Reprocessing Flexible Endoscopes in the Otolaryngology Clinic.

Reprocessing a flexible endoscope is a complex multistep process. Attention to detail is essential for patient safety. Physicians need to empower their staff to function as guardians and advocates for best practices in endoscope reprocessing. Current best practice standards and guidelines for flexible endoscope reprocessing in the United States have been led by the Society of Gastroenterology Nurses and Associates, the Association for the Advancement of Medical Instrumentation, the Association of periOperative Registered Nurses, American Society for Gastrointestinal Endoscopy, and Multisociety Guideline. This article focuses on important aspects and current best practices for flexible endoscope cleaning and high-level disinfection.

Reprocessing Standards for Medical Devices and Equipment in Otolaryngology: Safe Practices for Scopes, Speculums, and Single-Use Devices.

Stringent regulatory standards for reprocessing medical devices and equipment have proliferated in response to patient safety incidents in which improperly disinfected or contaminated endoscopes lead to large-scale disease transmission or outbreaks. This article details best practices in reprocessing reusable and single-use devices in otolaryngology, with particular attention to flexible fiberoptic endoscopes/nasophyarngoscopes, nasal speculums, and other clinic and operating room instruments. High-risk devices require sterilization, whereas lower risk devices may be reprocessed using various disinfection procedures. Reprocessing practices have implications for adequacy, efficiency, and cost. Nuanced understanding of procedures and their rationale ensures delivery of safe, ethical, and quality patient care.

[Ethical and legal problems arising from off-label use of medical devices and some solution recommendations]. / Tibbi cihazlarin endikasyon disi (off-label) kullanimindan kaynaklanan etik ve yasal sorunlar ve çözüm önerileri.

The off-label use of medical devices is becoming increasingly widespread. Though the off-label use of drugs has been controlled with the establishment of legal and ethical rules, similar regulations have not been implemented for medical devices. Legal gaps in this field, and the broad initiative granted to physicians have led to the emergence of problems in practice, and physicians are vulnerable to potential criminal sanctions that may emerge as a consequence of these off-label applications. Since the off-label use of medical devices cannot rely on scientifically proven, evidence-based information, evaluation of the risks creates critically important ethical problems that may have serious deleterious effects, despite the good intent of a physician tying to be helpful. During the process of obtaining informed consent from the patient for the off-label use of a device, the physician has crucial responsibilities. The ethical responsibilities of physicians particularly increase in vulnerable patient groups that should be protected from harm. In addition to the physician, the family members who make decisions on behalf of the patient also assume some responsibilities. The development of ethical norms and guidelines enforced by legal regulations concerning this issue, an effective role for ethics committees in the decision-making process, and collaboration between patients, scientists, nongovernmental organizations, medical device companies, specialists in the field of medical ethics, and legal authorities will be important in solving this problem.

Hygiene of venepuncture tourniquets in Denmark.

Tourniquets are widely used to make the vein more visible prior to blood collection. Venepuncture tourniquets are however a non-sterile and potentially reusable equipment. Several studies have shown that they are colonised by a variety of pathogenic bacteria and consecutively use of the same tourniquet on multiple patients will increase the risk of a nosocomial infection. This matter is however only scarcely studied. The objective of this study was to investigate the nationwide use of disposable and non-disposable venepuncture tourniquets and the standardised procedures for cleaning the tourniquets. A questionnaire concerning use and cleaning of tourniquets was therefore sent to all major Danish clinical biochemistry laboratories (n = 12). All but one laboratory had a local procedure for usage and handling of tourniquets, including structured procedures for cleaning. Despite this, only 75% of laboratories had a guideline for cleaning the tourniquets and only 50% had a specified cleaning program. At the hospitals using non-disposable tourniquets the handling differed considerably and at two hospitals the tourniquets were only cleaned once a week, while one laboratory did not clean the tourniquet before it was visibly stained. Of note, five of the eight hospitals using disposable tourniquets only disposed the tourniquets on a daily basis. In conclusion, there is a lack of guidelines for handling tourniquets in 25-33% of the hospitals and a number of hospitals used both types (disposable and non-disposable), which could confuse the handling of the tourniquets. A national guideline for usage and cleaning of venepuncture tourniquets is therefore strongly recommended.

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.

Engineering with uncertainty: monitoring air bag performance.

Modern engineering is complicated by an enormous number of uncertainties. Engineers know a great deal about the material world and how it works. But due to the inherent limits of testing and the complexities of the world outside the lab, engineers will never be able to fully predict how their creations will behave. One way the uncertainties of engineering can be dealt with is by actively monitoring technologies once they have left the development and production stage. This article uses an episode in the history of automobile air bags as an example of engineers who had the foresight and initiative to carefully track the technology on the road to discover problems as early as possible. Not only can monitoring help engineers identify problems that surface in the field, it can also assist them in their efforts to mobilize resources to resolve problem.

Ethics of medical device safety.

How safe is safe? The design intent of a medical device is to off er maximum flexibility, and low-cost and fail-safe features. Easily said, these requirements are difficult to deliver in a litigious society where performance standards are uncommon. Medical device manufacturers face challenges as they strive to offer the ultimate in product safety and keep the price affordable for the technology deployed, while making the usability of typically complex products common sense for the operator. As microprocessors are able to assist designers in providing intelligent, multifunctional systems, care must be taken during the design process to balance technological ability with intuitive use. The medical device development process requires rigor that is not often taught to biomedical engineers. Ethical product development requires a process that will be described in this paper using as an example the development of a recent cardiopulmonary perfusion system. However, the same techniques are germane to implantable devices such as cochlear implants. All engineering product development requires trade-off decisions considering how much is too much and how much is too little. Biomedical engineering faculty need to present this ethical dilemma to their students and give them the tools to help decide. However, in the final analysis, the operator of any medical product or installer of any medical device holds the primary responsibility for understanding how to use the system or install the implant in normal use as well as emergent or special situations; the technology is his or her backup in performing the medical professionals primary job.

Urogynaecological research: current and future developments.

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. In respect of the patients' altruism and confidence, which make drug trials possible, the industry and academia have an obligation to conduct and report clinical results in accordance with the highest standards of scientific and ethical integrity.