What does the department do?
Important
Compliance and Standards
Policies and Procedures support these functions.
Measurement
Issues to deal with
Questions
Purchasing
Supreme Court Decisions
Risk Factors
Mitigating factors
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.
References
ODT
Capsule Endoscopy
Single-chip catheter-based device
PET
2014/2015 changes to Environment of Care Standards related to Healthcare Technology Management/Biomedical Engineering for deemed sites.
EC.02.04.01, EP 2 - Inventory must now include all medical equipment.
EC.02.04.01, EP 3 - Evaluate what equipment is high-risk to the patient or staff if they fail to perform correctly. This is equal to the CMS expression "critical equipment".
EC.02.04.01, EP 4 - Keep a record of inspection procedures and inspection frequencies. Hospitals must follow manufacturer recommendations or an alternative plan. The alternative plan can not reduce safety and must be based on standard practices. Joint Commission referred to ANSI/AAMI EQ56 as an example of standard practices. George Mills referenced ANSI/AAMI EQ89 at the AAMI 2015 annual conference in Denver.
EC.02.04.01, EP 5 - The following equipment must be inspected according to manufacturer's recommendation: Medical Laser Devices, Imaging and Radiological devices, Equipment subject to federal or state law, Equipment subject to Medicare Conditions of Participation. A plan more stringent than manufacturer recommendations can be followed. New medical equipment must be inspected according to manufacturer's specifications unless there is enough history to justify a change.
EC.02.04.01, EPs 6, and 7 - Determinations to use AEP must be made by an individual qualified according to HR.01.02.01. The AEP assessment must consider "How the equipment or component is used; consequences of failure, including the seriousness and prevalence of harm; availability of an alternative or a backup in the event that the tool fails or malfunctions; incident history of identical or similar equipment; and maintenance requirements of the equipment."
EC.02.04.03, EP 1 - Safety, Operational and Functional checks must be performed before use of equipment and after major repairs.
EC.02.04.03, EPs 2 and 3 - 100% compliance with the Manufacturer's requirements is required for all high-risk equipment, with included life support equipment.
The above is alignment with CMS code 42 CFR 485.623(b)(1),
Facilities / Utilties - EC.02.05.01, EP 2, EC.02.05.01, EP 3, EC.02.05.01, EP 4, EC.02.05.01, EP 5, EC.02.05.01, EPs 6 and 7, EC.02.05.05, EPs 2 and 3 apply the same or similar rules to utilities and their components.
Other Standards
All Life Support Equipment is also high-risk equipment. EC.02.04.01 and EC.02.04.03 now require our customers to determine what is high risk equipment.
We would like your feedback as we develop this list. We will move our updated list online for further review. If you find any of the names inaccurate or redundant, please comment.
Life Support:
Anesthesia Machine
Apheresis System
Balloon Pump, Intra-Aortic (IABP)
Defibrillator
Extracorporeal Membrane Oxygenation (ECMO)
Heart-Lung Bypass Machine (Pump, Extracorporeal Perfusion)
Heart-Lung Bypass Heat Exchanger
Iron lung
Pacemaker, Cardiac External
Pump, Blood, Extraluminal (Roller Pump)
Ventilator / Respirator
Intermittent positive pressure breathing (IPPB) machines
Suction machine
High Risk Equipment:
Apnea monitor for infants (24 months and under)
Dialysis Machine
ECMO Equipment
Electrosurgical Unit (Including hyfrecators)
Fibrillator
Heat Exchanger, Heart-Lung Bypass
Monitor, Airway Pressure
Resuscitator, Infant
Vaporizer
Warmer, Blood / Plasma
Are these High Risk?
Ablation Unit, Ultrasonic
Aerosol tent
Air Compressor
Air Flow Guage
Angioplasty System
Aquapheresis System
Balloon Pump, Gastrointestinal
Bed Alarm
BIPAP/CPAP
Capnograph
Continuous Fluid Management Renal Replacement
Cryosurgical Unit, Cardiac
Electric nerve stimulator
Fluidotherapy
Gas Outlet
Heater, ECMO
Hypo/Hyperthermia
Imaging Equipment
Infusion pump
Insufflator
Irrigation
Laser
Lift
Liposuction Unit
Morcellator
Nebulizer, Electrostatic and Ultrasonic
Oxygen Concentrator
PCCTS Work Station
Phaco and Vietretomy System
Power Supply on Life Support Device
Pressure pads and pump
Surgical Robot
Terminal Cabinet
Tourniquet, Pneumatic
Ultrasound
Urinary Catheterization
Vacuum, Curettage System
Ventricular Assist Device Drive Console
Warmer, Radiant, Infant
Water Treatment System, RO
Wax Warmer
Wound Drainage Pump
Xenon Ventilation System
We have a couple more questions.
Is there any equipment that is high-risk only when used in special circumstances?
(Quadriplegic care, home care, neonate care, etc)
Are there any ventilators or anesthesia equipment that are not high-risk?
What equipment can harm staff if it fails?
Lab Equipment
Notes
Iron Lung is on the list because NIH reports that they have been reintroduced for neonatal use.
The new math is UDI = DI + PI.
Class II and Class III devices will require both a device identifier (unique to the specific item) and production identifier (unique to the model or version) which will be presented as a barcode and text description. Class I devices and devices expect from GMP (good manufacturing practice), such as bed pans, will require only the production identifier.
Where necessary, devices such as reusable surgical instruments and implants will be marked on the device. Standalone software that is not an integral part in a medical device will be required to display the production identifier when run.
What makes a model a model? Standard manufacturer methods for determining when a model has change can be used to determine this, with some exceptions:
• A change in the specifications, performance, size, or composition of the device to an extent greater than the specified limits requires the device to receive a new UDI.
• A change to the device package (for example, from a package containing 10 devices to one containing 12) or the addition of a new device package would entail a new UDI.
• A change that could significantly affect the safety or effectiveness of the device would require a change in the UDI.
• A change from sterile to non-sterile (or vice versa) would require a change in UDI.
• A device that is relabeled (with a change to a label that entails more than an addition of information such as a distributor’s name and contact information) would need to receive a new UDI. [Source: Eastern Research Group Lexington, MA]
Code included in the UDI
(01) Device unique identification
(21) Serial Number
(11) Manufacture date
(17) Expiration date
(10) Lot number
Compliance Dates:
10/24/2015 - Life Sustaining and Life Supporting devices (Extended 8/14/15 by FDA notice)
9/24/2016 - Class III devices and devices licensed under Public Health Services Act
9/24/2018 - Class II devices
9/24/2020 - Class I devices and unclassified devices
Open Questions:
21 CR 801.45(b) states that a device package and device may have different UDI labeling. If we are reading this correctly, should we be advising user to read the UDI only from the actual device?
Terms:
Global Trade Identification Numbers (GTIN) - GS1
Sources:
The Brookings Institution Washington, DC
Eastern Research Group Lexington, MA
Access GUDID at nih.gov
U.S. Department of Health and Human Services, Draft, Unique Device Identification: Direct Marking of Devices, June 26, 2015
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: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm:
Recognized Consensus Standards The FDA’s database of recognized consensus standards can be accessed at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
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: CDRHOmbudsman@fda.hhs.gov. More information about the office of the Ombudsman can be found at www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.
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.
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 http://www.fda.gov/default.htm 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 http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm/.
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 http://www.fda.gov/Safety/Recalls/default.htm site.
Here is a sample of what is included in the list.
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 http://www.fda.gov/MedicalDevices/Safety/default.htm 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 DICE@fda.hhs.gov.
Radiation emitting products
The FDA provides at
http://www.fda.gov/Radiation-EmittingProducts/default.htm 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:
As I travel the country I find that most technicians and most departments do not regularly fail inspections. A technician will often say, "I fixed it, it did not fail."
Recording failure is how we record the value of our scheduled work. If we perform 5000 work orders, and nothing is ever wrong, maybe we do not need any inspection other than those that fit legal requirements, compliance requirements or pressure from our own risk or safety committees. We might find we are inspecting only what everyone else inspects.
Recording failure and getting an idea if that failure is significant, is a good way to check progress in our program. We can determine the significance of failure by determining if it could have had a detrimental effect on the patient. We might also want to consider the financial risk of the failure. What would have happened next if we had not located a problem and fixed it.
Once we record failure, we can make a plan to reduce failure. If the failure is related to use error, we can implement training, signage, rewards or change the environment. If the failure is due to manufacturing problems, we can turn to the manufacturer for a remedy, making it clear their response will affect our decision in future purchases. If the failure relates to the environment, we can control temperatures, humidity or improve the quality of electrical supply. If the failure could have be prevented by more regular testing or maintenance, we might find the appropriate party to perform a daily check or routine process, such as cleaning.
If we do not record failure, it is left up to the general memory of events to determine our future plans. The importance we place on our actions may reflect factors other than science, such as our feeling about a staff member or the outcome of one specific event we experienced or heard about. We might not have a system in place for measuring the result of any changes we make. In the worst case, we may find out after a major incident we had been seeing a problem over and over, but never recording it. This is the type of information that often come out after a major problem has occurred.
Nowadays, taking care of one’s health has never been the same. In fact, more technologies are introduced now and then to empower everybody to look after one’s well being. Among the interesting gadgets that may play a big role in the future’s cardiovascular medicine are the wireless sensors. They can be employed using simple “smart band aids” monitored by Blackberry and iPhone devices. They can check a person’s vital signs and that includes respiratory rate, heart rate and pulse rate. It is interesting to note that you can now have mobile electrocardiogram using these simple sensor devices. It can also update you with your present temperature and extra cellular fluid volume. This means, you can have all the essential data that you need without necessarily going to a clinic or hospital. All you have to do is to apply the “Smart Bandage’ on your chest which will serve as the sensor to get all the data for you. All information will be sent to your iPhone making it very convenient to get all the physiologic readings that you need.
