Hill Country Memorial Health System
Originating Department: Biomed
TITLE: SAFE MEDICAL DEVICES
AFFECTED DEPARTMENTS: ALL
APPROVED: EOC/Patient Safety Committee
EFFECTED DATE: 09/03/96
REVISED DATE: 10/24/01
View/Print the Recall Response Form.
In order to promote the safety of Hill Country Memorial Hospital's patients, visitors and staff and comply with Safe Medical Device Act of 1990.
Appropriate corrective action will be taken to protect the safety of all patients, visitors and staff of Hill Country Memorial Hospital whenever information on a product related hazard or potential hazard is brought to the attention of this facility.
It is the policy of Hill Country Memorial Hospital to ensure that only Food and Drug Administration (FDA) approved pharmaceuticals and health devices, certified manufactured equipment and qualified hospital prepared products will be used throughout the facility and that the products and devices recalled by the manufacturer or the FDA are removed when found to be in use within this facility.
EXCEPTION: the Ethics Committee that serves as the Institutional Review Board will review any investigational pharmaceuticals and treatments.
The Safe Medical Device Act of 1990 requires that device user facilities (including hospitals, outpatient diagnostic and treatment facilities, nursing homes and ambulatory surgical facilities) report incidents to the device manufacturer when the facility determines a device has or may have caused or contributed to the death or serious injury of a patient. The facility must also send a copy of the report to the FDA in the case of a death.
Serious illness or injury as defined by the Act is an illness or injury that is life threatening or that either results in permanent impairment of a bodily function or permanent damage to a bodily structure or necessitates immediate medical or surgical intervention to preclude permanent impairment of a bodily function or permanent damage to a bodily structure.
The FDA defines a medical device as any instrument, apparatus or other article that is used to prevent, diagnose, mitigate or treat a disease or to affect the structure or function of the body, with the exception of drugs. A medical device includes but is not limited to ventilators, monitors, dialyzers, and any other electronic equipment, implants, thermometers, patient restraints, syringes, catheters, in vitro diagnostic test kits and reagents, disposables, components, parts, accessories and related software.
In accordance with Safe Medical Device Act of 1990, Hill Country Memorial Hospital will establish methods for reporting these events. Hill Country Memorial Hospital shall notify the FDA and the manufacturer (if known) within 10 working days of becoming aware of all incidents that reasonably suggest there is a probability that a medical device has caused or contributed to the death of a patient. In cases involving medical devices where patients are injured or become seriously ill, a report must be filed within 10 working days to the manufacturer or the FDA if the manufacturer is unknown.
For any device failure that has had an adverse outcome, the following procedure will be followed:
Complete an incident form.
To ensure proper follow-up and investigation of the incident, the medical personnel who report the adverse medical incident shall inform the Director of Quality Management of the following information:
Room and bed number
Name of attending physician notified
Type of adverse event
Relevant laboratory/test data and patient history
Initial reporter of the event
Location of product
Equipment identification number
Serial number of product
Name of manufacturer, if known
User facility/distributor name, address and contact
Event problem codes for device and patient
Brief description of incident
Where and when report was sent
Retain all packaging materials and disposable supplies.
Investigation of incident shall be conducted to determine if a device failed or if there was a user error.
A Root Cause Analysis shall be conducted according to the Root Cause Analysis Procedure in this manual.
Device failure investigation shall be carried out as appropriate before repair work is conducted. Investigation may include the following:
Team approach (Risk Management, Third Party Manufacturer, Biomedical Engineering, and Affected Department).
Third Party Investigation (May be recommended by facility insurance carrier).
All written communication submitted to the FDA or manufacturer shall be reviewed by the Director of Quality Management prior to submittal to determine the appropriateness and that the submitted communication meets the requirements of the Safe Medical Device Act of 1990.
Any additional communications with the manufacturer or vendor shall be carefully and completely documented. Written acknowledgments will be requested for all verbal responses given by the manufacturer.
Copies of all written communications will be forwarded to the Director of Quality Management.
Implantable devices which are suspected to be defective and are subsequently removed from the patient shall be forwarded to the Clinical Laboratory for cataloguing and safe storage.
The Department Manager shall contact the Clinical Laboratory for proper storage and labeling of the suspected defective device. The Clinical Laboratory will store the contaminated device and notify the Quality Management Director of its catalog identification for review and evaluation as above. These products or devices are NOT to be discarded nor are they to be released to the manufacturer or his\her representative.
MEDICAL DEVICE TRACKING:
The Safe Medical Device Act of 1990 requires manufacturers and distributors of permanently implantable, life sustaining and life supporting devices used outside a user facility to adopt a method for tracking devices. Manufacturers have been required to provide a system to track certain medical implants and devices. Hospitals are required to comply with the provisions of the tracking rule and are now required to assist manufacturers by providing the manufacturer with information to implement their programs.
The following three categories require tracking by law:
Life support and life sustaining devices used outside of a device user facility (such as infusion pumps or ventilators used in home care)
Permanently implantable devices (i.e., heart valves, pacemakers)
Any other devices specifically designated by the FDA (such as silicon implants)
List of Devices Tracked by the FDA (as of August 29, 1993)
Permanently Implantable Devices:
Vascular graft prostheses less than six millimeters in diameter
Vascular graft prostheses six millimeters or greater in diameter
Ventricular bypass (assist) devices
Implantable pacemaker pulse generators
Cardiovascular permanent pacemaker electrodes
Replacement heart valves
Automatic implantable cardioverters/defibrillators
Implanted cerebellar stimulators
Implanted diaphragmatic/phrenic nerve stimulators
Implantable infusion pumps
Total temporomandibular joint prostheses
Glenoid fossa prostheses
Mandibular condyle prostheses
Interarticular disk prostheses (interpositional implants)
Life Sustaining or Life Supporting Devices Used Outside Device User Facilities:
Breathing frequency monitors (apnea monitors), including ventilatory efforts monitors Continuous ventilators
DC-defibrillators and paddles
Silicone inflatable breast implants
Silicone gel-filled breast implants
Silicone gel-filled testicular prostheses
Silicone gel-filled chin prostheses
Silicone gel-filled Angelchik reflux valves
Inflatable penile implants
Note:The FDA requires tracking of electromechanical infusion pumps only when they are used outside of the facility.
FDA AND MANUFACTURER HAZARD ALERT AND PRODUCT RECALLS:
Recalls are responded to and actions documented in accordance with the Recall Procedure in this manual.
User facilities and manufacturers are required by the Safe Medical Device Act to establish and maintain records related to reportable events. These records must be easily identified, facilitate timely access and must include the following:
Information regarding the event or where the information is located. This information shall include all documentation of the reporting decisions and decision making process.
Copies of all completed Medical Device Reporting Forms and all information submitted to the FDA, distributors and/or manufacturers regarding the event.
Facilities shall keep records related to an event for two (2) years. Authorized FDA personnel may have access to all required records at all reasonable times to copy and verify the records.
Facilities shall submit to the FDA a semiannual summary of all reports sent to manufacturers and FDA in the applicable six (6) month reporting period. The six-month reporting periods are January 1 and July 1.
The following information is to be submitted on the semiannual report to the FDA (Form FDA 3419):
HCFA provider number or FDA assigned reporting number
Reporting year, reporting period and report date
Complete name and address of user facility
Name, title and address of the contact person
Lowest and highest report numbers of the reports submitted to the FDA and/or manufacturer during the reporting period
A summary of basic information about each reported event or a copy of FDA Form 3500A that was submitted for each event
Safe Medical Device Act of 1990
REASON FOR REVISION:
10/29/01 - To incorporate Root Cause Analysis language into the procedure, reference the Recall Procedure and correct typographical errors