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Surgical Device Poses A Rare But ((HOT))

The term gossypiboma is used to describe a retained surgical sponge after operation. It is a rare but serious complication which is seldom reported because of the medicolegal implications. Gossypiboma usually has varied and vague presentation and is also difficult to detect on radiological investigations. It can even remain silent and present years after the operation. We report a case of a 38-year-old lady who presented with vague pain and chronic lump in the right iliac fossa region. She had a history of cesarean section 4 years ago. Radiological investigations were inconclusive in detecting the retained sponge. A working diagnosis of mesenteric cyst was made and an exploratory laparotomy was done where she was found to have a large gossypiboma densely adhered to the small bowel and surrounding structures. Though rare, gossypiboma should be kept in mind as a differential diagnosis in postoperative cases presenting as vague pain or chronic lump even years after the operation.

surgical device poses a rare but

The retained surgical sponge triggers two biological responses: aseptic fibrinous response due to foreign body granuloma or exudative reaction leading to abscess formation [7]. The symptoms depend upon the location, size of swab, and the type of reaction that occurs. Gossypiboma may present early with pain with or without lump formation or may remain asymptomatic for a long time with only vague symptoms. Patients may present with abdominal mass or subacute intestinal obstruction. Patients may rarely also present with fistula, perforation, or even extrusion per anus. In our case the gossypiboma caused vague symptoms for quite some time before ultimately resulting in a chronic lump formation.

The FDA very rarely acts on this authority. Until 2016, the FDA banned only one other medical device, prosthetic hair fibers. The FDA found there was no public health benefit to this device. This device presented a substantial deception to patients or users about the benefits of the device. The prosthetic hair fibers did not stimulate hair growth nor conceal baldness, but could actually cause serious infections, illness, and injuries from their implantation. We believed that the labeling and advertising materials directly or implied misrepresented the device as safe, effective, and causing little or no discomfort, among other misleading claims.

Toxic shock syndrome (TSS) is a rare but potentially life-threatening condition caused by certain strains of bacteria that produce poisons (toxins). These toxins get into your bloodstream and can affect organs such as your heart, liver or kidneys. It's often associated with using tampons during menstruation. However, TSS can affect anyone of any age. Skin wounds, surgical incisions, nasal packing, scrapes, burns or other areas of injured skin can increase the risk of the condition. Half of all cases are unrelated to menstruation.

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Researchers need the participation of older people in their clinical trials so that scientists can learn more about how the new drugs, therapies, medical devices, surgical procedures, or tests will work for older people. Many older people have special health needs that are different from those of younger people. For example, as people age, their bodies may react differently to drugs. Older adults may need different dosages (or amounts) of a drug to have the right result. Also, some drugs may have different side effects in older people than younger people. Having seniors enrolled in drug trials helps researchers get the information they need to develop the right treatment for older people.

Definitions. For purposes of this section, the following shall apply:Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health, or designated representative.Blood means human blood, human blood components, and products made from human blood.Bloodborne Pathogens means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV).Clinical Laboratory means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials.Contaminated means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.Contaminated Laundry means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps.Contaminated Sharps means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires.Decontamination means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.Director means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designated representative.Engineering controls means controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace.Exposure Incident means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties.Handwashing facilities means a facility providing an adequate supply of running potable water, soap, and single-use towels or air-drying machines.Licensed Healthcare Professional is a person whose legally permitted scope of practice allows him or her to independently perform the activities required by paragraph (f) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up.HBV means hepatitis B virus.HIV means human immunodeficiency virus.Needleless systems means a device that does not use needles for:(1) The collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established;(2) The administration of medication or fluids; or(3) Any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps.Occupational Exposure means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.Other Potentially Infectious Materials means(1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;(2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and(3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.Parenteral means piercing mucous membranes or the skin barrier through such events as needlesticks, human bites, cuts, and abrasions.Personal Protective Equipment is specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.Production Facility means a facility engaged in industrial-scale, large-volume or high concentration production of HIV or HBV.Regulated Waste means liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.Research Laboratory means a laboratory producing or using research-laboratory-scale amounts of HIV or HBV. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in production facilities.Sharps with engineered sharps injury protections means a nonneedle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident.Source Individual means any individual, living or dead, whose blood or other potentially infectious mate


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