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  1. 1

    Standards and quality control in contraception.

    Kestelman P

    [Unpublished] 1980. Presented at the International Family Planning Association Seminar for Pharmacists, Dublin, Ireland, January 30, 1980. 8 p.

    In this discussion of standards and quality control in contraception, attention is directed to the following: scope; effectiveness; spermicides; diaphragms; condoms; labeling; evaluation; and stage of testing. The oral contraceptive (OC) is 100% effective, and the condom is not 100% effective. Couples limiting their families tend to use OCs most carefully, while couples spacing their families tend to use condoms less carefully. To make a fair comparison between OCs and the condom, it is necessary to compare like with like. In a recent UK study of married women, the 1st year pregancy rate was 5% for OC, 11% for the condom, and 14% for the diaphragm. For women married since 1970, contracepting after their 1st or 2nd pregnancies, the pregnancy rate was 4% for OCs and only 5% for the condom. Combining a good quality condom with a compatible spermicide is theoretically as effective as OCs. In regard to spermicides, their laboratory testing may bear practically no relation to their contraceptive effectiveness. It is plausible to suppose that spermicides satisfying the former International Planned Parenthood Federation (IPPF) Agreed Test are more effective contraceptives than other spermicides. When last submitted, all spermicides widely available in the UK satisfied the former IPPF Agreed Test. There are few national standards on diaphragms and none on other caps. The International Organization for Standardization (ISO) is attempting to fashion an international diaphragm standard. There are many national condom standards and an ISO technical committee is on the way to an international condom standard. It is important to distinguish between so-called electronic testing which is applied to all condoms, and sample testing, which is the concern of condom standards. Electronic testing seeks to eliminate condoms with holes or weak spots. The sample testing esentially checks the efficiency of that process, which may vary widely. Immediatly after electronic testing, the British Standard (1979) prescribes a sampling frequency of 1%. From each production quantum of 10,000 condoms, 100 random samples are taken and inspected for visible defects. The same condoms are then tested for holes. The Swedish State Standard (1972) prescribes the same test for holes, performed on condoms sampled from every batch imported into Sweden. Different standards also prescribe somewhat different tests for condom strength. Most condom standards prescribe dimensions. There are various requirements on labeling, and some standards prescribe instructions on storage and use. 99.5% freedom from holes is achieved, yet the main cause of method failure is a burst condom. It is guessed that at least 1 in 1000 good quality condoms burst, yielding a pregnancy rate of about 0.3/100 woman years.
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  2. 2

    International standardization of mechanical contraceptives.

    Mellstam S

    IPPF Medical Bulletin. 1983 Jun; 17(3):2-4.

    At least 12 countries have regulations for condoms, and because of the complicated regulations relating to condoms the International Organization for Standardization (ISO) was asked to create a committee for contraceptives. Its objective is to promote the development of standards throughout the world to help the international exchange of goods and services. Following discussions between the World Health Organization (WHO) and ISO it was decided in 1974 to establish a technical ISO committee that would deal with international standards for mechanical contraceptives, comprising condoms, diaphragms, and IUDs. It was also decided that spermicides and oral contraceptives (OCs) should be excluded from the ISO effort, but that they should fall within the responsibility of WHO. The committee, entitled ISO/TC 157 Mechanical Contraceptives, was represented by 35 member countries in 1982. The object of standardizing condoms is to obtain a satisfactory quality that can be accepted throughout the world. To achieve that purpose, acceptable test methods and associated limit requirements and values must be determined, along with rules for storage, packaging, and labeling. The most important factors in determining condom quality are the need to reach agreement on an acceptable number of holes in the condom and the ability to establish limit values for the mechanical properties of the condom. Specific requirements regarding dimensions, resistance to storage, packaging, labeling, and appropriate storage are also important. Up to 1982 the work of ISO for condoms resulted in 8 published international standards, of which 6 deal with test methods, 1 with packaging and labeling, and 1 with storage. Agreement has also been reached within the ISO committee on an additional 3 draft standards. Due to the comparatively small use of diaphragms, standardization efforts in this area do not have the highest priority. ISO/TC 157 has formulated 10 drafts which are being prepared for distribution to the ISO member countries for purposes of voting. 7 of these standards deal with test methods, 1 with sampling and requirements, 1 makes storage recommendations, and 1 refers to packaging and labeling. A working group for standardizing IUDs was established in 1976. It was agreed within ISO/TC 157 after almost 3 years to publish a Technical Report (TR 7439) for IUDs. The report deals with such things as the definition of IUDs, general requirements for type approval, batch inspection, storage recommendations, and packaging and labeling. The report shall constitute the basis for continued standardization efforts for IUDs.
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  3. 3

    Food and Drug Administration approves vaginal sponge.

    Kafka D; Gold RB

    Family Planning Perspectives. 1983 May-Jun; 15(3):146-8.

    On April 1, 1983, the US Food and Drug Administration (FDA) approved a disposable vaginal sponge of soft polyurethane foam saturated with 1 gm of nonoxynol-9 as a nonprescription contraceptive offering 2 improvements over products already available: ability to leave in place up to 24 hours, and no need for additional application of spermicide for repeated acts of intercourse. Clinical tests show the sponge to be comparable in effectiveness to other vaginal methods including the diaphragm. Although no major medical complications have been detected in studies of the sponge thus far, concern over the possibility of its causing toxic shock syndrome led the FDA to require package labeling recommending that the product not be used during menstruation. The sponge was developed by the V.L.I. Corporation of California and will be marketed for about $1 under the brand name "Today." The sponge must be moistened with water before insertion to activate the spermicide, and is believed to prevent conception by releasing the spermicide over 24 hours, blocking the cervix to some extent, and absorbing sperm. The sponge has undergone 5 years of clinical testing in the US and abroad and is the 1st nonprescription contraceptive to go through the safety and efficacy tests required for prescription drugs and devices. Controlled, comparative tests conducted by the International Fertility Research Program began in 1979 in volunteers aged 18-40 who were randomly assigned to the sponge or another vaginal method. Available results are based on 1582 sponge users and 1579 controls. The data reviewed by the FDA advisory committee were based on 720 sponge users and a similar number of diaphragm users in the US segment. The 12-month pregnancy rates from the US trials were 15.8/100 women for the sponge and 11.6/100 women with the diaphragm, not a statistically significant difference. The US data suggest that about 4% of users will develop allergic reactions such as itching, irritation, and rash.
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