Offering extended use of the contraceptive implant via an implementation science framework: a qualitative study of clinicians' perceived barriers and facilitators.

BACKGROUND: The etonogestrel contraceptive implant is currently approved by the United States Food and Drug Administration (FDA) for the prevention of pregnancy up to 3 years. However, studies that suggest efficacy up to 5 years. There is little information on the prevalence of extended use and the factors that influence clinicians in offering extended use. We investigated clinician perspectives on the barriers and facilitators to offering extended use of the contraceptive implant. METHODS: Using the Consolidated Framework for Implementation Research (CFIR), we conducted semi-structured qualitative interviews. Participants were recruited from a nationwide survey study of reproductive health clinicians on their knowledge and perspective of extended use of the contraceptive implant. To optimize the diversity of perspectives, we purposefully sampled participants from this study. We used content analysis and consensual qualitative research methods to inform our coding and data analysis. Themes arose deductively and inductively. RESULTS: We interviewed 20 clinicians including advance practice clinicians, family medicine physicians, obstetrician/gynecologist and complex family planning sub-specialists. Themes regarding barriers and facilitators to extended use of the contraceptive implant emerged. Barriers included the FDA approval for 3 years and clinician concern about liability in the context of off-label use of the contraceptive implant. Educational materials and a champion of extended use were facilitators. CONCLUSIONS: There is opportunity to expand access to extended use of the contraceptive implant by developing educational materials for clinicians and patients, identifying a champion of extended use, and providing information on extended use prior to replacement appointments at 3 years.

Evaluation of the effects of repeated disinfection on medical exam gloves: Part 2. Changes in mechanical properties.

Many healthcare professionals have been forced, under acute shortages, to extend medical exam gloves beyond their intended single use. Despite limited available literature, the CDC proposed a set of guidelines for repeated exam gloves use, indicating a maximum number of treatments for three widely available disinfectants. This study examines how these treatments affect the mechanical properties of latex and nitrile gloves. Furthermore, an acceptability threshold is proposed for changes in tensile property, specifically elastic modulus, as an indication of degradation. This proposed criterion was also applied to similar studies available in the literature to determine applicability and aid in recommendation development. Three different latex glove brands and three nitrile brands were exposed to repeated treatments of an alcohol-based hand rub, diluted bleach, or soap and water. Tensile tests of samples cut from untreated and treated gloves were performed to assess the change in elastic modulus induced by each treatment. The findings suggest that latex gloves performed well within the CDC recommended guidelines of six repeated treatments for an ethanol-based hand rub and 10 repeated treatments of either dilute bleach or soap and water. Nitrile exam gloves, on the other hand, showed significant changes in elastic modulus, with more inconclusive results among brands. This was especially true for treatment with dilute bleach and soap and water. Further research is needed to investigate the effects of disinfection products on the mechanical integrity of nitrile exam gloves. The results support the use of five repeated treatments of ethanol-based hand rub for nitrile exam gloves, a lower threshold than currently recommended by the CDC. This research also supports that the CDC recommendation of 10 repeated treatment with soap and water is appropriate for latex exam gloves, but not for nitrile exam gloves. Occupational safety and health professionals involved in the selection of disposable exam gloves for infection control should consider the compatibility of the glove polymer type with available disinfectants, especially if extended use with repeated disinfection becomes necessary.

Prospect of compassionate use in China from remdesivir. / ä»Žç‘žå¾·è¥¿éŸ¦å±•æœ›ä¸­å›½åŒæƒ ç”¨è¯.

Compassionate use may play an important role in responding to major public health emergencies. The Jinyintan Hospital in Wuhan launched the III phase of clinical trials of antiviral drug-remdesivir on February 6, 2020. As an unapproved drug, remdesivir raised great concerns about compassionate use in China. Compassionate use is therapeutic use of unauthorized drugs outside of clinical trials. It is used for critically ill patients with life-threatening diseases and no effective treatment means in China. Patients voluntarily apply to their medical institutions. The Center for Drug Evaluation, National Medical Products Administration shall conduct scientific and reasonable review, approval, and supervision on patients' application for compassionate medication. By analyzing and comparing the current situation of compassionate use at home and abroad, it is expected to provide thinking for the development of compassionate use system in China.

Effectiveness and safety of extending intrauterine device duration: a systematic review.

OBJECTIVE: To systematically review the literature to determine if extended use of intrauterine devices, including the copper or levonorgestrel intrauterine device, beyond approved durations is effective and safe for preventing pregnancy. STUDY DESIGN: We searched PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Global Index Medicus from inception through June 2019. We considered primary studies of women using the T380A copper or currently available levonorgestrel intrauterine devices past their approved duration (extended use). The primary outcome was pregnancy. Safety outcomes included adverse events and side effects that led to discontinuation. We abstracted study data into evidence tables and assessed study quality as related to the risk of bias, precision, and external validity. For each intrauterine device type, we calculated a pooled pregnancy rate during the first 2 years of extended use using the Poisson inverse variance method. RESULTS: Of 4068 studies identified by our search, 4 good-to-poor-quality studies of the 52 mg levonorgestrel intrauterine device (approved for 5 years), with a total of 2098 women starting extended use, and 2 good-to-fair-quality studies of the T380A copper intrauterine device (approved for 10 years), with 245 women starting extended use, met inclusion criteria. For the levonorgestrel intrauterine device, the pooled pregnancy rate was 0.02 per 100 person-years (95% confidence interval, 0.00-0.45) in year 6, 0.03 per 100 person-years (95% confidence interval, 0.00-0.71) in year 7, and 0.02 per 100 person-years (95% confidence interval, 0.00-0.29) in years 6 and 7 combined. During this same time, annual rates of adverse events or discontinuation owing to side effects ranged from 0 to 3.7 per 100 participants. For the copper intrauterine device, the pooled pregnancy rate for years 11 and 12 was 0.0 per 100 person-years (95% confidence interval, 0.0-0.8), and annual rates of adverse events and discontinuation owing to side effects during extended use ranged from 0 to 4.6 per 100 participants. CONCLUSION: The available evidence suggests that rates of pregnancy, adverse events, and discontinuation owing to side effects during the first 2 years of extended use of the 52 mg levonorgestrel intrauterine device and the T380A copper intrauterine device are low and comparable to rates during approved duration of use. Data were limited in quantity and quality, and may not be generalizable to all intrauterine device users.

Extended use of face masks during the COVID-19 pandemic - Thermal conditioning and spray-on surface disinfection.

The current COVID-19 pandemic has resulted in globally constrained supplies for face masks and personal protective equipment (PPE). Production capacity is limited in many countries and the future course of the pandemic will likely continue with shortages for high quality masks and PPE in the foreseeable future. Hence, expectations are that mask reuse, extended wear and similar approaches will enhance the availability of personal protective measures. Repeated thermal disinfection could be an important option and likely easier implemented in some situations, at least on the small scale, than UV illumination, irradiation or hydrogen peroxide vapor exposure. An overview on thermal responses and ongoing filtration performance of multiple face mask types is provided. Most masks have adequate material properties to survive a few cycles (i.e. 30 min disinfection steps) of thermal exposure in the 75°C regime. Some are more easily affected, as seen by the fusing of plastic liner or warping, given that preferred conditioning temperatures are near the softening point for some of the plastics and fibers used in these masks. Hence adequate temperature control is equally important. As guidance, disinfectants sprayed via dilute solutions maintain a surface presence over extended time at 25 and 37°C. Some spray-on alcohol-based solutions containing disinfectants were gently applied to the top surface of masks. Neither moderate thermal aging (less than 24 h at 80 and 95°C) nor gentle application of surface disinfectant sprays resulted in measurable loss of mask filter performance. Subject to bio-medical concurrence (additional checks for virus kill efficiency) and the use of low risk non-toxic disinfectants, such strategies, either individually or combined, by offering additional anti-viral properties or short term refreshing, may complement reuse options of professional masks or the now ubiquitous custom-made face masks with their often unknown filtration effectiveness.

Clinical safety and performance of VIVIA: a novel home hemodialysis system.

Background: The VIVIA Hemodialysis System (Baxter Healthcare Corporation, Deerfield, IL, USA) was designed for patient use at home to reduce the burden of treatment and improve patient safety. It has unique features including extended use of the dialyzer and blood set through in situ hot-water disinfection between treatments; generation of on-line infusible-quality dialysate for automated priming, rinseback and hemodynamic support during hypotension and a fully integrated access disconnect sensor. Methods: The safety and performance of VIVIA were assessed in two clinical studies. A first-in-man study was a prospective, single-arm study that involved 22 prevalent hemodialysis (HD) patients who were treated for ∼4 h, four times a week, for 10 weeks. A second clinical study was a prospective, single-arm study (6-8 h of dialysis treatment at night three times a week) that involved 17 prevalent patients treated for 6 weeks. Results: There were 1114 treatments from the two studies (first-in-man study, 816; extended duration study, 298). Adverse events (AEs) were similar in the two studies to those expected for prevalent HD patients. No deaths and no device-related serious AEs occurred. Adequacy of dialysis ( Kt / V ) urea in both clinical trials was well above the clinical guidelines. VIVIA performed ultrafiltration accurately as prescribed in the two studies. The majority of patients achieved 10 or more uses of the dialyzer. Endotoxin levels and bacterial dialysate sampling met infusible-quality dialysate standards. Conclusion: These results confirm the safety and expected performance of VIVIA.

Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant.

STUDY QUESTION: Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? SUMMARY ANSWER: The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. WHAT IS KNOWN ALREADY: The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. STUDY DESIGN SIZE, DURATION: For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan-Meier (K-M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. PARTICIPANTS/MATERIALS, SETTING, METHODS: The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. MAIN RESULTS AND THE ROLE OF CHANCE: Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K-M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2-1.8] and 0.8 per 100 W-Y [95% CI: 0.2-2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p < 0.05). The median duration of the implant removal procedure was 64 seconds shorter for the one-rod ENG-implant (inter-quartile range (IQR) = 30.5, 117.5) compared to the two-rod LNG product (IQR = 77.0, 180.0). The 2-year rate for pregnancy in the IUD group compared with the two implant groups combined was 4.1 per 100 W-Y [95% CI: 2.5-6.5]. LIMITATIONS, REASONS FOR CAUTION: Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. WIDER IMPLICATIONS OF THE FINDINGS: The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. TRIAL REGISTRATION: The trial was registered as ISRCTN33378571. STUDY FUNDING/COMPETING INTERESTS: The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.

Evolution of extended use of the combined oral contraceptive pill.

BACKGROUND: Extended use of the combined oral contraceptive pill (COC), defined as taking active pills for at least 28 days, has been used in order to avoid bleeding at important times and to treat gynaecological conditions such as endometriosis. We examined the main issues involved in extended use of the COC and how it has evolved from being one of medicine's best-kept secrets to becoming more widely accepted by women and the medical community. STUDY DESIGN: Literature review, using Medline, Embase, Pubmed, CINHAL Plus, the Cochrane Database of Systematic Reviews and the Ovid database for all relevant clinical trials, systematic reviews, meta-analyses, literature reviews, scientific papers and individual opinions between 1950 and October 2013. RESULTS: Accumulating evidence supports various forms of extended pill use as suitable alternatives to the standard (21/7) regimen. In terms of user preference, much hinges on whether women wish to reduce the frequency or duration of scheduled bleeding on the combined pill. Available data on the safety of extended pill regimens do not give cause for concern, but longer term data should be collected. CONCLUSIONS: Information for women considering extended COC regimens should keep pace with research findings to ensure that women and clinicians are better informed about the choices available.

An Integrative Review of Extended Use of Intrauterine Devices.

OBJECTIVE: To explore the evidence on the impact of extended use of intrauterine devices (IUDs) use among women of reproductive age. DATA SOURCES: Electronic resource databases used were PubMed, CINAHL, and Google Scholar. Peer-reviewed articles published during 2012 to 2022 were considered. ARTICLE SELECTION: Ten articles met the criteria and included data for a total of 7,420 women. DATA EXTRACTION: Data were extracted from each study using the subheadings "Author/Date," "Participants," "Methods," "Interventions," and "Outcomes." Additionally, the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were used to guide data extraction. DATA SYNTHESIS: Common themes were identified among each of the articles that supported the purpose of this integrative review, such as adverse effects, perceived effectiveness, pregnancy prevention, and cost effectiveness of extended use of IUDs. CONCLUSION: The available evidence supports the notion that extending IUD use beyond the original time frame approved by the U.S. Food and Drug Administration is safe and effective with minimal side effects. However, there remains a paucity of evidence examining this topic.

Inadvertent Extended use of ImplanonR Contraceptive Implants by Clients in Jos, Nigeria: An Interesting Finding.

Background: Contraceptive implants are popular methods among women accessing family planning in Jos. Women appear to be using these methods for longer periods despite adequate counselling including the use for a maximum period prescribed by the manufacturers. Methodology: This was a retrospective, cross sectional study of all clients who had ImplanonR classic removed between May 2006 and December 2019. The register of acceptors of the implant was retrieved and relevant variables collated and analyzed for age, duration of use of the implant and the indication for removal. The data was analyzed using the Stata statistical software version 14, College Station, Texas, USA. Results: A total of 1,805 implants were inserted, when all of them would have been removed, only 596(33%) were documented to have been removed. The mean age of the clients was 31.031 ± 5.56 years, range 18-51 years. The mean duration of use of ImplanonR was 29.370 ± 11.756 months, range 0.5-72months. About 83(13.9%) implants were used beyond the expected duration of use of 36 months. By the 3rd, 4th, and 5th years, 86.1%, 97.5% and 99.2% had had the implants removed. Clients used the method beyond the stipulated expiration of the implants, up to twice the period expected. There was no failure or pregnancy recorded. Conclusion: About one-sixth of women extended the use of ImplanonR implants. This may be more as only 33.0% of them returned for removal at the facility where it was inserted. However, there was no pregnancy recorded in this group of women despite the extended duration of use.

One for Everyone: A Study of User Satisfaction Among Health-Care Providers Regarding Extended Use of N95 Masks During the COVID-19 Pandemic.

OBJECTIVE: This study was conducted to assess the feasibility of extended use of N95 masks in our hospital during the coronavirus disease 2019 (COVID-19) pandemic. We also studied the use pattern, user satisfaction, and issues faced during extended use of the mask. METHODS: This cross-sectional study was conducted among health-care providers in a large tertiary care teaching hospital in northern India from April 1 to May 31, 2020. A list was prepared from the institute's register, and participants were chosen by random sampling. The data collected from the physical forms were transferred to excel sheets. RESULTS: A total of 1121 responses were received. The most common problem stated with reuse of N95 masks was loss of fit followed by damage to the slings, highlighted by 44.6% and 44.4% of the participants, respectively. A total of 476 (42.5%) participants responded that they would prefer "cup-shaped N95 mask with respirator". The median scores regarding the satisfaction with the quality of masks and their fit was also 4 each. CONCLUSIONS: It was concluded that the extended use of N95 masks was acceptable, with more than 96% of the participants using these masks.

Fit-failure rate associated with simulated reuse and extended use of N95 respirators assessed by a quantitative fit test.

OBJECTIVE: We quantitatively assessed the fit failure rate of N95 respirators according to the number of donning/doffing and hours worn. DESIGN: Experimental study. SETTING: A tertiary-care referral center in South Korea. PARTICIPANTS: In total, 10 infection control practitioners participated in the fit test. METHODS: The first experiment comprised 4 consecutive 1-hour donnings and fit tests between each donning. The second experiment comprised 2 consecutive 3-hour donnings and fit tests between each donning. The final experiment comprised fit tests after an 1-hour donning or a 2-hour donning. RESULTS: For 1-hour donnings, 60%, 70%, and 90% of the participants had fit failures after 2, 3, and 4 consecutive donnings, respectively. For 3-hour donnings, 50% had fit failure after the first donning and 70% had failures after 2 consecutive donnings. All participants passed the fit test after refitting whenever fit failure occurred. The final experiment showed that 50% had fit failure after a single use of 1 hour, and 30% had fit failure after a single use of 2 hours. CONCLUSIONS: High fit-failure rates were recorded after repeated donning and extended use of N95 respirators. Caution is needed for reuse (≥1 time) and extended use (≥1 hour) of N95 respirators in high-risk settings such as those involving aerosol-generating procedures. Although adequate refitting may recover the fit factor, the use of clean gloves and strict hand hygiene afterward should be ensured when touching the outer surfaces of N95 respirators for refitting.

Personal protective equipment preservation strategies in the covid-19 era: A narrative review.

BACKGROUND: The COVID-19 pandemic has led to personal protective equipment (PPE) supply concerns on a global scale. While efforts to increase production are underway in many jurisdictions, demand may yet outstrip supply leading to PPE shortages, particularly in low resource settings. PPE is critically important for the safety of healthcare workers (HCW) and patients and to reduce viral transmission within healthcare facilities. A structured narrative review was completed to identify methods for extending the use of available PPE as well as decontamination and reuse. METHODS: Database searches were conducted in MEDLINE and EMBASE for any available original research or review articles detailing guidelines for the safe extended use of PPE, and/or PPE decontamination and reuse protocols prior to September 28, 2020. Grey literature in addition to key websites from the Centers for Disease Control and Prevention (CDC), World Health Organization (WHO), Infection Prevention Association of Canada (IPAC), and the National Health Service (NHS) was also reviewed. RESULTS: Extended use guidelines support co-locating patients with confirmed COVID-19 within specific areas of healthcare facilities to enable the use of PPE between multiple patients, and reduce PPE requirements outside these areas. Decontamination strategies for N95 respirators and face shields range from individual HCWs using conventional ovens and microwave steam bags at home, to large-scale centralized decontamination using autoclave machines, ultraviolet germicidal irradiation, hydrogen peroxide vapors, or peracetic acid dry fogging systems. Specific protocols for such strategies have been recommended by the US CDC and WHO and are being implemented by multiple institutions across North America. Further studies are underway testing decontamination strategies that have been reported to be effective at inactivating coronavirus and influenza, and on SARs-CoV-2 specifically. CONCLUSIONS: This narrative review summarizes current extended use guidelines and decontamination protocols specific to COVID-19. Preserving PPE through the implementation of such strategies could help to mitigate shortages in PPE supply, and enable healthcare facilities in low resource settings to continue to operate safely for the remainder of the COVID-19 pandemic.

The N-95 mask: invaluable ally in the battle against the COVID-19 pandemic.

The present COVID-19 pandemic, caused by the airborne SARS-CoV-2 virus, has highlighted the vital importance of appropriate personal protective equipment for all exposed health care workers. The single most important part of this armor is the N-95 mask. With the awareness that the virus is spread by both droplets and through the aerosolized route, the N-95 provides protection that a surgical mask cannot match. This timely review looks at the special advantages that an N-95 offers over a surgical mask with specific reference to the COVID-19 epidemic. It also emphasizes the crucial importance of ensuring quality masks with a proper fit. Finally, with acute scarcities of N-95 masks being reported from hospitals globally, it reviews recent literature which attempts to prolong the life of these masks with extended use, reuse and decontamination of used masks.

Does Extended Use of Clopidogrel-Based Dual Anti-Platelet Therapy Increase the Risk of Gastrointestinal Bleeding?

BACKGROUND: Clopidogrel-based dual anti-platelet therapy (CDAPT) has shown significant benefits in the management of coronary artery disease (CAD), up to 1-year duration. Gastrointestinal bleeding (GIB) is one of the limiting factors for prolonged use of CDAPT. METHODS: We identified all patients taking CDAPT from our ambulatory clinics. Demographic, clinical, laboratory and pharmacological data were abstracted. American Heart Association (AHA) guidelines were used to determine the duration of CDAPT therapy. The study population was divided into two groups based on the duration of therapy. Individuals who received CDAPT more than 12 months were deemed as extended use. RESULTS: A total of 351 patients with CAD were taking CDAPT. Majority of patients (276/351, 79%) were taking CDAPT beyond 1 year. There were no differences in baseline characteristics between the two groups. There was no significant difference in the incidence of GIB between the two groups. However, in subgroup analysis, there was a significant difference in the incidence of GIB in men. Men who were taking CDAPT beyond 12 months had almost three times higher incidence of GIB compared to those who were taking less than 12 months (25% vs. 8%, P = 0.04). The excess GIB in men prevailed despite adjusting for non-steroidal anti-inflammatory drugs (NSAIDs) or direct oral anticoagulant (DOAC) use. CONCLUSIONS: We found that a majority of patients were taking CDAPT beyond the recommended duration. We observed that men taking CDAPT for an extended duration had a three times higher incidence of GIB. It would be reasonable for physicians to be aware of the higher risk of GIB in men and carefully assess the risks and benefits of extended use of CDAPT.

Impact of extended use and decontamination with vaporized hydrogen peroxide on N95 respirator fit.

BACKGROUND: To address the shortage of N95 respirators in the wake of the COVID-19 pandemic, some organizations have recommended the decontamination of respirators using vaporized hydrogen peroxide (VHP) sterilizer for up to 10 times. However, these recommendations are based on studies that did not take into account the extended use of respirators, which can degrade respirator fit. METHODS: We investigated the impact of extended use and decontamination with VHP on N95 Respirator Fit. We performed a prospective cohort study to determine the number of times respirators can be decontaminated before respirator fit test failure. The primary outcome was the overall number of cycles required for half of the respirators to fail (either mechanical failure or fit test failure). RESULTS: Thirty-six participants completed 360 hours of respirator usage across 90 cycles. The median number of cycles completed by participants before respirator failure was 2. The overall number of cycles required for half of respirators to fail was 1, 3, 5, and 4 for the 3M 1860(S), 3M 1870+, Moldex 151X and ProGear 88020 respirators, respectively. CONCLUSIONS: The combination of prolonged usage and VHP decontamination was associated with early failure. Decontamination and prolonged usage of respirators must be done cautiously.

Planning for Epidemics and Pandemics: Assessing the Potential Impact of Extended Use and Reuse Strategies on Respirator Usage Rates to Support Supply-and-Demand Planning Efforts.

During epidemics and pandemics healthcare personnel (HCP) are on the front line of disease containment and mitigation. Personal protective equipment (PPE), such as NIOSH-approved N95 filtering facepiece respirators (FFRs), serve an important role in minimizing HCP risks and are in high demand during public health emergencies. Because PPE demand can exceed supply, various public health strategies have been developed to reduce the rate of PPE consumption as supply dwindles. Extended use and limited reuse of N95 FFRs are strategies advocated by many governmental agencies used to increase the number of times a device can be used. Increased use of respirators designed for reuse-such as powered air-purifying respirators (PAPRs) and elastomeric half-mask and full facepiece air-purifying respirators- is another option designed to reduce the continuous need for new devices as the daily need for respirator use increases. Together, these strategies are designed to reduce the number of PPE units that must be discarded daily and, therefore, extend the longevity of available supply. The purpose of this paper is to theoretically estimate the impact of extended use and limited reuse strategies for N95 FFRs and the increased use of reusable respirator options on PPE consumed. The results suggest that a considerable reduction in PPE consumption would result from extended use and limited reuse of N95 FFRs and the increased use of respirators designed for reuse; however, the practical benefits must be balanced with the risks and economic costs. In addition, extended use and reuse strategies must be accompanied by proper procedures to reduce risk. The study is designed to support epidemic and pandemic PPE supply and demand planning efforts.

Contraception Update: Extended Use of Long Acting Methods, Hormonal Contraception Risks, and Over the Counter Access.

The clinical update serves as a brief review of recently published, high-impact, and potentially practice changing journal articles summarized for our readers. Topics include menopause, sexual dysfunction, breast health, contraception, osteoporosis, and cardiovascular disease. For this clinical update, we reviewed both reproductive and general medical journals for clinically relevant publications related to the use of contraceptive methods. We have chosen to highlight articles examining the extended use of highly effective (long-acting) methods, complications of implants, risks associated with oral combined hormonal contraceptives, and the availability of over the counter contraception.

Pregnancy outcomes associated with extended use of the 52-mg 20 µg/day levonorgestrel-releasing intrauterine system beyond 60 months: A chart review of 776 women in Brazil.

OBJECTIVE: To assess the contraceptive performance of the 52-mg 20 µg/day levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena; Bayer Oy, Turku, Finland) among women who maintain the same device without changes after 60 months. STUDY DESIGN: This is a chart review study in which we assessed the charts of 766 women who continue the same LNG-IUS for contraception beyond 60 months. The women were evaluated at the Family Planning clinic, University of Campinas Medical School, Campinas, SP, Brazil, from November 1990 to March 2011. We obtained sociodemographic data, duration of use, continuation and discontinuation rates and reasons, bleeding pattern at the recorded last visit. The statistical analysis was performed using Kaplan-Meier analysis. RESULTS: A total of 776 charts were identified of women who used the LNG-IUS beyond 60 months. The mean age (±S.E.M.) at LNG-IUS placement was 32.0±0.2 years (ranged 15 to 44 years; median was 32 years). The distribution of number of pregnancies was 0-1 (45%); 2-4 (54.1%) and≥5 (0.9%). The median length of the LNG-IUS' use was 73 months after placement (ranged 61-184 months). Zero pregnancies were reported and the main reasons for discontinuation were expiration of approved effective lifespan, menopause and planning pregnancy. The cumulative women-years (W-Y) of exposure were 967 and 1403 up to seven and 15 years, respectively. The main bleeding pattern reported by the women was amenorrhea. CONCLUSIONS: The 52-mg 20 µg/day LNG-IUD (Mirena) showed continue contraceptive efficacy beyond 5 years of use with no pregnancies detected over 967 and 1403 W-Y up to seven and 15 years after placement. IMPLICATIONS STATEMENT: The 52-mg 20 µg/day LNG-IUD presented a very high contraceptive efficacy beyond the first 5 years of lifetime labeled. Increasing data support that efficacy beyond 5 years of use, and new data suggested efficacy as long as 15 years. Healthcare professionals, policy makers and stakeholders could take advantage of the present information to decide to maintain the same device at least up to seven years. Furthermore, amenorrhea could be a good indicator of contraceptive effect.