October 2, 2014

FDA VCIP Program: Too Much Stick, Not Enough Carrot?

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s a growing trend in these United States: paying extra for convenience such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine for-pay express lanes.

Where I live in the Washington, D.C. area, the new express road program in Northern Virginia’s clotted traffic arteries appears to be a hit. For a buck or two, you get out of the more crowded free lanes. And you are allowed to go 65 miles an hour, while the peasants are held to 55 mph!

On the other hand, the express lane program at Reagan National Airport doesn’t appear to be generating much traffic.

If the FDA’s new VCIP (Voluntary Compliance Improvement Program) is trying to ride the “pay for convenience” bandwagon, early anecdotal evidence suggests they’re resembling airports more than highways. We’re hearing many in industry say the VCIP program doesn’t offer enough of an incentive to take on the extra work.

Undaunted, FDA released earlier this week a document that reads like a nice, bureaucrat gently trying to convince industry to give the program a try.

The joint pilot project housed in the Center for Devices and Radiological health (CDRH) and Office of Regulatory Affairs (ORA) “differs from the FDA’s traditional oversight model by allowing firms to voluntarily self identify and correct possible regulatory violations instead of undergoing FDA inspection.”

Regulated entities have to apply to participate, but those with violations that raise “imminent” public health concerns needn’t bother.

Here’s the FDA’s big carrot: “The FDA supports using new approaches to help companies come into compliance. These approaches benefit industry and may decrease the number of inspections that the FDA performs or permit the agency to focus on manufacturers with serious and ongoing problems.”

Pacemaker150Hmm. I guess I’m not super surprised that initial industry enthusiasm appears weak. To my knowledge, FDA has not released any statistics about participation. I’m basing my very early days’ assessment on discussions with medical device firms and consultants at recent trade shows and the like. I could be wrong, and VCIP might turn out to be a big hit.

If you want to get picked, know that FDA will identify manufacturers eligible to participate in VCIP through its 2014 inspection work plan and offer them an opportunity to apply rather. For the pilot, the FDA will choose three to five applicants. Of course, their feedback, whether official or in trade show hallway conversations, will tell us a lot about the merits of VCIP.

While it promises some benefits down the road, initial participation in VCIP sounds like it will just add another layer to a device manufacturer’s compliance program. VCIP participants will be required to retain an outside expert consultant to assess their manufacturing and quality assurance systems and to monitor and certify that they are following program requirements. Firms must also demonstrate the ability to define problems, analyze root causes, create appropriate corrective actions, and verify that the actions taken were effective.

If a firm does not meet its commitments under the VCIP, or if the FDA and the firm disagree about any of the results, then the firm may be removed from the program and undergo FDA inspection, which could lead to regulatory action. If a manufacturer ends its participation in the VCIP, it would be subject to FDA inspection and any resulting regulatory action.

FDA gets to the potentially big benefits toward the end of the new VCIP document. If you are selected and pass the tests, your firm “will not be subject to routine surveillance inspection while program participation is underway.” The exemption will be good for two years after a manufacturer successfully completes the program. FDA says it will also expedite review of export certificate requests and prioritize device and pre-amendment determination requests from program participants.

Clearly it’s too early to judge whether VCIP will be a success. And FDA is to be applauded, I think, for trying something a bit new.

Still, here’s hoping VCIP becomes the equivalent of sailing down the relatively empty highway at 65 mph, while others are slogging through heavy traffic at lower speeds.

 

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FDA Looks Overseas, Doesn’t Like What it Sees

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Thanks to the folks in Washington, most anything having to do with the federal government is closed until further notice. That means fixtures like the Grand Canyon and the Library of Congress (LOC) are off-limits.

The FDA is feeling the pinch too. It’s had to send about half of its staff home, according to RAPS. FDA’s website won’t be updated, either.

The lion’s share of the pre-shutdown device-related warning letters involved overseas entities. A good example comes in a September 5, 2013 letter to Vincent Medical Manufacturing Company, based in Dong Guan City, China.

FDA kicked the tires at this manufacturer of breathing circuits and sterile fluid management injection systems, and didn’t like some of what it saw. For example, Vincent’s Corrective and Prevention Action (CAPA) failed to establish and maintain a number of procedures.  Vincent was also charged with failing to ensure that inspection and test procedures could be validated with a “high degree of assurance.”

FDA also chided Vincent for “failure to establish and maintain procedures to ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed.”

FDAlogoFDA sent an August 26 letter to Bio Focus Co., based in Uiwang, Republic of South Korea.  FDA hit that firm for an inadequate CAPA program, process validation, device design validation, management of suppliers and other outside vendors, and environmental controls, among several other issues. Bio Focus manufactures Sure-Aid pregnancy tests.

In Taiwan, FDA challenged St. Shine Optical, manufacturer of contact lenses, for several shortcomings. Shortcomings cited in the August 26 warning letter include: inadequate validation reports, design control procedures, and process controls.

Earlier in August, FDA issued a warning letter to Denmark-based Dako Denmark, manufacturer of the HER2 CISH pharmaDx kit. In the August 21 letter, FDA noted that the firm closed six CAPA’s, but failed to provide any evidence that the CAPA’s were effective.  FDA also hit the firm for inadequate process validation protocol, and complaint processing.

FDA returned to the U.S. with a September 20 letter to Medical Device Resource Corporation. The Livermore, California-based maker of the LS2 Aspirator, and the K Pump was issued a warning letter because it’s process validation, outside products, and other product controls were found lacking.

Elsewhere in California, Medtronic MiniMed was hit with, among others issues, inadequate CAPA, device control, and complaint management. That came in a September 19 warning letter.

While medical device makers may not be overly worried about a hobbled FDA, let’s all agree that it would be nice someday to be allowed to visit the Grand Canyon and the LOC again. Those are both bi-partisan places, right?

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Former FDA Inspector’s Crystal Ball: Cloudy With a Chance of Inspected Meatballs

Patrick Stone

Patrick Stone, President, TradeStoneQA

The FDA’s “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by congress. More than half of the operating funds will be earmarked for food work. International food inspections will surely be a focus area for the coming year. The inspection goals/FTEs will be set low enough for the field staff to meet or exceed expectations. This again will ensure a steady flow of billions for operating costs. In recent years large chunks of the FDA budget were set for new facilities completion and the dreaded infrastructure technology (IT) upgrades which barely seem to keep up with private industry.

Opioid labeling rules newly penned will assist in identifying and tracking legal drugs, however Internet and backstreet sales will continue to plague the market. Insurance fraud is making it easier for mail-order diversion and out right second hand sales of the legally obtained opioids. So until the insurance scams are tapered this effort will only increase operating cost for the opioid manufacturers.

A medical device tax and new user fees will be required for doing business in our domestic market. It seems that every few years the fee structure increases and becomes more complex. Maybe this is part of the reason our health care cost are always going up exponentially. What will they think of next to add to the user fee list?

compounding pharmacyThe agency has issued product specific sterile drug consent decrees and lengthy 483s for cGMP violations across the nation. There are a few sterile drug manufacturers that judging by the 483 wording will be handed consent decrees very soon. These firms are major market shareholders that have had ample time for remediation without compliance. The recalls from these same firms have been persistent all year.

The great 2013 compounding pharmacy blitz and new regulations request for these manufacturers was not so much as shock and even less awe. The faster FDA defines what compounding drug manufacturing is and provides lengthy guidance on how it should not be done in a compounding pharmacy setting, the faster we will see market self-compliance. Compounding pharmacies must recognize themselves as manufacturing entities and adhere to strict USP <797> and 21 CFR 200 standards that are costly.

Compounding pharmacies are the first line of defense when it comes to the drug shortage so they must operate in strict compliance with sterile the drug cGMP systems approach. More patients will have adverse events and possibly die from non-compliant/contaminated compounded sterile drug preparations if the mindset of the manufacturers is not changed. The State board of Pharmacy cannot shield compounders from civil or criminal liability and the FDA may soon have what it needs for implementing jurisdictional authority.

Here’s to an exciting 2014!

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

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Unique Device Identifier (UDI) Rule Now a Reality for Manufacturers

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

On Friday morning, September 20, 2013, at the UDI User Conference in Baltimore, MD, Jay Crowley, FDA’s Senior Advisor for patient safety, CDRH, raised a glass to toast the completion of a decade long journey. He, his staff and members from the Medical Device industry and solution providers celebrated the announcement of the publishing of the Final Rule for the establishment of the Unique Device Identification system. The final rule will be officially published Sept 24, 2013 on the U.S. Federal Register.

That date is an important one as it establishes the start date for the timeline for all medical devices to be coded with a Unique Device Identifier (“UDI”), which is to be printed in plain text and barcode (or other AIDC technology) on the device’s label. Manufacturers of Class III medical devices will have one year to comply with the rule. Class II and Class I devices which are used as implants and/or are life supporting/sustaining in nature have 2 years to comply. All other Class II devices must comply within 3 years of the publish date and all Class I and unclassified medical devices must comply within 5 years of the published date, per the Final Rule.

A number of changes were made from the original proposed rule, but one proposed requirement which was hotly debated by industry was the proposed required date format. The original date format on labeling was proposed to be the US-centric “MMM DD, YYYY” format.  However, with the final rule, the requirement has been changed to the more global-friendly (and ISO compliant): YYYY-MM-DD

UDI barcodeFurthermore, this rule institutes a new FDA Global Unique Identification database (or “GUDID”, pronounced “Good ID”), into which all manufacturers (or “labelers” as defined in the rule) must populate their unique Device Identification numbers. This database will also require providing FDA required attribute information. Once populated, the GUDID database will be used by healthcare providers and the public to search for and gain information about the device.

The initial goal of this rule is to be able to better identify devices in the healthcare area, to help healthcare providers identify items in cases of adverse effects/recalls, as well as to better understand and manage their inventory.

AssurX will be working with current and future customers to use our solution to help them comply with their UDI management and eventual submission to FDA’s GUDID database.

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FDA Wants Your Patient Preference Input for Medical Device Regulatory Processes

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

After a surprisingly busy summer, the FDA is leaping into September with a two-day meeting where you can be the star — or on the defensive.

Mark your calendar for Sept. 18-19 at FDA headquarters in Rockville, MD for “The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes.”

FDA’s goal is to open a dialogue on the best ways to incorporate patient preferences on the benefit-risk tradeoffs of medical devices into the full spectrum of the Center for Devices and Radiological Health (CDRH) regulatory decision making.

It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers. The agency intends to use information gleaned from the workshop and subsequent public comments to help regulators, industry, providers, patients, and device innovators to get on the same page.

FDAlogoMeantime, FDA’s busy summer included a slew of new warning letters. In Taiwan, Soleetech Corporation, a manufacturer airway (extension) connectors, flat out told the FDA it didn’t have, and didn’t plan to develop, any kind of Corrective and Preventative Action (CAPA).

I understand that different nations have different cultural quirks, but telling the FDA you aren’t much interested in CAPA is a universally bad idea.

August was indeed a busy warning letter month. As of August 22, more than dozen had already been issued. And with the month not over, and a lag time in posting some letters, August is shaping up to be a big enforcement month.

Nearly half of August’s warning letters zeroed in on Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) alleged shortcomings. Typical of this trend was an August 8 letter to Healing Dives Inc.

So, as we all drive back from the beach, it’s time to examine FDA’s next moves. Look for an upcoming post from fellow blogger and former FDA inspector Patrick Stone with his wish list for what he views as the FDA’s most burning issues in September and beyond.

 

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FDA Warning Letters Emphasize CAPA, Design Issues

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA focused its regulatory laser beam on the Midwest and overseas in the latest wave of medical device warning letters.

Enraf-Nonius B.V., a device maker based in the Netherlands but doing business in the U.S., was hit in several areas, including:

Failure establish and maintain device controls in relation to acceptable validation during a clinical trial, failure to set up procedures to determine whether device changes require validation or verification, and failure to document post-production design changes.

As is so often the case in FDA warning letters, CAPA again reared its head. In the July 5 letter, the device maker was charged with several alleged CAPA shortcomings. These include failure to establish a process that makes certain corrective actions are noted and take steps to prevent the issue from happening again, and failure to address illegible, missing and/or incorrect component codes.

Back here at home, Pennsylvania-based firm Lenfest Media Group was advised in a July 1 letter that its product claims lack FDA clearance or approval. Lenfest markets its WaxVec that it claims “gently draws dirt particles and moisture out of your ear quickly and safely.

warning640In Ohio, x-ray systems-manufacturer Meridian Medical Systems was hit with CAPA violations, and alleged design history violations, including:

  • A design plan for the project
  • Established or approved design inputs/outputs for the system
  • Verification or validation testing for the system
  • Design transfer
  • Risk management for the system
  • Design reviews

The firm was also warned for allegedly not having a handle on its suppliers, an issue that the FDA appears to be focusing on more and more. It could be, in part, because more and more domestic firms and outsourcing device manufacturing work overseas.

Completing our latest round-up, we travel to Turkey, where FDA issued a June 27 warning letter to Aygun Cerrahi Aletler A.S. Surgical Instruments Co., with charges of CAPA shortcomings and several other issues, including failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, and failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

 

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Jeff Mazik joins AssurX as Vice President, Life Science Solutions

 

Jeff Mazik, Vice President, Life Science Solutions

Jeff Mazik, Vice President, Life Science Solutions

AssurX is pleased to announce the appointment of Jeff Mazik as Vice President, Life Science Solutions. Prior to joining AssurX, Jeff served as IT Head, Manufacturing & Engineering Systems for Alcon (a Division of Novartis). Jeff worked at Alcon for 15 years, and was responsible for the global rollout and support of many varied global software systems in the areas of Quality Management, Engineering, Manufacturing, Corporate, and Safety/Security/Environmental Affairs.

During his tenure at Alcon, Jeff helped implement and/or oversee the global use of many varied software solutions, including the rollout and use of over 60 CATSWeb processes, the implementation of physical access security systems to all plants, a global corrective and preventative maintenance solution, an eMSDS solution, global ERP initiatives, Business Intelligence solutions, as well as corporate projects such as CCTV systems, and the Point of Sale solutions for the company’s cafeteria and company store.

Furthermore, from 2008 to 2012 Jeff served as one of Alcon’s 9-person core team in the start-up of the Alcon Singapore Manufacturing plant. He was intimately involved in the initiation, planning, design, development, construction, commissioning and startup of Alcon’s first Asian-based aseptic pharmaceutical drop-tainer filling plant in the Republic of Singapore. As such, he oversaw the implementation and validation of multiple applications and was responsible for the design and implementation of the entire IT infrastructure for this new pharmaceutical manufacturing plant, including plans for cable tray trunking, network drops, communication room design, and audio/video conferencing technology. As the IT Manager for this new plant, he was also responsible for determining the policies and procedures for the operation of the new IT department: including processes required to meet FDA, HSA, and other regulatory guidelines for pharmaceutical and medical device companies.

Prior to his career at Alcon, Jeff consulted for a Division of IBM (ShowCase Corporation), implementing Business Intelligence and Data Warehousing tools to healthcare providers. Prior to IBM, Jeff was the Director of Implementations for McKesson Provider Technologies (previously Enterprise Systems, Inc.) implementing software solutions for Materials Management, Operating Room Scheduling, and Finance in Hospitals across the United States.

In 2003, Jeff won AssurX’s Customer of the Year, and has seen CATSWeb used in many varied ways to meet regulatory and business needs. He is excited to be able to help all of AssurX’s Life Science customers better realize the value of CATSWeb to meet their business demands in this constantly changing and evolving industry.

 

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You’ve Got eMDR Questions; FDA Has (Some) Answers

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

In a new 47-page guidance the FDA appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex Medical Device Reporting (MDR) requirements. Topics range from the big picture (who is subject to this rule) down to specifics (how many times must a manufacturer call a user facility for information before it can close the file).

In a perfect world, the FDA would pick an intelligent, telegenic representative and provide this information in a live Q&A format with follow-up questions from the audience. Until that day, we’ve got to rely on the new guidance, published July 9, 2013.

MDR is FDA’s mechanism to work with medical device companies to identify and monitor adverse events, with an eye to detecting and correcting problems as quickly as possible.

Medical device makers are required to report when one of its devices may have or could contribute to a death or serious injury. Device makers have between five and 30 days to report, depending on the severity of the potential adverse event.

eMDR, Electronic Medical Device Reporting

The Electronic Medical Device Reporting Process (Source: AssurX, Inc.)

We won’t try to summarize the entire document here. Instead, we’ll highlight some of the more interesting FDA “answers” to its questions.

  • How should you handle a voluntary report when you don’t know the source of it? FDA says to first evaluate the complaint to see if it is a reportable event. Base that determination on in-house information, and consider contacting a user facility, importer or other initial reporter related to the alleged event. “Your decision about whether or not the event is an MDR reportable event should be based on the findings of your evaluation,” the agency says.
  • What is a ‘remedial action,’ and are those reportable to FDA and included as part of the more urgent 5-day report? The short answer is yes. FDA wants medical device manufacturers to attack problems with a wide lens. “FDA does not consider an action taken to correct only a single device involved in an MDR reportable vent to be a remedial action.” In other words, don’t forget CAPA and root cause analysis.
  • What does FDA require for developing, maintaining, and implementing written MDR procedures? FDA says medical device manufacturers must include internal systems that provide for: timely and effective identification, communication, and evaluation of events; a standardized review process or procedure; and timely transmission of complete reports to the FDA.
  • What information contained in an MDR report is subject to public disclosure. The bad news: All of it. The good news: FDA, before releasing a MDR report subject to a Freedom of Information Act request, will delete information covering trade secrets, personal medical information, and names and other identifying information of a third party that voluntarily submits a report, e.g., physicians and other health care professionals.

Comments are due in early October. Submit them to www.regulations.gov. Include the docket number (1828) with comments. Short URL for the draft guidance document: https://federalregister.gov/a/2013-16395

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FDA Turns Regulatory Flashlight on Compounding Pharmacies

Patrick Stone

Patrick Stone, President, TradeStoneQA

The latest round of 483 notices of observation forms are out and most of the headlines are all about sterile compounding pharmacies in compliance hot water.  The FDA is now specifically targeting sterile compounding pharmacies for compliance and surveillance inspections. The individual State Pharmacy Boards are less likely to shield local firms in the wake of New England Compounding Center. (NECC). FDA has expanded its unhindered self-appointed access to sterile compounding pharmacies. It does not appear that FDA is limiting its inspections to large hospital system operations. The agency also appears to be targeting smaller regional firms, too.

With well over a hundred pharmaceuticals on the shortage list , sterile compounding pharmacies are more critical then ever. The normal size sterile bags are turned into numerous admixtures for many different drugs, which in turn helps alleviate the shortage. For instance, when treating children you have to turn an adult sized sterile drug into a child size dosage for administration; one big bag turns into three small ones. Otherwise only a portion of the large bag would be used on one patient and then discarded. Some of the drugs on the shortage list can’t be manufactured by a compounding pharmacy, but these operations may be able to stretch out some critically short drugs until more supplies may be manufactured.

The citations issued by FDA have very similar tone and compliance issues.

compounding pharmacyFor example, this Texas firm’s 483 from March 2013 is a laundry list of remediations. I don’t mean to single out this firm, because many other firms have similar citations. But this 483 shows that the main agency concerns include preventing microbial, pyrogen, and viral contaminations (maintaining aseptic environment). Operational configuration (enough hoods for amount of admixtures), employee aseptic technique (media fills), and product stability programs were all noted as deficient. Validations were also lacking for environmental monitoring and decontamination procedures. These are all basic cGMP requirements most pharma manufacturing companies spend much of their resources on. Sterile compounding pharmacies operate close to USP 797 standard but fall way short of FDA cGMP requirements for sterile drug manufacturing.  The above listed 483 Web page is from this FDA weblink:

Ready or not the sterile drug compounding pharmacies will now get a crash course in drug manufacturing 101. FDA will continue to conduct surprise audits on medium and large sterile drug compounders and inspect them as they would a cGMP manufacturer. Why would FDA investigators treat a compounding pharmacy like a manufacturer? FDA does not currently have a sterile compounding pharmacy training course; instead, they have a sterile drug manufacturing training course. It is that simple and until there is a distinction or separate training class offered, we will see more of the same. FDA inspectors are trained to use the USP 797 guide but they still inspect the firm using the 7356.002 Compliance Program Guidance Manual (CPGM) for drug manufacturers.

Will this push to regulate sterile compounding pharmacies make the drug shortage better or worse? Will compounding sterile operators invest in the capitol it takes to make a validated aseptic facility with anterooms and appropriate gowning procedures?

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Expert: Cool Down on Hot CAPA

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s no secret that FDA inspectors hone in on a medical device company’s Corrective and Preventive Action Program (CAPA) during an inspection.

But a leading certified body says many companies may have overreacted and made things unnecessarily difficult for themselves.

“Audits we’ve researched show the FDA has found CAPA deficiencies” at a company, says John DiMaria, Product Market Manager at BSI Group America Inc.

Irony: DiMaria says it’s usually not a a problem of a company doing too little.  “They take a ‘better safe than sorry’  approach” where they label almost any anomaly a problem that triggers their CAPA machinery. In other words, they are doing too much.   “They launch into a ten-step procedure that requires management sign-off” and a whole lot of other time-consuming activities.

Irony #2: By labeling too many small problems as potentially big CAPA issues, medical device companies often overwhelm themselves and “struggle” to give enough attention to the “preventive” part of CAPA. Medical device companies try to deal with so many “CAPAs” that they end up being sloppy with some, e.g., not closing the loop on an investigation.  It’s not company chicanery; it’s honest overload. But try telling that to an FDA inspector.

Image converted using ifftoanyFull disclosure: We may have helped contribute to that overreaction with our numerous blogs emphasizing FDA’s fixation on CAPA. Warning letter stats clearly show an FDA focus on CAPA.  However, DiMaria delivers a helpful reminder: Don’t throw a full-blown CAPA investigation at a minor, one-off mistake.

Instead, he advises medical device companies to have a strong investigative process up front. “If something small happens, say human error, you should have the data in place to show it doesn’t warrant a corrective action,” DiMaria notes.

“Understand the magnitude of the problem,” DiMaria adds.  “Sometimes it’s not a system problem at all.

Think of it as eating right and getting enough exercise, rather than calling a surgeon every time you’ve got a minor ache.

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