Managing medical device hazards and recalls. ECRI's guide for setting up an effective program

Each year, healthcare facilities are confronted with hundreds of medical device hazard reports and recalls. To ensure that appropriate actions are taken in response to all such reports, facilities must have an effective medical device hazard and recall management program in place. Such a program should ensure that hazard and recall information is received and communicated to the appropriate personnel and that the required action is taken and documented. This Guidance Article was developed to serve as a resource for healthcare facilities that wish to set up--or, more likely, refine--a hazard and recall management program. We have divided the discussion into three sections: The first part of this article addresses the role that hazards and recalls play in improving patient safety, focusing on the U.S. Food and Drug Administration's (FDA) role in the recall process and on healthcare facilities' responsibility to deal with hazards and recalls. The second part guides hospitals through the process of setting up an effective in-house hazard and recall management program. In the final section, we review some of the ECRI resources and tools you can use to develop and refine your program.     

Electrosurgical safety: conducting a safety audit

ECRI detailed some of the lesser-known risks of electrosurgery in a collection of articles published in the August 2005 Health Devices. However, it's also important to recognize that even hazards that are well understood by clinical personnel can lead to injury if appropriate safety measures aren't applied consistently. In this follow-up to our August 2005 articles, we offer guidance to help healthcare facilities conduct a safety audit that examines critical aspects of the facility's use of electrosurgical technology. ECRI recommends that healthcare facilities periodically conduct such an audit to ensure that the appropriate equipment and procedures are in place to protect patients and staff from injury. This article reviews some of the key questions to ask during a safety audit, and it includes detailed guidance for developing an electrosurgical safety checklist.     

Asset tracking: what it is and whether it's right for you

This Guidance Article examines asset tracking technology, reviewing what it is, how it works, and how it can be applied in the healthcare setting to help hospitals better manage medical equipment. The article also offers guidance to help healthcare facilities determine whether (or when) they should consider investing in asset tracking technology. Asset tracking refers to the ability to detect, identify, and locate assets-infusion pumps, wheelchairs, or just about any other object or device--at any time, as well as to record the physical locations of those assets over time. Though already commonplace in some industries, tracking technology is still relatively new to healthcare. As a result, the systems, the companies that supply them, and even the applications for which they can be used are still evolving. While some healthcare facilities could see almost immediate benefits from implementing an asset tracking system now, others would benefit from waiting a little while for the marketplace to develop further. This article provides information to help hospitals determine which option will be best for them. For facilities that choose to start the system selection process now, we outline factors that should be considered.     

The use of mercury-based medical devices across Croatian healthcare facilities

In 2009, we conducted a survey to assess the use of mercury-based thermometers and sphygmomanometers and their disposal in Croatian healthcare facilities. The questionnaire addressing the use of mercury-based medical devices, waste management, preferences between mercury-based and electronic devices, and the knowledge on mercury toxicity was filled by ward nurses affiliated with 40 (71.4 %) out of 56 contacted healthcare facilities. Only one of these facilities had given up the use of mercury-containing medical devices at the time. As many as 84.6 % of the nurses believed that broken devices did not increase the risk of mercury exposure, even though 90 % claimed they were aware of mercury toxicity. In fact, 69.4 % of the nurses preferred mercury-containing devices on account of their precision and reliability and because they received little training in the use of electronic devices.Breaking of thermometers and sphygmomanometers is common in healthcare facilities. The number of broken thermometers and sphygmomanometers was estimated to 278 and five per month, respectively. Only 18 (46.2 %) of the surveyed healthcare facilities claimed to have had a proper disposal procedure for mercury from broken devices. Nurses, who most often handle these devices and collect mercury spills, are primarily exposed to mercury vapours via inhalation. Croatia has adopted the EU Directive 76/769/EEC intended to reduce mercury exposure in the living and working environment. Our survey suggests that all healthcare professionals need training in proper management of broken mercury-based medical devices, nurses in particular. To reduce the risk of exposure, all Croatian healthcare facilities should implement guidelines for staff protection and programmes to gradually replace mercury-based with electronic devices.     

Keeping current with biphasic defibrillation waveforms

In recent years, defibrillators that use a biphasic waveform instead of the traditional monophasic waveform have become increasingly common. In fact, since we last published on this topic in 2001, most defibrillator suppliers have begun concentrating solely on developing and marketing biphasic defibrillators while phasing out their monophasic models. Healthcare facilities are wondering if they should do the same. ECRI believes that the time has come for healthcare facilities to begin making the switch to biphasic models. That's not to say, however, that immediate replacement is required. Continuing to use a monophasic device that is in proper working condition is certainly acceptable, and replacing all models at once would be a large--and we believe unnecessary--financial burden. Rather, ECRI recommends that healthcare facilities implement a plan to phase out their monophasic defibrillators over the next few years. We discuss why, and offer recommendations to facilitate a safe and smooth transition, on the pages that follow.     

Supply Chains in Healthcare Organizations: Lessons Learned from Recent Shortages

This paper examines the need for better management of supply chains in healthcare facilities. Recent shortages have highlighted the need for better supply chain systems. The reasons for the shortages are false scarcity, natural disasters, medical lawsuits, production process problems, and group purchasing organizations (GPO). These problems have occurred with increasing frequency. There are three possible solutions available to handle the shortages. First, better use of supply chain management, including multiple suppliers and safety stock. Second, there needs to be better cooperation between suppliers, consumers, and government entities. Finally, healthcare facilities should develop teams of individuals responsible for monitoring critical areas and developing contingency plans.     

Telemedicine: an overview

Telemedicine--the use of telecommunications and computer technology to provide medical information and services at a distance--is growing in popularity. Because of the rapid advances being made in the technology, more and more clinical applications can now be performed via telemedicine. However, the decision to adopt telemedicine should be made only if a clinical need for this technology can be demonstrated. And successful implementation and operation depend on specifically designing the technical infrastructure--that is, the computer hardware and software and the telecommunications system--to meet this clinical need. But even more important is making sure that everyone involved in such a program, including clinicians, telecommunications suppliers, and patients, understands the objectives, benefits, and particular requirements of telemedicine. In this Guidance Article, we provide an overview of the issues surrounding telemedicine. We present examples of successful telemedicine programs, along with guidance for facilities considering programs of their own. We also outline the barriers to successful implementation. And we discuss how, once a telemedicine program is in place, facilities can evaluate the effect of the program on their delivery of healthcare. In supplementary articles, we discuss the technology used for telemedicine and provide a list of telemedicine resources for readers who wish to learn more about the subject.     

ECRI institute recommends reporting EMI events

Electromagnetic interference (EMI), though rare, can have a detrimental effect on the performance of electronic medical devices, potentially posing a patient safety risk. We encourage healthcare facilities to report EMI events (both known and suspected) to external entities such as device manufacturers, regulatory bodies (e.g., the U.S. Food and Drug Administration [FDA]), and ECRI Institute. Reporting such events will allow these organizations to analyze a greater number of reports in order to recognize trends that can help identify the susceptibility of devices to this problem; this information can then be disseminated to the healthcare community.     

Top 10 health technology hazards: are you protecting your patients from these high-priority risks?

This list of 10 high-impact hazards was compiled by ECRI Institute to help healthcare facilities prioritize their efforts to protect patients and staff from injuries that can occur during the use of medical devices and systems.     

医用射线剂量数据的质量管理

目的：将统计学方法应用在医用射线剂量数据的管理,可以反映出现有剂量数据的稳定性,从而反映出射线类设备的使用状态,为医患人员的安全防护工作提供有效依据。方法：利用统计学方法,引进统计学中的计量值控制图,直观反映出医用射线类设备剂量及机房环境剂量数据的稳定性。结果：通过统计学中的计量值控制图,可以看出医用射线类设备剂量及机房环境剂量的稳定性,可以有效反映设备和机房质量情况。讨论：首次将统计学中的计量值控制图的概念引入医用射线剂量数据的管理中,这种方法可以提供给我们关于射线剂量数据更加有效直观的总体情况,可以反映出射线类设备的机械质量状况,为设备检修保养提供有效参考。为医护人员和患者的安全防护提供有效依据。     

Year 2000 compliance issues

This month, we continue our coverage of the year 2000 (Y2K) problem as it affects healthcare facilities and the professionals who work in them. We present the following articles: "Checking PCs for Y2K Compliance"--In this article, we describe the probable sources of Y2K-related errors in PCs and present simple procedures for testing the Y2K compliance of PCs and application software. "Y2K Assessment Equipment Expectations"--In this article, we review the Y2K compliance data from a small sampling of hospitals to help answer the question "What percentage of medical equipment will likely be susceptible to Y2K problems?" "Y2K Labeling of Medical Devices"--In this article, we discuss the pros and cons of instituting a program to label each medical device with its Y2K status. Also in this section, we present an updated list of organizations that support ECRI's Position Statement on the testing of medical devices for Y2K compliance, which we published in the December 1998 issue of Health Devices (27[12]). And we remind readers of the services ECRI can offer to help healthcare institutions cope with the Y2K problem.     

借鉴FDA管理经验降低医疗设备电磁干扰

针对我国医疗设备行业立法和行政管理现状，提出应借鉴美国FDA的先进管理经验，寻求解决电磁干扰问题的有效途径；论述了应着重改善医疗设备本身的性能和工艺，满足电磁兼容性，以更好地适应各地域的不同环境；分析了医疗电子设备满足电磁兼容性的设计方案。     

Secular trends in diagnostic code density in electronic healthcare data from health care systems in the Vaccine Safety Datalink Project

Large observational vaccine safety studies often use automated diagnoses extracted from medical care databases to identify pre-specified potential adverse events following immunization (AEFI). We assessed the secular trends and variability in the number of diagnoses per encounter regardless of immunization status referred as diagnostic code density, by healthcare setting, age, and pre-specified condition in eight large health care systems of the Vaccine Safety Datalink project during 2001–2009. An increasing trend in diagnostic code density was observed in all healthcare settings and age groups, with variations across the sites. Sudden increases in diagnostic code density were observed at certain sites when changes in coding policies or data inclusion criteria took place. When vaccine safety studies use an historical comparator, the increased diagnostic code density over time may generate low expected rates (based on historical data) and high observed rates (based on current data), suggesting a false positive association between a vaccine and AEFI. The ongoing monitoring of the diagnostic code density can provide guidance on study design and choice of appropriate comparison groups. It can also be used to ensure data quality and allow timely correction of errors in an active safety surveillance system.     

Liability for medical malpractice: an economic approach

In recent years, changes in the organization of healthcare institutions and the increased number of medical malpractice claims have revealed the need to study the concept of medical responsibility and the repercussion of these changes on healthcare provision. To date, discussion has focussed on legal aspects and economic implications have been largely ignored.The present article reviews studies that have performed an economic analysis the subject. Firstly, we examine studies that gradually introduce the concepts of uncertainty, risk aversion and moral hazard. Secondly, in the healthcare environment, we pay particular attention to models that include new arguments on professionals' objective duties or to bargaining models when there is asymmetric information. Finally, we consider the medical malpractice insurance market and investigate how reputation and the possibilities of exercising defensive medicine influence healthcare provision.Our analysis suggests that, due to the characteristics of the healthcare market, the models proposed by the economy of information are very useful for performing economic analyses of liability in medical malpractice. However, alternative hypotheses also need to be formulated so that these models can be adapted to the specific characteristics of different health systems.     

医学生农村基层择业意向调查及因素分析——基于甘肃省的调查

目的:基于甘肃省数据,调查医学院校毕业生农村基层择业意向,分析其影响因素,为农村卫生人力资源决策提供参考依据。方法:问卷调查甘肃省六所医学高校临床及护理专业临近毕业的学生(本科生五年级、专科生三年级,不包括甘肃省订单定向医学生),采用卡方检验和二元Logistic回归对统计资料进行分析。结果:具有农村基层择业意向的医学生占55.6%,其中,专科生是本科生的2.3倍;"非常愿意"去基层工作的医学生占比为13.8%;家庭人均收入低、月薪期望值不高、农村户籍、了解农村基层就业政策的医学生更容易选择去基层就业。结论:医学生农村基层择业意向受自身因素(学历、户籍等)、卫生人力干预政策、学校就业指导、社会环境等诸多因素影响。卫生决策及管理部门需要综合考虑上述因素,通过推行合理的招募政策,加强农村基层医疗技术设备及基础设施建设,改善农村基层就业环境和职业发展机会,强化医学生就业指导工作等策略,增强医学生农村基层择业意向。     

Copper T 380A IUD and magnetic resonance imaging

BACKGROUND: Concerns about women who have implanted or in situ medical devices undergoing magnetic resonance (MR) imaging engender the need for testing. Prior testing of the Copper T 380A intrauterine device (IUD) has been done using MR systems of 1.5 T or less. This study was performed to test this IUD in a MR system of 3.0 T. MATERIALS AND METHODS: In vitro safety testing was done via the Copper T 380A IUD using a GE Signa LX 3.0-T MR system. Variables tested included deflection, torque, heating and artifact. RESULTS: No significant deflection, torque, heating or artifact was found in this in vitro testing model. CONCLUSION: The outcomes measured revealed no safety concerns for the use of the Copper T 380A IUD at 3.0 T under the conditions of testing. This finding is compatible with the new standards adopted by the American Society for Testing and Materials and the Food and Drug Administration (FDA), with a rating of "MR Conditional."     

Creating a healing environment: the importance of the service setting in the new consumer-oriented healthcare system

Over the last ten years, the healthcare industry has recognized that the physical environment is a valuable resource that can and does affect all of its customers. Although most service organizations give some thought to setting, its importance to the service experience has been most thoroughly understood by those who view and treat their customers as guests, that is, the guest service industry. An excellent healing environment will reinforce excellent clinical quality, but an inferior environment can detract from fine clinical care. One of the most important principles learned by the guest service industry is to provide the setting customers expect. Another is to create an environment that meets or exceeds customer needs for safety, security, support, competence, physical comfort, and psychological comfort. This article provides a detailed discussion of how such an environment can be created in healthcare facilities drawing from the experience of the best guest service organizations.     

Working for a sustainable future: healthcare leaders provide input for new model

With each tick of the clock, healthcare leaders are coming face to face with a pressing quandary: How can they best guide their organizations to success and sustainability in a rocky and ever-changing healthcare environment? A new "model of sustainability," developed with input from nine CEOs of top medical institutions, may provide some guidance. The model includes six leadership imperatives that underscore critical approaches to supporting the hospital of the future: Build strong organization-wide leadership, become the employer of choice, generate financial strength, redesign structures and processes, develop productive physician relationships, and engage consumers.     

Developing a patient information brochure

In light of increasing consumer demands for information and the growing complexity of healthcare facilities, the need has arisen to present the public with useful information concerning your medical group. A patient information brochure can be a valuable public relations device as well as a time saver. It can serve as a written record of key policies and procedures and can also be a morale builder for patients and staff. If your medical group has not yet developed a patient information brochure, you will be able to glean many practical tips from this article. Drawing from experience, the author traces through the steps of developing the brochure--from exploring current models and choosing an appropriate team for the project, through production details.     

Managing biomedical waste in Ontario: a regional approach

The lack of landfill space, public perceptions, the escalating costs of disposal, and other factors have created a controversial environment for the disposal of healthcare waste. In the province of Ontario, a proposal has been made that aims to make Ontario self-sufficient in its management of healthcare waste through the use of regional incineration facilities. This article examines this proposal as well as other available options for Ontario's healthcare facilities.