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COVER STORY


ASCs have to be very cautious and attuned to how they intend to use a device. ASCs should confirm their use of the device complies with the device’s approved use.”


—Pamela Anderson, Vizient


to follow those instructions and ensure on-site education is provided to all who will use or handle the device.” Unlike indications for use, instruc- tions for use can change without the need for an application


for a


new 510(k) clearance, Harmer says. “Instructions for use are updated as needed to provide better comprehen- sion or make the instructions more comprehensive in the way the direc- tions are given. Device users some- times ask companies to provide new 510(k) information when instructions change, but new clearance is not usu- ally necessary in these cases.” One other important area Harmer


says ASCs should be mindful of con- cerns terminology. “It is not unusual to hear people say that FDA approves products. That is not necessarily correct. For 510(k), FDA clears products. They are only approved through a PMA.”


Be Proactive ASCs can take a few steps to look into companies from which they purchase devices, Goldman says. The first is requesting and verifying the device’s FDA 510(k) clearance number through the FDA’s online database. “Next, search the FDA warning let-


ter’s database (www.fda.gov/ICECI/ EnforcementActions/WarningLetters/ default.htm),” he says. “If this does not produce any results, ask the com- pany if it has recently been inspected by the FDA. If it has, request that the company send you either a 483 form or establishment inspection report (EIR).” A 483 report is issued after an inspection when an investigator has observed conditions that they judge may constitute violations of the FD&C and related acts. An EIR details any findings during the inspection.


10 ASC FOCUS NOVEMBER/DECEMBER 2017|www.ascfocus.org


“If the company will not share this information, that may be a red flag,” Goldman says. “The FDA issues warn- ing letters after an inspection where a 483 report is issued first. The FDA will give the manufacturer some time to address the GMP violations found during the inspection and documented in the 483 report.” If ASCs learn a device is sold in the European Union (EU), this may provide them with some comfort, he says. Com- panies must ensure their quality system complies with the ISO 13485 standard (www.iso.org/standard/59752.html) for their devices to receive the Conformité Européenn (CE) mark required to sell devices in the EU. “ISO 13485 requirements are simi- lar to the FDA’s GMPs,” Goldman says. “While certification to ISO 13485 is no guarantee that the manufacturer is doing everything correctly, the quality system must be inspected and recertified every year for conformance to the standard by an independent third party called a ‘notified body.’ This is not the case with the FDA and conformance to GMPs.” Finally, he notes that medical device consulting companies may perform “due diligence audits” on behalf of purchasing agents like ASCs. “These audits can often show if the device company is in compliance with GMPs.” ASCs must have confidence in the


device purchases they make, Harmer says. “A trust factor comes into play when a vendor you perceive to be legitimate comes to you with its new- est device on the market. There are certain assumptions you can usually make, with the biggest ones being that the FDA cleared the device and the vendor is sharing that they are being honest, ethical and forthright with the information provided to you. “If you have even an ounce of doubt, take it upon yourself to do as much research as is necessary to determine that the device you are pur- chasing will not cause harm to your patients,” she emphasizes.


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