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Problems with the use of medical equipment or devices can be broadly divided into two types. One type is when the equipment malfunctions as a result of a technical problem that is not caused by the user. The second type of problem is when the user causes or initiates a malfunction. The types of medical equipment that are associated with user problems range from the relatively simple, such as catheters and syringes, to the most technologically complex, such as computer-controlled diagnostic equipment. The distinction between technical failure of medical equipment and user-initiated failure or malfunction of the equipment is an important one with respect to prevention of related patient injuries. Medical devices sold in the United States are under the regulatory purview of the Food and Drug Administration (FDA). The FDA has invited proposals from time to time for outside investigators to study user error and other issues associated with particular equipment.

The effective use of medical device alarms continues to be a challenging area. In addition to whatever internal efforts an organization may have currently underway, The Joint CommissionYaccredited institutions must now comply with the specific elements of the new National Patient Safety Goal on Alarm Management. Completing these elements before the specified deadlineswill require considerable effort. A documented and functional plan of work will likely be necessary in order to achieve success in this endeavor.

This chapter describes the evolution and development of clinical engineering in China. Some major achievements and activities in the recent years of the largest professional association, Chinese Society of Clinical Engineering, are elaborated. The current training and continuing education for the clinical engineering profession in China are explained. In addition, talent selection and international academic exchanges in clinical engineering are expounded.

Every nurse has at times been faced with the use of a medical device that is excessively challenging. These challenges may include setting up the equipment, using the controls to get it to work as intended, checking on proper operation, identifying and correcting improper or undesired activity, actively avoiding preidentified errors in the use of the device, and hopefully avoiding other pitfalls in its use. These challenges often leave nurses wondering if the people who designed the equipment have any notions of the real world in which their devices must be used. The frustration that these challenges can create is magnified because, at least in principle, the device may be fully capable of being used correctly and without error. Thus the conclusion is often reached, often by nurses themselves, that because the device is technically fine, it must be the user that is at fault. This self-blame is compounded by the traditional nursing mindset of coping with what they have before them, rather than identifying that what they have before them is not right and must be changed. The coping and self-blame perspectives fail to recognize the possibility and necessity of designing equipment that facilitates easy and safe use, rather than leaving it to the user to solve the problems created by poor design. The medical devices that you use in the service of your patients should not be designed so that it is the equipment that unnecessarily needs intensive care because you must labor to overcome the shortcomings of their individual and collective designs. The principles of design that address these issues are in the domain of Human Factors.

Purpose We previously reported that four cycles of docetaxel/cyclophosphamide (TC) produced superior disease-free survival (DFS) compared with four cycles of doxorubicin/cyclophosphamide (AC) in early breast cancer. Older women are under-represented in adjuvant chemotherapy trials. In our trial 16% of patients were ≥ 65 years. We now report 7-year results for DFS and overall survival (OS) as well as the impact of age, hormone receptor status, and HER2 status on outcome and toxicity. Patients and Methods Patients were randomly assigned to receive either four cycles of standard-dose AC (60/600 mg/m2; n = 510), or TC (75/600 mg/m2; n = 506), administered by intravenous infusion every 3 weeks. Results The median age in women younger than 65, was 50 years (range, 27 to 64) and for women ≥ 65 was 69 years (range, 65 to 77). Baseline characteristics in the two age subgroups were generally well matched, except that older women tended to have more lymph node involvement. At a median of 7 years follow-up, the difference in DFS between TC and AC was significant (81% TC v 75% AC; P = .033; hazard ratio [HR], 0.74; 95% CI 0.56 to 0.98) as was OS (87% TC v 82% AC; P = .032; HR, 0.69; 95% CI, 0.50 to 0.97). TC was superior in older patients as well as younger patients. There was no interaction of hormone-receptor status or HER-2 status and treatment. Older women experienced more febrile neutropenia with TC and more anemia with AC. Conclusion With longer follow-up, four cycles of TC was superior to standard AC (DFS and OS) and was a tolerable regimen in both older and younger patients.

XELIRI (capecitabine/irinotecan) is effective and well tolerated in metastatic colorectal cancer (mCRC). Cetuximab is active in mCRC alone or with chemotherapy. This study evaluated cetuximab plus XELIRI in first-line treatment of mCRC.Subjects had histologically confirmed unresectable colorectal adenocarcinoma (with T4 lesions) after preoperative chemoradiation and/or metastases. Treatment was capecitabine 1700 mg/m2 (850 mg/m2 orally twice a day on days 1-14 for 3 weeks), irinotecan 200 mg/m2 intravenously (I.V.) on day 1 every 3 weeks, and weekly cetuximab (initially 400 mg/m2 I.V. [120 minutes], subsequently 250 mg/m2 [30 minutes]).Baseline characteristics (N = 70): 43 men (61%); median age, 61.5 years; Eastern Cooperative Oncology Group performance status 0/1 = 66%/34%; 94% adenocarcinoma. Previous therapy: surgery (91%), chemotherapy (14%), or radiation therapy (7%). Responses (patients completingor = 2 cycles): complete response (5.7%), partial response (37.7%), stable disease (43.4%), and progressive disease (PD; 13.2%); 16 patients discontinued early (n = 4 allergic reaction, n = 2 withdrew consent, n = 2 death, and n = 8 other adverse events [AEs]). The overall per-protocol response rate was 43.4% (34% intent to treat [ITT]; disease control rate, 86.8%; 69% ITT). The median time to progression was 8.1 months (range,1-27.0 months), and the median time to response was 1.6 months (range, 1.1-8.4 months). The median survival was 20.5 months, and 45.7% of patients remain alive. Of the 38 deaths, 84% were because of PD. No death was treatment related. The most frequent grade 3/4 treatment-related AEs included diarrhea, neutropenia, and nausea/vomiting; 32% of patients required dose reductions. All patients are off the study primarily because of PD (34.3%) or AEs (40.0%).In summary, XELIRI plus cetuximab is a promising regimen that merits further study for first-line mCRC.

Yadin David, EdD, PE, CCE, Matthew Baretich, PE PhD, William A. Hyman, PE, ScD, Wayne Morse, and James O. Wear, MSBME, CCE, FACCE From the Biomedical Engineering Consultants, LLC, Houston, Texas (Dr David); Baretich Engineering, Inc, Fort Collins, Colorado (Dr Baretich); Department of Biomedical Engineering, Texas AM Morse Medical, Linc Facility Services Company, Seattle, Washington (Mr Morse); Scientific Enterprises, Inc, North Little Rock, Arkansas (Mr Wear).

Clinical alarms have a deceptively simple purpose, which is to notify caregivers when a patient or a device needs their attention. This simple concept has been proven to be challenging as the number of available alarms has grown and been poorly integrated. When an anticipated notification is not received or an actual notification is not acted upon in a timely manner, patient harm can occur. In this regard, false alarms have been proven to be highly detrimental to the effective use of clinical alarms to enhance patient care. Equally problematical is the issue of false reliance in which a clinician’s vigilance is degraded by the expectation that if anything bad happens, the system will notify him or her. Similarly, alarms have also been part of staff downsizing and shifting to lower expertise, wherein it is believed that the alarms are an appropriate substitute. Human factor issues associated with setting, observing, and responding to alarms have also been proven to be inadequately addressed. This article presents a fault tree analysis of the patient harm-related clinical alarms failures. This analysis can be used to understand, debate, and educate. Medical device alarms continue to be a challenging area of clinical engineering and hospital patient care, and the subject continues to receive a great deal of scrutiny. 1-7 Alarms have the clear purpose of improving patient care by calling an attendant’s attention to a situation that may require his or her intervention. In many cases, each of the potential alarms must be set by the user with respect to a number of alarm parameters including on/off, upper/lower limit, volume of the alarm sound, and possibly a connection to or activation of a remote alarm notification location or system. This can involve a significant number of settings over a range of parameters and across a number of individual devices. Each of these settings may include default values that might be locally set or set by the manufacturer. When there are default values, it can be important when the device does or does not reset to the defaults. An alarm may be triggered by a patient parameter (eg

Device recall notices are a challenge for hospitals. They have to be recognized for what they are when received, and then they must be routed and appropriately acted on—if the hospital actually has the item recalled. And this must be done in the context of the ongoing and busy hospital environment. Similar issues can arise with FDA Public Health Notifications and other safety advisories, including those not related to devices. Removing the device from service is not always an appropriate or even a possible response. Many recalls and FDA notices expressly allow for continued use (see Table 1 for examples), and/or provide information on steps that should be taken to mitigate the problem while continuing to use the device. Other recalls are for disposables that can be relatively easily replaced, such as a recent FDA recall for a single use, disposable catheter. The impact in this type of recall can be minimal, if alternative products are available or replacements easily obtained. More challenging is a recall or alert from FDA or other party that says that a device must be taken out of service immediately (see Table 2). On the surface the “discontinue use” scenario sounds simple enough. Confirm if the institution has the device, find it (or them, if there are multiple devices), and stop using it. From the manufacturer’s perspective, and from FDA’s, the issue of the use of the device is now resolved, i.e., use has been stopped. The manufacturer at this point can argue that it has ended any further risk associated with the allegedly faulty device, since hospitals have been directed to stop using it. If a hospital chooses to continue using the device, the associated risk is substantially borne by the user facility. Similarly, FDA can assert that it has fulfilled its responsibility to protect the public from faulty medical devices by directing that use be stopped, even if there is not a suitable answer to the “now what?” question.