Esterilización y/o reuso de elementos de protección personal en la pandemia COVID-19 / Sterilization and reuse of personal protection elements in the COVID-19 pandemic

CONTEXTO CLÍNICO: Los equipos de protección personal (EPP) son usados por el personal de salud para crear una barrera entre el paciente y el ambiente o un objeto, potencialmente contaminados por microorganismos. En enfermedades infecciosas es clave adoptar medidas preventivas de contagio y de mitigación en el manejo comunitario y nosocomial de casos. La enfermedad por el Coronavirus 2019 (COVID­19, por su sigla en inglés Coronavirus Disease 2019) es una enfermedad respiratoria de humanos producida por un nuevo coronavirus identificado con la sigla SARS-CoV-2. El período de incubación de la infección es de 2 a 14 días. La mayor parte de los contagios se producen de persona a persona, siendo altamente transmisible. El cuadro clínico varía desde casos asintomáticos a cuadros febriles con tos y dificultad respiratoria, neumonía y distrés respiratorio. También puede acompañarse de alteraciones gastrointestinales. TECNOLOGÍA: Los equipos de protección personal pueden incluir barbijos, camisolines, mascaras filtrantes de alta eficiencia, máscaras faciales de acetato, guantes, cubrebotas descartables o de tela, y otros. En relación a los barbijos, se consideran aquellos descartables de una o dos capas (mascarillas protectoras), barbijos quirúrgicos (barbijos de 3 o 4 capas o barbijos tipo N95). Según la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) de la Argentina, los barbijos son productos de polipropileno (PP). La estructura textil producida por entrelazado de fibras y/o filamentos continuos consolidados por medios mecánicos, químicos, térmicos o sus combinaciones y según los gramos de entretejidos, se define su utilidad y tipo de barbijo. OBJETIVO: El objetivo del presente informe es evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados con la esterilización y/o reuso de equipos de protección personal en la pandemia por COVID-19. MÉTODOS: Se realizó una búsqueda en las principales bases de datos bibliográficas, en buscadores genéricos de internet, y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas (RS), ensayos clínicos controlados aleatorizados (ECAs), evaluaciones de tecnologías sanitarias (ETS), evaluaciones económicas, guías de práctica clínica (GPC) y recomendaciones de diferentes sistemas de salud. RESULTADOS: Se incluyeron tres ETS, 11 GPC, y un comunicado del fabricante de insumos médicos 3M acerca de la esterilización y/o reuso de elementos de protección personal en la pandemia por COVID-19. CONCLUSIONES: No se encontraron estudios comparativos acerca de la eficacia y/o de la seguridad de la esterilización y/o reuso de los elementos de protección personal (EPP) para el personal de salud en la atención de pacientes con infección por SARS-CoV-2 probable, sospechoso o confirmado, versus no tomar esas medidas. La necesidad de evaluar la posibilidad de esterilización y/o reuso de los EPP se basa en la situación crítica que la pandemia por COVID-19 ha puesto a los servicios de salud mundiales y en la necesidad de la conservación de los recursos necesarios para poder afrontar la pandemia. Los EPP usados por el personal de salud son fabricados para ser descartados después de su uso, luego de un tiempo determinado, según las recomendaciones de los fabricantes. El único estudio encontrado al momento de realizar este informe que evaluaba los métodos más frecuentes de esterilización sugeridos por las guías de buena práctica de manufactura (radiación ultravioleta, calor seco al 70°C, etanol al 70% y peróxido de hidrógeno vaporizado) sugirió que para los barbijos del tipo N95 el único método que podría reducir la contaminación sin afectar su funcionamiento es el peróxido de hidrógeno vaporizado. Las recomendaciones de organismos internacionales como la Organización Mundial de la Salud (OMS), el Centro de Control de Infecciones estadounidense, de varios ministerios de salud de Europa y Latinoamérica sugieren que, a pesar de no existir evidencia, podrían adoptarse las siguientes medidas: uso extendido (uso más allá del tiempo recomendado por el fabricante) de las máscaras con filtro y barbijos tipo N95 (por hasta cinco días), reprocesamiento seguido de reutilización (después de la limpieza o esterilización) de estos elementos, o bien considerar elementos alternativos en comparación con los elementos estándar recomendados por la OMS. Estos procesos deben garantizar una desinfección y esterilización adecuada, la no toxicidad residual en el material y sobre todo integridad funcional (sistemas de filtrado y sistemas de ajuste). En la extensión del uso de los barbijos de cualquier tipo se sugiere que su uso podría ser continuo o intermitente entre 4 a 8 hs antes de ser desechado en bolsa roja. El ministerio de Salud de Argentina recomienda el descarte de barbijos tipo N95 a los 15 días de su uso o cuando éste se encuentre dañado o manchado. Con respecto a los camisolines se sugiere el reemplazo de telas descartables por telas lavables que soporten hasta 75 ciclos de lavados y desinfección, a cuyo uso se debe sumar el de delantales de plástico descartables.

Risk assessment of accidental exposure of surgeons to blood during orthopedic surgery. Are we safe in surgical gloves?

AIM: To analyze tears in sterile surgical gloves used by surgeons in the operating theatre of the Trauma and Orthopedic Surgery Department, Copernicus Memorial Hospital, Lódz, Poland. MATERIALS AND METHOD: This study analyzes tears in sterile surgical gloves used by surgeons by ICD-9 and ICD-10 codes. 1,404 gloves were collected from 581 surgical procedures. All gloves were tested immediately following surgery using the test method described in Standard EN455-1 (each glove was inflated with 1,000 ± 50 ml of water and observed for leaks for 2-3 min.). RESULTS: Analysis of tears took into consideration the role of medical personnel (operator, first assistant, second assistant) during surgical procedure, the type of procedure according to ICD-9 and ICD-10 codes, and the elective or emergency nature of the procedure. The results of the study show that these factors have a significant influence on the risk of glove tears. Significant differences were observed in tear frequency and tear location depending on the function performed by the surgeon during the procedure. CONCLUSION: The study proved that the role performed by the surgeon during the procedure (operator, first assistant, second assistant) has a significant influence on the risk of glove tearing. The role in the procedure determines exposure to glove tears. Implementing a double gloving procedure in surgical procedures or using single gloves characterized by higher tear resistance should be considered.

Factors that influence the selection of sterile glove brand: a randomized controlled trial evaluating the performance and cost of gloves.

PURPOSE: To determine whether glove use modifies tactile and psychomotor performance of health care providers when compared with no glove use and to evaluate factors that influence the selection of sterile glove brand. METHODS: Forty-two anesthesia providers (nine anesthesiologists, seven nurse anesthetists, 20 residents, six student nurse anesthetists) enrolled in and completed this cross-over randomized trial from May 2010 until August 2011. Participants underwent standardized psychomotor testing while wearing five different types of protective gloves. Assessments of psychomotor performance included tactile, fine motor/dexterity, and hand-eye coordination tests. Subjective ratings of glove comfort and performance were reported at the completion of each glove trial. The manufacturer's suggested retail price was collected for each glove tested. RESULTS: There were statistically significant differences in touch sensitivity for all nerve distributions, with all glove types resulting in less sensitivity than a bare hand. When compared with the non-sterile glove, only the thickest glove tested (Ansell Perry Orthopaedic) was found to have less touch sensitivity. Fine motor dexterity testing revealed no statistically significant differences in time to completion amongst glove types or bare handed performance. In hand-eye coordination testing across treatment conditions, the thickest glove tested (Ansell Perry(®) Orthopaedic) was the only glove to show a statistically significant difference from a bare hand. There were statistically significant differences in glove comfort ratings across glove types, with latex-free, powder-free (Cardinal Esteem(®)), and latex powder-free (Mölnlycke-Biogel(®)) rated highest; however, there were no statistically significant differences in subjective performance ratings across glove types. CONCLUSIONS: Given the observed similarities in touch sensitivity and psychomotor performance associated with five different glove types, our results suggest that subjective provider preferences, such as glove comfort, should be balanced against material costs.

[Criteria for choice and purchase of gloves: quality or cheapness? The role of the Occupational Health Physician]. / Criteri per l'acquisto e la scelta dei guanti: qualità o economicità? II ruolo del medico competente.

BACKGROUND: The choice of gloves in the healthcare settings is very important because of the high biological and chemical risks present in these workplaces. In order to rationalize and optimize this choice we must balance cost, quality, security and comfort. OBJECTIVES: The aim of this study was to analyse the rules in force and to point out the relevant role of the Occupational Health Physician in the right choice and purchase of sanitary gloves. METHODS: We reviewed the rules in force and the most relevant studies on these topics. RESULTS AND CONCLUSIONS: The regulations in force provide that the manufacturers must perform tests to supply evidence for the quality of the products but they do not indicate which analytical method should be used and they do not require that the results are reported in the technical sheets. Thus the manufacturers have only to declare to be "in accordance with the rules". Therefore purchasers should require the manufacturing companies to give detailed information and verify their reliability. Moreover rules could be adapted to higher quality standards. The Occupational Health Physician should suggest the purchase of gloves with high biocompatibility, assuring the protection from the risks of specific tasks and suitable for preventing the onset of new glove-related diseases and the relapses in workers with already diagnosed occupational diseases.

[The risk of surgical glove perforations]. / Risiko for perforasjon av operasjonshansker.

BACKGROUND: The increasing prevalence of blood-borne viral diseases has drawn attention to the barrier between the surgical personnel's hands and the patients body fluids during surgery. At present, the typical practice is to use double gloving in orthopaedic surgery, and single gloving in other types of surgery. The main purpose of our study was to estimate and compare the perforation risk in different categories of surgery. MATERIAL AND METHODS: In a series of 655 surgical operations covering 5 main categories of surgery, all detected glove perforations were recorded and analysed. RESULTS: Perforations were found in 203 out of 655 operations (31%). The observed perforation frequency was 44.5% in gastrointestinal surgery, 34.7% in orthopaedic surgery, 31.1% in gynaecology, 18.6% in vascular surgery and 9.2% in general surgery. In some subcategories, the frequencies were even higher. INTERPRETATION: In several categories of surgery, we found high perforation frequencies. Perforations in single gloves are often not detected during operations. This may increase the risk of transmission of blood-borne infections, particularly because the time of exposure may be long. Double indicator gloves make the intra-operative detection of perforations easier. Also double gloving is known to significantly reduce the perforation risk. The use of double indicator gloves is recommended in all categories of surgery.

Safer surgical gloves: evaluation and implementation.

In 2003 the Scottish Health Service Central Legal Office was consulted on the requirement to supply an alternative to natural rubber latex gloves for healthcare professionals within NHS Lothian University Hospitals Trust. Counsel stated that as latex is now accepted as being hazardous to health, employers must prove the statutory defence in Regulation 7(1) of the Control ofSubstances Hazardous to Health Regulations (HSE 2002). Counsel also stated that, as there are now adequate alternatives to latex gloves, NHS employers would have an indefensible position if no attempt was made to supply alternatives.

Medical devices; patient examination and surgeons' gloves; test procedures and acceptance criteria. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to improve the barrier quality of medical gloves marketed in the United States. The rule will accomplish this by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. By reducing the AQLs for medical gloves, FDA will also harmonize its AQLs with consensus standards developed by the International Organization for Standardization (ISO) and ASTM International (ASTM).

Conversion to low-protein, powder-free surgical gloves: is it worth the cost?

This study was conducted to determine changes in overall costs associated with conversion to powder-free gloves including cost of workers' compensation cases for natural rubber latex (NRL)-related symptoms and health care workers' glove satisfaction. The study, a 2-year, longitudinal design with retrospective and prospective aspects, was developed to determine health care worker use of powder-free, low-protein NRL gloves, sensitization, cost, and glove satisfaction. Informed consent was obtained from 103 health care workers. Prior to glove conversion, nearly one-half (44%, 36 of 82) of the operating room staff reported symptoms related to NRL exposure. At the end of the 14-month data collection period, only 27% (22 of 82, McNemar test = .007) reported symptoms related to NRL exposure. Additionally, a cost savings of 10,000 dollars per year for gloves was evident with reports of increased user satisfaction. This study demonstrated that conversion to the use of powder-free, low-protein NRL gloves not only reduces health care worker NRL symptoms, but also positively affects the costs of glove purchases and workers' compensation.

A study on powdering of reusable surgical gloves.

OBJECTIVES: To study the need of powdering surgical gloves and to produce a powdering machine. MATERIAL AND METHOD: The need of powdering surgical gloves was done by questionnaires to directors or chiefs of purchase departments in 29 hospitals across the country. The practice in powdering surgical gloves was given by chiefs of the central sterile supply department (CSSD). A powdering machine was produced by the researchers in consultation with CSSD personnel in a hospital. The quality of powdering surgical gloves was evaluated by infection control nurses in the hospital. Cost comparison was done by a health economist. RESULTS: The study in 2002 revealed that all of the 29 hospitals used recycled surgical gloves. Powdering of surgical gloves was done by hand in 27.6% and by powdering machine in 62.10%. Corn powder was used in 55.2% and talc in 41.4%.Defects in powdering ranged from 1.1% to 51.7%. No defects was found in surgical gloves powdered by the machine produced by the researchers. The costs for powdering and one pair of reused surgical gloves were 0.10 and 5.59 baht respectively. CONCLUSION: Surgical gloves were reused in all hospitals in Thailand The powdering machine was effective and was not difficult to make.

Double gloving: a risk reduction strategy.

BACKGROUND: The use of sterile surgical gloves has become the international standard of care in the perioperative environment. Yet the potential for barrier failure exists, with the subsequent potential for the transfer of pathogens to both the patient and the surgical team. The practice of double gloving (wearing two pairs of sterile surgical gloves) is often considered a mechanism for managing the potential risk of exposure during surgery. LITERATURE ON DOUBLE GLOVING: In the 2002 Cochrane review of double gloving, findings were summarized from 18 studies. The review, which covers a variety of surgical environments and addresses several double gloving options, indicates that double gloving significantly reduced perforations to the innermost glove. Other studies report a risk reduction of 70%-78% attributed to double gloving. OVERCOMING PRACTITIONER OBJECTIONS: Practitioners, in voicing objections to double gloving, cite poor fit, loss of tactile sensitivity, and increased costs. An important issue is how the two gloves work together, especially when they are powder free. Several studies have reported good acceptance of double gloving without loss of tactile sensitivity, two-point discrimination, or loss of dexterity. Although double gloving increases the glove cost per practitioner, the reduction of bloodborne pathogen exposure and possible seroconversion of practitioners represents a significant savings. Strategies that may help to facilitate the process include sharing the data on double gloving to build justification for the implementation, enlisting the support of the champions of the change at hand, and providing a glove-fitting station. SUMMARY: The stresses placed on a surgical glove today--the length of cases, heavy and/or sharp instrumentation, and chemicals used in the surgical field--make it imperative that barrier protection be ensured.

How health care organizations can establish and conduct a program for a latex-safe environment.

BACKGROUND: The advent of universal precautions brought about a dramatic increase in the use of natural rubber latex gloves, and reports of rubber latex allergies began appearing in the literature. In 1997 the Johns Hopkins Hospital created the interdisciplinary Latex Task Force to address the issue of creating, implementing, and evaluating a latex-safe environment. CONVERSION TO NONLATEX PRODUCTS AND EXAMINATION GLOVES: When suitable alternatives were available, all medical products that contained latex were to be removed from the hospital and nonlatex alternatives substituted. Latex medical gloves, especially powdered latex examination gloves, which were used in all patient care areas, were replaced by vinyl gloves. Yet because of the ongoing concern about strike-through and the minimal level of acceptance of fit with the vinyl gloves, the search for alternatives to the vinyl gloves continued. The task force recommended switching to nitrile examination gloves throughout the hospital. To facilitate the transition to another examination glove, new educational pamphlets about the nitrile gloves were developed. POSTSCRIPT: The switch to nitrile examination gloves was successfully completed, but conversion to nonlatex surgical gloves was less successful, with costs being the overwhelming impediment. Monitoring of latex-containing products and ongoing evaluations of alternatives are crucial in ensuring patient and health care worker safety.

Synthetic surgical gloves.

Surgical gloves are used by healthcare workers to protect them against bloodborne pathogens and other potential infectants and to prevent wound contamination in patients. In response to the increasing prevalence of allergies to natural rubber latex (NRL) among patients and medical staff, the trend toward purchasing gloves made of synthetic materials is on the rise. However, latex continues to dominate the market, and some people still perceive synthetic gloves as providing less protection and being less comfortable than NRL gloves. For this Update Evaluation, we present our findings for three newly evaluated glove models from three manufacturers and summarize our findings for the seven previously evaluated models that are still on the market. (Our earlier Evaluation was published in the February-March 2000 Health Devices.) As in the previous Evaluation, our ratings are based on the gloves' barrier effectiveness--that is, their resistance to viral penetration and their durability--and comfort. We also compared these characteristics of the synthetic gloves to those of NRL gloves. We found that all the evaluated gloves offer adequate barrier protection but that their level of comfort varies considerably. We rate three models Preferred, five models Acceptable, and two models Not Recommended.

Health effects associated with medical glove use.

Adverse reactions to medical gloves represent an important public health issue. Accordingly, there is increasing interest in understanding the information reported to the US Food and Drug Administration (FDA) describing health effects associated with the use of medical gloves. This article provides a retrospective analysis and summary of health effects associated with medical glove use reported to the FDA. The FDA's medical device adverse event databases were searched via computer using keywords to identify reports of reactions associated with any type of medical glove. Demographic and clinical information abstracted from these reports was used to perform frequency and trend analyses. The reported medical glove-related events, including the noted trends in reporting, suggest the need for further study and continued monitoring of such reports.

Synthetic surgical gloves.

Surgical gloves are used by healthcare workers primarily to minimize the transmission of bloodborne pathogens and other potential infectants. Gloves made of synthetic materials are getting more attention with the increasing prevalence of allergies to natural rubber latex (NRL) among patients and medical staff. However, synthetic gloves are perceived by some people as providing less protection and being less comfortable than NRL gloves. In this study, we evaluated eight models of synthetic surgical gloves from six manufacturers. We examined their barrier effectiveness (that is, their resistance to viral penetration, resistance to puncture, and strength) durability, and comfort and compared these characteristics to those of NRL gloves. We found that all the gloves offered good barrier protection, but that their level of comfort varied widely. Three gloves were rated Preferred, three were Acceptable, and the remaining two gloves were Not Recommended.

Risky business: pre-powdered gloves or powder-free gloves in the operating suite?

Two of the emerging issues for the health-care sector in the 1990s are occupational health and safety, and iatrogenic issues. Both of these issues are implicated in the use of pre-powdered latex gloves. Hospital health-care workers are exposed to latex in many ways: gloves, intravenous sets, ventilator circuits, dental products, resuscitation equipment, anaesthetic equipment. Post-operative complications, delayed wound healing, scar formation, and the potential for misdiagnosis, in the presence of starch powder, have been well documented in the literature with the need for through glove rinsing prior to surgery. Another route for glove powder to enter wounds is through a barrier breach. For an institution to ensure it provides the most durable and effective barrier for healthcare worker protection and patient safety, knowledge is needed regarding the various factors which lead to glove barrier failure. The primary aim of the study was to evaluate the in-use durability of the surgical gloves in current use against powder-free gloves. Descriptive statistics were used to analyse the data, in addition a cost analysis was calculated. The results of this study demonstrated clinically important differences between existing glove products in terms of barrier quality.

A closer look at disposable gloves. An assessment of the value of vinyl, latex and plastic gloves.

Research has shown that people with broken skin can be at serious risk of cross infection. A study was undertaken to assess the relative benefits of wearing vinyl, latex and plastic gloves during invasive procedures.

Risk analysis as the basis for surgical glove selection.

The growing use of outcomes research will have a significant effect on the way surgeons make decisions concerning glove product selection. These effects will be both direct and indirect, as payers begin to use outcome data to develop practice guidelines. to reduce morbidity and mortality rates, and to alleviate long-term cost and consequences of acquired latex allergy or powder-related postoperative complications in patients. This article reviews elements of risk associated with surgical gloves.