Normativa vigente en España sobre la utilización de la diatermia en medicina y ciencias del deporte / Regulations in force in Spain about the use of diathermy in medicine and sport sciences / Regulamentos atuais na Espanha sobre o uso de diatermia em medicina e ciências do esporte

INTRODUCCIÓN: En el tratamiento de las lesiones deportivas se utilizan diferentes formas de energía electromagnética, entre ellas la diatermia, con fines terapéuticos. El uso seguro de los dispositivos de diatermia, tanto para el paciente como para el personal sanitario que los aplica, se basa en estándares profesionales, códigos de seguridad y directrices varias, que determinan los procedimientos de uso seguros. Estas recomendaciones se encuentran dispersas y no son bien conocidas por los usuarios, por lo que fue el objetivo de esta revisión el sintetizar y actualizar dichas recomendaciones. METODOLOGÍA: revisión de la normativa vigente en España, sobre el uso de los equipos médicos de Diatermia. DISCUSIÓN: Esta falta de claridad en algunos fabricantes hace que se cuestione la usabilidad o aplicación de los productos que se fabrican para uso sanitario. Esta situación favorece un marketing engañoso y el cliente final queda no solo a merced de una adquisición de un equipo sin la certificación médica adecuada, sino además desprotegido legalmente en su aplicación, lo que puede traer como consecuencia sanciones legales

INTRODUCTION: In the treatment of sports injuries, different forms of electromagnetic energy, including diathermy, are used for therapeutic purposes. The safe use of diathermy devices, both for the patient and for the healthcare personnel that apply them, is based on professional standards, safety codes and various guidelines, which determine the safe use procedures. These recommendations are scattered and are not well known by users, so it was the objective of this review to synthesize and update these recommendations. METHODOLOGY: review of current regulations in Spain, on the use of diathermy medical equipment. DISCUSSION: This lack of clarity in some manufacturers makes the usability or application of the products that are manufactured for sanitary use questionable. This situation favors a deceptive marketing and the end customer is not only at the mercy of an acquisition of a computer without proper medical certification, but also legally unprotected in its application, which can result in legal sanctions

INTRODUÇÃO: No tratamento de lesões esportivas, diferentes formas de energia eletromagnética são usadas para fins terapêuticos, incluindo a diatermia. A utilização segura de equipamentos de diatermia, tanto para o paciente quanto para o profissional de saúde que os aplica é baseada em padrões profissionais, códigos de segurança e várias diretrizes, que determinam os procedimentos de utilização segura. Essas recomendações são escassas e não são bem conhecidas pelos usuários, portanto o objetivo desta revisão foi sintetizar e atualizar essas recomendações. METODOLOGIA: revisão dos regulamentos vigentes na Espanha sobre o uso de equipamentos médicos de diatermia. DISCUSSÃO: Esta falta de clareza em alguns fabricantes faz com que a usabilidade ou aplicação dos produtos fabricados para uso sanitário seja questionável. Esta situação favorece um marketing enganoso e o cliente final não fica apenas à mercê de uma aquisição de um equipamento sem a certificação médica adequada, mas também legalmente desprotegido em sua aplicação, o que pode resultar em sanções legais

Comparison of Anti-Microbial Effects of Low-Level Laser Irradiation and Microwave Diathermy on Gram-Positive and Gram-Negative Bacteria in an In Vitro Model.

Background and Objectives: The aim of this study was to compare the effects of low-level laser therapy and continuous microwave diathermy on the growth of Gram-negative and Gram-positive bacteria and to establish their efficacy as an alternative therapeutic modality. MATERIALS AND METHODS: Laser fluence of 13 Joules (J)/cm2, 18 J/cm2 and 30 J/cm2 were used against several bacterial strains. Microwave dosages of 25, 50 and 100 watts (W) were used, respectively. RESULTS: A significant difference between the three groups was observed using repeated analysis of variance (RANOVA) (F value: 0.74, and p value: 0.001). The Greenhouse-Geisser correction (GG) revealed significant results for laser irradiation alone. However, effect size calculation showed effects with microwave diathermy as well as laser fluence. CONCLUSIONS: Low-level laser therapy appears to be an effective modality of treatment when compared with continuous microwave diathermy on the Gram-negative and the Gram-positive bacterial strains tested. Microwave diathermy revealed large and medium effects on the bacterial cell counts with dominant effects on Gram-negative strains.

The relationship between applied energy and ablation zone volume in patients with hepatocellular carcinoma and colorectal liver metastasis.

OBJECTIVES: To study the ratio of ablation zone volume to applied energy in computed tomography (CT)-guided radiofrequency ablation (RFA) and microwave ablation (MWA) in patients with hepatocellular carcinoma (HCC) in a cirrhotic liver and in patients with colorectal liver metastasis (CRLM). METHODS: In total, 90 liver tumors, 45 HCCs in a cirrhotic liver and 45 CRLMs were treated with RFA or with one of two MWA devices (MWA_A and MWA_B), resulting in 15 procedures for each tumor type, per device. Device settings were recorded and the applied energy was calculated. Ablation volumes were segmented on the contrast-enhanced CT scans obtained 1 week after the procedure. The ratio of ablation zone volume in milliliters to applied energy in kilojoules was determined for each procedure and compared between HCC (RHCC) and CRLM (RCRLM), stratified according to ablation device. RESULTS: With RFA, RHCC and RCRLM were 0.22 mL/kJ (0.14-0.45 mL/kJ) and 0.15 mL/kJ (0.14-0.22 mL/kJ; p = 0.110), respectively. With MWA_A, RHCC was 0.81 (0.61-1.07 mL/kJ) and RCRLM was 0.43 (0.35-0.61 mL/kJ; p = 0.001). With MWA_B, RHCC was 0.67 (0.41-0.85 mL/kJ) and RCRLM was 0.43 (0.35-0.61 mL/kJ; p = 0.040). CONCLUSIONS: With RFA, there was no significant difference in energy deposition ratio between tumor types. With both MWA devices, the ratios were higher for HCCs. Tailoring microwave ablation device protocols to tumor type might prevent incomplete ablations. KEY POINTS: • HCCs and CRLMs respond differently to microwave ablation • For MWA, CRLMs required more energy to achieve a similar ablation volume • Tailoring ablation protocols to tumor type might prevent incomplete ablations.

Effectiveness of diathermy in comparison with ultrasound or corticosteroids in patients with tendinopathy: a critically appraised topic.

CLINICAL SCENARIO: Many therapeutic modalities have been used to treat the pain and inflammation commonly associated with tendinopathies. One modality that has been used to treat patients with tendinopathies is diathermy. FOCUSED CLINICAL QUESTION: Is there evidence to suggest that diathermy is more or equally as effective at reducing pain in patients with tendinopathy when compared with ultrasound or corticosteroid treatments? SUMMARY OF SEARCH, "BEST EVIDENCE" APPRAISED, AND KEY FINDINGS: The literature was searched for randomized control trials (RCTs) that investigated the effects of diathermy treatments in comparison with ultrasound or corticosteroid treatments on pain in patients with tendinopathy. Three RCTs were selected from the search results and included in this critically appraised topic. CLINICAL BOTTOM LINE: There is moderate evidence to support that diathermy is more effective at reducing pain in patients with tendinopathy than ultrasound and equally as effective as corticosteroid treatments. STRENGTH OF RECOMMENDATION: There is grade B evidence to support that diathermy is more effective at reducing pain in patients with tendinopathy than ultrasound and equally effective at reducing pain as corticosteroid treatments.

Implementing AORN recommended practices for electrosurgery.

Technology is constantly changing, and it is important for perioperative nurses to stay current on new products and technologies in the perioperative setting. AORN's "Recommended practices for electrosurgery" addresses safety standards that all perioperative personnel should follow to minimize risks to both patients and staff members during the use of electrosurgical devices. Recommendations include how to select electrosurgical units and accessories for purchase, how to minimize the potential for patient and staff member injuries, what precautions to take during minimally invasive surgery, and how to avoid surgical smoke hazards. The recommendations also address education/competency, documentation, policies and procedures, and quality assurance/performance improvement. Perioperative nurses should consider the use of checklists and safety posters to remind staff members of the dangers of electrosurgery and the steps to take to minimize the risks for injury.

El método Indiba / The Indiba method

El equipo de hipertermia o Indiba (empresa catalana que la comercializa desde el año 1983) es una técnica electromédica no invasiva. Fue inventado por un catalán, pero los primeros en emplear dicha técnica fueron los italianos. Se basa en producir hipertermia en la zona del cuerpo deseada, utilizando corrientes de alta frecuencia. Es un tratamiento eficaz e indoloro en patologías agudas y crónicas osteoarticulares y musculares. Su difusión ha llegado a otras ramas de la medicina como la oncología, dermatología y estética con excelentes resultados. El calor que genera provoca el aumento del riego sanguíneo y de oxígeno en la zona a tratar. Es por ello que actúa como antiinflamatorio de los tejidos. Los deportistas Valentino Rossi y Francesco Totti fueron los primeros deportistas en ser tratados con el método Indiba y Rafa Nadal el último para mejorar su lesión. Con este artículo se pretende dar a conocer al colectivo de podólogos el método Indiba (AU)

The equipment of hyperthermia or Indiba (A Catalan Company that has dealt with it since 1983) is an electromedical non invasive technology. It was invented by a Catalan, but the first ones using it were the Italians. It produces hyperthermia on the chosen part of the body, using high-frequency currents. It is an effective and painless treatment for acute pathologies and chronic osteoarticular and muscular conditions. Its diffusion has reached other branches of the medicine such as oncology, dermatology and aesthetics, providing excellent results. The generated heat provokes an increase of blood irrigation and oxygen in the treated area. For this reason it acts like an anti-inflammatory for the tissues. Valentino Rossi and Francesco Totti were the first sportsmen to be treated by this method and Rafa Nadal is the latest one to receive treatment. The purpose of this article is to raise awareness of the Indiba method among podiatrist (AU)

The impact of insulin resistance on the outcome of laparoscopic ovarian diathermy in women with polycystic ovarian syndrome.

OBJECTIVE: Insulin resistance (IR), which is common in women with polycystic ovarian syndrome (PCOS), may adversely affect the outcome of ovulation induction due to its detrimental effect on ovarian function. The aim of this study was to evaluate the impact of IR on the outcome of laparoscopic ovarian diathermy (LOD). DESIGN: Prospective observational study. SETTING: Tertiary fertility centre. POPULATION: Forty-four anovulatory women with PCOS undergoing LOD. METHODS: Fasting serum concentrations of insulin and glucose were measured before and after LOD. Insulin sensitivity was determined using the homeostasis model assessment (HOMA) index. Values of HOMA index ≥2.1 were considered abnormal, indicating IR. MAIN OUTCOME MEASURES: Ovulation and pregnancy rates were compared between women with and without IR using χ(2) test and odds ratio (OR) with 95% confidence interval (CI). RESULTS: Eighteen women (41%) had elevated HOMA index (≥2.1). There was no change of HOMA index after LOD (median 1.89, range 0.53-8.48 vs. 1.92, range 0.53-8.46). The ovulation rate in women with IR (12 of 18, 67%) was significantly (p=0.013, OR 0.08; 95% CI 0.01-0.74) lower than that (25 of 26, 96%) of women without IR. Likewise, the pregnancy rate (six of 18, 33%) was significantly (p=0.037, OR 0.26; 95% CI 0.07-0.94) lower in women with IR than that of women without IR (17 of 26, 65%). Using a receiver operating characteristics curve, the HOMA index was useful in predicting no ovulation after LOD (area under the curve 0.826). CONCLUSIONS: Insulin resistance appears to have an adverse effect on the outcome of LOD and seems to be a useful prognostic factor.

Hazards of surgical diathermy.

BACKGROUND: Surgical diathermy is an invaluable facility widely used in the operating theatre. Its application in surgical practice is rapidly expanding. However, its use may be accompanied with hazards, which this review is intended to highlight. METHODS: Publications from local and international journals were reviewed. RESULTS: The role of diathermy in surgical practice has expanded beyond imagination in recent years. The patient, surgeon and the theatre staff are frequently exposed to hazards such as burns injury, electrocution, hypoxic stress, inhalation of diathermy plume, and gene mutation. However, strict adherence to preventive measures such as proper connection and handling of diathermy machine, avoidance of inflammable theatre gases, the use of suction device, theatre scavenging system and diathermy plume extraction system could significantly reduce the hazards. CONCLUSION: Continuous exposure to electrocautery appliances in surgical practice is associated with potential risks. Optimizing health and safety in work place should be an ongoing goal. Hence, all methods geared toward the reduction of these risks to health should be emphasized.

Ignorance of electrosurgery among obstetricians and gynaecologists.

OBJECTIVE: The purpose of this study was to assess the level of skill of laparoscopic surgeons in electrosurgery. DESIGN: Subjects were asked to complete a practical diathermy station and a written test of electrosurgical knowledge. SETTING: Tests were held in teaching and non-teaching hospitals. SAMPLE: Twenty specialists in obstetrics and gynaecology were randomly selected and tested on the Monash University gynaecological laparoscopic pelvi-trainer. Twelve candidates were consultants with 9-28 years of practice in operative laparoscopy, and 8 were registrars with up to six years of practice in operative laparoscopy. Seven consultants and one registrar were from rural Australia, and three consultants were from New Zealand. METHODS: Candidates were marked with checklist criteria resulting in a pass/fail score, as well as a weighted scoring system. We retested 11 candidates one year later with the same stations. MAIN OUTCOME MEASURES: No improvement in electrosurgery skill in one year of obstetric and gynaecological practice. RESULTS: No candidate successfully completed the written electrosurgery station in the initial test. A slight improvement in the pass rate to 18% was observed in the second test. The pass rate of the diathermy station dropped from 50% to 36% in the second test. CONCLUSION: The study found ignorance of electrosurgery/diathermy among gynaecological surgeons. One year later, skills were no better.

Virtual reality laparoscopic simulator for assessment in gynaecology.

A validated virtual reality laparoscopic simulator minimally invasive surgical trainer (MIST) 2 was used to assess the psychomotor skills of 21 gynaecologists (2 consultants, 8 registrars and 11 senior house officers). Nine gynaecologists failed to complete the VR tasks at the first attempt and were excluded for sequential evaluation. Each of the remaining 12 gynaecologists were tested on MIST 2 on four occasions within four weeks. The MIST 2 simulator provided quantitative data on time to complete tasks, errors, economy of movement and economy of diathermy use--for both right and left hand performance. The results show a significant early learning curve for the majority of tasks which plateaued by the third session. This suggests a high quality surgeon-computer interface. MIST 2 provides objective assessment of laparoscopic skills in gynaecologists.

Medical devices; effective date of requirement for premarket approval for three class III preamendments physical medicine devices--FDA. Proposed rule; opportunity to request a change in classification.

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for the following three high priority Group 3 preamendments class III devices: Microwave diathermy for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures; ultrasonic diathermy for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures; and ultrasound and muscle stimulator for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures. The uses of these three devices do not include use for the treatment of malignancies. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the agency change the classification of any of these devices based on new information.

Microwave diathermy of the retina and choroid.

Microwaves were used to induce chorioretinal scar formation in normal rabbit eyes. We have developed a directional 6.8-gigahertz microwave applicator with a rectangular aperture. It was designed to mimic the shape and function of a T-shaped scleral depressor. For treatment, the applicator was placed on the conjunctiva over the sclera. Then, indentation was used to visualize probe placement during indirect ophthalmoscopy. Thermocouple-controlled heating was initiated such that conjunctival temperatures in a range of 51 degrees C to 65 degrees C were induced for 10 seconds per treatment. We found that treatment at temperatures of 51 degrees C or 52 degrees C for 10 seconds produced circular areas of acute retinal whitening. From these microwave-induced lesions, there evolved chorioretinal attenuation with and without evidence of retinal pigment epithelial hyperplasia. No evidence of scleral damage was noted at these thermal doses.

An eccentrically coated asymmetric antenna applicator for intracavitary hyperthermia treatment of cancer.

In this paper a model based on transmission line theory is used to predict the behavior of an eccentrically coated asymmetric antenna applicator for use in intracavitary hyperthermia. Theoretical results for the heating rate (HR) of the applicators are compared to experimental results. The experimental results were obtained at City of Hope National Medical Center using four different 915-MHz applicators, each with a different antenna size and eccentricity of the coating. A parameter delta is defined where delta << 1.0 is a thin wire approximation; delta is primarily a function of the eccentricity of the coating, the antenna diameter, and the coating diameter. It is found that when delta approximately less than 0.5, the theoretical model works well. In particular, it predicts the directivity due to the eccentricity of the coating. However, as this eccentricity is increased or as the antenna diameter is increased (delta approximately greater than 0.6), the model no longer accurately predicts directivity. Thus, the model that can be used to predict the HR profiles for an eccentrically coated asymmetric antenna only when delta approximately less than 0.5.

Transurethral microwave thermotherapy for prostatism: early Mayo Foundation experience.

As part of a multicenter investigative trial, transurethral microwave thermotherapy of the prostate was used in 60 men with symptomatic benign prostatic hypertrophy. A single office treatment on the Prostatron, a device that provides concurrent microwave heating of the prostate and conductive cooling of the urethra, was well tolerated and caused no major adverse events. Symptomatic improvement, especially the decrease in nocturia and urgency, was dramatic, and urinary flow was improved at 6 weeks. Continued follow-up suggests that further improvement will be achieved and that transurethral microwave thermotherapy has a role in the treatment of benign prostatic hypertrophy.

Outpatient loop diathermy conization as an alternative to inpatient knife conization of the cervix.

A knife cone biopsy of the cervix is usually performed as an inpatient procedure under general anesthesia and is associated with significant morbidity. Loop diathermy conization was performed under local anesthesia on colposcopy outpatients as an alternative to knife conization. In 33 consecutive patients studied the procedure was well tolerated, there were no operative complications, and a satisfactory specimen for histologic examination was obtained in every case. One case of unsuspected invasive cancer and two of suspected microinvasive cancer were diagnosed. The diagnosis of cervical precancer was made in 24 (73%) of the cases. The introduction of outpatient loop diathermy conization of the cervix instead of knife conization would decrease hospitalization costs, avoid the need for general anesthesia and potentially reduce short-term patient morbidity.

Advances in colposcopy and management of cervical intraepithelial neoplasia.

Cervical intraepithelial neoplasia remains a significant problem with regard to diagnosis and treatment. The emphasis has now shifted toward selection for treatment, partly as a result of an improved understanding of risk and partly as a result of simple excisional methods of treatment with low morbidity. It is now apparent that diagnoses based on small directed biopsy specimens may be misleading and whole transformation zone specimens should be regarded as the ideal. Although the role of oncogenic human papillomaviruses still remains obscure with regard to the etiology of cervical intraepithelial neoplasia, continued investigation is essential and rewarding in terms of an improved understanding of the molecular biology of malignant transformation and the interaction of transformed cells with the host's immune system.

Sessile adenomas of the rectum: a personal series 1974-1984.

Sessile (villous) tumours of the rectum are uncommon and individual surgeons are unlikely to have wide experience in their management. A study was made of a unique personal series (AMC) of 104 cases encountered from 1974 to 1984; minimum duration of follow-up was 5 years. Clinically obvious rectal cancers were excluded from the study. Ages ranged from 42 to 89 years (mean 64.9 years) with a male:female ratio of 1.5:1. The commonest clinical presentations of sessile tumours of the rectum were rectal bleeding (45%) and altered bowel habit (38%). Hypokalaemia was a very uncommon presenting symptom (1%). These tumours ranged in longitudinal diameter from 1 to 9 cm, with 66% of cases greater than 3 cm and 33% of cases greater than 5 cm. The incidence of malignancy in sessile adenomas greater than 3 cm (27%) was more than triple that of adenomas less than 3 cm (8%) and the presence of induration on rectal examination was the most reliable clinical indicator of the presence of malignancy. Local transanal diathermy excision was a satisfactory form of treatment for most sessile tumours of the rectum (benign and malignant); especially if they were less than 3 cm (0% recurrence rate). It had the added advantage of preserving the anal sphincter and was possible in a higher proportion of sessile tumours in the lower half of the rectum (89%) than those in the upper half of the rectum (42%). The overall recurrence rate after local transanal excision was 8% for benign sessile adenomas and 33% for those containing invasive carcinoma.(ABSTRACT TRUNCATED AT 250 WORDS)

Hyperthermia: principles and quality assurance.

The methods of energy deposition, the power absorbtion properties of biological tissues and the basic components of a typical hyperthermia system are described. In addition, the clinical requirements of hyperthermia treatment are discussed. A perspective on treatment planning and quality control is presented.