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Featured Articles

Improved diagnosis of clinically relevant prostate

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In Europe prostate cancer (PCa) is currently the most commonly diagnosed cancer in men- around one in six in the West will eventually be diagnosed with the disease- but the majority of patients will die of unrelated causes. There are two major problems related to PCa diagnosis: firstly, because of the lack of a highly sensitive and specific biomarker, many elderly men without cancer, or with clinically insignificant tumours confined to the prostate gland, are still undergoing unnecessary biopsies. Secondly because of its random nature, the standard method of biopsy, the transrectal ultrasound biopsy (TRUS), frequently detects low risk cancers that do not need aggressive therapy but fails to detect many clinically significant tumours in the less accessible areas of the gland. Recent studies suggest that multiparametric MRI (mp-MRI) pre-biopsy, to identify suspicious areas, followed by targetted biopsy using MR-ultrasound fusion, which combines detailed MRI scans with real-time ultrasound images of the prostate, is the better approach.
One preliminary prospective cohort study reported last year was carried out at the US National Cancer Institute. During a seven year period more than 1000 men underwent mp-MRI followed by MR-ultrasound fusion and concurrent TRUS. Whole-gland pathology of the prostate was also carried out after any prostatectomies. It was found that MR-ultrasound fusion diagnosed 30% more high risk tumours and 17% fewer low-risk tumours than TRUS. However data are still needed on disease recurrence and PCa mortality, and the authors consider that random clinical trials should be carried out to determine eventual clinical outcomes. A retrospective analysis involving more than 600 Brazilian patients with suspected PCa was also reported recently with 286 patients undergoing MR-ultrasound fusion biopsies and 331 patients undergoing random ultrasound-guided biopsies. Again the former technique detected significantly more patients with high-risk cancer requiring surgery and significantly fewer low-risk tumours where only surveillance was needed. There are of course financial impacts of purchasing and using such technology, but improved patient risk stratification may well result in a negligible net cost increase.
Hopefully MR-ultrasound fusion can replace techniques such as TRUS for suspected PCa diagnosis, but a question still remains. Is it really always necessary to treat clinically significant PCa by radical prostatectomy or radiotherapy of the entire organ when erectile dysfunction, urinary incontinence and intestinal problems are such common side effects? Would it not be possible to utilize appropriate imaging technologies and confine treatment to the affected area of the gland?

INNOVATING VISUAL HEALTHCARE

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Clinical collaboration and affordable IT support matter

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High-speed communications and healthcare – Tele-ICUs and ambulance telemedicine

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The communications revolution has opened up dramatic possibilities for healthcare delivery across physical/geographical boundaries. Telemedicine, once held up as a miracle, and then seemingly forgotten, has been making a comeback in one of the most challenging frontiers of modern medicine – the ICU.
High-speed communications have also paved the way for ambulance-based telemedicine.

ICU Telemedicine
Video observation and advanced algorithms
The greatest benefit of ICU telemedicine or Tele-ICU care involves continuous surveillance and interactive care by offsite clinicians. This is achieved by direct video observation of the patient and interrogation of ICU equipment. Advanced computer algorithms, based on clinical data available in a patient

Probing the image quality and dose of thorax X-rays

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A 354-patient study on image quality and dose values for thorax images with the DX-D 300 digital radiography system and MUSICA 3 software was carried out at the Institute of Imaging Diagnostics and Therapy (BDI) in Erlangen.  Dr. Karina Hofmann-Preiss, summarizes here the details and findings of the study.

Agfa HealthCare

Cardiovascular risk assessment – new tools and imaging techniques

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Cardiovascular disease (CVD) is a major cause of death and disability across the world. In recent decades, the battle against CVD has focused on prevention, with the management of lifetime cardiovascular (CV) risk superseding treatment of individual cardiovascular (CV) risk factors. Such a strategy in turn is anchored in two complementary approaches – a population-based one promoting community health (e.g. anti-smoking campaigns, diet and nutritional management) and a clinical approach targeted at high-risk individuals.

Complexity of risk factors
In spite of this, CVD management remains less than optimal – even in countries with advanced and well-funded healthcare systems. In 2007, the authors of an article in the

Top 10 health technology hazards for 2017

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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

Best practices in resuscitation – interim updates for 5-Year ILCOR recommendations

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Over the past decade, resuscitation has become one of the fastest growing areas in emergency medical care. The drivers for growth include portable, remote monitoring equipment as well as real time video-consultation. The focus of attention is on cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC), and includes all responses to sudden life-threatening events impacting on the cardiovascular and respiratory system.

Local practices continue to drive growth of best practice in resuscitation. However, there is also substantial cooperation at the global level. The International Liaison Committee on Resuscitation (ILCOR) was founded in 1993 and currently includes representatives from the American Heart Association, the Heart and Stroke Foundation of Canada, the European Resuscitation Council, the Australian and New Zealand Committee on Resuscitation, the Resuscitation Council of Asia, the Resuscitation Council of Southern Africa and the InterAmerican Heart Foundation.
ILCOR members seek to both optimize and minimize international differences in resuscitation practices, but also leave space for geographic, economic, and other real-world differences in practice and the availability of medical devices and drugs.

In 1999, the American Heart Association (AHA) hosted the first ILCOR conference to evaluate best practices and chart resuscitation guidelines. The ILCOR recommendations, formally known as International Consensus on CPR and ECC Science With Treatment Recommendations (CoSTR), were published in 2000. Over the years, ILCOR task forces have evaluated and published CoSTR recommendations in 5-year cycles.
The most recent ILCOR Consensus Conference was held in Dallas in February 2015, and attended by over 230 participants from some 40 countries. Almost two-thirds of participants came from outside the US – giving weight to ILCOR’s position as a global group. The Conference focused, as before, on CPR and ECC, but also covered first aid topics.

One good recent example of the pace of evolution in resuscitation practices is ILCOR’s observation that five years (the task force recommendation cycle) was far too long a period to inform healthcare professionals of therapeutic advances in the field. As a result, it plans to systematically review new science and publish interim advisories on treatment guidelines. The aim is to give resuscitation practitioners access to providing state-of-the-art patient care.

ILCOR’s 2015 CoSTR consensus statements summarize the results of task forces in several areas:
BLS or basic life support (covers quality of CPR and the use of an automated external defibrillator), ALS or advanced life support (post-cardiac arrest care), ACS or acute coronary syndromes, along with education, implementation and teams (EIT), and, for the first time, first aid.
Although dedicated specific task forces cover pediatric BLS and ALS as well as neonatal resuscitation, this review of the 2015 ILCOR guidelines is restricted to adults.

ILCOR task forces perform detailed systematic reviews, evaluate evidence and make recommendations. Task forces identify and prioritize questions using the PICO (population, intervention, comparator, outcome) format, accompanied by a call for public comments. This is followed by a search (with detailed inclusion/exclusion and screening) of relevant articles in three major online databases (PubMed, Embase and the Cochrane Library).

The quality of evidence is tabulated as high, moderate, low, or very low, based on five core domains of risk of bias, inconsistency, indirectness, imprecision, and publication bias (and occasionally other considerations). Together, they follow the so-called GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology for drafting guidelines.
The final wording ranges from ‘we suggest…’ for weak recommendations to ‘we recommend…’ for the strong ones… .’

One of ILCOR’s major goals is continuously-updated and high-quality research into CPR and ECC. An online platform known as SEERS (Scientific Evaluation and Evidence Review System) guides task forces and their individual reviewers, as well as public comments and suggestions. (https://volunteer.heart.org/apps/pico/Pages/default.aspx).
On the other hand, ILCOR also avoids giving attention to areas where there is little development in technology or evidence on practices.

Developments in resuscitation (2010-2015)
The 2015 CoSTR notes that post-OHCA (out-of-hospital cardiac arrest) survival rates are rising, especially when the first monitored rhythm is shockable’ – that is, associated with ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT). However, survival rates from non-shockable rhythms are also improving. These developments directly correlate with an increased emphasis on improving basic life support (BLS) and advanced life support (ALS).
Given below is a summary of evidence-based recommendations by ILCOR task forces, covering developments since 2010.

Basic life support
EMS dispatchers play the critical role in identifying cardiac arrest, providing CPR instructions to the caller, and activating emergency response. In drowning, it appears that submersion time is a key prognostic factor for outcomes. However, fundamental metrics of high-quality CPR remain the same, with an emphasis on compressions of adequate rate and depth, allowing full chest recoil after each compression, minimizing pauses in compressions, and avoiding excessive ventilation. It is also noted that public access programmes which provide early defibrillation can save many more lives if the programmes are carefully planned and coordinated.

Advanced life support
Post-cardiac arrest care is probably the resuscitation segment undergoing the greatest evolution since 2010, with substantial potential to improve survival from cardiac arrest.
Key recent developments in ALS include results from three major trials on mechanical CPR devices, drug therapy, and insertion of advanced airway devices. In addition, the ALS task force evaluated several studies regarding post-cardiac arrest care and the use of targeted temperature management (TTM).

. Mechanical devices
The three mechanical compression device trials enrolled over 7,500 patients. However, it yielded outcomes similar to those from manual compressions. ILCOR concludes that mechanical CPR devices should not be seen as replacements, but may play a role in conditions where high-quality manual compressions are not feasible.

. Drug therapy
The 2010 CoSTR had pointed to insufficient evidence about drug administration improving survival from cardiac arrest. In 2015, a systematic review identified large observational studies that also challenged routine use of advanced airways and the use of epinephrine for ALS. Since observational studies are known to carry a risk of bias, the findings did not result in a recommendation to change practice. However, they do indicate a need for large randomized controlled trials to assess whether epinephrine and advanced airways are helpful during CPR.

. Targeted Temperature Management
Recent developments in ALS also include greater delineation of the timing and effects of TTM and the need to take account of controlling oxygenation/ventilation and optimizing cardiovascular function. Nevertheless, one high quality TTM trial could not demonstrate an advantage to a temperature goal of either 33C or 36C, while five other trials failed to identify benefits from pre-hospital hypothermia initiation via cold intravenous fluids. Though none of the trials dispelled with the view that post-cardiac arrest patients need a care plan taking account of TTM, there is still little consensus about optimal target temperature and its duration.

Acute coronary syndromes
There are several evidence-based recommendations for ACS since 2010.

. Catheterization, ADP and UFH, troponins
Firstly, pre-hospital ST-segment elevation myocardial infarction (STEMI) activation of a catheterization laboratory treatment delays and improves outcomes.
Secondly, adenosine diphosphate (ADP) receptor antagonists, along with unfractionated heparin (UFH) can be part of a planned percutaneous coronary intervention (PCI) approach and be administered either pre-hospital or in-hospital for suspected STEMI patients. In the pre-hospital setting, enoxaparin is an alternative to UFH. This is not the case with bivalirudin, for which there is insufficient evidence.
Thirdly, the 2015 CoSTR discourages the use of troponins at zero and 2 hours as a standalone measure to exclude ACS diagnosis. Instead, it suggests that negative high-sensitivity troponin I (hs-cTnI) at zero and 2 hours may be used together with low-risk stratification or negative cardiac troponin I (cTnI) or cardiac troponin T (cTnT) measured at zero and 3-6 hours to identify patients at low risk of a major adverse high-sensitivity cardiac troponin I (hs-cTnI) cardiac event (MACE).

. PCI and STEMI
ILCOR’s 2015 CoSTR also has several comments on PCI and STEMI. Its find primary PCI to be generally preferable to fibrinolysis for STEMI reperfusion. However, such decisions must be individualized’ based on time from symptom onset, anticipated delay to PCI, relative contraindications to fibrinolysis, and other patient factors.
Patients with STEMI in the emergency department (ED) of a non-PCI-capable hospital should either be transported rapidly for primary PCI (without fibrinolysis) or be administered fibrinolysis and transported for routine angiography in the first 3-6 hours.

Education, implementation, and teams
One of the most noteworthy areas of attention by ILCOR since 2010 concerns training and continuous quality improvement.

Training cycles
ILCOR states that, although more evidence is needed, it is ‘now recognized’ that training should be more frequent and less time consuming to prevent skill degradation. On the other hand, retraining cycles of 1-2 years are inadequate to maintain competence in resuscitation skills. Though ‘optimal retraining intervals’ remain to be defined, it is clear that more frequent training may help providers likely to encounter a cardiac arrest.

Hi-Fi manikins
ILCOR also suggests replacing standard manikins with high-fidelity manikins at training centres with the infrastructure and resources to maintain the programme.

Performance and quality metrics, social media
Another challenge is that though the role of performance measurement and feedback in cardiac arrest response systems (both in-hospital and out-of-hospital) is recognized, supporting data is of low quality. Closely coupled to improvements in the performance of resuscitation teams is the need for data-driven, performance-focused debriefing.
Finally, ILCOR also notes the rapidly-growing role of social media for notifying suspected OHCA to hospitals and for sourcing bystanders with CPR skills.

First aid
The First Aid Task Force considered stroke assessment, hypoglycemia treatment in diabetics, as well as treatment of open chest wounds and severe bleeding and the identification of concussion.

. Stroke assessment
Observers consider one of the most important recommendations from the First Aid task force is to use stroke assessment systems to improve early identification of possible stroke and enable subsequent referral for definitive treatment. Specific recommendations are made on the FAST (Face, Arm, Speech, Time) tool as well as the Cincinnati Prehospital Stroke Scale, alongside an important observation, that blood glucose measurement could improve the specificity of recognition.

. Hypoglycemia
ILCOR’s 2015 CoSTR observes that first aid providers often face symptoms of hypoglycemia, and a failure to identify and treat it can lead to loss of consciousness and seizures. It recommends administration of glucose tablets for conscious individuals who can swallow, or substitute forms of dietary sugars should glucose tablets not be immediately available.

. Open chest wounds, bleeding, concussion
The 2015 CoSTR recommends that occlusive dressings or devices, or those which might become occlusive, be avoided in the case of open chest wounds in order to avoid engendering a tension pneumothorax.
Recommendations for severe bleeding include using direct pressure, hemostatic dressings and tourniquets – after formal training to ensure effective application and use.
The 2015 First Aid Task Force also recommends developing a simple validated concussion scoring system to accurately identify and manage concussion (minor traumatic brain injury or TBI), which is a condition often encountered by prehospital first-aid providers.

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