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0.005% and the FDA Service Docket

G. Wayne Moore

Colgate Picture

Data mining in a flawed tunnel and then announcing a conclusion based on flawed data is not a compelling way to make a point. During the recent FDA Docket workshop on 3rd Party Repair the attendees, of which I was one, were treated to an amazingly dubious finding based on the search of a database where the information they were looking for could not reasonably be expected to contain. Nonetheless the number that was presented soon managed to take on the central focus of the workshop. That number was 0.005%. Instantly 0.005% was standing alongside the pantheons of numbers such as π, and Avogadros number as an indisputable value that explained the gravitational constant of the medical device service universe. Every panel presentation by independent service organizations (ISO) referenced this number as proof positive that the FDA should leave ISOs alone; nothing to see here, time to move on. This number, 0.005%, became, in a sense, the ISO holy grail. Only one problem; this number is bogus, and even if it were in some manner partially accurate it was being applied in a wholly unscientific way – and frankly was irrelevant to the topic being discussed. The FDA Maude Database upon which 0.005% hangs its metaphorical hat, was never intended to be a reliable source for fettering out specific service events, or even capturing events that did not rise to the level of “death or a serious injury” as explained in the following quote from the FDA: “Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.” – italics added for emphasis. Additionally, the FDA does not list or even mention 3rd party services providers as entities that are mandated to report MDR events: “Device user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Device user facilities must submit reports when they become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury of a patient in their facility. Death reports must be sent to the FDA and the manufacturer, if known. Serious injury reports must be sent to the manufacturer or to the FDA, if the manufacturer is not known.” Drawing conclusions from researching a database with the foregoing caveats seems very risky at best and certainly misleading. Colgate once used an interpretation of a survey of dentists conducted many years ago to conclude their famous tag line was an appropriate application of the research results. What the actual survey question said was; “would you recommend using toothpaste on the tooth brush, or just brushing alone?” Indeed, more than 80% of the dentist recommended using tooth paste, but they did not cite a preference for Colgate.

Accreditation and ISO Certification ≠ Regulation:

Other non-OEM panelists insisted they were already being regulated by, for example, the CMS (Center for Medicare and Medicaid Services) and TJC (The Joint Commission). Of course, neither the CMS or the TJC are directly involved with auditing or monitoring the activities of 3rd party service providers; when is the last time you heard of a CMS auditor going to a 3rd party service provider facility for a site audit of their quality management system? Accreditation does not equal regulation and it is an unwise co-mingling of terms that may lead the uninformed to conclude that they are already in compliance with the Quality Systems Regulations (QSR). While I strongly recommend 3rd party services obtain ISO certification to the appropriate standard, and which cover the scope of their services, ISO certification also does not equal regulation; ISO is voluntary, adherence to the QSR is mandatory. Certainly as part of the healthcare facility supplier selection process ISO certification as described above should be the very first question being asked of the 3rd party service provider.


Although a lot of various topics were brought up during the workshop I maintain the core question remains; “Is it in the best interest of patient safety for only half of the providers of medical device service to be regulated (OEMs), while the other half is not (3rd Party providers)?” The reluctance shown by the panelist representing 3rd parties to submit to FDA oversight was not reassuring. Additionally, the focus on patient safety, while critically important, did not allow time for discussing the other main facet of a proper functioning medical device; specifically – is it effective for its intended use? An MRI is at its safest when it is turned off, it is safe obviously, but not very effective. The flawed study of the Maude data base is a case in point – this data base does not capture the frequency of occurrence of sub-optimally performing devices, and the reasons for their lack of performance. The lack of this information skews the results to conclude there is no problem with service. I look forward to the next steps by the FDA in reconciling the bifurcation that has occurred in the service market with only ½ of the providers being regulated.


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.

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November 8, 2016 Newsletter