Medical device sales reps a law unto themselves?

WHY are medical technology sales representatives apparently exempt from providing proof of competency to the hospitals they access in the course of their work in the United Kingdom?

The employee’s knowledge and competencies in respect of the clinical environment they enter are not set, measured and validated by an independent agency.

This would appear to be an abdication of the National Health Service responsibility to its staff and patients, and it is at odds with the procedures and practices of other government bodies.

The National Health Service in the UK has in this last three years been rocked by increasingly worrying revelations and scandals.

  • There are almost daily reports of gagging orders on staff to prevent the reporting of patient neglect or incidents of medical negligence.
  • The minister of health has said that standards within the NHS are not acceptable.
  • Newspapers carry front-page headlines proclaiming that four out of 10 hospitals are unsafe. The Jimmy Savile debacle points to a lack of regulation in respect of non-clinical personnel having access to hospitals and clinical environments.

So who is running the show and, more importantly, who is responsible and accountable?

MatronYears ago, the likes of Sir Lancelot Spratt was responsible for the clinicians, and a formidable Matron was responsible for the non-clinical staff and oversaw everything else in the hospital from food to bed pans.

Sir Lancelot and the Matron are gone and have been replaced by an army of fresh-faced management graduates who now run the hospital.

However, and in spite of the efforts of this army of usually non-clinically trained managers, standards continue to fall.

Doctors, nurses and medical staff who are required to have a therapeutic contact with patients are trained to clearly defined national standards and are governed by colleges and associations who set competencies and maintain standards.

All clinical staff have to demonstrate by examination set by an independent body that they have achieved the required standard. In most cases they are required to maintain and update their skill set by acquiring continuing medical education (CME) points awarded after further training.

Technical and maintenance staff who are directly employed by the hospital are vetted by the hospital as part of their employer’s liability.

Laboratory and scientific staff will have proven qualifications from a university or other independent awarding body.

Directly employed maintenance staff, such as plumbers and electricians, have to show and maintain current Joint Industry Board (JIB) or Gas Safe registration to be employed.

Then there are the people who enter the hospital as part of their work who are not employed by the hospital.

In the case of building and technical maintenance workers, their presence is granted by short-term contracts – one for the company and one for the individual employee.

However, there is a group of people who access the hospital for work who appear to be exempt from providing proof of competency.

These are the sales representatives who work for medical technology companies.

They are the people who sell implants and technology to clinicians and provide technical support for the use of their products.

They may be required to be present in a clinical setting while patient-therapeutic or surgical procedures are being performed.

Furthermore , they may be asked to answer questions and solve problems arising during the patient use of their products.

The companies employing these representatives will say that their employees are adequately trained and have the knowledge and skills necessary to support the use of their products.

That may be true, and all responsible companies will ensure that their staff are trained and understand the technical aspects and indications for use of their products in a clinical setting.

That may suffice for their products. However, people entering a clinical environment must also understand all of the responsibilities expected of them by the hospital and the patient, or patients, undergoing treatment.

Where the company’s assurances fall down is that the employee’s knowledge and competencies in respect of the clinical environment are not set, measured and validated by an independent agency.

So self-regulation is no regulation.

There are a number of examples for which training content and methodology is validated and training outcomes are measured by an independent agency. Learning to drive is a good example.

To be registered as an Approved Driving Instructor (ADI) and to teach people to drive, it is necessary to complete a training course and pass an examination set by the Driving Standards Agency (DSA).

United Kingdom law requires driving instructors to be qualified before they can charge for their services. The licence to drive a car is issued by another government agency – the Driver and Vehicle Licensing Agency (DVLA) – upon successful completion of a theory and practical driving test.

In this case, the person providing the training cannot set the required standard to be achieved to pass the test, nor can they issue a licence to drive. 

The setting of standards and the assessment of outcomes of training by independent agencies protects trainers from accusations of inadequate standards and bias and guarantees that those trained are fit for purpose.

There are medical technology company trade associations who use third parties to register employees as having achieved the requisite standard to enter a clinical environment.

The question arising is: who sets the standard and how is it measured?

There is legislation which specifies the competencies and legal requirements for hospital access. It is therefore not within the gift of trade associations or any other agency with a commercial interest in accessing hospitals to set, measure and administer standards.

The safety of the patient, the company employees and the clinical staff is the responsibility of the hospital. It is they who should set the standards.

The medical device company’s responsibility is to achieve the standard and have it independently validated.

Within the last five years, credentialing companies have been set up to provide hospitals with a quick way of checking the criminal record status and competency of people seeking access to clinical areas.

This may give a false sense of security, as the hospital staff rely on the credentialing company’s validation. So, unless the credentialing companies examine those they register, which they do not, whose and what validation are they relying on?

Like the driving test, there must be a national standard for hospital access and a requirement that any training meets the standard and that the outcome is validated by an independent agency.

The criteria and requirements for hospital access cannot be at the discretion of individual hospitals or of medical companies or associations.

Failure to implement a standard is an abdication of the NHS responsibility to its staff and patients and is at odds with the procedures and practices of other government bodies.

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