Cardiovascular disease (CVD) is by far the leading cause of death in industrial countries. However, there are significant differences by continent/region, and even more so in terms of gender. There have also been some major recent changes in the evolution of CVD, compared to another major source of mortality – cancer. Once again here, there are some female-specific factors of interest.

The US and Europe
For Europe as a whole, latest figures from the World Health Organization (WHO) show CVD accounting for 45percent of deaths, approximately the same level as the US, where the figure is 44percent.
Cancer is the second largest cause of death in both the US and Europe. However, a significant margin separates its mortality impact from CVD.
There are also differences between the US and Europe in the relative impact of CVD versus cancer. In the former, cancer accounts for 32percent of deaths (or almost three-fourths of that from CVD). In Europe, the share of cancer is less than half CVD deaths. The WHO data cover 52 countries in Europe, including all members of the European Union (EU).

A man’s illness ?
Traditionally, heart disease was thought of as a man’s’ illness, although approximately the same number of women and men died each year of heart disease in the US and the EU.
Indeed, gender issues in CVD deaths are significant, both in the US and Europe. Although a higher number of males die in the US from CVD as compared to females, the share of CVD as a cause of death is only slightly higher in American women (44.3percent vs. 43.4percent).
In Europe, the gap is far more dramatic, with CVD accounting for 51percent of deaths among women and 42percent among men.

Cancer replaces CVD as leading cause of death in northern/western Europe
There are nevertheless considerable divergences across European countries in CVD mortality as well as in recent changes in death rates due to CVD.
In ten advanced EU countries, more men now die from cancer than CVD. These countries are Belgium, Denmark, France, Italy, Luxembourg, the Netherlands, Portugal, Slovenia, Spain, and the UK. The case is the same for an EU non-member, Norway. Conversely, the highest numbers of deaths from CVD tend to be seen in Eastern European countries.
In much of Europe, however, latest WHO data show more than double the number of deaths from CVD compared with cancer, in women. 15 countries in this group report CVD causing more than four times the number of deaths in women as cancer, compared to only 6 for men.
Meanwhile, death rates from CVD have declined in all countries over the past ten years. However, in some countries, women have seen a relatively lower fall than men in age standardized mortality rates, over the period. These include Luxembourg (50percent for men vs. 42percent for women), the Netherlands (39percent vs. 32percent) and Sweden (31percent vs. 26percent), and to some extent Ireland, Italy and Switzerland.

Raising awareness
One immediate priority for health professionals and policy makers is to raise awareness about CVD and women. Currently, Red Day’, Go Red for Women’ and Women at Heart’ campaigns by professional societies and patient groups in the US and Europe have sought to boost awareness further, and do this faster.
The reasons for this are evident. In the US, just over half of women surveyed recognize heart disease as their Number 1 killer, according to a 12-year follow-up study published in 2010 in Circulation: Cardiovascular Quality Outcomes’.
Nevertheless, the situation had improved significantly compared to the baseline year of 1997 when only 30 percent identified heart disease as the leading killer of women, with 35 percent believing that cancer took this role.
The situation is worse in parts of Europe. In Ireland, for example, a recent Irish Heart Foundation report showed that less than one in 5 Irish women knew CVD as being the leading cause of female mortality.

CVD protection in younger women
The reasons for believing CVD was a man’s’ disease (as mentioned above) were not simply hearsay. Women are protected by their hormones against CVD during their child-bearing years. However, this protection is lost as soon as they enter menopause. The net result is that women tend to get CVD at an age about 10 years more than men.
To complicate matters, CVD symptoms in women are sometimes different from those in men. This adds to under-recognition of heart disease in women. For example, heart attack symptoms in women such as chest pain can be less profound than in men. Women may only feel an uncomfortable pressure in the chest centre which occurs sporadically or lasts a few minutes, or experience pain in one or both arms, their neck, back or stomach, along with shortness of breath and accompanied by a cold sweat, nausea, vertigo and weakness. Moreover, it has also been established that women have a higher prevalence of silent ischemia and of unrecognized myocardial infarction than men.
As a result, both women and physicians need to be trained to recognize female-specific symptoms.

HRT and CVD risks
One of the beliefs which has endured for several decades is that the estrogen drop during menopausal transition induces increased post-menopausal CVD risk in women, probably through harmful changes in CVD risk factors. One of the findings supporting this conclusion was that women who reached menopause before the age of 40 had a two-year lower life expectancy than women with a normal or late menopause.
Indeed, circulating estrogens do have a regulating effect on several metabolic factors, such as lipids, inflammatory markers, and the coagulation system.
This was the reason for the popularity of Hormone Replacement Therapy (HRT), or exogenous estrogens. Until recently, HRT was recommended for use in post-menopausal women to limit CVD risk. The hypothesis was supported by several observational studies, but could not be conclusively proved in large randomized trials. Instead, HRT was shown to increase CVD event rate in older (>60 years) post-menopausal women. As a result, clinicians now recommend a careful evaluation of the risk/benefit of HRT replacement for preventing CVD, and the use of HRT has declined.

Concurrent risk factors for women
Other, concurrent risk factors include hypertension, hypercholesterolemia, hypertriglyceridemia and metabolic syndrome. These increase in women over the age of 45, or a few years before menopause.
For example, systolic blood pressure rises steeply in older women compared with men. Hypertension is associated strongly with a higher prevalence of left ventricular hypertrophy and diastolic heart failure (HF). Studies have shown that even borderline hypertension (less than 14/9 cm Hg) causes more cardiovascular complications in females than in men.
At younger age, the prevalence of hypercholesterolemia is lower in women than men, but at over 65 years age, mean LDL-cholesterol levels are higher in women. Hypertriglyceridemia and low HDL-C levels are far more important risk factors for CVD in women than for men, as discussed below.

Type 2 Diabetes
Nevertheless, of the biggest areas of concern is Type 2 diabetes mellitus, which poses a much higher greater risk for cardiovascular complications in women than in men.
One meta-analysis of 37 prospective cohort studies published in the British Medical Journal’ in December 2006 found mortality risk to be 50percent higher in women with diabetes compared with men. In addition, it has been shown that Type 2 diabetes is a potent, independent risk factor for heart failure in women. However, this cannot be fully explained by coexisting cardiovascular risk factors or previous myocardial infarctions.

Lifestyle factors
Lifestyle changes also play a role. Obesity, for example, is a major CVD risk factor. It is more prevalent in men under the age of 45, but has begun to increase with advancing age in women, reducing the gap with time, and often reversing it in older women. This was one of the findings of a report called European Heart Health Strategy: Red Alert on Women’s Hearts’, published in 2009 by the EuroHeart Project, funded by the EU Commission and conducted jointly by the European Heart Network (EHN) and the European Society of Cardiology (ESC).

Women and clinical trials
The case of HRT, where findings from large randomized trials reversed those of observational studies, has brought another priority to the forefront, namely to increase the presence of women in CVD clinical trials.
The EU-funded EuroHeart project (see above) found women to be under-represented in many trials, even where important gender differences are present within most areas of heart disease. The proportion of women enrolled was 27-41percent, even though the female prevalence of clinical conditions under study in the general population was similar for both men and women.
The case in the US is similar, in spite of a legal requirement that research funded by tax receipts must include women and minority groups. One study found that trials by the National Heart Lung and Blood Institute, attached to the National Institutes of Health (NIH), enrolled 38percent women for the years 1965-1998. This fell further to 27percent in 1997-2006. Furthermore, only 13 of 19 studies analysed gender differences.

Apart from the traditional belief that CVD was a man’s’ disease, some experts believe that cost may also have been a consideration in under-recruitment of women, whose hormonal fluctuations tend to complicate pharmacokinetic and pharmacodynamic analysis.
Nevertheless, given the growing burden of CVD in middle-aged women relative to men, it is evident that greater gender-specific cardiovascular research is required to adapt existing guidelines for better cardiovascular health in women.

Pregnancy as stress test for future CVD
There is intriguing evidence that pregnancy might be a useful stress-test’ for future CVD risk. Hypertensive disorders in pregnancy have been shown to be predictors for CVD events in later life. Impaired glucose tolerance and gestational diabetes in pregnancy are also female-specific risk factors for the development of diabetes and metabolic syndrome in young women.
One of the conditions under close scrutiny is pre-eclampsia, which is characterized by high blood pressure and large amounts of protein in the urine. Although the etiology of pre-eclampsia has yet to be established with certainty, the hyperlipidemia of normal pregnancy (elevated total cholesterol and triglycerides) becomes more extreme in women developing the condition. The sharp growth in triglycerides leads to increased production of LDL (up to 3-4 times more than in a normal’ pregnancy), along with reduced HDL-C. Together, this contributes to endothelial dysfunction.
One ongoing trial at Brigham and Women’s Hospital in Massachusetts seeks to demonstrate an association between pre-eclampsia during pregnancy and altered blood vessel function and abnormal hormone levels in later life. The trial, known as Preeclampsia: A Marker for Future Cardiovascular Risk in Women’ commenced in 2012. Its results are expected to be published in the near future.

The safe use of health technology-from basic infusion pumps to large, complex imaging systems-requires identifying possible sources of danger or difficulty with those technologies and taking steps to minimize the likelihood that adverse events will occur. This list will help healthcare facilities do that.

Produced each year by ECRI Institute’s Health Devices Group, the Top 10 Health Technology Hazards list identifies the potential sources of danger that it believes warrant the greatest attention for the coming year. The list does not enumerate the most frequently reported problems or the ones associated with the most severe consequences-although such information is certainly considered in the analysis. Rather, the list reflects the Health Devices Group’s judgment about which risks should receive priority now.

All the items on the list represent problems that can be avoided or risks that can be minimized through the careful management of technologies. Additional content provided with the full article, which is available separately to members of certain ECRI Institute programmes, provides guidance to help manage the risks. In this way, the list serves as a tool that healthcare facilities can use to prioritize their patient safety efforts.

International Hospital presents here the abridged version of ECRI Institute’s 2017 Top 10 list of health technology hazards which is available as a free public service to inform healthcare facilities about important safety issues involving the use of medical devices and systems.

1. Infusion errors can be deadly if simple safety steps are overlooked
Most large-volume infusion pumps incorporate safety mechanisms for reducing the risks of potentially deadly intravenous (IV) infusion errors. These mechanisms have greatly improved infusion safety, but can’t eliminate all potential errors. And the mechanisms themselves have been known to fail.
ECRI Institute continues to learn about and investigate incidents of infusion errors involving pump or administration set failures, staff unknowingly defeating a safety mechanism, or incorrect infusion programming. Such errors- particularly those that result in the uncontrolled flow of medication to the patient, known as ‘IV free flow’-can lead to patient harm and even death.

In many of these incidents, harm could have been averted if staff had:

• Noticed signs of physical damage to infusion pump components
• Made appropriate use of the roller clamp on the IV tubing
• Checked the drip chamber beneath the medication reservoir for unexpected flow

Once commonplace, these simple practices are now often overlooked-perhaps because staff implicitly trust the pump’s advanced safety features.

2. Inadequate cleaning of complex reusable instruments can lead to infections
The use of contaminated medical instruments can lead to disabling or deadly patient infections or instrument malfunctions.
Outbreaks associated with the use of contaminated duodenoscopes-such as those that caused headlines in recent years-illustrate the severity of this issue. But duodenoscopes are not the only devices that warrant attention. ECRI Institute has received reports involving a variety of contaminated medical instruments that have been used, or almost used, on patients.
Complex, reusable instruments-such as endoscopes, cannulated drills, and arthroscopic shavers-are of particular concern. They can be difficult to clean and then disinfect or sterilize (i.e., reprocess) between uses, and the presence of any lingering contamination on, or in, the instrument can be difficult to detect.
Often, we find that inattention to the cleaning steps within the reprocessing protocol is a contributing factor. Healthcare facilities should verify that comprehensive reprocessing instructions are available to staff and that all steps are consistently followed, including precleaning of the device at the point of use.

3. Missed ventilator alarms can lead to patient harm
Ventilator alarm management challenges complicate efforts to prevent patient harm resulting from missed alarms. Ventilators deliver life-sustaining therapy, and a missed alarm could be deadly. Concerns include:

• Alarm fatigue-in which staff become overwhelmed by, distracted by, or desensitized to the number of alarms that activate.
• Alarm notification failures-in which alarms are not effectively communicated to staff.

These concerns, and the ways to manage them, are similar to those that exist with physiologic monitoring systems, which we have addressed in previous Top 10 Health Technology Hazards lists. Ventilators, however, pose some unique challenges. For example: Collecting and analysing ventilator alarm data can be difficult, making it harder for hospitals to identify where their vulnerabilities lie. And the options for supplementing a ventilator’s alarms-so that the alarm can be noticed outside the patient’s room, for example-are limited.
As a result, ventilators will require different methods for studying the problem and different strategies for addressing it.

4. Undetected opioid-induced respiratory depression
Patients receiving opioids-such as morphine, hydromorphone, or fentanyl-are at risk for drug-induced respiratory depression. If not detected, this condition can quickly lead to anoxic brain injury or death. Thus, spot checks every few hours of a patient’s oxygenation and ventilation are inadequate.
Drug-induced respiratory depression is of particular concern for patients receiving parenteral and neuraxial opioids in medical-surgical and general care areas. However, it is also of concern for hospital or ambulatory surgery/endoscopy facility patients receiving opioids during procedural sedation and while in the postanesthesia care unit (PACU).

Even if they are otherwise healthy, such patients can be at risk if, for example:

• They are receiving another drug that also has a sedating effect
• They have diagnosed or undiagnosed sleep apnea or other conditions that predispose them to respiratory compromise
• They receive more medication than intended-for example, because of a medication error

ECRI Institute recommends that healthcare facilities implement measures to continuously monitor the adequacy of ventilation of these patients and has recently tested and rated monitoring devices for this application.

5. Infection risks with heater-cooler devices used in cardiothoracic surgery
Heater-cooler systems have been identified as a potential source of nontuberculous mycobacteria (NTM) infections in heart surgery. The likelihood of infection during surgery is not fully understood. However, these infections can be life-threatening and have resulted in patient deaths.
Heater-cooler systems are used in cardiothoracic surgeries to warm or cool the patient by extracorporeal heat exchange with the patient’s blood during heart-lung bypass procedures. These devices circulate warm or cold water through a closed circuit. Water in the circuit is not intended to come into direct contact with the patient or the patient’s circulating blood. However, aerosolized water carried by air from the exhaust vents of contaminated heater-coolers has been suggested as a cause of NTM infections.
Initial reports focused on one specific model of heater-cooler, but models from other suppliers could likewise become contaminated under certain circumstances and if appropriate precautions are not taken.
The U.S. Food and Drug Administration has issued recommendations for all heater-cooler devices; they are intended to help prevent and manage device contamination risks and to minimize patient exposure to heater-cooler exhaust air, which may contain aerosolized contaminated water.

6. Software management gaps put patients, and patient data, at risk
Inadequate medical device software management can delay a facility’s responses to safety alerts, allow cybersecurity vulnerabilities to be exploited, and impact patient safety.
Maintaining a central repository of up-to-date and easily retrievable information about the software versions used in a healthcare facility’s medical devices is challenging. But failure to do so leaves the facility ill-prepared to effectively manage software updates and alerts.

Mismanagement of software updates and alerts can adversely affect patient care or impact patient/staff safety- for example, by:

• Causing downtime or otherwise affecting the performance of medical devices or interconnected systems
• Delaying identification and implementation of key software updates, including those that address safety concerns
• Allowing cybersecurity vulnerabilities to persist, possibly leading to lost, stolen, or inaccessible data

To address the hazard, a healthcare facility should verify that its computerized maintenance management system (CMMS) provides the capabilities needed to effectively track software versions for its medical devices and systems. In addition, the facility should establish practices for keeping the software version information in the CMMS current and complete.

7. Occupational radiation hazards in hybrid ORs
Clinicians working in hybrid ORs-operating suites that include built-in x-ray imaging systems-are at risk of unnecessary occupational exposures to ionizing radiation if appropriate precautions are not consistently followed.
Particular concern exists in this environment because hybrid OR staff may be less knowledgeable than radiology and interventional radiology staff about the risks of radiation exposure, and they may be less experienced at taking appropriate precautions.
In addition, with the increasing reliance on X-ray imaging systems during complex OR procedures, an increasing number of specialists and staff members who previously would have had little exposure to ionizing radiation during surgeries are now participating in these procedures.
Because long-term exposure to radiation increases the risk of cancer, it is imperative that hybrid OR staff obtain OR-specific radiation protection training, that they put this training into action, and that available tools and methods be used to minimize radiation exposures.

8. Automated dispensing cabinet setup and use errors may cause medication mishaps
Poor choices made when setting up automated dispensing cabinets (ADCs), as well as mistakes made during use, can lead to harmful medication errors.
Medication errors and near misses associated with ADCs have been traced to insufficient planning when setting up medication drawers, as well as errors made when stocking them. Incidents reported to ECRI Institute include: the presence of the wrong drug or dose in an ADC pocket, the availability of high-alert drugs in unsecured areas of the cabinet, and the unavailability of needed drugs.
Problems such as these have resulted in delays in patient care and the administration of incorrect drugs or drug concentrations, leading in some cases to severe patient injury.

Careful planning is required to determine:

• Which medications should be available in a particular care area
• Where in the drawer a medication should be placed (e.g., to reduce the chances that one drug will be mistaken for another)
• Whether locked pockets or other control mechanisms should be used to further restrict access to certain medications

9. Surgical stapler misuse and malfunctions
Problems associated with the use and functioning of surgical staplers can lead to intraoperative hemorrhaging, tissue damage, unexpected postoperative bleeding, failed anastomoses, and other forms of patient harm.
Surgical staplers require meticulous technique to operate, and problems during use are not uncommon. The U.S. Food and Drug Administration receives thousands of adverse event reports related to surgical staplers each year, and ECRI Institute likewise consistently receives reports of surgical stapler problems. Although severe injuries are infrequent, they do occur: We have investigated fatalities and other cases of serious patient harm.
Commonly reported problems include: misfiring or difficulty in firing, misapplied staples, unusual sounds during firing (which can indicate a damaged or malfunctioning mechanism), and tissue becoming ‘jammed’ in the mechanism.
To prevent patient harm, users must be familiar with device operation, they must carefully select the appropriate staple size for the patient and tissue type, and they must be alert to the signs that the stapler may not be functioning as intended.

10. Device failures caused by cleaning products and practices
The use of cleaning agents or cleaning practices that are incompatible with the materials used in a medical device’s construction, or that are otherwise inappropriate for the device’s design, can cause the device to malfunction or to fail prematurely, possibly affecting patient care. Specifically:

• Repeated use of incompatible cleaning agents can damage equipment surfaces and degrade plastics, often resulting in device breakage-possibly with no visible warning signs.
• The use of improper cleaning practices can damage seals, degrade lubricants, and cause fluid intrusion. This can result in damage to electronics, power supplies, and motors.

Because there is no single cleaner or cleaning process that will work with all devices, hospitals must stock and use multiple cleaning products and familiarize staff with device-specific cleaning methods-tasks that pose a significant burden. Nevertheless, failure to do so can lead to ineffective cleaning (a potentially deadly circumstance), as well as excessive component breakage and premature equipment failures (which can affect patient care and be a significant financial burden).

www.ecri.org.uk www.ecri.org

Hospital noise is an issue for babies born prematurely who are at high risk when it comes to external influences such as noise. Their systems are underdeveloped and they need as much sleep and rest as possible to recuperate. This is one of the reasons why the Neonatal Unit at the highly specialized Rigshospitalet hospital in Denmark, began cooperating with the noise measurement company SoundEar this year.

Not all sound is noise
Staff at the Neonatal Unit stress that there is a difference between what they call good sound’ and noise. The point being that not all sound is noise, and not all sound should be eliminated. It is important for the development of the newborns that they hear sound such as their parents and siblings talking and singing to them. It is also important that staff can communicate audibly in critical situations, and it is inevitable that some medical equipment, such as respirators, are noisy. What they do want to reduce is unnecessary sound stemming from alarms, furniture, work flow and talk.

Keeping parents in the loop
An important part of the project is to keep parents informed about why the noise meters are installed and not only focus on reducing noise, but also inform them that they should still talk to their newborns and that some medical care routines will result in a certain level of noise. One way of going about this has been to develop a flyer to hand out to new parents in the neonatal intensive care unit (NICU).

Reducing hospital noise through awareness
The aim is to bring down hospital noise levels at the NICU through installing noise meters in all rooms. Half of the noise meters are anonymous white boxes which solely measure and collect noise levels. The other half of the noise meters also have a display with an ear, that lights up green, yellow or red, indicating the current level of noise in the room.
Reduction in noise levels at the NICU is expected to be achieved through different layers of nudging:

• The noise meters with displays should help staff and families become aware of their own noise levels and change their noisy behaviour.
• The software helps staff become aware of when and where noise levels are critical and something should be done differently.
• The software sends out noise reports on a weekly basis via email to key staff members who use these reports as a basis for further discussion about noise at staff meetings.

Changing routines
After having the SoundEar devices hanging in the NICU for a few months, staff was asked to fill out a questionnaire about the perceived hospital noise levels, and whether the SoundEar devices seemed to have changed anything. 14 staff members, primarily nurses, answered the questionnaire and 78.6 percent reported that the SoundEar devices had made them more attentive to noise levels. The same amount reported to have changed some of their behaviour because of the SoundEar devices.
The change that most staff members reported to have made, was to unpack syringes and other types of medical equipment outside of patient rooms, because they had noticed that the ripping of plastic made an unnecessary amount of noise around the children. Others reported lowering their voices and lowering the noise level of alarms as changes they had made after the installation of the SoundEar devices.
Several staff members also reported to have seen an increase in parents’ attention to noise levels, and that they commented on noise to other visitors and siblings, thereby spreading the attention to noise.

Custom-made software
All the noise meters transfer noise measurement data wirelessly to a central computer, where it is accessible to staff through a piece of software, developed specifically for hospital use by SoundEar in cooperation with staff at the NICU.

Jointly creating a noise measurement system
An important part of the project was to create a system that would help reduce hospital noise and become part of the daily routine at hospitals. For SoundEar, this meant focusing on what staff needed and what their everyday work life looked like and adjusting to that.
In the early days of the project, SoundEar viewed the software platform as the main component of the system and something that staff should be able to interact with daily. They should monitor noise levels just as they were used to monitoring the health levels of the newborns.
To make the software as useful as possible, SoundEar conducted several interviews with staff members. Very soon, it became clear that even though nurses viewed reducing hospital noise as important, their focus was on the critical medical care for the newborns and keeping them alive and well. Their time was limited and they would not be able to prioritize time from their busy schedules to consult a piece of software that did not have immediate medical importance for the children.
Instead, they suggested that a few members of the staff should be responsible for driving the hospital noise reduction, checking the software and gathering insights for the rest of the staff to discuss at weekly meetings. Along the way, the procedure evolved into auto-generated noise reports being sent to key staff members to be discussed at staff meetings on a weekly basis.
www.soundear.dk