Quality in the Medical Device Industry

Quality is defined as the “measure of excellence or a state of being free from defects, deficiencies and significant variations,” (WebFinance Inc.). In today’s competitive industries, manufacturers need to keep a multifaceted approach with their products to be profitable – not only do the products need to be manufactured quickly, but they need to be high quality. Especially in the medical industry, it is no longer acceptable just to produce the cheapest, fastest product possible. Manufacturers are expected to reduce costs across the board while maintaining high quality standards – consumers want it all. This can leave upper management in a difficult position where they are pressured by stakeholders to choose between these two goals. It’s a delicate balance that must be maintained.

The FDA considers any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes”

as a medical device (FDA). This is a very broad definition that covers a huge array of products and services. While some devices are less critical, others (such as surgical tools) can mean the difference between life and death for patients if they have manufacturing defects. Aspects such as sterilization are heavily regulated and monitored to ensure the products can be used safely in medical procedures. The FDA states that a quality-centered approach helps manufacturers reduce costs and increase profits while also bolstering confidence among hospitals, payers, health care providers, and patients that the devices they rely on will perform as intended (FDA). Manufacturers who fail to monitor the quality of these high impact devices can be subject to anything from heavy fines, payments to users, and even imprisonment for those guilty of compromising product quality.

In March of 2010, a huge scandal broke out that has since started a large restructuring of regulations and quality standards worldwide. Poly Implant Prothèse (PIP) was a French manufacturer of silicone breast implants. Starting in 2001, several higher-level company executives were involved in a decision to start using industrial grade silicone in their implants rather than medical grade silicone. This change in the grade of silicone used in their implants was not approved by French authorities and proper testing confirming safety hadn’t been performed. The cheaper and weaker-grade silicone was found to have a significantly higher risk of rupturing, and causing inflammation and pain. Other risks still need to be explored further (WHO). As of the most recent report released by ANSM, the regulatory agency in France, over five thousand women reported having adverse reactions to the lower grade silicone (ANSM). The company has since closed, the founder of PIP, Jean-Claude Mas, was given a four-year prison sentence and four other executives also received prison sentences (BBC News).

In current news are the DePuy Pinnacle hip implant trials. In December of last year, Johnson & Johnson was ordered to pay over $1 billion (this amount may be reduced over the course of the trial) to plaintiffs who claimed that the Pinnacle hip implant was defective. The jury found that the metal-on-metal joint was badly designed, that there was an error in the measuring processes used. The six plaintiffs suffered a variety of ailments because of the improper design, including metallosis (a condition where debris, from the wearing down of the metal joint, can enter the bloodstream and cause many serious conditions), tissue death, bone erosion, and others (Fortune). There are over eight thousand plaintiffs awaiting results from these continuing trials, alleging further harm, as well as claiming that Johnson & Johnson/DePuy “failed to adequately research the design or warn about the large number of implants that were failing within a few years and requiring revision surgery,” (Kirk).

The potential for painful and/or life threatening problems with medical devices is significant. Companies who fast track their designs, who take short cuts to save money, and who don’t have a proper quality management system in place are playing with fire – sometimes literally, in the case of battery fires. Quality must be the top priority of any medical device manufacturer. An important step in maintaining quality is certifying to quality management standards through a reputable certification body.

TUV USA, as part of the TÜV Nord Group, is an industry leader in providing value-added certification. As one of the few certification bodies to be chosen to pilot the new MDSAP program, we are excited to be a part of bringing this powerful new quality management standard to the market. For more information regarding TUV USA and the medical device standards we offer, please go here. For more information regarding other quality management certifications we offer, like ISO 9001 and SQF, please visit the TUV USA homepage.