A brief illustration of the official national standards for the safe use of cupping therapy (Hijama) in Saudi Arabia.

Cupping therapy (Hijama in Arabic) is a popular traditional treatment especially in Asia, the Middle East and Central Europe. Traditionally, cupping therapy has been one of the most used practices in Saudi Arabia. Standardization of the practice of cupping therapy is a very important step to eliminate or reduce any adverse events related to cupping. This article gives a brief illustration and highlights the important points of the first accredited Saudi Arabian standards for the safe use of cupping equipment and its applications.

Evaluation of the Carefusion Alaris PC infusion pump for hyperbaric oxygen therapy conditions: Technical report.

We present a standardized test methodology and results for our evaluation of the Carefusion Alaris PC infusion pump, comprising the model 8015 PC Unit and the model 8100 Large Volume Pump (LVP) module. The evaluation consisted of basic suitability testing, internal component inspection, surface temperature measurement of selected internal components, and critical performance testing (infusion rate accuracy and occlusion alarm pressure) during conditions of typical hyperbaric oxygen (HBO2) treatment in our facility's class A multiplace chamber. We have found that the pumps pose no enhanced risk as an ignition source, and that the pumps operate within manufacturer's specifications for flow rate and occlusion alarms at all stages of HBO2 treatments, up to 4.0 ATA and pressurization and depressurization rates up to 180 kPa/minute. The pumps do not require purging with air or nitrogen and can be used unmodified, subject to the following conditions: pumps are undamaged, clean, fully charged, and absent from alcohol cleaning residue; pumps are powered from the internal NiMH battery only; maximum pressure exposure 4.0 ATA; maximum pressurization and depressurization rate of 180 kPa/minute; LVP modules locked in place with retaining screws.

Test results for the evaluation of a glucometer for use under hyperbaric conditions: Technical report.

This study aimed to evaluate a recently developed equipment test method by assessing the safe and accurate functioning of the Abbott Optium FreeStyle H portable blood glucose monitor for use in the Alfred Hospital's hyperbaric chamber. The results of this study indicate that the test method can be used successfully to evaluate instruments and/or devices for use in the hyperbaric environment. The evaluation initially found that this particular glucose monitor contained a lithium battery which can be hazardous when used in the hyperbaric environment. However, upon further inspection it was determined the battery posed minimal risk for fire and explosion due to its small capacity and design application. The results indicate that the Abbott Optium FreeStyle H blood glucose monitor operated normally when used in the hyperbaric chamber. This glucometer was found to perform within the calibration specification requirements for accuracy at all stages of a typical hyperbaric treatment and as such the Abbott Optium FreeStyle H blood glucose monitor was deemed safe for use in the hyperbaric chamber at the Alfred Hospital.

Assessing the dose values received by patients during conventional radiography X-ray examinations and the technical condition of the equipment used for this purpose.

BACKGROUND: X-ray examination is associated with patient exposure to ionizing radiation. Dose values depend on the type of medical procedure used, the X-ray unit technical condition and exposure conditions selected. The aim of this study was to determine the dose value received by patients during certain conventional radiography X-ray examinations and to assess the technical condition of medical equipment used for this purpose. MATERIAL AND METHODS: The study covered the total number of 118 conventional diagnostic X-ray units located in the Masovian Voivodeship. The methodology used to assess the conventional diagnostic X-ray unit technical condition and the measurement of the radiation dose rate received by patients are based on test procedures developed by the Department of Radiation Protection and Radiobiology of the National Institute of Public Health - National Institute of Hygiene (Warszawa, Poland) accredited for compliance with PN-EN 17025 standard by the Polish Centre for Accreditation. RESULTS: It was found that 84.7% of X-ray units fully meet the criteria set out in the Polish legislation regarding the safe use of ionizing radiation in medicine, while 15.3% of the units do not meet some of them. The broadest dose value range was recorded for adult patients. Particularly, during lateral (LATl) lumbar spine radiography the recorded entrance surface dose (ESD) values ranged from 283.5 to 7827 µGy (mean: 2183.3 µGy). CONCLUSIONS: It is absolutely necessary to constantly monitor the technical condition of all X-ray units, because it affects population exposure to ionizing radiation. Furthermore, it is essential to raise radiographers' awareness of the effects that ionizing radiation exposure can have on the human body.

[Utility of medical devices: approaches to planning and conducting clinical trials]. / Nutzen von Medizinprodukten: Lösungsansätze bei der Planung und Durchführung von Studien.

Medicines and medical devices do not only differ in the approval process, but also in the aim and conduct of clinical trials. We first discuss important differences between medicinal products and medical devices. Emphasis is put on the differences in the framework for clinical trials. We point out that a different analysis set should be used in clinical trials of medical devices when compared with medicinal products and medical devices in the USA. Specifically, regulators generally ask for the full analysis set based on the intention-to-treat principle as proof of efficacy of medicines. A central aspect of clinical trials of medical devices is that they have to be tested under normal conditions of use according to the performance data. As a result, all data acquired while the medical device was not during normal conditions of use should be excluded from statistical analyses. We discuss statistical methodological particularities of medical devices, such as blinding and the control of placebo effects. Using the conservative treatment of anal incontinence as an example, we show that comprehensive technical and physical knowledge is required for assessing the utility of medical devices. Finally, we consider reporting of severe adverse events and of severe adverse device effects of medical devices.

Addendum to "Personal and Public Safety Issues Related to Arrhythmias That May Affect Consciousness: Implications for Regulation and Physician Recommendations. A medical/scientific statement from the American Heart Association and the North American Society of Pacing and Electrophysiology". Public safety issues in patients with implantable defibrillators. A Scientific statement from the American Heart Association and the Heart Rhythm Society.

OVERVIEW: In 1996, the American Heart Association developed a scientific statement entitled "Personal and Public Safety Issues Related to Arrhythmias That May Affect Consciousness: Implications for Regulation and Physician Recommendations." Since then, multiple trials have established the role of implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death in patients at risk for life-threatening ventricular arrhythmias. OBJECTIVE: The issue of driving for patients with ICDs implanted for primary prevention was briefly discussed in the original statement, with the recommendation that such patients not be restricted from driving beyond the initial phase of healing. This scientific statement has been developed to extend the original 1996 recommendations and to provide specific recommendations on driving for individuals with ICDs implanted for primary prevention. SUMMARY OF RECOMMENDATIONS: (1) Patients receiving ICDs for primary prevention should be restricted from driving a private automobile for at least 1 week to allow for recovery from implantation of the defibrillator. Thereafter, these driving privileges should not be restricted in the absence of symptoms potentially related to an arrhythmia. (2) Patients who have received an ICD for primary prevention who subsequently receive an appropriate therapy for ventricular tachycardia or ventricular fibrillation, especially with symptoms of cerebral hypoperfusion, should then be considered to be subject to the driving guidelines previously published for patients who received an ICD for secondary prevention. (3) Patients with ICDs for primary prevention must be instructed that impairment of consciousness is a possible future event. (4) These recommendations do not apply to the licensing of commercial drivers.

Internal defibrillation: where we have been and where we should be going?

Internal cardioversion has been developed as an alternative technique for patients who are resistant to external DC cardioversion of atrial fibrillation (AF) and was found to be associated with higher success rates. It used initially high energies (200-300 J) delivered between an intracardiac catheter and a backplate. Subsequent studies have shown that it is possible to terminate with energies of 1 to 6 Joules, paroxysmal or induced AF in 90 percent of patients and persistent AF in 75 percent of patients, using biphasic shocks delivered between a right atrium-coronary sinus vectors. Consequently, internal atrial defibrillation can be performed under sedation only without the need for general anesthesia. Recently developed external defibrillators, capable of delivering biphasic shocks, have increased the success rates of external cardioversion and reduced the need for internal cardioversion. However, internal defibrillation is still useful in overweight or obese patients, in patients with chronic obstructive pulmonary disease or asthma who are more difficult to defibrillate, and in patients with implanted devices which may be injured by high energy shocks. Low energy internal defibrillation has also proven to be safe and this has prompted the development of implantable devices for terminating AF. The first device used was the Metrix system, a stand-alone atrial defibrillator (without ventricular defibrillation) which was found to be safe and effective in selected groups of patients. Unfortunately, this device is no longer being marketed. Only double chamber defibrillators with pacing capabilities are presently available: the Medtronic GEM III AT, an updated version of the Jewel AF and the Guidant PRIZM AVT. These devices can be patient-activated or programmed to deliver automatically ounce atrial tachyarrhythmias are detected, therapies including pacing or/and shocks. Attempts to define the group of patients who might benefit from these devices are described but the respective role of atrial defibrillators versus other non-pharmacologic therapies for AF, such as surgery and radiofrequency catheter ablation, remains to be determined. Advantages and limitations or atrial defibrillators and approaches to reduce shock related discomfort which may be a concern in some patients, are reviewed. Studies have shown that despite shock discomfort, quality of life was improved in patients with atrial defibrillators and the need for repeated hospitalizations was reduced. The cost of these devices remains a concern for the treatment of a non-lethal arrhythmia. Attention that atrial defibrillators will receive from cardiologists and from the industry in the future, will depend of the long-term results of other non-pharmacological options and of the identification of the group of AF patients which will require restoration and maintenance of sinus rhythm. But there is no doubt that selected subsets of patients with AF could benefit from atrial defibrillation.

Neurostimulation system used for deep brain stimulation (DBS): MR safety issues and implications of failing to follow safety recommendations.

The use of magnetic resonance imaging (MRI) in patients with neurostimulation systems used for deep brain stimulation requires the utmost care, and no individual should undergo an MR examination in the absence of empirical evidence that the procedure can be performed safely. The risks of performing MRI in patients with neurostimulators include those associated with heating, magnetic field interactions, induced currents, and the functional disruption of these devices. The exact safety recommendations for the particular neurostimulation system with regard to the pulse generator, leads, electrodes, operational conditions for the device, the positioning of these components, and the MR system conditions must be carefully followed for MRI. As highlighted by 2 recent accidents, the failure to strictly follow safety recommendations (eg, use a 1.5-T MR system with a send/receive head radiofrequency coil only; limit the specific absorption rate to 0.4 W/kg; etc.) may result in serious, temporary, or permanent injury to the patient including the possibility of transient dystonia, paralysis, coma, or even death.

RTOG quality assurance guidelines for interstitial hyperthermia.

This document specifies the current recommendations for quality assurance for hyperthermia administration with interstitial techniques as specified by the Radiation Therapy Oncology Group (RTOG). The document begins by providing a brief description of the physical principles behind the use of the three most commonly used methods of interstitial hyperthermia: radiofrequency (RF-LCF), microwave antennas, and ferromagnetic seeds. Emphasis is placed on features that effect quality assurance. Specific recommendations are provided for: a) Pretreatment planning and equipment performance checks, b) Implant considerations and documentation, c) Thermometry, and d) Safety procedures. Specific details regarding quality assurance issues that are common to all local and regional hyperthermia methods are outlined in previous documents sponsored by the RTOG. It is anticipated that technological advances may lead to future modifications of this document.