FDANews MDQC: Live

CDRH Signal Escalation Program

- no one person at CDRH responsible for TPLC
- signal escalation is for internal (CDRH) discussion
- signals can be escalated to working groups
- goals of SE is to coordinate information within the CDRH
- SE is not 1-1 match w CAPA and complaints
- identifying: off-label promotion, silent recall, etc
- developed w help from McKinsey consulting
- signal is unexpected risk to patient or user
- source of signals: MAUDE and MedSun, post-approval studies, complaints, patterns in product families, patterns of patterns – types of signals: model-specific, product-specific
- 10 signals associated w product recalls (20%)
- 2010 strategic priority: upgrade IT and move from pilot to practice, more engagement w industry – program is still under construction

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FDANews MDCQ: Live

Closing the Loop on CAPA
- important because (in aggregate) most FDA observations are CAPA- related
- reactive CAPA (CA) is more costly than preventve actions
-

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FDANews MDQC: Live

How to Handle Medical Device Recalls (BD presenter)
- BD now has corporate (global) procedure to assure recall procedure – responsibility: Biz units, Corporate, Regions
- don’t use “recall” in procedure – has different meaning in other countries – may mean “removal from market”
- Health Hazard Analysis includes: PMA, complaints, scientific info, MDRs, in-house data – custom definitions of: minor, moderate, serious injury risk – HHA follows FDA regs
- “Health Risk Index” definitions are “remote, rare, occasional, frequent, continuously” and ability to detect hazard – severity is a 1-5 scale – elevated index requires meeting of Field Action Committee
- “Field Action Committee” – does not include marketing or ops – BD estimates that they only capture 50-70% of total financial impact of recall
- process: product hold verification, draft strategy, create assignee list, create communication for customers – decide form of communication: letters, phone, personal visits – 3 attempts are considered sufficient for customer contact

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FDANews MDQC: Live

Managing Operations and FDA Audits

A New Day at FDA…

- FDA will take risk-based approach to audits
- Will speed enforcement and close-outs
- new program (PREDICT) – to target imports – more import enforcement – increases risk of overseas suppliers
- more resources and increased sampling
- Tim Ulatowski retiringClydes, Tower Oaks Lodge. 2 Preserve Parkway, Rockville MD. 20852 – 10 injunctions filed as of April – vs 15 in all of 2009
- courts are rejecting settlements if it doesn’t include a respinsible person – 700+ new inspectors – seasoned candidates vs raw recruits
- schedule regular internal audits and mock audits
- consider 3rd party independent audits
- key areas to focus on: CAPA!, validation, design control, purchasing control (supplier quality), training – more key areas: MDR: timeliness, supplemental reports, risk evaluations – be cautious of claim/change creep – 510k updates
- need to have effective listening systems: track and trend findings, CAPA, complaints, training or sales reps, service records, product analysis/lab analyses, journal articles, conferences – must trend and evaluate information from these sources
- GHTF (SG3) CAPA (proposed document) document is valuable guidance – document all CAPA activity – especially verification and validation – #1 483 observation is complaint handling
- supplier quality observations are expected to increase

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FDANews MDQC: Live

GHTF Supplier Control: Kimberly Trautman

- manufacturers cannot delegate resposibility for supplied products/services – recent emphasis by FDA is not lessening
- RX360 is focusing on shared supplier audit data in pharma – KT recommeds looking at their website
MM: I saw a presentation by this group earlier this year – the feeling among the med dev attendees is that this is not as relevant for devices – pharma supliers provide commodities – med dev suppliers provide custom components
- GHTF Supplier Control guidance is (relatively) new guidance on how to control outsourced processes – internal suppliers must be controlled (same as external suppliers) -
if your internal audits don’t cover “facility A”, then facility A must be treated as an internal supplier – cannot contractually relinquish or delegate responsibility – planning is critical – based on the risk presented by the supplier
- must consider biz risks – eg overseas suppliers. FDA only needs “appearance of nonconformance” to issue import detention
- low risk suppliers, fewer controls…higher risk suppliers, more control (assurance) – 2 sources of assurances: supplier control and acceptance criteria – supplier audits not “be all-end all” – only as good as scope and auditor
Question: FDA not supposed to go to suppliers – but FDA is inspecting some high-risk suppliers as part of PMA process – there is no policy shift at FDA that would precipitate FDA supplier audits
- if process validation is required, then the process validation records must be maintained if outsourced
- be careful about email communications to Asia – it is considered informal, ie not required to be acted on – gHTF guidance on capa – draft available very soon

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FDANews MDQC: Live

CDRH Update on Design Control: Kimberly Trautman

- FDA data: majority of citations is capa and production and process control – design control was 13% of citations – after CAPA, design controls is the most reviewed area
- incoming FDA inspectors are generally not confident w device inspections (especially design control) due to wide variety of devices
- internal audits were largest number of warning letters ( no procedure or not following) – process validation also large source of warning letters
- risk acceptability criteria is one basic area that inspectors are focusing on
- important to use risk mgmt data from design control in eg supplier control, capa, etc
- class 1 products w any level of automation (eg software) requires full design control
- more time spent in design, the more profitable and faster to market – demonstrated by ASQ etc – watch out for conflicting design inputs from eg marketing (from the field) – design output must be measurable for verification
- design output includes device, labeling and packaging
- risk acceptance criteria is key for FDA – do they exist? Are they met?

Questions:
- FDA will question “user needs” for home use devices
- harmonization of 13485 and QSR? FDA will start using 13485 data -
also ISO 9001 will undergo major revision and these will carry into 13485…13485 will be revised in 2017 or 2018.

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FDANews MDQC: Live

Understanding Risk Management – ISO 14971

what makes for good RM?
- policy: must have sr mgmt involvement, resources, processes outlined – planning is key: policy, product specs, training, part of development plan – personnel: don’t outsource! Involve key functions
- contributing systems: eg capa, field reports, etc
- risk-based incoming inspection: set inspection levels according component risk (eg labeling/translation are considered high risk by notified bodies) – use hazard analysis early
- fault tree analysis for product vs process are nearly identical – FMEA best developed after components have been identified
- can force exponential assessment by modulating risk scale: eg 1, 2, 3, 5 – increase detection in order to reduce residual risk

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Medical Device Quality Congress 2010: Live Blogging

Keynote: Dr Jonathan Sackner-Bernstein, Associate Director, CDRH

CDRH Outlook
- priority 1: TOtal product lifecycle approach
- priority 3: strengthen workforce

FDA mission includes: advance public health by speeding innovation – integrate premarket, postmarket, compliance info
- integrate new and evolving science in regulatory decision-making

New science task force
- systems that allow FDA to be “predictively adaptive”
- steps to get new science into CDRH decision making
- task force report draft under internal review
- open to public comment in august 10

Strengthen workforce
- CDRH creating a network of external experts to consult on new science (leveraging NIH, other govt orgs) – why? increased pace of change…evolutionary and revolutionary – areas of focus are largely biological – points to combo products…
- risk/benefit approach to product oversight: as complexity increases, much more oversight required
- risk acceptance affected by benefit of product? Presence of alternatives/severity of condition affect risk acceptance? Yes.

FDA priority: facilitate innovation and address unmet public health needs
- FDA will work w federal partners and external constituencies to ID unmet public health needs that could be addressed by med devices – and work to reduce barriers – FDA working to guide innovation by reducing regulatory barriers
- example is current work in diabetes treatment – eg artificial pancreas (infusion pump + monitor) – closed loop system

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Another Crimson First: ISO 14971 Recertification

Other medical translation suppliers enjoy “tooting their horn” about awards that their blogs have won. Of course, there’s nothing wrong with putting substantial time and effort into a well-written/researched blog – clients always appreciate relevant information.

However, at Crimson, we feel that our most substantial energy is best put into quality and risk management systems and processes for producing higher quality at a lower cost. While we have been known to toot our own horn, it’s typically around process achievements – like now.

We are very proud to announce that Crimson has achieved a translation industry first: formal recertification to ISO 14971. Although some translation suppliers claim to possess an ISO 14971 compliant risk management system – it’s not the same as a registered, third-party certified system. Under the guidance of Dr. Harvey Rudolph and UL, Crimson registered the first ISO 14971-certified risk management system. Now, two years later, Crimson has successfully developed and re-registered its risk management system. This is a valuable asset to manufacturers – especially those who are transitioning to the third edition of IEC 60601 – because risk management is due to become a more important consideration, especially for safety-related items like labeling.

Toot, toot.