Don’t Tell Me You Care about Quality, Show Me You Care
G. Wayne Moore, B.Sc., MBA, FASE
July 12, 2016
Assuring the quality of a test device measurement used to assess the functionality of a medical imaging device is crucial. In order to achieve the finest objective measurement and then using that result in making the correct performance evaluation, calibration of test equipment as recommended by the manufacturer of the test device is essential. Calibration of test equipment establishes both metrological traceability for the measurement results and is required by ISO 9001 Clause 7.6, as well as the FDA Quality System Regulations (QSR) – Section 820.72 (Inspection, measuring, and test equipment.) As an HTM professional it is important for you to know that any 3rd party repair service you use to diagnose, troubleshoot, repair, and post-repair validate the effectiveness of their repair use appropriate and calibrated test equipment. It is easy enough to speak with the 3rd party repair entity and ask for current copies of the calibration certificates for test equipment they will be using to evaluate the device you are sending in for repair, and the test equipment used to validate the effectiveness of the repair. Seems easy enough, but unfortunately and all too often it doesn’t happen. With renewed regulatory emphasis being shone on the 3rd party repair market the HTM sending medical devices out for repair needs to become a great deal more familiar with the repair entities quality management system and their compliance to it. If you are using a company that is not ISO certified you must ask yourself the question “why am I using them, and how do I ensure they are doing the right things?”
As an ISO17025:2007 accredited testing and calibration laboratory focused on diagnostic ultrasound devices and active implantable devices we too often become involved in situations where we see a test report from a FirstCall probe tester that was out of calibration at the time of the test. Most recently we saw one where the calibration date was FIVE years overdue! As we were the inventors of FirstCall we established a calibration requirement of every 12 months to assure the user that the measurements being taken and that were being used to judge the performance of the probe both pre and post repair, were the finest objective measurements possible. We told the customer of this 3rd party that the values produced by a device 5 years past its calibration date could not be trusted. It also made us wonder about other test devices this particular third party repair company was using, voltmeters, oscilloscopes, calipers, etc. – were they all out of calibrations as well? This type of behavior is exactly what is causing the FDA to wonder about the 3rd party repair market – and was the partial genesis of the recent Docket.
The International Vocabulary of Metrology (VIM 2.39) defines the term calibration as an “operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.” To have a calibrated piece of test equipment assures that the general measurement uncertainties have been identified and the range of those uncertainties reported. These uncertainties become non-deterministic when the device is outside of its calibration date, rendering the resulting measurements as unreliable. There is no legitimate excuse for using test equipment that is out of calibration, it shows laziness and lack of concern. Below are the ISO and FDA references.
ISO 9001 Requirement
“The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see Clause 4.2.4 – Control of Records);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected.
Records of the results of calibration and verification shall be maintained (see Clause 4.2.4).
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.”
FDA Section 820.72
(a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.
(b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented.
(1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
Although the FDA language currently speaks to manufacturers, there is no credible argument that the same requirements should not also apply to any entity repairing medical devices – it is common sense. I am confident that change is coming to the 3rd party repair market and that it will be good change resulting in higher quality and consistent repairs across the board. More next month.
About the Author, G. Wayne Moore:
A 30-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Wayne has been directly involved in the development and commercialization of more than 15 technologically intensive ultrasound systems. He is widely published in diagnostic ultrasound literature, a sought after speaker at medical imaging conferences, has served as an expert witness in multiple ultrasound litigations, and holds more than 16 United States ultrasound related patents. Wayne obtained his MBA from the University of Denver – Daniels College of Business.
He was elected as a Fellow of the American Society of Echocardiography (FASE) in 2009.