Equipment Safety

Publication Title: 
Journal of Alternative and Complementary Medicine (New York, N.Y.)

Criteria for therapeutic efficacy and safety include significant amelioration of symptoms and, ideally, cure (i.e., patients' belief in effective improvement of symptoms and quality of life, durable impact on symptoms, verifiable subjective and objective changes); improved patient management (e.g., diminishing, or ceasing medication, physiotherapy, and other interventions); safety for patient and practitioner and an acceptable side effect profile; cost-effectiveness of the therapy in practice and to teach to others.

Jobst, K. A.
Publication Title: 
Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology: Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology

AIMS: Several case reports have demonstrated negative interactions between various physiotherapy modalities and cardiac rhythm devices (CRD). Fear of these potential interactions may lead to suboptimal utilization of physiotherapy treatments in CRD patients. No prior review of available guidelines, or management strategies, on the interaction between physiotherapy modalities and CRD patients has been reported. To review existing guidelines regarding the use of physiotherapy modalities in patients with pacemakers and/or implantable cardioverter-defibrillators (ICDs).

Digby, Geneviève C.
Daubney, Marguerite E.
Baggs, Jim
Campbell, Debra
Simpson, Christopher S.
Redfearn, Damian P.
Brennan, F. James
Abdollah, Hoshiar
Baranchuk, Adrián
Publication Title: 
International Urogynecology Journal and Pelvic Floor Dysfunction

The massive introduction of new products from device and drug industries together with a scanty device approval process and a growing scepticism about the reliability of drug trials call for new improved strategies in urogynaecological research. Device companies and physicians have a mutual ethical responsibility of contributing to create clinical data based on the framework of trials in surgery before new surgical products are implemented and disseminated.

Lose, Gunnar
Publication Title: 

BACKGROUND: Automatic control of depth of hypnosis using the Bispectral Index (BIS) can help to reduce phases of inadequate control. Automated BIS control with propofol or isoflurane administration via an infusion system has recently been described, a comparable study with isoflurane administration via a vaporizer had not been conducted yet. Our hypothesis was that our new model based closed-loop control system can safely be applied clinically and maintains the BIS within a defined target range better than manual control.

Locher, Stephan
Stadler, Konrad S.
Boehlen, Thomas
Bouillon, Thomas
Leibundgut, Daniel
Schumacher, Peter M.
Wymann, Rolf
Zbinden, Alex M.
Publication Title: 
The American Journal of Emergency Medicine

The purpose of this study was to compare the Oxylator EM-100, a ventilator with a fixed flow and working pressure of 25 to 50 cm H(2)O, with a bag-valve device with respect to safety, efficiency, and efficacy when used by professionals. We conducted a prospective, controlled, caregiver-blind single center study. Induction was followed by ventilation with a bag-valve device oxylator in manual and automatic modes. Steps were repeated under hypnosis, after muscle relaxation with mask, and with an endotracheal tube. Forty patients, aged 48.8 +/- 13.5 years weighing 50 to 111 kg were studied.

Noordergraaf, Gerrit J.
Van Dun, Peter J.
Schors, Marcel P.
De Jong, Wim
Noordergraaf, Abraham
Publication Title: 

Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia.

Ghosh, Dilip
Skinner, Margot
Ferguson, Lynnette R.
Publication Title: 
Biomedical Instrumentation & Technology / Association for the Advancement of Medical Instrumentation

Eighty-one patients suffering from neck pain and tension-type headaches were treated by the application of a unique physical therapy device combining transcutaneous electrical nerve stimulation (TENS), traction, massage, vibration, and acupressure applied to the forehead, posterior cervical spine, and scapula. The device employed eight silver silicone electrodes for modality application. Its safety and effectiveness were assessed by evaluating patients before and after treatment. No complication ensued.

Stone, R. G.
Wharton, R. B.
Publication Title: 
Applied Radiation and Isotopes: Including Data, Instrumentation and Methods for Use in Agriculture, Industry and Medicine

Compliance testing is nominally that part of a quality assurance program dealing with those aspects of X-ray equipment performance that are subject to radiation control legislation. Quality assurance programs for medical X-ray equipment should be an integral part of the quality culture in health care.

Hutchinson, D. E.
Cobb, B. J.
Jacob, C. S.
Publication Title: 
Journal of Manipulative and Physiological Therapeutics

INTRODUCTION: Many devices have been marketed claiming to increase the mobility of the articulations of the spine with active or passive distraction. In this study, the Rola Stretcher (Unique Relief, Inc, Davenport, Iowa) and an earlier version, the True Back II (True Back, Inc, Clearwater, Fla), were evaluated to see if they have a measurable biomechanic effect on the spine. METHODS: Two studies were conducted, each with 6 male participants and 6 female participants, using a stadiometer to accurately measure a person's sitting height.

Devocht, J. W.
Pope, M. H.
Magnusson, M.
Spratt, K. F.
Publication Title: 
Australasian Physical & Engineering Sciences in Medicine / Supported by the Australasian College of Physical Scientists in Medicine and the Australasian Association of Physical Sciences in Medicine

The impact of a formal compliance testing program has been evaluated three years post-implementation on a major teaching hospital (Sir Charles Gairdner Hospital) with 46 x-ray tubes located throughout 37 rooms. The mandatory program, implemented by the statutory authority in January 1997, called for all medical (including chiropractic and dental) equipment used in human diagnosis to be tested at prescribed frequencies using established protocols. The application of the required test methods demonstrated various non-compliance issues.

Tuchyna, T.
Wilkinson, S.
Jacob, C. S.


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