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On-farm composting hand­ • It must have a resistance threshold greater than that book anxiety symptoms or ms buy hydroxyzine 10 mg with visa. Because the science of infection prevention is rapidly advancing and the knowledge base continues to anxiety symptoms gi purchase 25 mg hydroxyzine with amex expand anxiety weight loss generic hydroxyzine 10 mg overnight delivery, readers are advised to anxiety symptoms weakness discount hydroxyzine 10 mg overnight delivery check current product information provided by the manufacturer of: x each drug to verify the recommended dose, method of administration and precautions for use; and x each device, instrument or piece of equipment to verify recommendations for use and/or operating instructions. In addition, all forms, instructions, checklists, guidelines and examples are intended as resources to be used and adapted to meet national and local healthcare settings’ needs and requirements. Printed in the United States of America this publication was made possible in part through support provided by the Population, Health and Nutrition Office of the U. Agency for International Development/Indonesia, and by the Maternal and Child Health Division, Office of Health, Infectious Diseases and Nutrition, Bureau for Global Health, U. The opinions expressed herein are those of the authors and do not necessarily reflect the views of the U. It is based in large part on the experience gained during the last 11 years since publication of the first manual, 1 Infection Prevention for Family Planning Service Programs. It reflects what we (the authors) have learned from countless healthcare workers throughout the world who abstracted, translated, taught and used the simple, practical procedures and practices contained in that manual. During the past decade, the success of the first manual as an international infection prevention reference for use in outpatient settings, such as family planning programs, has been amply documented. The challenge in writing this new manual has been to keep the content as simple and practical as possible while at the same time incorporating essential information on a much larger scale—infection prevention guidelines for hospitals providing general medical, surgical and obstetric services. Therefore, to make it as useful as possible, we sought input from a wide range of health professionals and international organizations, and we are deeply indebted to them for their interest, support and contributions. Over the years, both individuals have contributed greatly to making hospitals safer for patients as well as for the healthcare professionals and staff working in them. In particular: x Pat Lynch has worked in the field of infection control since 1968. Infection Prevention for Family Planning Service Programs: A Problem Solving Reference Manual. His contribution to Chapter 7 (Safe Practices in the Operating Room) and Appendix D (Precautions for the Surgical Team) was crucial and freely given. Finally, this manual could not have been produced without the exceptional patience, editing and desktop publishing expertise of Youngae Kim. How Personal Protective Equipment Blocks the Spread of Microorganisms 5-4 Figure 5-2. Creating Gauntlet Gloves from Previously Used Surgical Gloves 7-8 Figure 7-2a and b. Single-Chamber Clay Incinerator 8-9 xiv Infection Prevention Guidelines Figure 8-4. Guidelines for Processing Instruments, Surgical Gloves and Other Items 9-4 Table 10-1. Formula for Making a Dilute Solution from a Concentrated Solution 10-3 Table 10-2. Floor Plans for Instrument Cleaning, High-Level Disinfecting and Sterilizing Areas in a Clinic and Larger Facility 15-3 Figure 15-2. Checklist to Assess Whether Infection Prevention Guidelines Are Being Followed 19-7 Table 21-1. Empiric Use of Transmission-Based Precautions (by signs and symptoms) 21-6 Table 21-5. Clinical Syndromes or Conditions to Be Considered for “Empiric Use” of Transmission-Based Precautions 21-7 Table 21-6. Summary of Types of Precautions and Patients Requiring the Precautions 21-8 Infection Prevention Guidelines xv Figure 22-1a and b. Patient and Operation Characteristics That May Influence the Risk of Developing a Surgical Site Infection 23-5 Table 23-2. Key concepts and practices that are now more widely accepted in many countries include: x Recognition of the dual role of infection prevention not only in reducing the risk of disease transmission to clients and patients but also protecting healthcare workers at all levels—from physicians and nurses to cleaning and housekeeping staff. Because of the demand for infection prevention guidelines for use at district hospitals, not just ambulatory family planning services, this manual contains many new chapters and has been completely rewritten to take advantage of the wealth of new information and practical interventions. The intent is to provide the user a quick reference to what Infection Prevention Guidelines xvii the essentials are without having to consult other sources. In addition, the manual has been designed to provide the information and recommendations in a simple, easily understandable format so that users can find what they want, when they want it. The infection prevention principles and scientific information, on which this manual is based, are universally applicable. In selecting the material, the emphasis has been on choosing those practices and procedures that are doable even in the poorest settings. Ones designed to minimize cost and the need for expensive technology or fragile equipment while at the same time assuring a high degree of safety. As such, this manual is not intended to be a major resource for infection prevention programs in affluent settings. In fact, some of the practices recommended may be at odds with established norms; for example, the need for decontamination as the first step in processing soiled instruments and other items in order to make them safer for cleaning staff to handle; or an even larger issue—the reuse of disposable (single use) items. Because of the severe cost constraints faced by hospital managers in the poorest countries, the manual is geared to prevention, especially preventing postoperative obstetrical and general surgical infections, as well as those resulting from the use of invasive medical devices. Infection surveillance and control, both important elements of infection control programs, are only briefly touched on because sound surveillance systems are lacking in most countries and resources to treat hospital-acquired (nosocomial) infections or antibiotic-resistant infections, even when 1 identified, rarely are available. It is recognized, however, that the strategies, priorities and proven methods of infection risk reduction described in this manual will need to be adapted to reflect the existing conditions in each country. Only through this process can much needed changes be implemented and patient care in hospitals and clinics improved. In addition to providing new insights on improving infection prevention, it also contains much needed practical guidance on the role of infection surveillance and control efforts when resources are limited. Moreover, it provides a broader framework, one that includes the control and treatment of antibiotic-resistant nosocomial infections. Readers are encouraged to consult this manual for additional information on these topics. The emphasis is on providing the scientific data supporting their use and appropriateness in situations where resources and manpower are limited. Also, several new chapters have been added based on the new Standard Precautions, which must be used when caring for all clients and patients attending healthcare facilities. Moreover, because the most serious and frequent site for accidental injuries and exposure to bloodborne pathogens is the operating room, a separate chapter and appendix detailing safety practices, tips on how to design safer operations and a full set of safety checklists for making the operating room safer have been added. When combined with data from several new or updated appendices, which contain more detailed supplemental “how to” information, health workers now have the information they need to solve many of the instrument and equipment problems and reprocessing issues not previously addressed. In hospitals, housekeeping services and traffic flow systems and activity patterns are more diverse and complex as well. Moreover, the risk of exposure to bloodborne pathogens and other life threatening infections is not confined just to operating and recovery rooms and patient care areas. Staff working in routine chemistry, clinical pathology and bacteriology laboratories as well as those providing blood bank and transfusions services need to be aware of the risks and how to prevent accidental injuries and exposures. Therefore, guidelines and recommended preventive practices for these staff have been included. Finally, in dealing with the overall management of infection prevention programs, the role of the infection prevention committee or working group is critical for handling routine problems, developing workable guidelines and protocols, actively supporting their use and modeling the appropriate preventive behaviors. Representatives from all parts of the healthcare facility who are interested in making the workplace safer should be encouraged to serve this vitally important function. Hospitals now need practical, symptom-based isolation guidelines to prevent patients and health workers at all levels Infection Prevention Guidelines xix from being inadvertently exposed to these serious infectious diseases as well as others transmitted by the airborne, droplet and contact routes. Also included is practical guidance designed to help prevent the most common and serious nosocomial infections in hospitalized patients—urinary tract infections, diarrhea and pneumonia—as well as infections following surgery, maternal and newborn infections and those associated with the use of an ever-increasing number of intravascular devices. Because safely managing food and water in hospitals is important in preventing the spread of infections, these topics are also covered. Finally, because outbreaks of serious infections do occur, guidelines are included for how to investigate them as well as how to monitor infection prevention program activities most cost-effectively. Using the Manual It is anticipated this manual will serve as an international reference guide for use in limited resource settings.

Mita Kotecha An Extensive Assessment of Ethnomedicinal Professor Plants of Tribal Areas of Udipur District w anxiety symptoms 2 buy discount hydroxyzine 10mg online. Mohan Lal Jaiswal Ethanobotanical Survey of Amboli Ecohotspot of Associate Professor Western Ghats of Maharasstra in Prospective of Dravyaduna anxiety young living cheap hydroxyzine 25 mg online. Sudipta Kumar An In-Vitro Study to anxiety symptoms 7 months after quitting smoking buy hydroxyzine 10 mg with mastercard evaluate the Effect of Gajarmal Rath Chaturthamalaka Rasayan on Leucocyte and Assistant Professor Immunoglobulin w anxiety quotes cheap 10 mg hydroxyzine with mastercard. Mohan Lal Jaiswal In-vivo Madhumehgan Karma Antidiabetic Associate Professor Activity of Snuhi Ksheer w. A Rama Murthy An Experimental Evaluation of Anti Fatigue Assistant Professor Activity of Sharmhar Mahakashya and its Applicability in Sports Medicine. Clinical: Clinical services were rendered to Indoor and Outdoor patients of the hospitals by this Department. Mita Kotecha A Beginner’s Guide To Ayurveda Chakrapani Publications Professor Jaipur (B) Articles Published in Journals/Magazines: Sl. International Journal of Professor Ayurvedic and Herbal Medicine Volume 6, Issuee:1 (2016) 2. Mita Kotecha Role of Ayurveda Herbs in Drugs Induced World Journal of Professor Toxicity. Mita Kotecha Antimicrobial Evaluation of Leaves and Root World Journal of Professor Bark of Moringa oleifera lam. Mita Kotecha An Ayurveda Approach to Combat Toxicity of International Journal of Professor Chemo-Radiotherapy in Cancer Patients. Mita Kotecha Antimicrobial Evaluation of Leaves of International Journal of Professor Balanites Aegyptiaca(Linn. Mita Kotecha Rationality Behind Ayurveda Compound International Journal of Professor Formulations A Bird’s Eye View. Mita Kotecha Preliminary Phytochemical Screening of Journal of Pharmacognocy Professor Basella rubra linn. Mohan lal Medicinal Uses of Snuhi A Historical Review Journal of Drug Research, Jaiswal Volume 5, Issue 2 Associate Professor June 2016 12. Mohan lal Therapeutic Benefits of Takra (Buttermilk) International Journal of Jaiswal For Human Health. Ayurveda and Pharma Associate Professor Research Volume 4, Issue 8 September 2016 14. Mohan lal Rationality Behind Ayurveda compound International Journal of Jaiswal Formulations A Bird’s Eye View. Ayurveda and Pharma Associate Professor Research Volume 4, Issue 9 September 2016 15. Mohan lal Preliminary Pharmacognostical and Ancient Science of Life Jaiswal Phytochemical Investigation of Blepharis Volume 36, Issue 2 Associate Professor Sindica T Anders Seed. Mohan lal Ayurveda Medicinal Plants for Asthikshaya Journal of Ayurvedic and Jaiswal (Osteoporosis): A Review. International Journal of Assistant Professor Ayurvedic and Herbal Medicine 2016; 2(3) May –June2016 23. A Rama Murthi Medicinal Plants Used in Various Indian International Journal of Assistant Professor Traditional Customs. A Rama Murthi Hypertension: Management through World Journal of Assistant Professor Ayurveda Herbs World Journal of Pharmacy Pharmacy and and Pharmaceutical Sciences. A Rama Murthi A Comparative Phytochemical Study of World Journal of Assistant Professor Different Types of Kapikachhu Seeds w. Sudipta Kumar Refine Flour (Maida) as a Hidden Cause of Journal of Ayurveda Rath Diabetes Mellitus. Sudipta Kumar Antimicrobial Activity of Six Ayurveda Herbs Journal of Ayurveda & Rath Used for Wound Wrapping Explained by Holistic Medicine Assistant Professor Charaka w. Sudipta Kumar Immunomodulatory Activity of Triphala and Int j ayu pharm chem Rath its Individual Constituents w. Dr Sumit Nathani Role of Ayurveda Herbs in Drug Induced World Journal of Assistant Professor Toxicity. Dr Sumit Nathani A Clinical Evaluation of Efficacy of International Journal of Assistant Professor Kapikacchu Churna (Black Seeds) in the Ayurvedic Medicine Management of Klaibya. Dr Sumit Nathani Critical Appraisal on Raktavaha Srotas in World Journal of Assistant Professor Context to Raktapradoshaj Vyadhi. Gaurav Sharma A Comparative Pharmacognosy Study of International Journal of Pharmacologist Black And White Seeds of Kapikacchu Pharmaceutical Sciences (Mucuna Pruriens (L. Gaurav Sharma Antimicrobial Evaluation of Leaves of International Journal of Pharmacologist Balanites Aegyptica (Linn. Gaurav Sharma Antimicrobial Evaluation of Leaves & Root World Journal of Pharmacologist Bark of Moringa Oleifera Lam A Pharmacy and Comparative Study. Gaurav Sharma Review on Pharmacological and Medicinal Journal of Drug Research Pharmacologist Properties of Papaya (Carica Papata Linn. Mita Kotecha Participated as Co-ordinator of a Rice in Madhumeha: What Professor Scientific Session of Sambhasha: Ayurveda Says Mita Kotecha Pre-conference Symposium and Participated as Subject Professor Conference Madhusamvada 17 held at Expert. Mohan Lal Jaiswal 2-day Workshop on ‘Documentation and Participated as Expert Associate Professor Validation of the Local Health Traditions Member. Mohan Lal Jaiswal Participated as Co-ordinator of a Attended as Co-Chairperson Associate Professor Scientific Session of Sambhasha: of a Scientific Session. Mohan Lal Jaiswal Workshop on Scientific Writing, Associate Professor organised by National Institute of Ayurveda, Jaipur on 8-9 February 2017. Mohan Lal Jaiswal National Seminar on Ethno–Medicinal Attended as Chairperson of a Associate Professor Practices in Andaman and Nicobar Scientific Session. Islands: Scope, Limitation and Prospective at Rigional Research Centre of Ayurveda on 11-12 November 2013 at Port-Blair. Mohan Lal Jaiswal Launch of National Campain and National Medicinal Plants for National Associate Professor Seminar on Medicinal Plant organised by Health and Wealth. National Medicinal Plants Board, New Delhi at Agricultural Research Centre, Jaipur on 20-21 August 2016. Associate Professor Research and Development Strategy for Endocrine Disorders organised by M. Assistant Professor Management of Annavahasrotas Vyadhi organsied at Rishikul Campus, Haridwar Uttarakhand on 2-3 September 2016. A Ramamurthy Participated as Co-ordinator of a Attended as Chairperson of a Assistant Professor Scientific Session of Sambhasha: Scientific Session. Assistant Professor organised by National Institute of Ayurveda, Jaipur on 8-9 February 2017. Rath organised by National Institute of Assistant Professor Ayurveda, Jaipur on 8-9 February 2017. Sumit Nathani National Seminar on Role of Ayurveda on Concept of Local Hemostatics Assistant Professor Rakta Pradoshaj Vikaar organised by w. Sumit Nathani Conclave on Translational Research Phytochemical Study of Assistant Professor Opportunity in Ayurveda organised by Gingers Processed by Banaras Hindu University, Varanasi on Different Methods. Pharmacologist between Academia and Industry in Biotechnology for Welfare of the Society, 14-15 November, 2016 organized by department of Biosciences, School of Basic Sciences, Manipal University Jaipur and Ayushraj Enterprises Pvt. Pharmacologist Management of Madhumeha (Diabetes Mellitys) and its Complications, 5th 7th February 2017, organized by National Institute of Ayurveda, Jaipur. D Scholars of the Department have actively participated in the following National and International Seminar/Conferences/Workshops organized at different places in the country: Name of Presenter and Name of Topic /Details of Conferences/ Sl. Amit Ashok Gajarmal Sambhasha: International Conference on the Scope and Role of Dr. Some Anti diabetic Plants used in Amboli region (Eco Hotspot of Western Ghats) of Maharashtra. Sudipt Kumar Rath Madan Mohan Malviya Ayurvedic College, Udaipur on 24-25 March 2017. Dilip Kumar Singh & National Seminar on Opportunities and Role of Ayurveda in Non Dr. Mita Kotecha Communicable Diseases-Present Global Challenge organized by Madan Mohan Malviya Government Ayurved College, Udaipur on 24-25 March, 2017.

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Child care providers born after 1980 with a negative or uncertain history of varicella and no history of immunization should be immunized with 2 doses of varicella vaccine or undergo serologic testing for susceptibility; providers who are not immune should be offered 2 doses of varicella vaccine anxiety symptoms worksheet order 10 mg hydroxyzine fast delivery, unless it is contraindicated medically anxiety x rays order hydroxyzine 10 mg with visa. All child care providers should receive written information about varicella anxiety symptoms zoloft buy hydroxyzine 25mg without prescription, particularly disease manifes tations in adults anxiety xanax benzodiazepines buy hydroxyzine 25 mg visa, complications, and means of prevention. All adults who work in child care facilities should receive a 1-time dose of Tdap (teta nus toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccine for booster immu nization against tetanus, diphtheria, and pertussis regardless of how recently they received their last dose of Td. Pregnant women should be immunized with Tdap vaccine during each pregnancy, preferably between 27 and 36 weeks’ gestation. For other recommen dations for Tdap vaccine use in adults, including unimmunized or partially immunized adults, see Pertussis (p 608) and the adult immunization schedule. General Practices the following practices are recommended to decrease transmission of infectious agents in a child care setting: Each child care facility should have written policies for managing child and provider illness in child care. The changing surface should be covered with nonabsorbent paper liners large enough to cover the surface from the child’s shoulders to beyond the child’s feet. Soiled dispos able diapers, training pants, and soiled disposable wiping cloths should be discarded in a secure, hands-free, plastic-lined container with a lid. Diapers should contain all urine and stool and should minimize fecal contamination of children, child care providers, environmental surfaces, and objects in the child care environment. Children should be diapered with disposable diapers containing absorbent gelling material or carboxy methylcellulose or with cloth diapers that have an absorbent inner layer completely covered by an outer waterproof layer with a waist closure (ie, not pull-on pants) that are changed as a unit. Clothes should be worn over diapers while the child is in the child care facility. Clothing, including shoes and socks, should be removed as needed to expose the diaper and prevent contact with diaper contents during the diaper change. Both the child’s and caregiver’s hands should be washed with soap after the diaper change is complete. Sinks used to wash hands after diaper changing should not be in the food preparation area. The use of potty chairs should be dis couraged, but if used, potty chairs should be emptied into a toilet, cleaned in a utility sink, and disinfected after each use. These sinks should be washed and disinfected at least daily and should not be used for food preparation. Food and drinking utensils should not be washed in sinks in diaper changing areas. Handwashing sinks should not be used for rinsing soiled clothing or for cleaning potty chairs. Children should have access to height-appropriate sinks, soap dispensers, and disposable paper towels. In general, routine housekeeping procedures using a freshly pre pared solution of commercially available cleaner (eg, detergents, disinfectant detergents, or chemical germicides) compatible with most surfaces are satisfactory for cleaning spills of vomitus, urine, and feces. Crib mattresses should have a nonporous easy-to-wipe surface and should be cleaned and sanitized when soiled or wet. Sleeping cots should be stored so that contact with the sleeping surface of another mat does not occur. Bedding (sheets and blankets) should be assigned to each child and cleaned and sanitized when soiled or wet. All frequently touched toys in rooms that house infants and toddlers should be cleaned and sanitized daily. Toys in rooms for older continent children should be cleaned at least weekly and when soiled. Soft, nonwashable toys should not be used in infant and toddler areas of child care programs. Tables and countertops used for food prepara tion, food service, and eating should be cleaned and sanitized between uses and between preparation of raw and cooked food. People with signs or symptoms of illness, including vomiting, diarrhea, jaundice, or infectious skin lesions that cannot be covered or with sus pected asymptomatic infection with a foodborne pathogen should not be responsible for food handling. Because of their frequent exposure to feces and children with enteric dis eases, staff members who change diapers ideally should not prepare or serve food. Except in home-based care, staff members who work with diapered children should not prepare food for, or serve food to, groups of older children. Staff members should not be permitted to change diapers and prepare or serve food on the same day. If doing both is necessary, staff members should prepare food before changing diapers, do both tasks for as few children as possible, and handle food only for the infants and toddlers in their own group and only after thoroughly washing their hands. Hands should be washed after handling all animals or animal wastes, cages, or food. Reptiles, rodents, amphibians, and baby poultry and their habitats should not be handled by children younger than 5 years (see Diseases Transmitted by Animals [Zoonoses]: Household Pets, Including Nontraditional Pets, 1 and Exposure to Animals in Public Settings, p 219). The health consultant should conduct program observations to correct hazards and risky practices. A monitoring program should be instituted with policies to deal with incidents when human milk inadvertently is fed to an infant other than the designated infant (see Human Milk Banks, p 131). Health care facilities have developed policies that could be adapted to the child care setting to address such incidents. Compendium of measures to prevent disease associated with animals in public settings, 2013. Determining the likelihood that infection in one or more children will pose a risk for schoolmates depends on an understanding of several factors: (1) the mechanism of pathogen transmission; (2) the ease with which the organ ism is spread (contagion); and (3) the likelihood that classmates are immune because of immunization or previous infection. All states require immunization of children at the time of entry into school, and many states require immunization of children throughout grade school, of older children in upper grades, and of young adults entering college. General methods for control and prevention of spread of infection in the school set ting include: Meticulous hand and environmental hygiene. Decisions about postexposure prophylaxis after an in-school exposure are best made in conjunction with local public health authorities. Physicians involved with school health should be aware of current public health guidelines to prevent and control infectious diseases. Close collaboration between the school and physician also is encouraged, helping to ensure that the school receives appro priate guidance and is stocked with the necessary materials to deal with outbreaks and limit spread of infections. In all circumstances requiring intervention to prevent spread of infection within the school setting, the privacy of children who are infected should be protected. Diseases Preventable by Routine Childhood Immunization Children and adolescents who have been fully immunized according to the recommended childhood and adolescent immunization schedule redbook. Measles and varicella vaccines have been demonstrated to provide protection in some susceptible people if administered within 72 hours after exposure, and up to 5 days after exposure in the case of varicella vaccine. Measles or varicella immunization should be recommended immediately for all nonimmune people during a measles or varicella outbreak, respectively, except for people with a contraindication to immunization. Many people without evidence of immunity may not yet have been exposed; therefore, vacci nating at any stage of an outbreak can prevent disease. Although measles vaccination should be delayed in people with moderate to severe febrile illnesses until resolution of the acute phase of the illness, an outbreak is an exception to this rule. Mumps and rubella vaccines administered after exposure have not been demon strated to prevent infection among susceptible contacts, but unimmunized students should receive the vaccines to protect them from infection from subsequent exposure. People who receive mumps immunization should be provided with information on symptoms and signs of illness and be instructed to contact their medical provider should they become sick. As an additional prevention measure, it is imperative that any child diagnosed with mumps stay home from school for 5 days after onset of parotid gland swelling. Those with rubella should be excluded from school for 7 days after the onset of rash. Students and staff members with documented pertussis should be excluded from school and related activities until they have received at least 5 days of the recommended course of azithromycin; public health authorities should be contacted to assist with out break investigation and control. Symptomatic contacts should be tested and treated for pertussis; they also should also be excluded until they have completed 5 days of appropri ate antimicrobial treatment. Children and staff members who refuse appropriate anti microbial treatment should be excluded for 21 days after last contact with the infected person. Unimmunized or underimmunized contacts should be immunized (see Pertussis, p 608). Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine should be substituted for a single dose of tetanus and diphtheria toxoids vaccine for children 7 years or older and adults (Td) in the primary catch-up series or as a booster dose if age appropriate redbook. Bacterial meningitis in school-aged children may be caused by Neisseria meningitidis.

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We also considered the burden that may be incurred in your attempt to anxiety symptoms vomiting discount hydroxyzine 25mg fast delivery comply with the statutory and regulatory criteria in the manner suggested by the guidance and in your attempt to anxiety symptoms in young males purchase 25mg hydroxyzine otc address the issues we have identified anxiety symptoms jaw spasms cheap hydroxyzine 10 mg free shipping. We believe that we have considered the least burdensome approach to anxiety symptoms head discount hydroxyzine 10mg online resolving the issues presented in the guidance document. If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in the “A Suggested Approach to Resolving Least Burdensome Issues” document. The report should describe how this special control guidance document was used during the device development and testing and should briefly describe the methods or tests used and a summary of the test data or description of the acceptance criteria applied to address the risks identified in this guidance document, as well as any additional risks specific to your device. Proposed labeling Proposed labeling should be sufficient to describe the device, its intended use, and the directions for its use. We recommend that the description include a complete discussion of the performance specifications and, when appropriate, detailed, labeled drawings of the device. If you follow a suggested test method, you may cite the method rather than describing it. For each test, you may either (1) briefly present the data resulting from the test in clear and concise form, such as a table, or (2) describe the acceptance criteria that 3 you will apply to your test results. Please note that testing must be completed before submitting a declaration of conformity to a recognized standard. We may also request additional information if we need it to assess the adequacy of your acceptance criteria. A Traditional 510(k) should include all of yo ur methods, data, acceptance criteria, and conclusions. Manufacturers considering modifications to their own cleared devices should consider submitting Special 510(k)s. The general discussion above applies to any device subject to a special controls guidance document. The following is a specific discussion of how you should apply this special controls guidance document to a premarket notification for intraoral devices for snoring and/or obstructive sleep apnea. Scope the scope of this document is limited to the generic type of device described below. These are removable medical devices that are fitted in the patient’s mouth and are indicated to treat patients who snore and patients who have obstructive sleep apnea. The devices are indicated to be used when the diagnosis is simple snoring or obstructive sleep apnea. The devices are indicated for use during sleep to aid in the treatment of these conditions. Simple snoring is a form of sleep disordered breathing in which there is a narrowing of the upper airway which leads to an inspiratory noise produced by vibration of the pharyngeal soft tissues. Intraoral devices to treat snoring and/or obstructive sleep apnea include three basic designs: mandibular repositioners, tongue retaining devices, and palatal lifting devices. All of these devices provide the same therapeutic goal of increasing the pharyngeal space to improve the patient’s ability to exchange air. The increase in airway space decreases the air turbulence, which is a causative factor in snoring. In addition to the removable devices, there are implantable screw devices that may be used with a suturing technique as part of a surgical procedure to lift the intraoral musculature and provide improved oropharyngeal patency (airway space). The measures recommended to mitigate these identified risks are given in this guidance document, as shown in the table below. You should also conduct a risk analysis, prior to submitting your premarket notification, to identify any other risks specific to your device. If you elect to use an alternative approach to address a particular risk identified in this guidance document, or have identified risks additional to those in the guidance, 5 you should provide sufficient detail to support the approach you have used to address that risk. Material Composition Your summary report sho uld include the following information for all components. Please contact the Dental Devices Branch to discuss any clinical testing before initiating studies. When a clinical study is needed, the summary report should include the clinical protocol defining inclusion and exclusion criteria and a sample size justification. For devices for simple snoring, performance measurements should include the rate of reduction of snoring based on clinical observation. For devices for obstructive sleep apnea, performance measurements should include the rate of reduction of apneic events measured by polysomnograms. Baseline and post insertion polysomnograms should be obtained for each subject in the study. These polysomnograms should include measurements of the respiratory disturbance index, apnea index, duration of the apnea, and oxygen saturation. Clinical studies to support a substantially equivalent determination for a non-prescription intraoral device for simple snoring also need to demonstrate the adequacy of the instructions for use. We suggest that you discuss your proposed protocol with the Dental Devices Branch before initiating a clinical study of this kind. Instructions should encourage local/institutional training programs designed to familiarize users with the features of the device and how to use it in a safe and effective manner. Devices with Thermal Setting Resins If the device contains a thermal setting resin, you should include instructions for heating, cooling, and setting time in the labeling. Contraindications You should include the following contraindications in your labeling. The device is contraindicated for patients who: • have central sleep apnea • have severe respiratory disorders • have loose teeth or advanced periodontal disease • are under 18 years of age. Labeling recommendations in this guidance are consistent with the requirements of part 801. Precautions You should include the following precaution: Dentists should consider the medical history of the patients, including history of asthma, breathing, or respiratory disorders, or other relevant health problems, and refer the patient to the appropriate healthcare provider before prescribing the device. Patient Labeling Patient labeling should be clear, accurate, and provide complete use and care instructions for the patient. While the principles of splinting the airway and delivering assisted ventilation underpin the basics of this therapy, the introduction of newer technologies and minia turization are revolutionizing the former conventions of the field. Dissemination of such information is vital in order to prevent knowledge gaps in healthcare providers and systems. Key words: obstructive sleep apnea; continuous positive airway pressure; adherence; adult; pediatric; com pliance; sleep apnea; artificial respiration; central sleep apnea; servo ventilation; obesity. More over, the bible contains references to mouth-to-mouth ad Historically, the administration of positive airway pres ministration of breaths as a means of resuscitation. Research and Development, Southern Arizona Veterans Administration Healthcare System, and the Department of Medicine, University of Ar Dr Antonescu-Turcu has disclosed no conflicts of interest. However, the introduction of positive-pressure ventilation into modern medicine did not occur until the disastrous polio epidemic in the middle of last century. In 1953, Bjorn Ibsen, an anesthesiologist, used bag ventilation connected to a tra cheotomy to resuscitate a teenage girl suffering from re spiratory failure due to bulbar poliomyelitis, and thereby gave rise to the concept of the modern intensive care unit. Representative tracings of flow, tidal volume, and airway be much more sophisticated than a mere reversal of the pressure (Paw) during administration of continuous positive airway vacuum pump. Most often, such a pres sure is achieved by a servo-controlled air compressor that maintains the airway pressure as closely to the prescribed pressure despite the pull (inspiration) and push (exhala tion) of the patient (Fig. Other side effects may be attributable to mask sleep that is not continually interrupted by spontaneous interface-related skin changes (abrasions, pressure sores, arousals or awakenings at the selected pressure. Many questions can be one that does not meet any one of the above grades of raised. What mask interface do we should be considered if the initial titration does not achieve use How soon should we measure adher study, it fails to meet American Academy of Sleep Med ence to therapy Such consensus do we monitor the quality of services provided by the in terminology is vital so as to standardize the interpreta durable medical equipment provider When and how often tion of titration studies across laboratories and institutions. What are the determinants of non demonstration, careful mask fitting, and acclimatization adherence


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