MvPI – Reportable adverse events

The MvPI reportable adverse events include but are not limited to:

1. A malfunction or deterioration in the characteristics or performance of the medical device
2. An incorrect or out-of-specification test result
3. The discovery of a design flaw during design review
4. An inaccuracy in labeling, instructions for use and/or promotional materials.Inaccuracies include omissions and deficiencies. Omissions do not include the absenceof information that should generally be known by the intended users
5. The discovery of a serious public health threat. This may include an event that is of significant and unexpected nature and is a potential public health hazard, e.g. Human Immunodeficiency Virus (HIV) or Creutzfeldt-Jacob Disease (CJD).
6. Increase in user error or application error with the medical device
7. Any other information (Recall or field corrective notice) made available by medical device regulators in other countries for the same product
8. Information available by way of literature, scientific documentation, or increase in complaint trend

Reporting under medical device vigilance systems is not usually required :

1. When deficiency of a medical device found by the user prior to its use:
   • Regardless of the existence of provisions in the instructions for use provided by the manufacturer, deficiencies of devices that are always detected (that could not go undetected) by the healthcare professional or end user, prior to its use do not need to be reported under the vigilance system.
   • This is without prejudice to the fact that the user should inform the manufacture of any deficiency identified prior to the use of a medical device.

Examples :-

• The packaging of a sterile single use device is labeled with the caution ‘do not use if the packaging is opened or damaged’. Prior to use, obvious damage to the packaging was observed, and the device was not used.
• Intravenous administration set tip protector has fallen off the set during distribution resulting in a non-sterile fluid pathway. The intravenous administration set was not used.
• A vaginal speculum has multiple fractures. Upon activating the handle, the device fell apart. The device was not used.
• A patient is admitted to hospital with hypoglycemia based on an incorrect insulin dosage following a blood glucose result. The investigation found that the test strip was used beyond the expiry date specified by the manufacturer

2. When an inbuilt protection mechanism in medical device functioned correctly:

Events which did not lead to serious deterioration in state of health or death, because a design feature protected against a fault becoming a hazard (in accordance with relevant standards or documented design inputs), do not need to be reported. As a precondition, there must be no danger for the patient to justify not reporting. If an alarm system is used, the concept of this system should be generally acknowledged for that type of product.

Examples :-

• An infusion pump stops, due to a malfunction, but gives an appropriate alarm (e.g. in compliance with relevant standards) and there was no injury to the patient.
• Microprocessor-controlled radiant warmers malfunction and provide an audible appropriate alarm. (e.g., in compliance with relevant standards) and there was no deterioration in state of health of the patient.
• During radiation treatment, the automatic exposure control is engaged. Treatment stops. Although patient receives less than optimal dose, patient is not exposed to excess radiation.
• A laboratory analyzer stops during analysis due to a malfunction of the sample pipetting module, but the appropriate error message was provided for the healthcare professional or end user. An intervention by the user or an immediate remote intervention by the manufacturer allowed the analyzer to resume the analysis, resulting in correct results.

3. In case of an expected and foreseeable side effect associated with medical device:

Cases which meet all the following criteria:

• clearly identified in the manufactures labeling;
• clinically well known (scientifically/clinically/ technically identified or declared during clinical trial or clinical practices) as being foreseeable and having a certain qualitative (Condition that lead to side effect cannot be numerically predicted) and quantitative predictability when the device is used and performs as intended;
• documented in the device master record, with an appropriate risk assessment, prior to the occurrence of the event, and
• Clinically acceptable in terms of the individual patient benefit are ordinarily not reportable
• If the MDMC or Manufacturer detects a change in the risk-benefit-ratio (e.g. an increase of frequency and/or severity) based on reports of expected and foreseeable side effects that led or might lead to death or serious deterioration of state of health, this must be considered as deterioration in the characteristics of the performance of the device. A trend report must be submitted to the NCC (IPC) where the manufacturer or its representative has his registered place of business.

Examples :-

• A patient who is known to suffer from claustrophobia experiences severe anxiety in the confined space of a MRI machine which subsequently led to the patient being injured. Potential for claustrophobia is known and documented in the device product information.
• A patient receives a second-degree burn during the use in an emergency of an external defibrillator. Risk assessment documents that such a burn has been accepted in view of potential patient benefit and is warned in the instructions for use. The frequency of burns is occurring within range specified in the device master record.
• A patient has an undesirable tissue reaction (e.g. nickel allergy) previously known and documented in the device product information.
• Patient who has a mechanical heart valve developed endocarditic ten years after implantation and then died. Risk assessment documents that endocarditic at this stage is clinically acceptable in view of patient benefit and the instructions for use warn of this potential side effect.
• Placement of central line catheter results in anxiety reaction and shortness of breath. Both reactions are known and labeled side effects.

4. In case of negligible likelihood of occurrence of death or serious deterioration of health due to event:

If an event resulting in death or serious deterioration in state of health has happened, the event is reportable and a reassessment of the risk is necessary. If reassessment determines that the risk remains negligibly small compared to previous events of the same type, then there is no need to be reported retrospectively. Decisions not to report subsequent failures of the same type must be documented. Changes in the trend, usually an increase, of these non-serious outcomes must be reported.

Where the risk of a death or serious deterioration in state of health has been quantified and found to be negligibly small need not be reported if no death or serious deterioration in state of health occurred and the risk has been characterized and documented as acceptable within a full risk assessment.

Example :-

• Manufacturer of a pacemaker released on the market identified a software bug and quantified the probability of occurrence of a serious deterioration in state of health with a particular setting to be negligible. No patients experienced adverse health effects