Computer Support Services-MEDICAL DEVICE PROSEC：计算机支持服务的医疗设备高发.pptVIP

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Computer Support Services-MEDICAL DEVICE PROSEC：计算机支持服务的医疗设备高发.ppt

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Computer Support Services-MEDICAL DEVICE PROSEC：计算机支持服务的医疗设备高发

Doing it Right Pressures from: Competitors on pricing, quality Customers on service, delivery, pricing QC on following the processes Regulatory affairs on following the rules Government programs reducing reimbursement rates What happens: Cutting of corners Sloppiness, rushing can become criminal Growing culture of acceptance United States v. Caputo 517 F.3d 935 (7th Cir. 2008) Co. sought approval for small autoclave device Submitted only “tests that favored the device’s effectiveness” FDA approved only for use with solid stainless steel instruments: those with plastic, solder, brass “outside the scope of the FDA’s approval” Because of price -- $100,000 – and restriction – only solid stainless steel instruments – device had “no prospect in the market.” Defendant’s solution: “immediately began promoting” larger machine for all instruments Caputo continued “[L]ong before receiving the FDA’s approval” to sell the small machine, “it knew that the small device would never be marketed” and that it would promote the large machine “for use with many kinds of instruments.” “Problems ensued” when customers used the machine to sterilize brass instruments, leaving “a blue green residue” that was “harmful to patients’ eyes”. Caputo continued After the FDA sent a warning letter and rejected a request for expedited approval, again warning against marketing without approval, “AbTox went on promoting the large [machine] as before.” “FDA inspected AbTox’s facilities and discovered it was still selling [large machine]. The inspectors told Abtox to desist; it didn’t.” Caputo continued “Promoting the large Plazlyte as suitable for use with all medical instruments is a major change in intended use, compared with using it for solid stainless steel instruments alone.” “So, the large Plazlyte, with its expanded “intended use” was not covered by the FDA’s approval of the small Plazlyte and could not lawfully be sold at all.” Caputo continued “Until [told to stop], Caputo and Riley were at l