that creates a hazard, such as sharp edges or no output from power supply. Harm Physical injury or damage to health or property. Hazard Adverse condition that directly affects the safety of a patient, operator, bystander, external equipment, or facilities. Severity A measure of the level of concern associated with each hazard. Severity is expressed qualitatively as minor, moderate, or major: Minor Assigned to a hazard that would not be expected to result in any harm to the patient or user. Moderate Assigned to a hazard that could result in nonserious harm to patient or user or a hazard that could delay therapy or provide incorrect information resulting in a nonserious injury to the patient or user. Major Assigned to a hazard that could result in death or serious harm to patient or user or a hazard that could delay therapy or provide incorrect information resulting in death or serious injury to the patient or user. Because pregnancy can cause death or serious injury to the mother, it is defined as a major hazard. 6 Arevalo M, Jennings V, Sinai I. Efficacy of a new method of family planning: the Standard Days Method. Contraception. 2002;65: CycleBeads Procurement and Production Guide 73

4 Likelihood of Occurrence Probability that a given cause of a hazard will occur. Occurrence is expressed qualitatively as remote, possible, or frequent. Remote Conceivable, but will probably never occur. No reported instances in field data or MDRs. Possible The failure is less likely to occur, but will probably occur at some time during normal operation of the device. Failure has been reported previously in MDRs or field data, but is considered rare. Frequent The failure is likely to occur often. Situations reported repeatedly in MDRs, recalls, and field data. Mitigation Specific activity of reducing or eliminating the risk of a hazard. Mode of Control General method for implementing mitigations, such as mechanical redesign, labeling, or training. Hazard Analysis The sole hazard of a failure of CycleBeads is the heightened risk of pregnancy for the woman relying on CycleBeads as her primary method of birth control. These potential failures fall into two domains: 1. Device failures in which the actual device fails and causes the woman to either incorrectly identify her fertile days or abandon the method. 2. Methodological failures during which the woman incorrectly uses the CycleBeads and increases her risk of pregnancy. Note: The severity of the hazard of pregnancy is designated as major because it could result in death or serious injury to the woman. 74 CycleBeads Procurement and Production Guide

5 Device Failures Cause of Failure Beads are in the incorrect order and woman incorrectly identifies fertile period. Incorrect number of beads on necklace and woman incorrectly identifies fertile period. Bead is assembled in wrong direction and woman is unable to slide o-ring. Likelihood of Occurrence Severity Hazard Risk Assessment Control Measure(s) QC QC QC Mitigation and Number (details in list after table) Implement an appropriate QC method at the point of assembly. (M-10) Implement an appropriate QC method at the point of packaging. (M-11) Implement an appropriate QC method at the point of assembly. (M-10) Implement an appropriate QC method at the point of packaging. (M-11) Implement an appropriate QC method at the point of assembly. (M-10) Implement an appropriate QC method at the point of packaging. (M-11) String breaks, beads fall off, and woman loses record of day. Labeling Design the device with string of appropriate strength and longevity under conditions of use. (M-12) Include instructions for use of the back-up calendar. (M-2) Clasp breaks and renders necklace into shoelace. Knot unties, beads fall off, and woman loses record of day. Colors of beads fade or rub off and user is unable to distinguish beads. Color of dark brown bead is not noticeable enough. Design QC Design Design Design the clasp with appropriate dimensions and materials. (M-13) Implement an appropriate QC method at the point of assembly. (M-10) Include instructions for use of the back-up calendar. (M-2) Design the beads with colorant in resin (not painted). (M-14) Design beads with resin colorant of appropriate longevity under conditions of use. (M-15 Design beads with easily distinguishable colors. (M-16) CycleBeads Procurement and Production Guide 75

6 (Device Failures continued) Cause of Failure Beads are manufactured too small and the o-ring slips past desired bead. Beads are manufactured too large and the o-ring is unable to pass by beads. The o-ring breaks and woman loses record of day. The o-ring is too small and is difficult to move. The o-ring is too big and slips past the desired bead. Likelihood of Occurrence Severity Hazard Risk Assessment Control Measure(s) Design Design QC/Labeling Design Design Mitigation and Number (details in list after table) Design beads with appropriate dimensions. (M-17) Design and fabricate molds to ensure correct and consistent dimensions. (M-18) Design beads with appropriate dimensions. (M-17) Design and fabricate molds to ensure correct and consistent dimensions. (M-18) Design the o-ring with appropriate dimensions and modulus. (M-19) Implement a QC method for sampling of o-ring properties. (M-20) Include instructions for use of the back-up calendar. (M-2) Design the o-ring with appropriate dimensions and modulus. (M-19) Design the o-ring with appropriate dimensions and modulus. (M-19) Design and fabricate molds to ensure correct and consistent dimensions. (M-18) 76 CycleBeads Procurement and Production Guide

7 Methodological Failures Cause of Failure Likelihood of Occurrence Severity Hazard Risk Assessment Control Measure(s) Mitigation and Number (details in list after table) Woman forgets to advance marker every day and incorrectly identifies fertile period. Frequent Major Significant Include instructions for use of the back-up calendar. (M-2) Woman advances marker in wrong direction and incorrectly identifies fertile period. Design with asymmetric beads that emphasize the correct direction of marker advancement. (M-3) Design with a clear indication of the correct direction (arrow). (M-4) Woman continues to use CycleBeads even though her cycle is not between 26 and 32 days. Design with an easily distinguishable 26-day marker bead. (M-5) Woman has unprotected sex during fertile period. Frequent Major Significant Design with easily distinguishable beads designating the fertile period. (M-6) Woman has protected sex during fertile period but the additional method fails. Woman is unable to read or understand instructions. Include labeling and instructions appropriate for the country/region of use. (M-7) Include instructions appropriate for low-literacy users. (M-8) Include pictorial instructions. (M-9) Woman mistakenly advances o-ring over more than one bead in a day. Include instructions for use of the back-up calendar. (M-2) Woman is colorblind and cannot clearly distinguish the different beads. Remote Major Significant Design with easily distinguishable beads designating the fertile period. (M-6) CycleBeads Procurement and Production Guide 77

8 Mitigations M-1. Emphasize correct use. If the user is able to meet with a service provider, correct use of the CycleBeads should be emphasized including: Necessity for abstinence or back-up contraceptive method during fertile period. Method and direction of advancing the o-ring. Proper use of the calendar in case of failure of the CycleBeads. Eligibility of women and couples (regular cycle, 26- to 32-day cycle, contraindications about postpartum mothers, injectable contraceptives, IUDs, miscarriages or abortions, desire to avoid pregnancy, STI free). M-2. M-3. M-4. M-5. M-6. M-7. M-8. M-9. Include instructions for use of the back-up calendar. The correct use of the back-up calendar can help prevent method failures attributable to both methodological and device failures. Design with asymmetric beads that emphasize the correct direction of marker advancement. Design with a clear indication of the correct direction (arrow). The directional arrow should be clearly highlighted and placed on the barrel clasp bead (to prevent abrasive removal by the o-ring). Design with an easily distinguishable 26-day marker bead. The bead should be of similar color (to designate as nonfertile day) but of a recognizably different hue. Design with easily distinguishable beads designating the fertile period. Beads should be of a different color than beads representing the nonfertile period. (The current embodiment uses white beads to represent the fertile period.) Include labeling and instructions appropriate for the country/region of use. Include instructions appropriate for low-literacy users. Written instructions should conform to local educational levels. Include pictorial instructions. Included pictorial instructions should adequately demonstrate correct use for non-literate users. M-10. Implement an appropriate QC method at the point of assembly. 78 CycleBeads Procurement and Production Guide

9 M-11. Implement an appropriate QC method at the point of packaging. Based on results of QC audits, QC at assembly should be supplemented by QC procedures at the point of packaging. M-12. Design the device with string of appropriate strength and longevity under conditions of use. M-13. Design the clasp with appropriate dimensions and materials. M-14. Design the beads with colorant in resin. Because of the desire for longevity and the abrasive effects of the o-ring during typical use, colorant should be included in the resin and not applied to the bead after manufacture (like paint). M-15. Design beads with resin colorant of appropriate longevity under conditions of use. M-16. Design beads with easily distinguishable colors. M-17. Design beads with appropriate dimensions. Beads should be designed with appropriate dimensions for easy interaction with the o-ring. M-18. Design and fabricate molds to ensure correct and consistent dimensions. The mold design should incorporate expected (and verified) part shrinkage and should be fabricated from appropriate materials to ensure intra- and interlot consistency. M-19. Design the o-ring with appropriate dimensions and modulus. O-rings should either be procured or molded with appropriate dimensions to ensure correct interaction with the beads. M.-20. Implement a QC method for sampling of the o-ring properties. CycleBeads Procurement and Production Guide 79

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