Today cyber attacks are more common than we think and system hijacking or ransomware is a sensitive issue that institutions, companies, and especially hospitals have put on the table to take urgent cybersecurity measures.

It has been shown that the issue of cybersecurity is growing stronger and that it is now easier to protect personal use devices connected to the internet in order to protect our sensitive personal data. For health institutions, the real issue of cybersecurity focuses on patient information and the protection of the medical equipment network, cyber attackers always look for the vulnerability of the equipment to access the network, block access to their use and all the information that is stored in the equipment to then ask for a reward in exchange for the release, this delicate information is the key to keeping the patient safe and, without that information, patients are at risk.

According to Security Boulevard, at least one in five Americans was a victim of cyberattacks in their health care last year and are worried that ransomware make the movement again and affect their care, also a third of the persons who were interviewed are thinking to switch providers.

If you want to protect your medical equipment network from ransomware, the first step to take is to have a good management system with an extended inventory of the pieces of equipment that includes equipment digital persona, data security fields (Bluetooth, USB interfaces and ePHI) and, a model control profile. By having a centralized management system, you will be able to monitor the technology that are vulnerable to this type of situation, identify the constant failures, administrate the maintenance cycle, and which equipments are affected before, during, and after a cyber attack.

Call the manufacturer: medical equipment needs patches every certain time and unlike a computer, they do not automatically download and install, so you need to ask your provider for the patches available for your equipment, this is a really hard task for the Clinical Engineering department since in a hospital there can be thousands of equipments and not all will be of the same brand or manufacturer but with the last update of “right to repair” law, clinical engineers will be able soon to get the patches from the manufacturers and install them themselves with a faster response time, the only little obstacle will be the OEM since all installations, patches, and other endpoint security solutions for medical technology need to have validation by they first.

TI department and CE department need to make a good team evaluating constantly all the medical technology and prevent every vulnerability they will found on medical equipment, update all the patches available and management maintenance cycles, protect leaks of ePHI data and always keep an eye on the alerts and in this way hackers will have no opportunity to attack the network or at least it will not be easy.

Our CMMS MediMizer has integration with ASIMILY, a smart solution for the IoMT risk management where you can correlate the data based on several parameters to enrich inventory, initiate automatic remediation of vulnerabilities detected, and plan activities.

The results of 3D printers have been impressive for years, but printing human tissue is the next step for NASA. The two finalist teams from the Wake Forest Institute for Regenerative Medicine, aimed to create human organ tissue in a lab, this had to be similar enough, strong and durable for at least 30 days, and they achieved it, an advance for the study of artificial organs and bioengineering.

The teams had to take two different approaches and methods to replicate a functional tissue that fulfilled all the functions of a human tissue, in the end they both agreed to print it in three dimensions. A study of this magnitude allows us to take the next step towards the creation of functional organs for transplantation.

Laura Niklason, a professor of anesthesia and biomedical engineering at Yale University, stated, “The biological effects of low gravity are becoming more and more important, especially as the world is considering private and commercial space travel, and this is a great tool to help us understand it.”

NASA has a breakthrough in studies of the creation of organic tissue under microgravity and with this collaboration, they are one step away from solving the long waiting times that patients have to receive an organ, as well as more alternatives to regenerative and tissue medicine.

The winning team of the challenge will have the opportunity to continue their research on the International Space Station (ISS) as well as a bonus of $300,000. They certainly have an exciting and difficult task for the future of artificial organs.

In this post, CMS proposed "public reporting of clinical quality measure data", specifying limited criteria for each type of organization.

According to NPR Health News, April 18, 2017, "The move follows steps CMS took several years ago to post government inspection reports online for nursing homes and some hospitals."  Nursing Home Inspect at allow the public to review deficiencies.

In response, The Joint Commission responded, "The Joint Commission is opposed to the CMS proposal to make all accreditation survey reports (including statements of deficiencies) and acceptable plans of correction publicly available on the websites hosted by accreditation organizations."

We observed on the ProPublica page that the data is not shown relative to patient count, actual incidents, benchmarks or other factors.  This does support TJC arguments that it would inhibit participation and cause hospitals to seek deeming organizations that present the friendliest findings.

If the information presented is not uniform and educational, it is possible a member of the public could choose to travel 30 minutes further for a critical heart procedure because an exit door was inappropriately left open or locked according to a report.  An assortment of comments on Yelp can be very helpful when selecting a care-giver for dentistry or dermatologist.  For critical and long term care, it is good there is a healthy debate taking place about the nature of information to be reported.  Maybe the deeming agencies need to be proactive about working with AAMI and similar organizations to standardize public reporting before they are ordered to do so.

Many arguments have been made in support of "transparency."
Whatever reporting is required, the expected benefit should be supported by evidence.
According to the CMS post, these accreditation organizations are affected:

Under CLIA (Clinical Laboratory Improvement Amendments), additional organizations are recognized:

For now, the change is on hold indefinitely. posted on 8-2-1017 in a fact sheet (CMS-1677-F):
"After consideration of the public comments received, CMS decided that it would be best if the proposal was not finalized and instead, the proposal was withdrawn. CMS is committed to ensuring that patients have the ability to review the findings used to determine that a facility meets the health and safety standards required for Medicare participation. However, we believe further review, consideration, and refinement of this proposal is necessary to ensure that CMS establishes requirements, consistent with our statutory authority, that will inform patients and continue to support high quality care."

This single matrix is now used to evaluate risk instead of various criteria that varied by EP.  It is a simple 3 level risk evaluation relative to a 3 level scope.  The new evaluation has no effect on events that are an immediate threat to life and therefore this is shown above the matrix.


Placement on the matrix is based on surveyor experience, definitions, context and team discussion.  "Anchors" are specific examples which have been compared to a pain scale indicating the examples have various levels of severity.  We read one report that a "library of anchors" will be produced by TJC over time.  (Compass Clinical Consulting, Feb 20, 2017)

If there is an ITL (Immediate Threat to Life), the organization has 72 hours to eliminate the ITL.  If it can not be eliminated in that time, an emergency plan that can take up to 23 days (including the 72 hours) to complete.

In all other cases, there are 60 days to show evidence of compliance, including Who, What, When and How.

For  non-compliance in the red or dark orange regions, the evidence much also include leadership involvement and preventive analysis.  Also these will be consider for special consideration in future surveys through the next full survey.

Leadership involvements looks first at the sustainability of changes and support from the top levels of leadership. Examples give of support are providing resources, speaking out on behalf of the change and establishing plans for period measurement of and reporting on the changes.

Preventive analysis assures that the corrective action is global and not only a solution for the specific case.  The analysis reviews underlying reasons.  The focus is in preventing future incidents.

The SAFER matrix applies to the entire organization and results will be included in the report as the EC (Environment of Care) rules cited displayed on the matrix. If examples or one EP fit into more than one risk group, it will appear in the most severe group.

Initial evaluation (June 2016) roughly estimated about a fifth of findings were in the widespread and about 2/5ths were limited.  The JC Extranet site further defines Likely as harm that can happen at any time without any contributing factors.  Moderate likelihood may require other contributing factors or conditions.

(Key Sources: Presentations by George Mills and Caroline Heskett of The Joint Commission 2016-2017)

Relevant information presented by TJC (The Joint Commission) before 2017:

For the past several years, facilities management and hospital safety have been under a microscope during Joint Commission surveys, particularly since the addition of dedicated Life Safety Code surveyors whose sole responsibility is to review the physical environment for compliance with safety standards. Joint Commission surveys are no longer on a set schedule--while they are approximately triennial, surveyors can arrive unannounced and without warning at any time, requiring organizations to be in a state of continual readiness. Leadership needs to acknowledge that Joint Commission surveyors can arrive when they themselves are not present, and must make sure that their staff members, from the ground floor up to unit directors, are prepared for survey.

This is particularly challenging in the area of medical equipment and what the responsibilities are for staff from top to bottom. George Mills, MBA, FASHE, CEM, CHFM, director of the Department of Engineering at the Joint Commission, spoke recently at the Association for the Advancement of Medical Instrumentation (AAMI) conference on what the Joint Commission survey process is with inspection of medical instrumentation and what surveyors will be looking at.
To begin with, surveyors will examine the inventory, looking to see if the work has been done according to schedule and what the organization has determined for frequency of inspections.

By role

Department leaders should be not only qualified, but must know how the inventory of devices was created. If organizations are using Alternate Equipment Management (AEM) processes, department leaders should understand and evaluate the monitoring process as well as its effectiveness. What is the organization’s criteria? What is the completion rate for the AEM processes?

Equipment maintainers must have a working understanding of the process and strategy of equipment maintenance, both according to manufacturer guidelines and AEM processes if used. They must be prepared to address the completion of scheduled work and how to address repeated work orders if asked by surveyors.
Equipment users must also be prepared to demonstrate a high level of knowledge. They should be able to address the reliability of the equipment, know what the response time is when the equipment fails, and have an understanding of the organization’s culture of safety.
Equipment users should be trained on equipment use, and be prepared to address customer satisfaction within the department.

Policies and procedures

Surveyors are going to look at policies and procedures, Mills said. Specifically, they will ask how equipment is evaluated to ensure there is no degradation of performance and how to identify and address if there are any mis-calibrations.
Policies and procedures should address how equipment is tested for calibration.

Surveyors will also look at errors and near misses. How are incidents investigated, according to your policies and procedures? Was an equipment failure preventable? Did the use of AEM processes contribute to the equipment failure? And how do your policies and procedures dictate how potentially unsafe equipment will be sequestered to avoid further potential harm?

Surveyors will want to know how an organization evaluates potential modifications to its medical device and equipment maintenance strategy.
They will also examine the accuracy of an organization’s inventory, with focus on evaluation of High Risk and Life Support equipment. How the organization indicates the use of AEM for specific equipment is a necessary requirement. Staff should be prepared to answer the question: is grouping of like equipment acceptable?
Lastly, when evaluating the organization’s inventory, the question should be addressed: are the  imaging/radiological devices and medical laser devices exempt from AEM?

Surveyor focus

Surveyors will have a focus on High Risk equipment, and will expect that appropriate manuals are available. Documentation of inspections, tests, activities, and frequencies of use should be accurate and readily available--documentation issues have been one of the most-cited standards for 2013 and even earlier, a challenge which many organizations still struggle mightily with.

Staff should be prepared to discuss organizational strategies for equipment maintenance and explain how current policies are appropriate and effective in order ensure that medical equipment on site is reliable.
Lastly, Mills mentioned some of the most challenging standards for 2013, all of which organizations are still struggling with even as 2014 comes to a close. These include many physical environment issues, including corridor clutter, ventilation, fire barrier penetration, documentation of inspections and testing, smoke barrier penetration, maintenance of an 18” clearance from the ceiling, and unsafe environment standards.

Leadership would do well to maintain a firm understanding and keen eye on medical equipment policies, procedures, and processes as well as staff awareness and training in preparation for upcoming Joint Commission surveys.

Automation of lab work, more efficient diagnostic testing, and electronic medical records have transformed the speed and accuracy of medical diagnoses. A vital part of this advancement has been medical imaging. By pinpointing the bleed, tumor, or site of infection, modern medical imaging confirms a physician’s suspicion based on clinical evidence, and in many cases identifies problems that are not detectable by physical examination alone. Four innovative medical imaging modalities are reviewed here: optical coherence Doppler tomography, capsule endoscopy, a single-chip catheter-based device, and positron emission tomography.

Optical coherence Doppler tomography (ODT) is a way to see blood vessels in real-time without piercing the skin. The arteries carry oxygenated blood to our body, and an interruption in this rich blood supply (whether due to a cholesterol plaque growing on the inner wall, a blood clot from the heart clogging the artery, stiffening of the artery due to uncontrolled high blood pressure, or weakness of the artery’s wall because of diabetes) can wreak damage instantly in the case of a stroke, or slowly in the case of decades of uncontrolled hypertension. The adage that prevention is the best medicine rings true today. If physicians could study the health of their patients’ blood vessels in an inexpensive and efficient way (for example, in the office), then there would be a potential to intervene earlier to possibly prevent the heart attack, stroke, or amputated foot. ODT is a technology that can acquire tomographic images (“slices”) of biological tissues at the level of micrometers (one millionth of a meter – the width of human hair is 17 micrometers). Just as ultrasound uses sound waves that strike the target and are deflected back to a receiver, ODT uses light waves. ODT is based on optical coherence tomography (OCT), which uses a reference light and back-scattered light from the tissue to visualize it. The Doppler aspect comes from the scattering of light as blood cells move towards or away from the detection site. The technology has been applied to human health in the early 2000’s, to scan the retina as surveillance for a known complication of diabetes or for the diagnosis of optic nerve injury seen in multiple sclerosis. Recent studies in animals have demonstrated the ability of ODT to visualize blood vessels under the skull. In time, these newer applications will be validated in humans and then applied to the non-invasive visualization of other organs. The maintenance of OCT and ODT devices is important to their proper functioning and should be performed by a trained clinical engineer or technologist.

Not all imaging is non-invasive. The digestive system consists of the esophagus, stomach, small intestine, and large intestine. An upper endoscopy or colonoscopy can be used to look for abnormalities in the stomach/esophagus and colon, respectively. However, sometimes a patient is bleeding and the source is not identified on these two endoscopic approaches. It would be difficult to advance a semi-rigid camera to the middle of the digestive tract. This lack of access led to the innovation of capsule endoscopy, which was approved for use in humans by the Food and Drug Administration (FDA) in 2001. The capsule is the size of a large pill yet contains all the necessary hardware (lens, LEDs, semiconductor imager, battery, transmitter, and antenna) to safely travel through the digestive system, taking snapshots of the small intestine along the journey. Just as pictures from outer space being relayed to NASA on earth, the capsule endoscope transmits the pictures via radio telemetry to a recorder that the patient wears on his/her belt. Within 72 hours, the capsule exits the body. The benefits of this invasive yet safe technology include: that the patient can be at home (saves costs to the healthcare system), doesn’t need to extremely modify his/her activities (patient flexibility), and is able to get a diagnosis of a disease of the small intestine that was previously not possible. The capsule costs approximately $500, which is less expensive than a standard colonoscopy. This LED many technologists, engineers, and physicians to investigate follow-up technologies that may be able to serve as substitutes for the traditional colonoscopy or CT scan of the abdomen. As a result, the FDA approved the PillCam® COLON 2 Capsule Endoscopy System in January 2014.

Capsule endoscopy takes advantage of one of the body’s natural conduits, the digestive system. Cardiologists would benefit from being able to visualize small blood vessels from the inside as well. This would enable to them to understand patient’s risk factors for cardiovascular disease and intervene preemptively in cases of eminent danger (for example, a fatal heart attack due to a gradually narrowing left anterior descending coronary artery, the so-called “widow maker,” that finally seals off). Just as gastroenterologists use the GI system as their atlas, cardiologists use the complex highway of blood vessels to navigate their way to the heart. Using the gold-standard technique of coronary angiography to tunnel a catheter (with a camera located at the tip) from the femoral artery to the coronary arteries on the surface of the heart, the blood flow through these critical vessels can be visualized. A breakthrough technology published this year may lead to real-time 3D images from within the heart and blood vessels. Researchers at the Georgia Institute of Technology have developed a 1.4 millimeter chip that contains ultrasound transducers and on-board processing hardware that, when attached to the angiography catheter, could provide such real-time images. This technology is in the very early stages and next needs to be studied in animal models before it can be tested in humans. Thus, this is yet another imaging modality that may become commonplace in the future and save thousands of lives through earlier detection of subtler abnormalities.

Positron emission tomography (PET) is a nuclear medicine study in which radioisotope-labeled tracers are injected into the bloodstream and their decay signal (positron emission) is detected by the PET scanner, a gamma ray detector. Unlike MRI and CT scans, which provide static anatomic images, PET scans provide functional imaging. In other words, they reveal areas of the body that are consuming a disproportionately increased amount of the radiotracer. PET is most commonly used in the field of cancer and FDG, a radio-labeled form of glucose, is most often used. Because tumor cells are rapidly dividing and need to consume a lot of energy (in the form of glucose) to grow and form the cancer, the PET scan of a patient with a lung tumor would “light up” in the area of the lung containing the tumor. This area may not be seen on anatomical MRI or CT imaging alone. Thus, the combination of the structural and functional information can improve the accuracy of a cancer diagnosis. Based on its size, the brain consumes more glucose than other organs. Therefore, using FDG-PET to diagnose brain tumors is difficult because it is not clear whether the increased radiotracer uptake is due to cancer or just an area of the brain that is active. New radiotracers have been developed to help diagnose and monitor patients with brain tumors. For example, tracers based on the amino acid dopamine are now being studied in human clinical trials. Because dopamine is not used up at such a high rate by the brain as is glucose, it may prove to be a more specific way of distinguishing brain cancer from the normal background brain activity.

In summary, these four imaging methods provide a small insight into the exciting role of innovation and engineering in the field of medicine for the betterment of human health. Although they are in varying stages of development and clinical application, they represent the potential for innovation when biomedical technology is applied to the human body.



Capsule Endoscopy

Single-chip catheter-based device


Federal Consensus Standards for Medical Devices

The Center for Devices and Radiological Health (CDRH), which is a part of the Food and Drug Administration (FDA), is responsible, in conjunction with the Standards Management Staff (SMS), for the development and implementation of both national and international medical device consensus standards. This involves working closely with the Standards Developing Organizations (SDOs) and advertising standards liaison representative positions to maintain an appropriate standards database. SMS publishes updated medical device standards no less than twice annually.

See organizational and contact information for the SMS below or visit:
Recognized Consensus Standards The FDA’s database of recognized consensus standards can be accessed at

 Procedures for the Use of Consensus Standards
The CDHR and SMS believe that conformance to their domestic and international consensus standards ensures the safety and/or effectiveness of a health device. Designers and manufacturers of new health devices can benefit from conformance to these standards since such conformance often eliminates the need to review the test data that applies to the standards when seeking regulatory approval. It should be noted, however, that conformance to the consensus standards will not always be a satisfactory basis for waiving regulatory decisions about a new device.
The CDHR and SMS believe that compliance with their consensus standards represents “the least burdensome approach in all areas of medical device regulation,” but also encourages those who believe an alternative approach would be less burdensome to contact the CDHR Ombudsman at this email address: More information about the office of the Ombudsman can be found at

General Use of Consensus Standards in the Premarket Applications Review Process
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. Conformity to the recognized standard should, in these cases, minimize the amount of data and documentation needed in the 510(k) submission to demonstrate substantial equivalence and, thus, streamline the premarket review process.
Applicants referencing a national or international standard should include a completed Standards Data Form for 510(k)s (FDA Form #3654, Form Approved OMB #0910-0120) as part of their 510(k).

Declaration of Conformity
If a manufacturer decides to conform to one or more recognized consensus standards in its premarket review process for a new device, the manufacturer must submit a “declaration of conformity” to the standards. A manufacturer can use in-house testing or third-party analysis to determine a device’s conformance to consensus standards. The manufacturer is also expected to maintain all records relating to its compliance with the standards.
The FDA recommends that submissions showing a device’s compliance with a consensus standard indicate “yes,” “no,” or “not applicable” for all sections of that standard. Any deviation from the standard should also be clearly indicated.
The FDA states that a declaration of conformity to a recognized consensus standard should do the following:

Review of Documentation
When a manufacturer’s declaration of conformity is deemed to conform adequately to FDA-recognized consensus standards, the aspects of the device addressed by the consensus standard are acceptable. There are, however, occasions in which a reviewer may have specific concerns and request additional information from the manufacturer.

Recognition of New and Revised Consensus Standards
To recognize a new standard or a new version of an existing standard, the FDA will post updated information in one of the Supplemental Information Sheets on CDRH's internet page and publish a notice in the Federal Register. The FDA will accept a declaration of conformity to a standard after it is recognized.

Additional Information
Scott Colburn, Director, Standards Management Staff, Office of the Center Director (OCD), is available to answer questions on consensus standards and issues related to declarations of conformity. He can be reached at (301) 796-6287.

Joint Commission 101

Patient Safety - Joint Commission, National Patient Safety Goals (NPSGs)

The Joint Commission

The Joint Commission is an independent (not government), not-for-profit organization which accredits and certifies more than 20,500 health care organizations and programs, including hospitals, doctors’ offices, nursing homes, behavioral health facilities, office-based surgery centers and home-care services.

The purposes of The Joint Commission include helping health care operations improve the quality and safety of the care they provide, as well as reduce the risk of adverse outcomes.

In 2002, in keeping with its mission to continuously improve health care for the public, The Joint Commission launched a National Patient Safety Goals (NPSGs) program to address specific safety concerns.

The Patient Safety Advisory Group

A Patient Safety Advisory Group was formed – a panel of prominent safety experts composed of nurses, physicians, pharmacists, risk managers, clinical engineers and other professionals with hands-on experience addressing patient safety concerns in a variety of clinical settings. The panel’s purpose is to advise the Joint Commission on the development and updating of the NPSGs, the first of which became effective January 1, 2003.

The Patient Safety Advisory Group works with the Joint Commission to identify emerging safety concerns. They seek input from practitioners, care-providing institutions, consumer groups and other entities invested in patient safety. The Patient Safety Advisory Group uses the information to advise the Joint Commission in the effective use of NPSGs, standards, surveys, performance measures, educational materials, Sentinel Event Alerts and The Joint Commission Center for Transforming Healthcare (to be discussed.)

2014 National Patient Safety Goals (NPSGs)

There are different sets of NPSGs for particular settings, including:

Some of the goals are applicable to all settings. The full text containing the NPSGs can be purchased from Joint Commission Resources,

Sentinel Event Alerts

An additional safety operation of The Joint Commission is the management of what the commission calls sentinel events; reports of the events are called Sentinel Event Alerts.

A sentinel event is an unintentional, unexpected, occurrence which results in death, serious physical and/or psychological injury, or confers the risk of serious adverse outcome if the event were to recur. These events are not related to the natural course of the patient’s disease or condition. Inherent to the definition of adverse outcomes is loss of life, limb or function.

Such events demand immediate attention and responses. They differ from medical errors, although some errors may trigger sentinel events, and sentinel events can increase the risk that medical errors will occur.

The Joint Commission, during the accreditation process, critiques the organization’s response to sentinel events. Already accredited organizations will have periodic, scheduled reviews, as well as random, unannounced reviews and for-cause investigations.
Accredited organizations are expected to respond appropriately with timely, credible analysis, to find the root cause of the adverse event. The analysis focuses on procedures and systems, not on individuals. The organization then must develop a plan for action, to reduce the risk of recurrences.

Some of the sentinel events that are reviewable under The Joint Commission’s Sentinel Events Policy include (not all inclusive):

Examples of sentinel events which are not reviewable, under the same Joint Commission policy include (not all inclusive):

Procedures for Implementing the Sentinel Event Policy

The Joint Commission staff will determine whether an event is reviewable based on available information they received about the event. Urgent threats to health or safety are referred to Joint Commission Executive Leadership for authorization to conduct an immediate, unannounced for-cause survey. The organization of interest must submit the complete root analysis and the action plan within 45 days from the date the event was reported.

The Joint Commission staff assess the acceptability of the organization’s response to the reviewable sentinel event. If the root cause analysis information and action plan are deemed to be thorough and credible, the organization is assigned one or more Sentinel Event Measures of Success (SE MOS). An MOS is a numerical or quantifiable measure that determines if a planned action was effective and sustained.

If the response is unacceptable, Joint Commission staff will provide consultation to the organization on the unmet criteria and extend an additional 15 calendar days beyond the original submission date for the organization to demonstrate acceptable analysis and an appropriate plan for action.

If the amended report does not meet established criteria, or The Joint Commission determines that the organization has not made serious improvement efforts, accreditation may be affected.
If the report is acceptable, The Joint Commission determines appropriate follow-up – usually reassessment in four months.

Universal Protocol for Preventing Wrong-site, Wrong-procedure, Wrong-person Events

The Joint Commission’s Universal Protocol applies to all invasive procedures. Those which place the patient at the most risk involve general anesthesia or deep sedation. The protocol is based on the following principles:

The Universal Protocol is most effective in environments which promote teamwork, and all members are empowered to pursue patient safety.
Timing and location of preprocedure verification of patient identity and site marking must be determined by an individual organization. The frequency and scope of preprocedure verification is determined by the type and complexity of the procedure. Preprocedure verification, site marking, and time-out procedures must be as consistent as possible throughout the organization. Site marking is not required when the person performing the procedure is with the patient from the time the decision to do the procedure is made, through to completion of the procedure.

Joint Commission Center for Transforming Healthcare

The Joint Commission, in 2008, created a Center for Transforming Healthcare, to tackle the most critical healthcare quality and patient safety problems. With the NPSGs, core measures, and high standards for accreditation, hospitals and other organizations that deliver healthcare can determine where to focus their resources, to have the greatest impact on quality and safety. However, some major shortcomings in quality and patient safety persist, despite considerable efforts to find solutions, including hand hygiene, wrong-site surgery and hand-off communication. The demand is great for more specific, effective and durable solutions.

The Center participants – some of the nation’s leading hospitals and health systems - are using a systematic approach to analyze the underlying causes of dangerous breakdowns in care, and to develop proven solutions to the more complex problems.

The Joint Commission makes available the proven solutions to the more than 20,500 healthcare organizations it accredits and certifies. With the proven solutions, significant advances in safety for all have been made in health systems and processes of care.

In September 2010, the Targeted Solutions Tool (TST) was introduced. The Joint Commission Center for Transforming Healthcare developed the application. It guides healthcare organizations through a step-by-step process to accurately measure their organizations’ performance, identify the barriers to excellent performance, and direct them to proven solutions that are customized to address the particular barriers of each organization.
The TST currently provides targeted solutions for hand hygiene, wrong-site surgery, and hand-off communications. Targeted solutions for surgical site infections, heart failure hospitalizations, patient falls, sepsis and others will be incorporated into the TST as the center completes their development.

National Patient Safety Foundation

The National Patient Safety Foundation (NPSF) is a not-for-profit organization dedicated to identifying problems in safety and creating solutions for both patients and healthcare workers. The NPSF, although it has a similar mission to that of The Joint Commission, it is entirely independent, with no affiliation to the commission.
The NPSF partners with patients, families, communities, healthcare workers and institutions to address safety issues, solve problems, and provide education in regard to patient and healthcare worker safety.
Among its educational resources is the NPSF On-line Patient Safety Curriculum. The 10 – module course is approved for continuing education credit by the Joint Commission and the American Board of Medical Specialties. The NPSF can be reached at (617) 391-9900 and


Institute of Medicine:

The Joint Commission:

The Joint Commission Sentinel Events:

The Joint Commission: Patient Safety:

The Joint Commission Resources:

The National Patient Safety Foundation:

The Center for Transforming Healthcare – Joint Commission:

Product Recall Processes for Medical Devices

The Food and Drug Administration (FDA) provides guidance to regulated industries when it comes to product recalls. These regulated industries include medical and radiological devices. According to regulation, the FDA has the right to recall products. The FDA follows the Code of Federal Regulations (CFR) and specifically 21 CFR 10.115 when it comes to recalls of this type.

If the FDA decides to recall a product

When the FDA makes the decision to recall a product from a firm, a representative from the firm should notify a local FDA District Recall Coordinator before issuing a press release or notifying customers. Firms should find the name of this coordinator from the site.

After the FDA makes a decision to recall a product and someone from the recalling firm notifies an FDA coordinator, the firm should submit as much information as possible to the FDA so that the FDA can review the information and offer assistance in resolving issues.
The FDA provides guidelines concerning this recall submission provided by a firm.
The site that provides the guidelines from the FDA to the firm is

FDA Recall Notice

The site indicates that when providing this recall submission to the FDA, the firm providing the submission should provide the information about the product to include:

A description of the reason for the recall should be part of the submission. The description should explain the product defect and how the defect relates to product performance and safety.  The submission should also include information about:

Health hazard assessments

A health hazard assessment should also be included in the submission to the FDA as should information about the volume of the recalled product. Concerning the recall strategy, the firm should indicate:

The FDA also provides guidelines on how to notify the public about product recalls, press releases, product recall notification letters, and instructions to customers.

Recalls and safety alerts

The FDA produces a list of recalls with notices and press releases about the products regulated by the FDA. The public has access to this list at the site.
Here is a sample of what is included in the list.
safety alert

As an example, for the brand name Hospira a recall exists for a problem due to the presence of particulate matter. The product description is Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9 percent Sodium Chloride Injection, 500 mL. The FDA web site provides more detailed information including the press release and other information provided by the manufacturer.

Medical device recalls

For a list of recent medical device recalls, the FDA maintains the site.
Here is an example of what the list is like:


As an example for the Ventlab Manual Resuscitator recalled on May 16, 2014, the problem is that the duckbill valve may stick and prevent air from getting to the patient. The recalled devices were manufactured from January 10, 2013 through July 1, 2013.

The press release that comes from the manufacturer states that this “disposable device is used to provide temporary support to patients who cannot breathe on their own… The duckbill valve inside the resuscitator may stick and prevent air from getting through the valve and to the patient. If a patient does not receive oxygen or treatment is delayed, life-threatening health consequences including inadequate oxygen supply to the tissues (hypoxia) and too shallow or too slow breathing as well as death may occur. The firm received one report of injury requiring medical intervention due to lack of a functioning resuscitation bag.”
This is a Class I recall. According to the FDA site this is the “most serious type of recall in which there is a reasonable probability that use of these products will cause serious adverse health consequence or death.”

Getting updates on medical device problems

If someone would like updates on problems with medical devices, the FDA can provide via their web site a way to sign up for email updates. Additional information about safety communication from the FDA is available by calling 1-800-638-2041 or emailing


Radiation emitting products

The FDA provides at information covering radiation emitting products including information on topics such as:

Concerning safety related information for radiation-emitting products, the FDA site provides information about:

On the site is additional information about recalls and alerts. A sample of this type of information includes:

Reporting a problem with a radiation-emitting product

Here is the page the FDA maintains to report a problem. As stated on the page, manufacturers must report to the FDA all accidental radiation events. Manufacturers should also follow FDA guidelines on recordkeeping and recording regarding radiation emitting products.
Anyone, not just a manufacturer, can use the FDA form available from the following site to report a radiation incident or event that could be hazardous. In addition consumers or health professionals can find a form on this site to report problems with medical products including:


Risk Management Plan

1. Introduction

Risk management is mostly defined as the systematic applications of management. Risk management is to be integrated with different activities like device design control activities and other compliance activities. The main importance of applying risk management to medical devices is to provide the patient with safety. In risk management, the risk evaluation process is a key step.

1.1 Risk Management Procedures

Risk management involves a three-step procedure:

1) Hazards Identifications:

The hazard identification process should account not only for hazards directly related to the medical devices, such as designs and manufactures, but this is also used in the clinical worlds.

2) Risks Assessments:

In risk management, it includes some difficulties of risk assessments are difficult of measurement of the quantities, potential loss and probability of occurrence. There is more chance of errors to measure these contents . Risks with more potential loss and a less probability are often treated differently from other less potential loss. In practically, it is more difficult to manage, but in theory. it is nearly equal priority. The risk assessments face many problems like rareness of resources, specifically time.

Expressed mathematically:


3) Risks Mitigation:

Risks mitigation is the process of an organization defining the measures to minimize or the process by which an organization introduces specific measures to minimize or remove unnecessary risks and operations. Risk mitigation is also the process of developing some options and actions to increase opportunities and reduce damage to project objectives. Risk mitigation handling options include:


Acknowledge the existence of risks, make decisions about medical devices and accept them without engaging in special efforts, which is controlled.


Adjust program requirements or constraints to eliminate or reduce the plan risks. This is used to avoid the financial or technical problems.


Reassign organizational accounts and responsibilities and provide the authorities to different people who have the ability to accept the risks


Monitor the environment for changes that affect the nature and/or the impact of the risk.


Implement actions to minimize the impact or likelihood of the risk.

1.2. Principles of Risk Management

The organization identifies the following principles of risk management:

1.3. Risk Management Process


2. Medical Device Risk Analysis

Medical devices are providing risk analysis services. Risk analysis is a structured tool for the evaluation of potential problems. Risk analysis could be encountered in connection with the use of anything, like driving a car or using medical devices. Risk analysis of medical devices includes:

2.1 Why should we perform risk analysis?

2.2 Ways of Risk Analysis

1) Hazard Identification: Toltec has experience with many types of medical devices and can assist you in understanding what hazards exist. The main examples of risk analysis of medical devices are as follows:

3. What is Hazard?

3.1 Hazard Detectability

Hazard detection accounts for the likelihood of discovering and correcting a hazard or failure mode prior to an incident. Detection of hazards provides an inverse relationship between the level of detectability and the degree of risk seriousness. Detectability should then be scaled such that increasing scores denote a decreasing likelihood of hazard detection.

3.2 Hazard Correctability

The hazard correctability factor rates the relative ease of mitigating a certain risk. It accounts for the associated feasibility and effort required in reducing a particular risk to the lowest practicable level. In other words, in assessing the level of hazard correctability, both the availability of technical solutions and their economic feasibility and budget constraints should be considered. Practicability has main two procedures, and these are as follows:

1) Technical practicability: Ability to mitigate the risk regardless of cost

2) Economic practicability: The ability to reduce a risk without making the medical device into an unsound economic proposition

3.3 Types of Hazards

1) Biological hazards: These include bio-contamination, bio-incompatibility, incorrect formulation, toxicity, allergen-city, mutagen-city, ontogeny, carcinogenicity, re-and/or cross-infection, progeny-city, inability to maintain hygienic safety and degradation.

2) Physical and Mechanical hazards: These include erroneous data transfer, lack of, functional checks, inadequate maintenance, lack of adequate, loss of electrical/ mechanical integrity, inadequate packaging, re-use and/ or improper re-use.

3) Others: These include electricity, radiation, volume, pressure, supply of medical gases and supply of anesthetic agents.

4) Medical hazards: Hazards related to the use of the medical device, etc. This medical hazard includes trained and untrained people, width, etc.

5) Energy hazards: These include heat, electrical vibrations, etc.

6) Communication hazards: These include mistakes and experts errors, complexes or confused systems or unknown devices and their states, etc.

4. Methods of a Risk Analysis

The risk analysis includes the three factors of risk assessment, risk communications and risk managements. This risk analysis is to assure that medical devices processed in healthcare institutions are sterile. A risk analysis is performed to identify the risks to reduce the likelihood of a sterilization failure occurring.

Step 1) Risk Assessment: The risk analysis begins with a risk assessment. The possible risks are reviewed and then rated to assess which risk or risks pose the highest vulnerability. The CSSD Risk Assessment form can be completed using the following steps:

Step 2) Risk Management: Next are the risk managements, which perform some actions that are known for the risks rated as the highest in huge . This plan is used to reduce the failure of risk which is occurring when it is used . This is the part of the risk analysis which is used to eliminate the risks and to develop the plans.

Step 3) Risk Communication: A risk analysis should be conducted annually or whenever major changes occur. This step is used to provide communication between the different people for managing the risk plans.

5. General Requirements for Risk Management

1) National Regulatory Requirements: XXX shall establish, document and maintain a quality management system to ensure that all known potential risks within the field of application of risk management to medical devices are identified and that all relevant risks are controlled in such a manner that the products of our company do not harm the user/consumer.

2) Risk Management Process: The XXX shall establish and maintain a process for identifying hazards associated with devices, estimating and evaluating the risk and alternatives of the risks, controlling the risk and monitoring the risk. The XXX shall document the risk management processes, which include:

3) Management Responsibilities: There are many management responsibilities of general requirements. These are:
Policy: The top management of our company is committed with regard to evaluates, IDs, and risk controls, which is related to a safety plan. The risk management plan is used to communicate with the organizations so that they can easily understand the problems.

Suitability: The company’s management shall review the continuing suitability and effectiveness of the quality management system at defined intervals to fulfill the requirement of customers and authorities, satisfy the company’s stated risk management policy and meet the company’s risk management objective.

6. Qualification of Personnel

6.1 Task, Responsibilities and Authorities
The Managing Director is the leader responsible for overall system qualities, policies of risk management and objectives. The responsibilities and policies of risk management plan are as follows:

6.2 Risk Management Team
XXX has set up the risk management teams, which are used for developing, maintaining, establishing and reviewing the system of quality managements. The managers or director of management has selected the technical manager as the quality management representative, who shall have the defined authority for:

6.3 Risk Management Plan
The risk management file is the subset of the risk management plan. These include following:

6.4 Risk Management File
The company will have to save and maintain the record of all the risk management activities in the risk management file for the particular medical device or accessory being considered.

7. Medical Device Users

A medical device can be easy for one person to use safely and effectively, but creates present problems for different people. On the other hand, the medical devices that are easy for a certain group of users to use safely and effectively could be difficult for different groups. The users have to needs the medical devices so that they users can use it safely and effectively.
7.1 Characteristics of Medical Devices Users
The main characteristics of medical devices users are as follows:

7.2 Medical Device User Interfaces
A well-designed user interface will facilitate correct actions and will prevent or discourage actions that could result in hazards. The user interfaces are as follows:

8. Document Risk Management Activities for Device Use

In risk management, it can help demonstrate that a manufacturer has addressed the needs of the intended users and documented the incorporation of human factors engineering (HFE). Submitting this documentation can streamline and facilitate, which is the part of the pre-market review process that is concerned with safe and effective device use. The information that should be included with the device use documentation is described below.

8.1 Device Overall

8.2 Device User Interface

8.3 Device Use

8.4 Device User Population

8.5 Device Use Environments

8.6 Use-Related Hazards

9. Verification and Validation

The validation and verification process of medical devices are as follows: Testing and evaluation processes and results associated with determining.

10. Scope of the Medical Devices

The scope of the medical devices is as follows:

11. Performance Measurements of Medical Devices

Performance measurement is the measurement of the accuracy of the medical device or the medical system. It is using by the standard measurement system whose accuracy is known and is the determination and the record of the deviations. It is established whether the medical devices are appropriate to the international standards or not. The problems are also determined if the device is not adequate to the international standards.
11.1 Objectives of Performance Measurements
In the objective of the performance measurement, the following procedures are observed.


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