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Example of Medical Device Incident Form






Medical device definition (food, drug & cosmetic act)
  • Use in the diagnosis, cure, mitigation, treatment or prevention of disease or condition.
  • Affects structure and function of the body
  • Does not achieve intended use through chemical reaction
  • Is not metabolized
New Devices
  • Acceptance, safety inspection, compatibility, education, procedures, and appropriate purchasing documents (including loan agreements)
  • To have technician checks or not to have technician checks? When in doubt, have technician checks
Device Failure Procedure
  • Remove the device from the patient
  • Take emergency measures to minimize the injury to the patient or caregiver
  • Take appropriate action to minimize damage to the equipment and the environment. Do not change any equipment settings
  • Keep all disposable products and packaging. Retrieve packaging of supplies if possible
  • Impound all equipment so that it cannot be accidently applied to another patient
  • Tag Equipment with a Tag, describe problems. Call Agency, MD, Supplier to retrieve equipment
  • Before, during or after use.
  • Remove the device from the patient.
  • Take emergency measures to minimize the injury to the patient or caregiver
  • Take appropriate action to minimize damage to the supply and the environment
  • Retrieve packaging of supplies of possible. If not, record catalog number, lot number and mfr info and storeroom ID # as applicable.
  • Bag the supply and call Agency, MD, and/or Supplier
Device Failure Reporting
  • Problems with Medical Devices must be reported to:
    • Supplier Company (Supplies) or HME (Equipment) (if not patient injury)
    • Risk Management (if patient injury)
    • Quality Improvement via Quality Report
      • Fill out all equipment information on the Communication Log, including equipment ID, manufacturer name, catalog number of known, or number as applies
What types of Medical Device Problems Should I Look for?
  • Instructions/Labeling/packaging
  • Non-sterility
  • Defects
  • Software problems if applicable
  • Failure to work as intended/malfunction
  • Interactions with other devices
  • User errors
  • Combinations of the above
Why Reporting Medical Device Problems is Important in our Agency?
  • Prevent future problems and protect our patients, staff, families, and caregivers
  • Achieve performance improvement goals
  • Assist Risk Management with claims or litigation
  • Provide information to manufacturers and/or U.S Food and Drug Administration
  • Impact the public health for the general good of patients and health care providers
  • Effect changes in policies and procedures
When Do I Report?
When you think a device has or may have caused or contributed to any of the following outcomes (for a patient, staff member or visitor):
  • Death
  • Serious in jury
  • Minor injury
  • Close Calls or other potential for harm
Your Role
  • Identify actual and potential problems, adverse events, close calls with medical devices
  • Report the problem or adverse event to your supervisor, according to policy and procedure
  • Make sure your report includes details
  • Remove the device, sequester all affected items, save the packaging

And remember… We can’t address issues we don’t know about. Please report.


Ensure Medical Device Safety

A safe medical device is one that does not injure a patient, user or caregiver. Processes and procedures that ensure the manufacture of safe and effective products should be inherent in a medical device manufacturer’s quality system. This premise— ensuring public safety—is the backbone of most regulatory agencies’ reasons for being. Safety is defined as “freedom from unacceptable risk.” Risk is defined as “the combination of the probability of occurrence of harm and the severity of that harm.” Harm is defined as “physical injury or damage to the health of people or damage to property or the environment” in ISO 14971:2000, Medical Devices—Application of Risk Management to Medical Devices. To address these concerns and thereby achieve compliance with one of the key components of national and international regulatory requirements, companies must develop, implement and maintain an effective risk management process that identifies potential hazards associated with the use of their medical devices. A hazard is “a potential source of harm” and may stem from energy, biological and environmental sources, functional failure, aging of the device and use. In addition to ensuring proper sanitary conditions, sterilization (when appropriate) and general cleanliness, a risk management program is a critical necessity to a robust regulatory compliance program. In the medical device world, such a program should be based on an accepted set of principles and guidelines, such as ISO 14971. This international standard, published in 2000, is a valuable tool that helps a manufacturer determines the safety of its products.

Changes to devices that affect or may affect the safety, effectiveness, operability or packaging of the devices (for example, design, materials, use or application, manufacturing process and methods and suppliers) require re-evaluation of risk.


Risk Management

Risk management is the systematic process of identifying the hazards posed by a medical device or its associated production and development systems, estimating the risks of the hazards and evaluating, product undergoing risk analysis is documented. This process includes the identification of characteristics related to safety and a review of clinical literature. Known or foreseeable hazards are documented in both the normal (intended use) and fault (reasonably anticipated misuse) conditions. Known hazards include complaint investigation results and any vigilance or medical device report analysis. Foreseeable sequences of events that may result in a hazard are considered and recorded. Risks for each identified hazard in both normal and fault conditions are estimated, and the estimation is documented in the risk management file. Data for estimation of risks are obtained, for example, from published standards, technical and field data, usability tests by typical users, clinical evidence, results of investigations, expert opinion and external quality assessments. The severity and likelihood of risk associated with each hazard are classified.


Risk Evaluation

Risk evaluation results in a decision regarding risk classification (risk index) and is based on the severity and likelihood classifications. One method that can be used for interpretation of the risk level is:
• Intolerable: The risk is unacceptable.
• ALARP (as low as reasonably practical): But effort should be made to reduce the risk.
• Acceptable: The risk is broadly acceptable.

Risk Analysis

Risk analysis consists of the identification of intended uses and purposes of the product, identification of hazards and estimation of risk. The device or system is defined with the detail required to perform the analysis. The definition includes a description of the device and accessories, the use of the device, environmental conditions under which it is used and the typical operator skills. These comprise the qualitative and quantitative characteristics of the device or system that could potentially impact safety. The intended use or purpose of other generated hazards and completeness of risk evaluation. Option analysis is performed as an integrated approach using one or more of the following in priority order:
1. Design changes.
2. Protective measures and information in the device itself or in the manufacturing process.
3. Labeling.
4. Training.
Any risk classified as intolerable should be addressed through redesign efforts to reduce the severity or likelihood. Risk mitigation is verified and validated. Risk control measures selected in the option analysis phase are typically implemented, and the effectiveness and implementation of these measures are verified. After risk control measures have been applied, any remaining or residual risks are evaluated following the criteria defined in the risk management plan. If required by the plan, residual risk is reduced by the application of additional risk control measures. If risks cannot be reduced, a risk/benefit analysis of the residual risk is conducted. Risk control measures are then reviewed to determine if other hazards have been introduced as a result of the risk control process. Any new hazards introduced are assessed and addressed.


Risk Control

Risk control is the process of reducing risk to an acceptable level. It includes option analysis, implementation of risk control measures, residual risk evaluation, risk and benefit analysis, determination of gating and managing the risks. The risk management process consists of the following steps:
• Qualitative and quantitative identification of characteristics.
• Preliminary hazard identification.
• Risk analysis.
• Assessment of risks, causes and mitigation.
• Mitigation (including verification and validation).
• Summary report.
• Periodic review and update.
• Development of a risk management plan to describe the activities to be carried out during the course of the design development and change process. Risk management is a requirement of the European Commission’s Medical Device Directive and the U.S. Food and Drug Administration’s Quality System Regulation. The process consists of five activities: risk analysis, risk evaluation, risk control, evaluation of overall residual risk and review of postproduction information. Results of the activities associated with the process should be placed into a risk management file that contains, at minimum, the description and identification of the medical device (or accessory), the identification of personnel who performed the risk assessment, the dates of the activities and the results of all risk management activities. The risk management file is prepared or updated throughout the development process and product life cycle.


Risk/Benefit Analysis

If the residual risk is judged unacceptable using criteria in the risk management plan and further risk control is impractical, a risk/benefit analysis is conducted. The team should gather medical expert opinion by reviewing data and literature about the medical benefits of the intended use of the product and then determine whether the medical benefits outweigh the risks. An independent assessment of the risks from all identified hazards is carried out. This assessment should review the residual risk posed by the product to determine whether it is acceptable. If the data gathered and reviewed do not support the conclusion that the benefits of the product outweigh the risks, the risk remains unacceptable and the team is required to find risk control measures to reduce the risk to an acceptable level before proceeding.


Postproduction Review

This stage in the risk management process includes the review of postproduction and risk management experiences. During this phase, complaints and proposed changes to the product are reviewed to aid in evaluating the performance of the product for potential safety issues.
Questions to answer include:
• Are any previously unidentified hazards present?
• Is the estimated risk no longer acceptable?
• Is the original risk assessment invalid?
If any of the answers are affirmative, the risk management process should be repeated to update the assessment and initiate any required new control measures. While the risk assessment process sounds fairly simple on the surface, it can be onerous and definitely requires participation only of trained personnel. Excellent analytical skills are useful in performing an adequate and effective risk assessment.
A company must be willing to invest in the resources to ensure its risk management program is functioning properly, has adequate oversight with respect to product development and that the medical devices it markets are, indeed, safe and effective.


Blood Glucose Monitors (BGMs) also Known as Glucometers


Portable Blood Glucose Monitors (BGMs), also known as Glucometers, are portable, battery operated medical devices that measure the blood glucose concentration from a small drop of capillary blood (from finger sticks or alternate sites) using methodologies such as: reflectance photometry, absorbance photometry, or electrochemistry.
Benefits: Some of the benefits of this device are convenience and safety to the patient on many levels:

1) Since patients can check and monitor their own blood glucose levels at their leisure, they do not have to travel to a healthcare facility to have their venous and/or arterial blood drawn.
2) Therapy/treatment can be rendered quickly at their homes.
3) Since the blood sample these portable devices require is smaller than that needed for automated laboratory/chemistry analyzers, BGMs can reduce patient blood loss due to laboratory testing.
4) Cost is greatly reduced for the care and treatment of diabetic patients for all parties involved: the patient, the healthcare facility,



Hazards: Recent FDA and manufacturers’ notifications and recalls of these devices have proven that there are associated vulnerabilities in the use of glucometers.
Note: Not every brand of portable blood glucose monitor is affected by the identified vulnerabilities. Some manufacturers have modified their devices to improve safety by applying certain forcing functions; e.g. when changing the time of day, to observe daylight savings time for instance, patients cannot inadvertently change the unit of
measure. Some brands of devices sold in the Unites States will now display in milligrams per deciliter (mg/dL) only.



I. Nature of portable battery-operated medical devices

• Dropping and breakage: As compared to stationary (those that are heavy or bolted down) medical devices, there is higher incidence of dropping portable devices and the result may lead to a broken, malfunctioning device, changed unit of measure [from milligrams per deciliter (mg/dL) to milli-moles per liter (mmol/L)] 2 or an inaccurate device.

• Liquid intrusion: It is a common problem with patient owned, portable, medical devices that they are often dropped in toilet bowls, sinks, bath tubs, etc. which in turn may lead to a broken, malfunctioning device or an inaccurate device.

• Battery powered: As batteries drain, the devices could become inaccurate and malfunction. Depleted batteries or replacement of batteries may lead to loss of memory in some devices.


II. Patient Interaction

• Unsuitable patient selection and matching of the device to the patient can lead to improper use, erroneous results and poor outcomes. Patients with dementia or memory loss are contraindicated for this device. Patients must have manual dexterity to be able to perform the tests themselves, otherwise a partner will have to be assigned and trained. Care givers must accurately assess the patient’s underlying physiologic conditions to make sure that the patient is capable of self monitoring.

• The operators’ manual must be clear concise and must be written in layman’s terms without medical jargon. Care givers must provide initial instructions, demonstrations, and training on how to use the device correctly and accurately. Periodic reviews on how to use the device should occur to assure that the patient is using the device properly. Audio visual aids such as video tapes, CDs and DVDs are good examples of cognitive aids.

• Contaminants such as food, chemicals, and dirt at the site of puncture can interfere with the test results. It is important to wash the puncture site and allow it to dry, especially if rubbing alcohol is used to clean the puncture site.

• Body fluids other than blood can interfere with the test results. Avoid squeezing the puncture site: Patients must have adequate circulation at the proposed puncture site or sites to be able to use these devices effectively and accurately.


III. Accuracy

• Methodology: Certain products, such as those containing maltose, galactose, or oral xylose, interfere with specific glucose testing methods and will result in inaccurate readings.3

• Electronic malfunction: Manufacturing errors and general wear of the electronics can cause the device to become inoperable or display erroneous results (missing digits). Often no feedback of the malfunction is relayed to the patient.

• Terminology: When the patient’s glucose level was less than 10 mg/dL, the display of the meter shows “Bad Strip” without mentioning the possibility of a critically low glucose reading NOTE: Manual has new inserts on what “bad strip” means. However this is not as effective as the meter displaying a warning of “critically low values”.


IV. Strips

• Undesired exposure to temperature, altitude, and humidity can cause abnormal/erroneous readings. Reports of cracked or deformed vials have prevented a proper seal and resulted in exposure to humidity. Strips should be stored in their original vial to avoid deterioration.

• When the patient’s glucose level was less than 10 mg/dL, the display of the meter shows “Bad Strip” without mentioning the possibility of a critically low glucose reading 4 NOTE: Manual has new inserts on what “bad strip” means. However this is not as effective as the meter displaying a warning of “critically low values”.

• Third-party test strips may not be compatible and may lead to incorrect results. Meter manufacturers are apt to change their meters and strips without relaying this information to third-party strip manufacturers. 5

• Strips improperly placed in the meter may lead to inaccurate results.


V. Lancets

• Sharing lancets can spread communicable diseases6.

• Lancets must be discarded as a biohazard in sharps-disposal containers.


VI. Information System Data Interface

• Erroneous downloads may lead to inappropriate error messages and memory problems.7


VII. Manufacturers’ Issues

• Systems approach incorporating the user/ patient into the equation. This is accomplished by actually observing true diabetic patients use a specific brand, specific model of device and eliciting their feedback and incorporating it into the design of the specific model.

• Operator’s manual must be written in layman’s terms in large enough print with short step-by step procedures, facilitated with clear diagrams and pictures of the buttons and displays. Cognitive aids are strongly recommended.

• Device operator/patient interface related problems. Refer to Jakob Nielsen’s “Ten Usability Heuristics.” papers/heuristic/heuristic_list.html

• Software to software interface issues. Data transfer should not corrupt identifiers and measured values. Follow industry standard protocols. Devices that are compatible (interface able) with the VA patient information (VistA) and computerized medical records system (CPRS) are highly recommend, assuring that patient identifiers and tests results are recorded efficiently without human error.


Recommendations to Mitigate the Identified Vulnerabilities
I. Matching Device to Patient

The decision to provide the glucometer and its accessories, to patients for self monitoring of glucose,
must be carefully evaluated, following Clinical Practice Recommendations (CPR), where the indications
and contraindications for use of the device are identified. Pharmacy Benefits Program (PBM) is in charge
of distributing BGMs.

Patients must be selected carefully, to assure that they are physically and mentally
capable to self monitor. If this is not possible, a partner will have to be assigned and trained.


II. Instructing Patients on Use

1. Care givers must provide initial instructions and demonstrations on how to:
a) Prepare the puncture site, and clean and dry it properly before the sample is collected, especially if alcohol is used.
b) Not squeeze the puncture site.
c) Assure adequate circulation at the proposed puncture site or sites.
d) Take special precautions to not drop portable, battery operated medical devices and to keep them away from bathrooms, kitchens and showers to prevent liquid intrusion.
e) Use the device correctly and accurately, retesting the glucose level if a result differs from how the patient feels and calling their healthcare professional if the problem persists.
f) Properly store the device and dispose of lancets, test strips, and other waste as a result of testing.
g) Replace batteries two times per year at time change.

2. Users must be informed of the implications for alternate site testing:
a) Results may differ significantly from fingertip testing, especially when blood glucose levels are rapidly changing. Rapid change typically occurs after a meal, insulin dose, or physical exercise.
b) Testing should follow the above activities by at least 2 hours.
c) Alternate site testing is NOT recommended if testing for hypoglycemia or the patient suffers from hyperglycemic unawareness.
d) Vigorous rubbing, until the test site feels warm, should precede lancing to better match results from the fingertip.

3. Care givers must conduct periodic reviews, with their patients, on how to use the device to assure
that the patients are using the devices properly.

4. Use of audio visual aids such as video tapes, CDs and
DVDs are good examples of cognitive aids that will augment the training.


III. Purchasing

1.Specifications for purchasing new glucometers should address these identified vulnerabilities. A good
medical device company will design their device and products following the “systems approach” and will
provide many resources to train the patient, and conduct usability testing to identify and mitigate human factors and device/user interface issues.

2. In addition to addressing the patient within the system, the company will also need to address the other components of the system such as the device, the strips, the lancets and control solutions.

3. Pre-purchase evaluation should be conducted by VA facilities that are planning to purchase the device. Standardization of the device and its accessories is highly recommended.

4. Devices that are compatible (interface able) with the VA patient information (VistA) and computerized medical records system (CPRS) are highly recommended to assure that patient identifiers and tests results are recorded efficiently without human error.

5. Audio/visual displays and prompts for the patient must be clear, concise and use layman’s terms, and not medical jargon.


Oxygen (Compressed Gas) Cylinder Hazard Summary


Scope of this Summary
This Summary addresses portable medical grade oxygen cylinders (also called tanks or bottles)
This Summary is a SUPPLEMENT; It DOES NOT replace existing guidelines and directives for proper handling, storage, and operation of medical oxygen (e.g., JCAHO guidance on storage of “E” cylinders)


Patient and occupational safety personnel (e.g., patient safety managers, industrial hygienists)
Respiratory technicians
Nurses and technicians who handle oxygen (especially in high use areas like OR & Urgent Care)
Physicians who direct the usage of oxygen and other gases (interventional radiologists)
Biomedical Engineers, physical plant personnel, and medical system maintenance personnel


Close calls and adverse events have occurred at VA facilities and private hospitals
Human factors engineering design problems have been identified by NCPS through RCAs and the SPOT data base
Case studies and “alerts” involving adverse events with oxygen cylinders have been issued from:
- Center for Devices and Radiology Health (CDRH) at FDA
- Compressed Gas Association (CGA)




Fire -Materials that are slow to ignite or that will not burn in air will ignite and burn in an oxygen rich environment. This environment is created by oxygen flowing during treatment and the inadvertent releases. 100% O2 saturates into surgical drapes, bed sheets, clothing, etc. Ignition sources could include electro-surgical instruments (e.g., ESU devices - Bovie or cautery pencil), defibrillators, cigarette lighter, matches, outdoor grills, or any other spark or heat-producing appliance. Recent fires have included a patient on O2 who’s hair and clothing started on fire while grilling (Hibachi) in his back yard; a patient in the OR who was burned when surgical drapes ignited due to oxygen and use of an ESU.

-Rapidly opening a valve on a compressed gas cylinder can cause particle impact ignition resulting in a fire (this is why aluminum regulators are not permitted – aluminum is a combustible metal).



Mix- ups - CO2 and O2: A grayish green cylinder was confused for a greenish gray cylinder that resulted in a patient inhaling CO2 during transport instead of oxygen. The use of universal adaptors (universal adaptors override the pin indexing system on the cylinder) contributed to this event. - CO2/O2 and CO2: Insufflation of the body cavity for arthroscopy is done with CO2 as the gas will not sustain combustion and is easily absorbed by the body. A gray and green CO2/O2 cylinder was confused with the gray CO2 cylinder that resulted in an internal body cavity fire when a surgical laser was used. The CO2/O2 gas will support combustion.


Oxygen not Available - It isn’t always apparent whether an oxygen cylinder is full, partially full, or empty. In cases where the cylinder valve is closed and the regulator valve is open (see photograph), no pressure will register on the pressure gauge. Staff in a hurry has assumed the cylinder is empty when in fact it is full. -In some cases the O2 cylinder is believed to be empty when trapped pressure in regulator is bled off by opening the flow meter/regulator valve when the cylinder valve is in the closed position. - You can’t always tell by just looking at the valve if it’s open or closed. Valves controlling the oxygen flow are not indicating type valves. What’s an indicating valve? See: A Brief History of Indicating Valves for Fire Protection, for further information on this topic.


Cylinder goes ballistic -Ferromagnetic O2 cylinders introduced into the MRI environment can inadvertently be turned into missiles when they are drawn into the magnet.For more information on projectile hazards in and around MRIs see:

-A second way a cylinder can be turned into a missile is to fracture the cylinder. Escaping gas will propel the cylinder with enough force to penetrate cinder block walls.


Case Studies (From FDA Manufacturer and User Facility Device Experience Database (MAUDE), ECRI, and VA databases)

- An “E” cylinder containing CO2 was mistaken for O2 and was used during patient transport - he died. The modified O2 regulator had been modified to fit “grayish” O2 cylinder that really contained CO2. This event emphasizes the point that cylinder color alone cannot be used to confirm the content of the cylinder.

- A gray “E” cylinder (usually indicating CO2) was used for insufflating a uterus for endoscopic laser surgery. Instead, it contained a 20% CO2 - 80% O2 mixture normally used by anesthesiologists to induce breathing. Use of the laser resulted in an internal fire. This event again emphasizes the point that cylinder color may not be used as the primary indicator for the type of gas the cylinder contains.

- Misunderstanding of the dangers of using O2 near ignition sources have resulted in minor fires and burns while: a) patient using a Hibachi grill on home O2 therapy; b) hospital team used a defibrillator during cardioversion; and c) operating room team used electrosurgery.

- Empty O2 cylinders have been inadvertently stored in code (crash) carts. During ACLS, the empty cylinder either contributed to difficulties in resuscitation, or caused undue commotion and diversion.


Root Causes/Contributing Factors and Suggested Action

- The most obvious cue for staff on the contents of a gas cylinder is the cylinder color, however, the color may be misleading or misunderstood. The cylinder label is the primary means of identifying the cylinder content. Follow directions and labels first – not color or other cues (e.g., storage location)… To be truly effective, CGA/ECRI recommends that the label be overwhelming in size

- If there is a mismatch between the color of the cylinder and the cylinder content, for example a gray cylinder that contains oxygen or a green cylinder that contains nitrogen, this is a guarantee that future problems will occur. For more information on color mismatch confusion and how humans cannot ignored conflicting inputs see the “Stroop Effect” exercises at Provide as many cues that a cylinder does not contain 100% O2 as possible for mixed and non-O2 gas cylinders (e.g., store separately, transport in “odd-shaped” wheel cart)

- Text labels on cylinder can be damaged or for some reason may be illegible;, if the label cannot be reliably read the cylinder should not be used.

- Cylinder tags (Full/In-use/Empty) are often misused and misunderstood and are a relic from systems used for compressed gases found in industry (welding torches, etc). Relying upon the pressure gauge reading is the most effective method of determining how much gas is left in the cylinder

- Improved cues are needed to signify to non-experts when cylinders are “empty” (like the empty cylinder warning light on your dashboard). For example, caution labels stating which valves need to be open.

- The regulator pressure gauge appears to be direct measure of gas available in the cylinder – however it can be isolated from the cylinder by closing the cylinder valve. If this occurs the gauge is only reading pressure trapped between the cylinder valve and the flow meter/regulator valve.

- Compressed gas pin indexing systems should not be overridden or defeated under any circumstances.




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I was In-Serviced in the following (please check yes or no)

Adverse Events involving medical devices

Design Considerations


Reporting Problems (results wrong)

Troubling Human Factors Problems (deficit acknowledgement)

Use & Look after all Devices Properly (following guidelines)

Medical Device Incident Report Form

Equipment Safety followed/checked

Device failure procedure (if any)

Equipment/Device storage problem/unsafe

Blood Blucose Monitors checked at least weekly

Oxygen Therapy - safety steps to follow